MolDX: Pharmacogenomics Testing

Pharmacogenomics testing is covered only as an adjunctive tool when a treating clinician has already selected or narrowed consideration to specific medication(s) that have clinically actionable gene–drug interactions per FDA labeling or CPIC level A/B, and when results are necessary for safe prescribing or dosing. Coverage requires tests to demonstrate analytical and clinical validity and utility via a technical assessment, appropriate laboratory reporting of genotype significance, documentation of clinician's preliminary non-genetic drug selection and intent to prescribe, and ordering by a provider qualified to both diagnose and prescribe; non-actionable genes, combinatorial algorithms, and tests ordered solely on diagnosis are not covered.

"PGx testing is covered as an adjunctive tool when a treating clinician has already narrowed treatment options to specific medication(s) and those medication(s) have a clinically actionable gene–dru..."