MolDX: Molecular Diagnostic Tests (MDT)

MolDX (Palmetto GBA) determines coverage for molecular diagnostic tests; CGS accepts these determinations. Tests (including LDTs, modified FDA kits, multi-code services, and NOC‑billed tests) are covered only if registered with MolDX, have an assigned unique test identifier, and demonstrate analytical validity, clinical validity, and clinical utility meeting Medicare's reasonable and necessary criteria; claims must include the MolDX identifier and a comprehensive dossier/TA must be submitted prior to claim submission.

"MolDX will cover a molecular diagnostic test only if the test has completed MolDX registration and a technical assessment (TA) and demonstrates analytical validity, clinical validity, and clinical ..."

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