LCDActive
Pharmacogenomics Testing
L39073
First Coast Service Options, Inc. (J09)
Effective: December 12, 2021
Updated: December 31, 2025
Policy Summary
Medicare covers pharmacogenomic testing when a patient requires a medication with a known gene–drug interaction and the test is actionable per CPIC level A/B or listed in FDA pharmacogenomic/pharmacogenetic tables, such that results would directly change drug selection or dosing. Germline testing is limited to once per lifetime and duplicate testing of the same germline content is not covered; the ordering provider must be the treating clinician qualified to diagnose and prescribe and documentation must demonstrate medical necessity and evidence of actionability.
Coverage Criteria Preview
Key requirements from the full policy
"Pharmacogenomic testing is reasonable and necessary when the patient requires a medication for which a known gene–drug interaction exists and the test result would directly impact drug management."
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