Billing and Coding: MolDX: FDA-Approved KRAS Tests

FDA-approved therascreen® and cobas® KRAS tests are recognized for detecting KRAS mutations in colorectal cancer patients to guide treatment with cetuximab (therascreen) and cetuximab or panitumumab (cobas, codons 12/13). Claims must include the appropriate CPT code (1 unit of service), an ICD-10-CM diagnosis, and the assigned DEX Z-Code™ identifier submitted in the specified electronic or paper claim fields; laboratories must register the test on the DEX Diagnostics Exchange and confirm unmodified kit use.

"therascreen® KRAS test: detection of somatic KRAS mutations to identify colorectal cancer (CRC) patients for treatment with cetuximab (Erbitux®)."

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