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IMPORTANT: THIS DOCUMENT CONTAINS OUTDATED INFORMATION.
Content provided on this page contains outdated information and instruction and should not be considered current. CGS is providing this archived information for research purposes only. This archived section contains previously issued instructions that have since been updated or are no longer applicable for Medicare billing purposes.

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™ Identifieron 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™External Website.

This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.

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