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    v1.0.30
    OpenPayerPolicy UpdatesGenetic & Molecular TestingMedStar Family Choice Biomarker Coverage | OpenPay…
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    CurrentMedStar Family Choice MarylandPolicy N/A

    Biomarkers for Companion Diagnostic Testing & Targeted Drug Therapy

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    Coverage and prior authorization for biomarker testing used as a companion diagnostic to direct specific cancer treatments for Maryland Medicaid members in Maryland.

    Policy Summary
    PayerMedStar Family Choice Maryland
    PolicyBiomarkers for Companion Diagnostic Testing & Targeted Drug Therapy
    Policy CodePolicy N/A
    Change TypeInitial policy
    Effective DateAugust 1, 2023
    Next Review DateN/A
    Key ActionObtain prior authorization for biomarker testing and confirm that it is used as an FDA-approved companion diagnostic consistent with current NCCN recommendations.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    Category 2A+Minimum NCCN evidence and consensus level for coverage
    Prior authUtilization management requirement
    Once/lifetimeGeneral testing frequency limit
    3Listed frequency exceptions

    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.

    Not coveredExcluded testing

    Coverage Criteria

    Companion diagnostic testing

    Covered when ALL of the following are met:

    Companion diagnostic coverage requirements

    • ALL of the following

      • The biomarker test is approved by the Food and Drug Administration.
      • The biomarker test meets the applicable Clinical Laboratory Improvement Amendments standards.
      • The biomarker test is recommended under the current NCCN guidelines for its intended and specific use.
      • The biomarker test has NCCN evidence and consensus of Category 2A or higher.NCCN Category 2A or higher
      • The companion drug or therapy is approved by the Food and Drug Administration for the specific cancer treatment.

    Testing frequency and repeat testing

    Repeat testing may be considered only under the following circumstances:

    Exceptions to once-per-lifetime testing

    • The patient has more than one primary cancer diagnosis.
    • The patient develops a new primary cancer diagnosis.
    • Repeat biomarker testing is being performed for Measurable Residual Disease testing and is supported by medical literature and clinical evidence.

      Companion biomarker testing is generally limited to once per lifetime.

    Biomarker testing is used as a companion diagnostic to identify patients who may be appropriate for a specific targeted cancer treatment. Coverage depends on the biomarker being FDA approved, recommended by the current NCCN guidelines for the intended and specific use, and supported at NCCN Category 2A or higher. The corresponding drug or therapy must also be FDA approved for the specific cancer treatment.

    Biomarkers are not covered when they are not FDA approved or when the applicable NCCN evidence and consensus level is Category 2B or below.

    Provider Actions and Authorization Requirements

    Prior Authorization

    Obtain prior authorization

    Prior authorization is required for biomarker testing. The requested test must be used as a companion diagnostic consistent with the current NCCN guideline recommendation and applicable coverage criteria.

    Denial Risk

    Confirm FDA and NCCN support

    Coverage is not available when the biomarker is not FDA approved or when its NCCN evidence and consensus level is Category 2B or below.

    Denial Risk

    Do not order asymptomatic screening

    Biomarker testing performed on asymptomatic patients for screening the patient or the patient's relatives is not covered.

    Policy Background

    Companion diagnostic tests identify biomarkers intended to direct selection or use of a specific cancer treatment. Coverage is linked to the test's FDA approval, the current NCCN recommendation for its specific use, and the FDA approval of the corresponding targeted drug or therapy. NCCN support must be Category 2A or higher for coverage consideration; Category 2B or below does not meet the coverage standard.

    Definitions

    Companion diagnostic test
    DefinitionA test intended to direct selection or use of a specific cancer treatment.
    Approval requirementThe biomarker test must be approved by the Food and Drug Administration.
    Clinical and treatment requirementsThe test must meet applicable NCCN cancer guidelines and Clinical Laboratory Improvement Amendments standards, and the companion drug or therapy must be FDA approved for the specific cancer treatment.
    NCCN Levels of Evidence and Consensus Categories
    Category 1Based on high-level evidence, with uniform NCCN consensus that the intervention is appropriate.
    Category 2ABased on lower-level evidence, with uniform NCCN consensus that the intervention is appropriate.

    Covered Indications

    Biomarker testing used as a companion diagnostic to direct a specific cancer treatment

    Covered when ALL of the following are met:

    Specific companion diagnostic use

    • The biomarker test is used as a companion diagnostic to direct a specific cancer treatment.
    • The test is recommended by the current NCCN guidelines for the intended and specific use.
    • The test has NCCN evidence and consensus of Category 2A or higher.NCCN Category 2A or higher

      Coverage is considered for the biomarker test's specific NCCN algorithm of care recommendation.

    Repeat biomarker testing

    Repeat testing may be considered when ANY of the following circumstances apply:

    Not Covered Services

    The following are not covered: biomarkers that are not FDA approved; biomarkers with NCCN evidence and consensus of Category 2B or below; and biomarker testing performed on asymptomatic patients to screen the patient or the patient's relatives.

    Policy Summary
    PayerMedStar Family Choice Maryland
    PolicyBiomarkers for Companion Diagnostic Testing & Targeted Drug Therapy
    Policy CodePolicy N/A
    Change TypeInitial policy
    Effective DateAugust 1, 2023
    Next Review DateN/A
    Key ActionObtain prior authorization for biomarker testing and confirm that it is used as an FDA-approved companion diagnostic consistent with current NCCN recommendations.
    SourceLink
    On This Page
    Coverage CriteriaProvider Actions and Authorization RequirementsPolicy BackgroundDefinitionsCovered IndicationsNot Covered Services
    Denial Risk

    Meet companion diagnostic criteria

    Requests may be denied when the test is not used as an FDA-approved companion diagnostic under the current NCCN recommendation for the specific cancer treatment, or when the applicable coverage criteria are not met.

    Category 2BBased on lower-level evidence, with NCCN consensus that the intervention is appropriate.
    Category 3Based on any level of evidence, with major NCCN disagreement that the intervention is appropriate.

    Covered repeat-testing circumstances

    • The patient has more than one primary cancer diagnosis.
    • The patient develops a new primary cancer diagnosis.
    • The patient requires repeat biomarker testing for Measurable Residual Disease, and the testing is supported by medical literature and clinical evidence.

      Companion biomarkers are generally performed once per lifetime.