Billing and Coding: MolDX: FDA-Approved KRAS Tests

FDA-approved KRAS tests (therascreen® and cobas®) are covered to identify colorectal cancer patients for anti-EGFR therapy (cetuximab and/or panitumumab) when performed with the specified FDA kits. Claims must include the appropriate CPT, one unit of service, the DEX Z-Code™ identifier in the specified claim fields, and an appropriate ICD-10-CM diagnosis; laboratories must register the test on DEX and confirm unmodified kit use and be subject to NPI-based ID editing.

"therascreen® KRAS kit (effective 2012-07-06) for detection of seven somatic KRAS mutations is covered to identify colorectal cancer patients for treatment with cetuximab (Erbitux®)."

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