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    v1.0.31
    OpenPayerPolicy UpdatesGenetic & Molecular TestingArkansas BCBS Ovarian Biomarker Coverage | OpenPay…
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    CurrentArkansas Blue Cross and Blue ShieldPolicy 2022044

    Genetic Test: Biomarker Testing (including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Ovarian Cancer

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    Coverage of tissue-based and liquid biopsy biomarker testing used to identify candidates for FDA-approved targeted therapies and immunotherapy in recurrent or persistent ovarian cancer, subject to specified indications and testing circumstances.

    Policy Summary
    PayerArkansas Blue Cross and Blue Shield
    PolicyGenetic Test: Biomarker Testing (including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Ovarian Cancer
    Policy CodePolicy 2022044
    Change TypeAdded restricted coverage
    Effective DateMar 1, 2026
    Next Review DateNot specified
    Key ActionDocument that the individual is a candidate for the applicable FDA-approved targeted agent, has not had prior metastatic-setting testing, and meets tissue or biopsy requirements for liquid ctDNA testing.
    SourceLink
    POLICY UPDATE CHANGES

    Restricted coverage was added for NTRK gene fusion analysis, tumor mutational burden, RET gene fusion expression, FOLR1 protein expression, BRAF V600E testing, and liquid ctDNA-based testing.

    Codes 81191-81194, 81301, 81479, 88360, and 81210 were added with restricted coverage.

    6Biomarker or testing categories with restricted coverage added
    7Newly listed procedure codes or code ranges

    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.

    3NTRK gene targets covered
    >=75%Positive tumor-cell threshold for FOLR1 expression
    5Targeted agents or immunotherapy drugs named

    Biomarker Testing Coverage Criteria

    NTRK Gene Fusion Analysis

    NTRK1, NTRK2, or NTRK3 gene fusion analysis of tumor tissue is covered when ALL of the following are met:

    ALL of the following

    • The individual has recurrent ovarian cancer and testing is being performed to select candidacy for entrectinib, larotrectinib, or repotrectinib.
    • The individual is a candidate for use per the drug label of an applicable FDA-approved targeted agent.
    • The individual has not had prior testing for the targeted gene(s) of interest in the metastatic setting.
    • There is insufficient tumor tissue available for NGS-based somatic profiling, or tissue biopsy is unsafe or considered infeasible due to the individual's clinical condition.

    Tumor Mutational Burden

    Tumor mutational burden testing is covered when ALL of the following are met:

    ALL of the following

    • The individual has recurrent or persistent ovarian cancer and testing is being performed to determine candidacy for pembrolizumab.
    • The individual is a candidate for use per the drug label of an applicable FDA-approved targeted agent or immunotherapy.
    • The individual has not had prior testing for the targeted gene(s) of interest in the metastatic setting.
    • There is insufficient tumor tissue available for NGS-based somatic profiling, or tissue biopsy is unsafe or considered infeasible due to the individual's clinical condition.

    RET Gene Fusion Expression

    RET gene fusion expression testing is covered when ALL of the following are met:

    ALL of the following

    • The individual has recurrent or persistent ovarian cancer and testing is being performed to determine candidacy for selpercatinib.
    • The individual is a candidate for use per the drug label of an applicable FDA-approved targeted agent.
    • The individual has not had prior testing for the targeted gene(s) of interest in the metastatic setting.
    • There is insufficient tumor tissue available for NGS-based somatic profiling, or tissue biopsy is unsafe or considered infeasible due to the individual's clinical condition.

    FOLR1 Protein Expression

    Folate receptor alpha 1 (FOLR1) protein expression testing is covered when ALL of the following are met:

    ALL of the following

    • Testing is performed to determine candidacy for mirvetuximab soravtansine-gynx in an individual with a FOLR1-expressing tumor.
    • The tumor has at least 75% positive tumor cells.>= 75% positive tumor cells
    • The individual is a candidate for use per the drug label of an applicable FDA-approved targeted agent.
    • The individual has not had prior testing for the targeted gene(s) of interest in the metastatic setting.
    • There is insufficient tumor tissue available for NGS-based somatic profiling, or tissue biopsy is unsafe or considered infeasible due to the individual's clinical condition.

