MolDX: Pharmacogenomics Testing

This LCD covers pharmacogenomics testing (single-gene and multi-gene panels) only when a clinician has already selected or intends to use a specific medication(s) with an actionable gene–drug interaction (FDA actionable labeling or CPIC level A/B) and the test result is necessary for safe drug selection or dosing. Tests must meet technical assessment requirements demonstrating analytical/clinical validity and utility, be reported with clear genotype–drug interpretation, and ordering providers must be qualified to both diagnose and prescribe; non-actionable genes, certain combinatorial algorithm components, and anticoagulation dosing (NCD 90.1) are excluded from coverage.

"Pharmacogenomics (PGx) testing is covered when the treating clinician has selected or intends to use a specific, medically appropriate medication that has a clinically actionable gene–drug interact..."