Billing and Coding: MolDX: FDA-Approved BRAF Tests

FDA‑approved BRAF V600 tests (cobas 4800 and ThxID BRAF V600/K) are covered for detection of BRAF V600 mutations in melanoma to determine eligibility for vemurafenib (unresectable/metastatic), dabrafenib (V600E), or trametinib (V600E or V600K). Claims must use CPT 81210, include the appropriate DEX Z‑Code adjacent to the CPT in specified claim fields, and list the appropriate ICD‑10‑CM diagnosis; laboratories must register the test on DEX and confirm unmodified use. Coverage is limited to FDA‑approved indications at the time of the policy (with future FDA approvals considered), and MolDX will enforce NPI‑to‑ID editing for these kits.

"Perform BRAF V600 mutation testing (cobas 4800) to detect a BRAF V600 mutation in melanoma cells to determine eligibility for vemurafenib for unresectable or metastatic melanoma."

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