Billing and Coding: MolDX: FDA-Approved BRAF Tests

MolDX covers FDA-approved BRAF V600 mutation tests (cobas® 4800 and ThxID™ BRAF V600/K) for identifying BRAF V600, V600E, or V600K mutations in melanoma to determine eligibility for targeted therapies (vemurafenib, dabrafenib, trametinib). Claims must use CPT 81210, include the assigned DEX Z-Code identifier in specified claim fields (electronic and paper), select the appropriate ICD-10-CM diagnosis, and labs must register the test and confirm unmodified kit use on the DEX Diagnostics Exchange. Coverage is limited to FDA-approved indications as reflected by MolDX; deviations or unregistered/modified kit use may be denied and require manual review.

"BRAF V600 mutation testing (cobas® 4800 BRAF V600) is covered to detect BRAF mutation in melanoma to determine eligibility for vemurafenib (Zelboraf) in patients with melanoma that is unresectable ..."

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