Billing and Coding: MolDX: FDA-Approved KRAS Tests

MolDX recognizes two FDA-approved KRAS assays: therascreen® (seven somatic KRAS mutations) for identifying colorectal cancer patients for cetuximab therapy, and cobas® (KRAS codons 12/13) for identifying colorectal cancer patients for cetuximab or panitumumab therapy. Claims must include the appropriate CPT (1 UOS), the DEX Z-Code in the specified narrative fields, and an ICD-10-CM diagnosis; laboratories must register tests on the DEX portal, confirm unmodified kit use, and ensure proper NPI identification for MolDX editing.

"therascreen® KRAS test to detect seven somatic KRAS mutations is indicated to identify colorectal cancer patients for consideration of treatment with cetuximab (Erbitux)."

Sign up to see full coverage criteria, indications, and limitations.