October 12, 2015 - Updated: 01.04.18
FDA-Approved BRAF Tests (CM00029, V2)
Two tests have met the FDA criteria for BRAF genetic testing:
Effective 09/07/2012
cobas® 4800 BRAF V600 to detect the presence of a mutation in the BRAF gene in melanoma cells and determine if a patient is eligible for Zelboraf™ (vemurafenib), a treatment indicated for a melanoma that cannot be surgically excised or has spread in the body
Effective 5/29/13
ThxID™ BRAF V600/K to detect the BRAF V600E and V600K mutations in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™].
To report an FDA approved BRAF V600 test kit service, please submit the following claim information:
- CPT 81210 Enter DEX Z-Code™ identifier in the comment/narrative field for the following claim field/types:
- Line SV202.7 for Part A or Loop 2400 or SV101 - 7 for the 5010A1 837P for Part B
- Submit theDEX Z - Code™ Identifier on an attachment to the claim form for paper claim (Form locator 80 for Part A or Box 19 for Part B)
Select appropriate ICD-10-CM codes:
- C43.0 - Malignant melanoma of lip
- C43.11 - Malignant melanoma of right eyelid, including canthus
- C43.12 - Malignant melanoma of left eyelid, including canthus
- C43.21 - Malignant melanoma of right ear and external auricular canal
- C43.22 - Malignant melanoma of left ear and external auricular canal
- C43.31 - Malignant melanoma of nose
- C43.39 - Malignant melanoma of other parts of face
- C43.4 - Malignant melanoma of scalp and neck
- C43.51 - Malignant melanoma of anal skin
- C43.52 - Malignant melanoma of skin of breast
- C43.59 - Malignant melanoma of other part of trunk
- C43.61 - Malignant melanoma of right upper limb, including shoulder
- C43.62 - Malignant melanoma of left upper limb, including shoulder
- C43.71 - Malignant melanoma of right lower limb, including hip
- C43.72 - Malignant melanoma of left lower limb, including hip
- C43.8 - Malignant melanoma of overlapping sites of skin
- C43.9 - Malignant melanoma of skin, unspecified
- C79.2 - Secondary malignant neoplasm of skin
- D03.0 - Melanoma in situ of lip
- D03.11 - Melanoma in situ of right eyelid, including canthus
- D03.12 - Melanoma in situ of left eyelid, including canthus
- D03.21 - Melanoma in situ of right ear and external auricular canal
- D03.22 - Melanoma in situ of left ear and external auricular canal
- D03.39 - Melanoma in situ of other parts of face
- D03.4 - Melanoma in situ of scalp and neck
- D03.51 - Melanoma in situ of anal skin
- D03.52 - Melanoma in situ of breast (skin) (soft tissue)
- D03.59 - Melanoma in situ of other part of trunk
- D03.61 - Melanoma in situ of right upper limb, including shoulder
- D03.62 - Melanoma in situ of left upper limb, including shoulder
- D03.71 - Melanoma in situ of right lower limb, including hip
- D03.72 - Melanoma in situ of left lower limb, including hip
- D03.8 - Melanoma in situ of other sites
- D03.9 - Melanoma in situ, unspecified
NOTE: MolDX will apply NPI to ID editing on FDA approved BRAF kits. All labs that submit claims for a BRAF V600 test kit MUST register the test and confirm the UNMODIFIED use of the kit. Tests may be registered on theDEX Diagnostics Exchange™.
This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.