Billing and Coding: MolDX: FDA-Approved EGFR Tests

FDA-approved cobas and therascreen EGFR test kits are covered as companion diagnostics for NSCLC to detect specified EGFR mutations (eg, exon 19 deletions, L858R, T790M) using FFPET and, for cobas v2, plasma cfDNA when consistent with FDA labeling; positive plasma cobas v2 results for exon 19/L858R support erlotinib use and negative plasma results require reflex to FFPET testing. Claims must report CPT 81235 with the appropriate DEX Z-Code in specified electronic/paper claim fields, submit supporting ICD-10-CM diagnosis codes, and laboratories must register the test and confirm unmodified kit use.

"The cobas EGFR Mutation Test is covered as a companion diagnostic for patients with non-small-cell lung cancer (NSCLC) to detect defined EGFR mutations (exon 19 deletions, L858R, T790M) using DNA f..."

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