MolDX: Molecular Testing for Solid Organ Allograft Rejection

MolDX covers molecular diagnostic tests for solid organ allograft rejection when the test informs AR or ACR/AMR status and meets specified intended uses (e.g., immunosuppression assessment, rule-out for-cause testing, post-biopsy inconclusive evaluation, or validated surveillance). Coverage requires analytical and clinical validity demonstrated in peer-reviewed literature, completion of the MolDX Technical Assessment, use in the validated population, and adherence to surveillance cadence limits (first-year: kidney 4, heart 12, lung 12; thereafter up to 2/year). Only one molecular test per encounter is allowed and simultaneous biopsy/testing is generally prohibited except in narrowly defined, high-risk exceptions.

"The molecular test must provide information about allograft acute rejection (AR) status or about cellular (ACR/TCMR) or antibody-mediated rejection (AMR) status."