Billing and Coding: MolDX: FDA-Approved BRAF Tests

FDA-approved BRAF V600 tests (cobas® 4800 and ThxID™ BRAF V600/K) are indicated for detecting BRAF V600 mutations in melanoma to determine eligibility for vemurafenib, dabrafenib, and to aid selection for trametinib per their FDA-labeled uses. Claims for these tests must use CPT 81210, include the appropriate DEX Z-Code in the specified claim fields, report an appropriate ICD-10-CM diagnosis, and laboratories must register the test and confirm unmodified kit use on the DEX portal; MolDX will apply NPI-to-test ID editing. Coverage is limited to FDA-approved indications current at policy creation and tests or claims that fail registration/identification requirements may be subject to editing or denial.

"Perform cobas® 4800 BRAF V600 test to detect BRAF V600 mutations in melanoma tumor cells to determine eligibility for vemurafenib (Zelboraf) in unresectable or metastatic melanoma."