MolDX: Pharmacogenomics Testing

Medically necessary PGx testing (single-gene, multi-gene panels, or combinatorial) is covered only as an adjunct when a clinician has already selected or is using specific medication(s) known to have actionable gene–drug interactions per FDA labeling or CPIC level A/B, and when test results are needed to safely select or dose the drug. Tests must demonstrate analytic and clinical validity and utility via the contractor’s technical assessment, exclude non-actionable gene content and proprietary combinatorial algorithms from coverage, and require documentation that the clinician made a prior personalized, non-genetic treatment decision and has documented the drug(s) and indications. Anticoagulation dosing PGx is excluded here (governed by NCD 90.1), and ordering is restricted to providers qualified to both diagnose and prescribe.

"Pharmacogenomics (PGx) testing (single-gene, multi-gene panels, or combinatorial tests) is reasonable and necessary as an adjunctive tool when a treating clinician has already narrowed treatment op..."