    BRAF V600E Testing

    BRAF V600E testing is covered when ALL of the following are met:

    ALL of the following

    • The individual has recurrent or persistent ovarian cancer and testing is being performed to determine candidacy for dabrafenib plus trametinib.
    • The individual is a candidate for use per the drug label of an applicable FDA-approved targeted agent.
    • The individual has not had prior testing for the targeted gene(s) of interest in the metastatic setting.
    • There is insufficient tumor tissue available for NGS-based somatic profiling, or tissue biopsy is unsafe or considered infeasible due to the individual's clinical condition.

    Liquid ctDNA-Based Testing for Olaparib Treatment Selection

    Liquid circulating tumor DNA (ctDNA)-based testing using FoundationOne Liquid CDx (0239U) to identify individuals who may benefit from olaparib is covered when ALL of the following are met:

    ALL of the following

    • The individual has ovarian cancer and is being evaluated to identify whether the individual may benefit from olaparib.
    • The individual is a candidate for use of olaparib per the FDA-approved drug label.
    • The individual has not had prior testing for the targeted gene(s) of interest in the metastatic setting.
    • There is insufficient tumor tissue available for NGS-based somatic profiling, or tissue biopsy is unsafe or considered infeasible due to the individual's clinical condition.
    • Testing is performed using liquid ctDNA-based testing with FoundationOne Liquid CDx (0239U).

    Covered Testing Indications

    Recurrent Ovarian Cancer: NTRK Gene Fusion Analysis

    Covered under restricted coverage for treatment selection in recurrent ovarian cancer.

    Tumor-tissue NTRK fusion analysis: The individual has recurrent ovarian cancer and tumor-tissue testing evaluates NTRK1, NTRK2, or NTRK3 gene fusions to select candidates for entrectinib, larotrectinib, or repotrectinib.

    Recurrent or Persistent Ovarian Cancer: Tumor Mutational Burden

    Covered under restricted coverage for treatment selection in recurrent or persistent ovarian cancer.

    Tumor mutational burden testing: The individual has recurrent or persistent ovarian cancer and tumor mutational burden testing is performed to determine candidacy for pembrolizumab.

    Recurrent or Persistent Ovarian Cancer: RET Gene Fusion Expression

    Covered under restricted coverage for treatment selection in recurrent or persistent ovarian cancer.

    Applicable Procedure Codes and Thresholds

    Codes added with restricted coverageCPTCovered
    81191Added with restricted coverage
    81192Added with restricted coverage
    81193Added with restricted coverage
    81194Added with restricted coverage
    81301Added with restricted coverage
    81479Added with restricted coverage
    88360Added with restricted coverage
    81210Added with restricted coverage
    Liquid ctDNA-based testingHCPCSCovered
    0239UFoundation One Liquid CDx
    FOLR1-positive tumor cells
    BiomarkerFOLR1 protein expression
    Treatment selectionDetermine candidacy for mirvetuximab soravtansine-gynx
    Positive tumor-cell thresholdGreater than or equal to 75% positive tumor cells

    Documentation and Coverage Conditions

    Prior Authorization

    Document treatment candidacy and testing circumstances

    Document that the individual is a candidate for the applicable FDA-approved targeted agent under its drug label and has not had prior testing for the targeted gene or genes of interest in the metastatic setting. For liquid ctDNA-based testing, also document insufficient tumor tissue for NGS-based somatic profiling or that tissue biopsy is unsafe or infeasible due to the individual's clinical condition.

