MolDX: Molecular Diagnostic Tests (MDT)

MolDX covers molecular diagnostic tests (MDTs) — including LDTs, modified FDA assays, multi-code-billed tests, and certain NOC-billed tests — only after the laboratory registers the test, obtains a MolDX unique test identifier, and completes a technical assessment demonstrating analytical validity, clinical validity, and clinical utility that meet Medicare's reasonable and necessary standard. Claims lacking the MolDX identifier, without a completed TA/dossier, or for tests that fail to demonstrate required validity/utility or are outside the coverage effective date may be denied; coding, billing, and specific covered/excluded test lists are available on the MolDX website.

"Molecular diagnostic tests (MDTs) that have completed MolDX registration and a technical assessment (TA) and that demonstrate analytical validity, clinical validity, and clinical utility meeting Me..."