Ongoing Review of National Liver Review Board (NLRB) Diagnoses At a glance Current policy When a liver transplant program believes that a candidate’s calculated model for end-stage liver disease (MELD) or pediatric end-stage liver disease (PELD) score does not accurately reflect their medical urgency for transplant, they can submit a request for a MELD or PELD exception score. The National Liver Review Board (NLRB) reviews requests from transplant programs for these exception scores. The NLRB uses policy and guidance documents to decide whether to approve or deny exception score requests. Since implementation in 2019, the OPTN Liver and Intestinal Organ Transplantation Committee has regularly evaluated the NLRB to identify opportunities for improvement. Supporting media Presentation View presentation Proposed changes Update Hepatocellular Carcinoma (HCC) policy to align with the terminology used by the American College of Radiology. Simplify guidance for candidates who had HCC that was treated and subsequently recurs. Update guidance for candidates meeting criteria for Ischemic Cholangiopathy (IC) so they will get a score equal to median MELD at transplant (MMaT). Update polycystic liver disease (PLD) guidance by clarifying list of qualifying comorbidities and recommending all candidates meeting criteria be considered for a score equal to MMaT. Anticipated impact What it's expected to do Provide NLRB members with updated guidance to use when reviewing MELD exception requests for specific candidates Ensure the transplant community is using consistent terminology for HCC exceptions What it won't do Will not impact how liver candidates are prioritized on a match run Terms to know Guidance Documents: Documents that provide more information to transplant programs and NLRB members to use when making decisions on exception requests Model for End-Stage Liver Disease (MELD): The scoring system used in allocation of livers to candidates who are at least 12 years old Pediatric End-Stage Liver Disease (PELD): The scoring system used in allocation of livers to candidates who are under 12 years old National Liver Review Board (NLRB): A review board of members drawn from a nationwide pool of liver transplant physicians and surgeons, who review exception requests from transplant programs for candidates whose automatically calculated model for end-stage liver disease (MELD) score or pediatric end-stage liver disease (PELD) score does not accurately reflect the candidate’s medical urgency for transplant. Standardized exception: A exception with criteria outlined in policy that is automatically approved when submitted and is not reviewed by the NLRB Hepatocellular Carcinoma (HCC): The most common type of primary liver cancer Ischemic Cholangiopathy (IC): Extensive damage to the bile ducts due to impaired blood supply Polycystic liver disease (PLD): The growth of more than 10 cysts in the liver Click here to search the OPTN glossary Comments Greg McKenna | 03/24/2022 I support the proposed changes to the MLRB diagnoses. In particular I strongly support the proposal recognizing the need for patients with DCD ischemic cholangiopathy to receive a MELD score that is set higher, such as MMaT. We need a “safety net” for those patients who are willing to assume the increased risks of graft failure associated with DCD livers, which is 7-10% higher than those risks for standard transplants. As this would be the only MELD exception that applies specifically to retransplants (with the exception of HAT patients who receive an even higher 40 points) it is imperative that these patients receive a score that is higher, to facilitate an organ with a quality that is suitable for a retransplant. Without a higher score, these patients will be disadvantaged compared to all other MELD exceptions which only apply to primary transplants. The majority of transplant centers in the country perform less than 2 DCD transplants per year (and only 20 programs perform double digits of DCD), The hope is that with this safety net for their patients, more programs will be willing to consider using DCD allografts. It is in the interest of the system for more centers to pursue DCD livers and thereby expand the donor pool and reduce the supply-demand burden. Anything that serves to increase the utilization of DCD donors will serve to benefit the recipients of all transplant centers in the country, by more appropriately improving the utilization of DBD livers as well. Given the 831 DCD transplants performed in 2020, at a DCD IC rate of 7%, this would translate to only about 1 exception per UNOS region every 2-3 months — a small number. So the burden of the proposal is not large, but could reap immense benefits to the system, while being most fair to the patients who assumed the increased risk. UC San Diego Health Center for Transplantation | 03/23/2022 CASD generally supports the concepts proposed in the proposal for ongoing review of the NLRB Diagnoses and approve of the HCC and PCLD modifications. CASD is not however, in agreement with the proposed modifications to the Ischemic Cholangiopathy (IC) Guidance. We have concerns that the criteria as proposed is too liberal and that there should be some demonstration of attempts to modify and/or treat (ERCP and stenting and/or