Billing and Coding: MolDX: FDA-Approved EGFR Tests

FDA‑approved EGFR test kits (cobas EGFR Mutation Test v2 and therascreen EGFR RGQ PCR kit) are covered as companion diagnostics to detect EGFR mutations in NSCLC using specified specimen types (FFPET and/or plasma) when used unmodified and per FDA labeling to select patients for targeted EGFR TKIs. Claims must report CPT 81235 with the appropriate DEX Z‑Code and required claim field placement, list the correct ICD‑10‑CM diagnosis codes, and the performing laboratory must register the test on the DEX portal; plasma positives for exon 19 deletions or L858R allow erlotinib, and negative plasma should be reflexed to tissue testing.

"The cobas EGFR Mutation Test v2 is indicated as a companion diagnostic to detect defined EGFR mutations in patients with non-small cell lung cancer (NSCLC) using DNA from formalin-fixed paraffin-em..."

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