MolDX: Molecular Diagnostic Tests (MDT)

MolDX covers molecular diagnostic tests that are registered, have an assigned unique test identifier, and have completed a technical assessment demonstrating analytical validity, clinical validity, and clinical utility sufficient to meet Medicare's reasonable and necessary requirement. The policy applies to MDTs including non‑FDA laboratory-developed tests, modified FDA kits, and multi-code or NOC‑billed assays, but tests not vetted by MolDX, lacking registration/identifier, or failing to demonstrate required validity/utility are not covered; labs must submit a comprehensive dossier and include the MolDX unique identifier on claims.

"Molecular diagnostic tests (MDTs) are covered when the test is registered with MolDX, has an assigned unique test identifier, has completed the required technical assessment (TA), and MolDX determi..."

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