MolDX: Molecular Diagnostic Tests (MDT)

MolDx covers molecular diagnostic tests (MDTs), including LDTs, modified FDA assays, and tests billed with multiple or NOC HIPAA-compliant codes, only if the test is registered with MolDx, has completed a technical assessment (TA), and demonstrates analytical validity, clinical validity, and clinical utility sufficient to meet Medicare's reasonable and necessary criteria. Laboratories must submit a comprehensive TA/dossier and obtain a unique MolDx test identifier that must be included on claims; services are covered only for dates of service on or after the effective coverage date and claims missing required identifiers or TA/registration may be denied.

"Molecular diagnostic tests (MDTs) that have completed MolDx registration and technical assessment (TA) and are listed as covered by MolDx are covered when they meet Medicare's reasonable and necess..."

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