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System notice

HCC automatic approval criteria updated

Audience

Liver Transplant Programs: Directors, Surgeons, Physicians, Administrators, Data Coordinators and Clinical Coordinators

Please share this notice with anyone in your organization who would benefit from this information.

Implementation

December 12, 2017

Background

In December 2016, the OPTN/UNOS Board of Directors approved updates to criteria for automatic approval of exceptions for liver transplant candidates with hepatocellular carcinoma (see Policy Notice).  The new criteria are intended to establish a more consistent national policy regarding HCC patients, increase equity in access to transplants and improve waitlisted patient and transplanted recipient outcomes through modifications to the current standardized HCC exception process. View frequently asked questions and answers about the changes.

Changes

The updated policy has four primary changes:

Adult HCC candidates are now subject to a new schedule of automatic score assignment.  The schedule is included with the training in UNOS Connect (see “Training available” below).

Candidates with lesions meeting T2 criteria, but with an AFP greater than 1000, are not initially eligible for a standardized MELD exception. Candidates who have an AFP below 500 after local-regional therapy will be eligible for a standardized MELD exception. Candidates with an AFP level greater than or equal to 500 at any time following local-regional therapy will be referred to the review board.

New criteria establish eligibility for certain candidates whose tumor(s) can be downstaged.  Candidates meeting the criteria will be eligible for automatic priority after they’ve had local-regional treatment, and if their residual lesions fall within T2 criteria.

Pediatric candidates (less than age 18 at time of registration) who meet criteria will receive a standard exception MELD/PELD score of 40 after review by the Regional Review Board.  Also, there will no longer be a cap of 34 or 6-month delay prior to assigning the exception score for pediatric candidates.  Please note: This score assignment is a change from the original HCC policy but reflects the assignment these candidates will receive under the National Liver Review Board (NLRB) policy change, which has been approved by the OPTN/UNOS Board and will be fully implemented in 2018 (see Policy Notice).  The exception score for pediatric candidates is being implemented at this time to prevent unnecessary disruption in score assignments between HCC and NLRB implementation.

For any exception candidate requiring an extension request after the implementation date, you must submit an updated request indicating that the candidate still meets the initial eligibility criteria.

The policy no longer contains recommendations that had existed in previous policy regarding imaging characteristics used for CT scans and MRIs performed to support an exception request.  These recommendations are now included in a guidance document.

Training available

A recorded training session is available on UNOS Connect in the Liver section of the Course Catalog that outlines the revised policy and associated changes for assessment and data reporting for eligible candidates.  A PDF version of the slide set is also available as a separate link.

Contact

If you have questions about new or updated data requirements, contact the UNet Help Desk at (800) 978-4334 or unethelpdesk@unos.org.  Contact your regional administrator at 804-782-4800 if you have policy-related questions.

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