    • Applicable FDA-approved targeted-agent candidacy under the drug label
    • No prior testing for the targeted gene or genes of interest in the metastatic setting
    • For liquid ctDNA-based testing: insufficient tumor tissue for NGS-based somatic profiling, or an unsafe or infeasible tissue biopsy
    Denial Risk

    Avoid restricted-indication denial

    Testing is subject to restricted coverage and may be denied when it is not used to determine candidacy for the applicable FDA-approved targeted agent or immunotherapy, when the individual is not a candidate for the drug under its FDA-approved label, or when the liquid-testing conditions are not met. Liquid ctDNA-based testing may also be denied when prior testing for the targeted gene or genes was performed in the metastatic setting or sufficient tumor tissue is available for NGS-based somatic profiling.

    Policy Background

    This policy addresses biomarker testing in recurrent or persistent ovarian cancer to identify individuals who may be candidates for molecularly targeted treatment or immunotherapy. Covered services include tumor-tissue analysis, protein-expression testing, and liquid circulating tumor DNA (ctDNA) testing when tissue-based profiling cannot reasonably be performed. Testing is tied to specific treatment-selection uses, including NTRK-directed agents, pembrolizumab, selpercatinib, mirvetuximab soravtansine-gynx, dabrafenib plus trametinib, and olaparib.

    Liquid ctDNA Testing Eligibility

    For liquid ctDNA-based testing, the individual must be a candidate for the applicable FDA-approved targeted agent under its drug label and must not have had prior testing for the targeted gene or genes of interest in the metastatic setting. Liquid testing also requires insufficient tumor tissue for NGS-based somatic profiling or a tissue biopsy that is unsafe or infeasible because of the individual's clinical condition.

    Policy Summary
    PayerArkansas Blue Cross and Blue Shield
    PolicyGenetic Test: Biomarker Testing (including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Ovarian Cancer
    Policy CodePolicy 2022044
    Change TypeAdded restricted coverage
    Effective DateMar 1, 2026
    Next Review DateNot specified
    Key ActionDocument that the individual is a candidate for the applicable FDA-approved targeted agent, has not had prior metastatic-setting testing, and meets tissue or biopsy requirements for liquid ctDNA testing.
    SourceLink
    On This Page
    Biomarker Testing Coverage CriteriaCovered Testing IndicationsApplicable Procedure Codes and ThresholdsDocumentation and Coverage ConditionsPolicy BackgroundLiquid ctDNA Testing Eligibility
    RET gene fusion expression testing: The individual has recurrent or persistent ovarian cancer and RET gene fusion expression testing is performed to determine candidacy for selpercatinib.

    FOLR1 Protein Expression for Mirvetuximab Soravtansine-Gynx

    Covered under restricted coverage for treatment selection.

    FOLR1 protein expression testing is performed to determine candidacy for mirvetuximab soravtansine-gynx in a tumor with FOLR1 expression.greater than or equal to 75% positive tumor cells

    Recurrent or Persistent Ovarian Cancer: BRAF V600E Testing

    Covered under restricted coverage for treatment selection in recurrent or persistent ovarian cancer.

    BRAF V600E testing: The individual has recurrent or persistent ovarian cancer and BRAF V600E testing is performed to determine candidacy for dabrafenib plus trametinib.

    Liquid ctDNA-Based Testing, Including FoundationOne Liquid CDx, for Olaparib

    Covered under restricted coverage when all liquid-testing conditions are met.

    Liquid ctDNA-based testing for olaparib

    • FDA-labeled drug candidacy: The individual is a candidate for use per drug label of an applicable FDA-approved targeted agent.
    • No prior metastatic-setting testing: The individual has not had prior testing for the targeted gene or genes of interest in the metastatic setting.
    • Tissue unavailable or biopsy infeasible: There is insufficient tumor tissue available for NGS-based somatic profiling, or tissue biopsy is unsafe or considered infeasible due to the individual's clinical condition.
    • Use testing to determine candidacy for the applicable FDA-approved targeted agent or immunotherapy.
    • For liquid ctDNA-based testing, verify no prior metastatic-setting testing for the targeted gene or genes of interest.
    • For liquid ctDNA-based testing, verify insufficient tissue for NGS-based somatic profiling or an unsafe or infeasible biopsy.