medication adjustment) before eligibility for exception points. Further assigning an exception score equal to MMaT for a re-transplant candidate, effectively prioritizing these candidates over those who have not yet received a transplant regardless of their indication, does not seem justifiable as a means to increase DCD organ utilization particularly in light of the data reviewed demonstrating no significant difference in waitlist mortality rate between candidates re-listed after receiving a DCD transplant as opposed to a non-DCD transplant. We would urge the Committee to advance this proposal without this addition. Anonymous | 03/23/2022 Strongly support. MMaT-3 for IC removes a barrier to use of DCD livers, which are vastly underutilized as is apparent across regions. Anonymous | 03/23/2022 Strongly support giving patients with DCD cholangiopathy higher priority with MMaT, this removes competition from patients with other exceptions such as HCC and allows patients who already had a complication from getting a DCD organ access to better quality organs Anonymous | 03/23/2022 We should get exception points for patients with ischemic cholangiopathy set at MMaT to facilitate getting a suitable liver. this should be above all the other exceptions at MMaT-3. Apurva Modi | 03/23/2022 Post transplant patients who develop ischemic cholangiopathy should be allowed to be re-listed at Median MELD at transplant thanks Anonymous | 03/23/2022 Strongly consider setting exception points for ischemic cholangiopathy at MMaT to facilitate getting a suitable liver for retransplant Anonymous | 03/23/2022 We need to get exception points for ischemic cholangiopathy set at MMaT to facilitate getting a suitable liver for retransplant (above all the other exceptions at MMaT-3 ) Region 6 | 03/23/2022 1 strongly support, 9 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose American Society of Transplantation | 03/22/2022 The American Society of Transplantation is supportive of the proposal as written. These proposed policies are all straightforward modifications to streamline the NLRB process, clarify issues, and introduce appropriate changes to diagnoses eligible for exception points. We also support adopting the use of LI-RADS terminology. Attachment Anonymous | 03/22/2022 With the rising number of DCD organ donors, unfortunately we are seeing more cases of Ischemic Cholangiopathy in liver transplantation. There should be a mMAT exception for these circumstances. Thank you. Anonymous | 03/22/2022 Having a safety net for liver transplant recipients who need a retransplant for ischemic cholangiopathy is essential to encourage the utilization of DCD donors. I strongly support mMAT exception points for IC. Region 2 | 03/22/2022 3 strongly support, 15 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose - This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. A member noted that maintaining an ongoing review approach of the NLRB will give the transplant community a refreshed look with some degree of frequency at this national review methodology and its effectiveness. Region 11 | 03/21/2022 Sentiment: 3 strongly support, 7 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: No additional comments. NATCO | 03/21/2022 NATCO supports the proposed changes to the guidance provided when reviewing exception requests by the NLRB. We support the updates to align terminology used by the American College of Radiology and the proposal to simplify guidance for candidates with HCC. Similarly we support the proposal to update criteria for Ischemic Cholangiopathy and updates to the guidance for polycystic liver disease. Region 7 | 03/21/2022 Sentiment: 1 strongly support, 11 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member voiced their strong support for the proposal and noted that currently patients with rare liver diseases are not treated equally across programs. Hopefully this initiative will clear up those issues so that patients can expect similar treatment at different programs. Common language will help drive a clear understanding, across programs, of how to provide the correct treatment at the right time given differing projected rates of decline. Region 1 | 03/18/2022 Sentiment: 5 Strongly Support; 6 Support; 2 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No additional comments. Region 9 | 03/17/2022 Sentiment: 3 strongly support, 6 support, 3 neutral/abstain, 0 oppose, 0 strongly oppose. No comments. American Society of Transplant Surgeons | 03/17/2022 The American Society of Transplant Surgeons (ASTS) supports this policy proposal as written and provides the following responses to the OPTN Liver & Intestinal Organ Transplantation Committee’s request for feedback: 1) Changes to HCC guidance: Specifically, are there candidates who would be able to bypass the six-month waiting period that shouldn’t be able to? Or are there candidates who should be able to bypass the six-month waiting period but are not able to? No. The policy is well-conceived, and evidence based. ASTS does not advocate for additional candidates to bypass the waiting period and believes candidate classifications that would be able to bypass the six-month waiting period are appropriate as well. We also do not recommend changes to the proposed HCC guidance language. 