MolDX: Molecular Diagnostic Tests (MDT)

This MolDX policy requires molecular diagnostic tests (MDTs) to complete MolDX registration and a technical assessment and to demonstrate analytical validity, clinical validity, and clinical utility before Medicare coverage and reimbursement. Labs must submit a comprehensive TA dossier and include the MolDX-assigned unique test identifier on claims; tests used solely for QC/QA, not vetted/approved by MolDX, or performed without demonstrated impact on patient management are not covered.

"MolDX will cover and reimburse molecular diagnostic tests (MDTs) that have completed MolDX registration and a technical assessment (TA) and that meet Medicare's reasonable and necessary criteria fo..."

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