Pharmacogenomic Testing

Medically reasonable and necessary pharmacogenomic testing is covered when a treating clinician documents that a patient requires a medication with known gene–drug interactions and when the specific test demonstrates actionability (CPIC level A/B or FDA pharmacogenomic listing/label) that will directly alter drug selection or dosing. Multi‑gene panels or combinatorial tests are covered only for components that meet those actionability standards; tests lacking established analytical validity, clinical validity, or clinical utility are not covered. Germline testing is limited to one lifetime per beneficiary, duplicate testing of the same germline content is not covered, and orders must be placed by the treating clinician qualified to diagnose and prescribe (see NCD 90.1 for warfarin).

"PGx testing is reasonable and necessary when the patient has a condition for which clinical evaluation has determined a need for a medication that has known gene–drug interaction(s) and the test re..."