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    v1.0.31
    OpenPayerPolicy UpdatesGenetic & Molecular TestingRegence BRAF Genetic Testing Coverage | OpenPayer
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    CurrentRegence BlueCross BlueShieldPolicy N/A

    BRAF Genetic Testing to Select Melanoma or Glioma Patients for Targeted Therapy

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    This policy governs coverage of tumor-tissue testing for BRAF variants when used to select targeted therapy for individuals with advanced, metastatic, or unresectable melanoma or with glioma. It also identifies investigational uses and the documentation required for medical-necessity review.

    Policy Summary
    PayerRegence BlueCross Blue Shield
    PolicyBRAF Genetic Testing to Select Melanoma or Glioma Patients for Targeted Therapy
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateOctober 1, 2026
    Last ReviewAug 1, 2026
    Next Review DateJuly 1, 2027
    Key ActionSubmit clinical documentation supporting the medical-policy criteria for review.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    2Medically necessary indication groups
    2Investigational use categories
    2Disease categories addressed
    4Cross-referenced genetic-testing policies

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    Coverage Criteria

    Medically Necessary Targeted-Therapy Selection

    Testing for BRAF variants in tumor tissue may be considered medically necessary when performed to select an FDA-approved targeted therapy and one of the applicable clinical indications below is met.

    ONE of the following indications

    • Melanoma

      • The individual has advanced, metastatic, or unresectable melanoma.
      • BRAF variant testing is performed in tumor tissue to select targeted therapy.

    • Glioma

      • The individual has glioma.
      • BRAF variant testing is performed in tumor tissue to select targeted therapy.

    Investigational Uses

    BRAF variant testing is considered investigational under either of the following circumstances:

    ONE of the following investigational conditions

    • Testing for BRAF variants in melanoma when the medically necessary criteria for advanced, metastatic, or unresectable melanoma are not met.
    • Testing for BRAF variants in glioma for any purpose other than selecting targeted therapy.

    Melanoma

    BRAF variant testing may be considered medically necessary to select an FDA-approved targeted treatment when all of the following are met:

    ALL of the following

    • The individual has advanced, metastatic, or unresectable melanoma.
    • Testing is performed for BRAF variants in tumor tissue.
    • Testing is used to select an FDA-approved targeted treatment.

    Glioma

    BRAF variant testing may be considered medically necessary to select an FDA-approved targeted treatment when all of the following are met:

    ALL of the following

    • The individual has glioma.
    • Testing is performed for BRAF variants in tumor tissue.
    • Testing is used to select an FDA-approved targeted treatment.

    Investigational Testing

    Testing is considered investigational when medically necessary criteria are not met or when performed for purposes outside targeted-therapy selection.

    ONE of the following applies

    • BRAF variant testing in melanoma is performed when the criteria for advanced, metastatic, or unresectable melanoma are not met.
    • BRAF variant testing in glioma is performed for a purpose other than selecting targeted therapy.

    For glioma, BRAF variant testing is considered investigational for all purposes other than targeted therapy selection.

    For melanoma, BRAF variant testing is considered investigational when the criteria for advanced, metastatic, or unresectable melanoma are not met.

    Covered Indications

    Tumor-Tissue BRAF Testing for Advanced, Metastatic, or Unresectable Disease

    Tumor-tissue BRAF variant testing may be considered medically necessary when both of the following are met:

    Advanced, metastatic, or unresectable disease

    • The individual has advanced, metastatic, or unresectable disease.
    • Testing is performed on tumor tissue to select targeted therapy.

    Tumor-Tissue BRAF Testing for Glioma

    Tumor-tissue BRAF variant testing may be considered medically necessary when both of the following are met:

    Glioma targeted-therapy selection

    • The individual has glioma.
    • Testing is performed on tumor tissue to select targeted therapy.

    BRAF Testing for Advanced, Metastatic, or Unresectable Melanoma

    Testing may be considered medically necessary when both of the following are met:

    Melanoma targeted-treatment selection

    • The patient has advanced, metastatic, or unresectable melanoma.
    • BRAF variant testing results will be used to select an FDA-approved targeted treatment.

    BRAF Testing for Glioma

    Testing may be considered medically necessary when both of the following are met:

    Glioma targeted-treatment selection

    • The patient has glioma.
    • BRAF variant testing results will be used to select an FDA-approved targeted treatment.

    Molecular Testing for Glioblastoma or Pediatric Glioma

    Molecular testing may be clinically useful when all of the following apply:

    Glioblastoma or pediatric glioma molecular testing

    • Disease category

      • The patient has glioblastoma.
      • The patient has pediatric glioma.

    • Alteration and clinical purpose

      • Testing is performed to identify a BRAF V600E alteration that may inform targeted treatment, clinical trial eligibility, diagnosis, or prognosis.
      • Testing is performed to identify a BRAF fusion alteration that may inform targeted treatment, clinical trial eligibility, diagnosis, or prognosis.

