Billing and Coding: MolDX: FDA-Approved EGFR Tests

FDA-approved cobas and therascreen EGFR tests are covered as companion diagnostics to detect EGFR mutations in patients with non-small cell lung cancer (NSCLC) using FFPET or plasma (cfDNA) as specified. Positive plasma cobas results for exon 19 deletions or L858R indicate eligibility for erlotinib and negative plasma results should reflex to FFPET testing; therascreen is indicated for FFPET to select patients for afatinib. Billing requires CPT 81235, appropriate DEX Z-Code placement on claims, registration of unmodified kit use on McKesson Diagnostics Exchange, and LDTs/modified tests must be reported with the assigned LDT ID and no modifier.

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

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