LCDActive
MolDX: Molecular Diagnostic Tests (MDT)
L35160
Effective: May 4, 2023
Updated: December 31, 2025
Policy Summary
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.
Coverage Criteria Preview
Key requirements from the full policy
"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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