    Eligibility Requirements

    If initial BRAF single-gene testing is negative in a patient with melanoma, clinicians should strongly consider multi-gene panel testing to identify other potential treatment targets, including KIT or non-V600 BRAF alterations.

    Not Covered

    BRAF variant testing is not covered when melanoma is not advanced, metastatic, or unresectable. Testing is also not covered for glioma when it is performed for purposes other than selecting targeted therapy. These uses are considered investigational.

    Coding

    CodesCPT
    81210BRAF (B-Raf proto-oncogene, serine/threonine kinase) (e.g., colon cancer, melanoma), gene analysis, V600 variant(s)

    Provider Actions

    Documentation Required

    Submit Medical-Necessity Documentation

    Submit the documentation needed for medical-necessity review with the BRAF genetic test request. Missing information may affect the review and coverage decision.

    • Genetic test or panel name
    • Performing laboratory or genetic testing organization
    • Clinical records supporting the applicable policy criteria
    Documentation Required

    Required Clinical and Laboratory Documentation

    Include complete clinical and laboratory documentation so Regence can determine whether the policy criteria are met and how the result will guide treatment decisions.

    • Name of the genetic test or panel
    • Performing laboratory and/or genetic testing organization; more than one may be listed
    • Exact gene(s) and/or variants being tested
    • Brief explanation of how results will guide clinical decisions that would not otherwise be made without testing
    • Medical records related to the test, including history and physical examination
    • Conventional testing and outcomes
    • Conservative treatment provided, if any
    • Relevant billing codes
    Denial Risk

    Investigational Indications

    BRAF variant testing in melanoma is investigational when the applicable policy criteria are not met. Testing in glioma is investigational for any purpose other than selecting targeted therapy.

    • Melanoma: investigational when Criterion I is not met
    • Glioma: investigational for all purposes other than targeted therapy selection
    Billing Rule

    Contract Exclusions and Member Liability

    Contract terms control benefit determinations when they conflict with the medical policy. Contracts exclude services or procedures considered investigational or cosmetic, and providers may bill members for those services.

    • Inform members before rendering investigational or cosmetic services that they are likely to be financially responsible
    • Contract language takes precedence over the medical policy
    Denial Risk

    Testing Outside Targeted-Treatment Selection

    BRAF testing performed for purposes other than selecting FDA-approved targeted treatment is investigational because evidence is limited for these uses.

    • Melanoma: testing is investigational when not used to select FDA-approved targeted treatment for advanced, metastatic, or unresectable disease, or when policy criteria are not met
    • Glioma: testing is investigational when not used to select FDA-approved targeted treatment

    Background

    BRAF variants activate a signaling pathway involved in oncogenic proliferation and are found in approximately 50%–70% of melanoma tumors. BRAF and MEK inhibitors are targeted therapies developed for melanoma with BRAF variants. BRAF V600E variants also occur in several glioma subtypes, making tumor testing useful when results may guide targeted-treatment selection.

    Definitions

    Advanced melanoma
    Disease categoryAdvanced melanoma is melanoma that has spread beyond the original area of skin.
    Additional spreadThe disease may also have spread to nearby lymph nodes.
    Stage IVStage IV melanoma is advanced disease.
    BRAF variant testing
    SpecimenTesting is performed on tumor tissue.
    Variant identifiedThe test identifies BRAF variants.
    Clinical purposeResults are used to select targeted therapy.
    Glioma
    Tumor groupGlioma is a heterogeneous group of tumors.
    Classification basisGliomas are classified using histopathologic appearance and molecular parameters.
    WHO gradesThe classification ranges from WHO grade I through grade IV.
    Companion diagnostic test
    Therapy associationA companion diagnostic test is used with a specific therapy.
    Patient selectionThe test helps identify patients whose tumors may carry the variant relevant to that therapy.
    Treatment riskThe test can help avoid preventable treatment risk.
    Analytic validity
    DefinitionAnalytic validity is the technical accuracy of a test.
    Variant presentIt measures whether the test correctly detects a variant that is present.
    Variant absentIt also measures whether the test correctly excludes a variant that is absent.
    Clinical validity
    DefinitionClinical validity is the diagnostic performance of a test in detecting clinical disease.
    Performance measuresIt includes sensitivity and specificity.
    Predictive valuesIt also includes positive and negative predictive values.
    Clinical utility
    DefinitionClinical utility describes how test results are used to change patient management.
    Management impactIt considers whether test results lead to changes in the patient's management.
    Health outcomesIt evaluates whether those management changes produce clinically important improvements in health outcomes.
    Policy Summary
    PayerRegence BlueCross Blue Shield
    PolicyBRAF Genetic Testing to Select Melanoma or Glioma Patients for Targeted Therapy
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateOctober 1, 2026
    Last ReviewAug 1, 2026
    Next Review DateJuly 1, 2027
    Key ActionSubmit clinical documentation supporting the medical-policy criteria for review.
    SourceLink
    On This Page
    Coverage CriteriaCovered IndicationsEligibility RequirementsNot CoveredCodingProvider ActionsBackgroundDefinitions