Billing and Coding: MolDX: FDA-Approved KRAS Tests

Coverage applies to FDA‑approved KRAS tests (therascreen and cobas) and eligible laboratory‑developed KRAS tests when used for their FDA‑approved indications to identify colorectal cancer patients for anti‑EGFR therapy (cetuximab or panitumumab). Claims must include the appropriate CPT code with 1 unit of service, the appropriate ICD‑10‑CM diagnosis, and the DEX Z‑Code™ in the specified claim fields; laboratories must register the test and confirm the kit is used unmodified and will be subject to NPI‑based editing.

"therascreen® KRAS (7-mutation panel) is covered to detect somatic KRAS mutations to identify colorectal cancer patients for treatment with cetuximab (Erbitux)."

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