MolDX: Molecular Testing for Solid Organ Allograft Rejection

Molecular tests for solid organ allograft rejection are covered only when they provide information about AR or ACR/AMR status, are analytically and clinically validated for the intended population, and are used to inform specified clinical decisions (e.g., assess immunosuppression response, rule-out AR, evaluate inconclusive biopsy, or perform validated surveillance). Surveillance testing is limited to validated cadences (first-year maxima: kidney 4, heart 12, lung 12; thereafter up to 2/year), only one molecular test is allowed per encounter, multianalyte tests must show added benefit, and tests must complete a MolDX Technical Assessment with supporting peer-reviewed evidence.

"Covered molecular tests must provide information about acute rejection (AR) status or cellular or antibody-mediated rejection (ACR/AMR) status of a transplanted allograft."

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