MolDX: Molecular Syndromic Panels for Infectious Disease Pathogen Identification Testing

Outpatient molecular syndromic panels detecting multiple pathogens are covered when testing is clinically indicated, performed in the intended validated population and sample type, and results will affect management; panels must meet CLIA/FDA requirements and laboratory limitations must be documented. Expanded panels (≥6 pathogens) are only covered when targeted testing is inadequate and specific additional criteria apply for panel types (RP/PNP, GI, UG/AG, ME, BSI, UTI); testing is not covered as a test-of-cure, for home use, or when duplicative within 14 days except in narrowly defined exceptions.

"Outpatient molecular syndromic panels (tests detecting >1 pathogen) are covered when all general coverage criteria in the policy are met."

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