MolDX: Molecular Testing for Solid Organ Allograft Rejection

Molecular diagnostic tests for solid organ allograft rejection are covered only when they provide information about AR or ACR/AMR status and meet all requirements including specific intended uses (e.g., replace biopsy for immunosuppression decisions, rule-out in validated populations, post-pretest evaluation, or adjunct after inconclusive biopsy). Coverage requires analytical and clinical validation with peer-reviewed evidence, successful Technical Assessment, use in a validated patient population, ordering by a qualified transplant-affiliated physician, and is limited to one test per patient encounter unless a necessary adjunct is justified.

"The test provides information about active rejection (AR) status or cellular or antibody-mediated rejection (ACR or AMR) status of a solid organ allograft."

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