2) Changes to IC guidance and PLD guidance: The proposed IC and PLD guidance are appropriate and we do not recommend changes to this proposed policy. Transplant Coordinators Committee | 03/16/2022 The Transplant Coordinators Committee thanks the Liver Transplantation Committee for the opportunity to provide feedback on their proposal Ongoing Review of National Liver Review Board (NLRB) Diagnoses. The Committee supports the proposal, and has the following comments: ischemic cholangiopathy should have a higher score than any hepatocellular carcinoma diagnosis due to the low prevalence but high severity of ischemic cholangiopathy; the proposal addresses current confusing language within NLRB exceptions very well; the Committee supports the elimination of the six month waiting period for an HCC patient as it could incentivize programs to use local and regional therapies available; finally, the proposed changes will hopefully increase the rate of DCD liver acceptances, as the rate of waitlist mortality for liver patients is too high. Region 3 | 03/02/2022 • Sentiment: 3 strongly support, 13 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose Region 8 | 02/23/2022 3 strongly support, 11 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose - Region 8 supported this proposal. A member commented that her institution appreciates that the selectivity of exception decisions is nationally applied. Region 4 | 02/18/2022 4 strongly support, 18 support, 4 neutral/abstain, 0 oppose, 0 strongly oppose Region 5 | 02/16/2022 6 Strongly Support, 22 Support, 5 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose - A member suggested to exclude ischemic cholangiopathy modifications. Another member noted that he is generally support the proposal and approves the HCC and PCLD modifications but does not agree with the modifications to the Ischemic Cholangiopathy (IC) Guidance Region 10 | 02/16/2022 4 Strongly Support, 9 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose Reena Jha | 02/14/2022 LI-RADS categorization of findings seen on liver imaging allows clear multidisciplinary discussion in the care of patients at risk for HCC. We have being using LI-RADS since it’s early iteration and it has become standard at all tumor boards and in daily clinical practice. After implementation, both radiologist, clinicians, interventional radiologists as well as ancillary staff have become very comfortable using LI-RADS and converting to OPTN for pre-liver transplant patients. Robert Marks | 02/10/2022 As the AASLD harmonized with the ACR in adopting LI-RADS as the diagnostic imaging system for HCC, it is important for further standardization of the terminology for HCC diagnosis, especially in respect to the transplant community. Thus I fully support the NLRB proposal to update the policy language to align with LI-RADS terminology and classifications. Matthew McInnes | 02/08/2022 Adopting LI-RADS terminology is key for optimizing diagnosis and allowing clear communication. These have become the standard international nomenclature for liver imaging. Elizabeth Hecht | 02/08/2022 Communication is key. Standardizing terminology across specialties and societies such as AASLD and OPTN/UNOS is critical for advancing patient care. I strongly support the proposed update to Hepatocellular Carcinoma (HCC) policy to better align with the American College of Radiology terminology. Hero Hussain | 02/07/2022 It is a about time to unify OPTN/UNOS standards and terminologies for liver transplant allocation in patients with HCC with AASLD guidelines and LI-RADS terminologies. Having one system makes more sense and is easier for all. This move will help further refine and update existing OPTN/UNOS guidelines using up-to-date literature. Mustafa Bashir | 02/04/2022 Adopting LI-RADS terminology makes a lot of sense. These have become the common nomenclature for liver imaging and are standardized and well-accepted. Kathryn Fowler | 02/04/2022 Wonderful to see LI-RADS and OPTN align better. We routinely use LI-RADS in practice and it will be great to not have to translate between systems. Future versions should consider adding treatment response standardized language. Alexandra Roudenko | 02/04/2022 LI-RADS is a well vetted system, currently used across many sites all over the nation and helps standardize terminology across all stakeholders. It does not compete with OPTN allocation and only serves to improve the transplant coordination process across sites with everyone speaking the same language when it comes to patients with HCC. There is extensive research on LIRADS and with recent concordance achieved with AASLD, this would be a great opportunity to unify our terminology when discussing HCC to improve patient care, avoid confusion, and optimally allocate the supply of organs available. Donald Mitchell | 02/04/2022 LI-RADS is a multidisciplinary international consensus standardizing methods and terminology for diagnosing liver lesions in patients at increased risk for primary malignancy. It does not compete with or attempt to replace any OPTN/UNOS standards for transplant allocation. Rather, it facilitates ongoing optimization of the allocation process by assuring that the clearest language and best diagnostic methodology are available for this purpose.