MolDX: Pharmacogenomics Testing

Pharmacogenomics testing is covered only as an adjunctive tool when a clinician has already selected one or more specific, medically necessary medications and those medications have actionable gene-drug interactions per FDA labeling/warnings or CPIC level A/B, and the test result is necessary to guide safe drug selection or dosing. Single-gene tests are covered when individually ordered and necessary; multi-gene panels are covered only when multiple panel genes are independently necessary or multiple medications requiring different genes are under consideration; combinatorial algorithm components and non-actionable gene content are excluded. Documentation must show the diagnosis, initial non-genetic treatment considerations, drugs considered, and labs must report genotype significance and supporting genotype-drug interactions; tests must meet analytic/clinical validity and utility via technical assessment.

"Pharmacogenomics (PGx) testing is covered when a treating clinician has selected one or more specific, medically necessary medications and those medications have gene-drug interactions that are cli..."