MolDX: Molecular Testing for Solid Organ Allograft Rejection

This policy provides limited coverage for molecular diagnostic tests that evaluate solid organ allograft rejection when tests inform AR or ACR/AMR status, have demonstrated analytical and clinical validity, and complete a MolDX Technical Assessment. Covered uses include replacing biopsy when appropriate, ruling out rejection in validated populations, evaluating equivocal biopsy results, and surveillance per validated cadences (first-year limits: kidney 4, heart 12, lung 12; thereafter up to 2/year); only one molecular test is allowed per patient encounter.

"Molecular diagnostic tests are covered when they provide information on acute rejection (AR) status of a solid organ allograft."

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