MolDX: Pharmacogenomics Testing

Pharmacogenomic (PGx) testing is covered only as an adjunct to a clinician’s narrowed medication decision when the medication(s) in question have actionable gene–drug interactions per FDA labeling or CPIC level A/B guidance and the test result is necessary for safe prescribing or dosing. Coverage requires validated test performance (analytical/clinical validity and utility), appropriate lab reporting of genotype significance, clinician documentation of non-genetic decision-making and intended drug use, excludes non-actionable genes and proprietary combinatorial algorithms, and does not address anticoagulation PGx dosing (NCD 90.1).

"PGx testing is covered as an adjunctive tool when a treating clinician has already narrowed treatment options to specific medication(s) being considered or is already using a specified medication a..."

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