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    v1.0.30
    OpenPayerPolicy UpdatesGenetic & Molecular TestingMedStar Family Choice Biomarker Prior Auth | OpenP…
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    CurrentMedStar Family Choice of MarylandPolicy 1432

    Biomarkers for Companion Diagnostic Testing & Targeted Drug Therapy

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    This policy governs MedStar Family Choice coverage and prior authorization for biomarker testing used to guide FDA-approved targeted cancer treatments. It applies to providers requesting testing for members with an established cancer diagnosis or clinically substantiated suspicion of cancer.

    Policy Summary
    PayerMedStar Family Choice of Maryland
    PolicyBiomarkers for Companion Diagnostic Testing & Targeted Drug Therapy
    Policy CodePolicy 1432
    Change TypeAdministrative updateno material clinical or coverage change
    Effective DateJuly 1, 2025
    Last ReviewAug 1, 2023
    Next Review DateN/A
    Key ActionObtain prior authorization for companion diagnostic biomarker testing and submit supporting clinical information for medical director review.
    SourceLink
    POLICY UPDATE CHANGES

    The July 2025 revision added a link and URL to the Maryland Department of Health biomarker clinical criteria document.

    The July 2024 revision replaced named responsible parties and approvers with role titles.

    The July 2024 revision added PT 13-24 to the regulatory reference.

    Prior authorization

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    Utilization management requirement
    Once per lifetimeStandard testing frequency
    Category 1 or 2AMinimum NCCN evidence level
    Hematology/oncologyRequired ordering provider
    Not coveredAsymptomatic screening

    Coverage Criteria

    Initial companion diagnostic coverage

    Biomarker testing used as a companion diagnostic to direct a specific cancer treatment may be considered for approval when all of the following are met:

    All requirements

    • The biomarker test is approved under current FDA guidelines for the intended and specific use, including the type of cancer the member has.
    • The biomarker test is recommended under current NCCN guidelines for the intended and specific use.NCCN evidence Category 1 or Category 2A
    • The biomarker testing facility meets Clinical Laboratory Improvement Amendments (CLIA) standards.
    • The companion drug or therapy is FDA approved for the specific cancer treatment.
    • The companion drug or therapy is listed on the Maryland Medicaid Fee Schedule.

    Utilization and repeat-testing criteria

    Testing to identify companion biomarkers is limited to once per lifetime unless one of the following exceptions applies:

    Standard utilization

    • Testing to identify companion biomarkers is performed no more than once per lifetime.

    • Exceptions to the lifetime limit

      • The member has more than one primary cancer diagnosis.
      • The member develops a new primary cancer diagnosis.
      • Repeat biomarker testing is requested for measurable residual disease (MRD) testing and is supported by submitted medical literature and clinical evidence.

        Submit the supporting literature and clinical evidence with the request.

    Ordering and clinical context

    The following ordering and clinical-context conditions apply to biomarker testing:

    All requirements

    • The biomarker test is ordered by a hematology/oncology specialist.Ordering provider: hematology/oncology specialist
    • The testing is performed by an allowed laboratory and may be directed to a preferred laboratory vendor unless it is a covered proprietary test.

      Testing may also be redirected to a specific MCO-preferred test consistent with NCCN recommendations to determine companion therapy.

    • The member has an established diagnosis of cancer or a clinically substantiated suspicion of cancer supported by abnormal results from histologic and/or cytologic examination when applicable.

    Biomarkers that are not FDA approved for the intended use are excluded from coverage.

    Biomarker testing is excluded when current NCCN evidence is Category 2B or Category 3.

    Biomarker testing performed on asymptomatic members to screen the member or the member’s relatives is not covered under this clinical criterion.

    Biomarker testing performed for research is not covered.

    Testing may not be covered when the member lacks an established cancer diagnosis or a clinically substantiated suspicion of cancer supported by abnormal histologic and/or cytologic examination.

    Covered Indications

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

    Biomarker testing used as a companion diagnostic to direct a specific cancer treatment may be considered medically necessary when all of the following are met:

    Covered indication requirements

    • The biomarker test is FDA approved under current FDA guidelines for the member's specific cancer and intended use.
    • The biomarker test is recommended under current NCCN guidelines for that specific intended use.NCCN evidence Category 1 or Category 2A
    • The testing facility meets Clinical Laboratory Improvement Amendments (CLIA) standards.
    • The companion drug or therapy is FDA approved for the specific cancer treatment.

    Eligibility Requirements

    For a clinically substantiated suspicion of cancer, the request must include abnormal histologic and/or cytologic examination results supporting the cancer or suspicion of cancer. Repeat measurable residual disease biomarker testing requires supporting medical literature and clinical evidence submitted with the request.

    Provider Actions

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for biomarker testing used as a companion diagnostic to direct specific cancer treatment. MFC reviews requests for medical necessity after supporting clinical information is submitted; a medical director issues the coverage decision.

    • The MFC nurse enters the request into the clinical software system and attaches supporting clinical information.
    • The request is forwarded to a medical director for review, and the requesting provider is notified of the decision according to UM Process Policy 110.
    • A companion diagnostic test determines whether a specific medication or therapy is likely to be more effective and guides clinical management.
    Step Therapy

    Preferred Laboratory or Test Redirection

    Biomarker testing may be directed to a preferred laboratory vendor unless the test is a covered proprietary test. MFC may also redirect testing to a specific MCO-preferred test consistent with NCCN recommendations for determining companion therapy.

    Background

    Cancer biomarkers can provide information that affects treatment selection. A biomarker is considered a companion diagnostic when it determines whether a specific medication or therapy is likely to be more effective and thereby guides clinical management.

    Definitions

    Companion Diagnostic Test
    DefinitionA biomarker test that determines whether a specific medication or therapy is likely to be more effective in treatment, thereby guiding clinical management.

    Not Covered

    The following biomarker testing is not covered: non-FDA-approved biomarkers; tests with NCCN evidence of Category 2B or Category 3; testing of asymptomatic members to screen the member or the member’s relatives; testing performed for research; and testing when the member lacks an established cancer diagnosis or a clinically substantiated suspicion of cancer supported by abnormal histologic and/or cytologic examination.

    Policy Summary
    PayerMedStar Family Choice of Maryland
    PolicyBiomarkers for Companion Diagnostic Testing & Targeted Drug Therapy
    Policy CodePolicy 1432
    Change TypeAdministrative updateno material clinical or coverage change
    Effective DateJuly 1, 2025
    Last ReviewAug 1, 2023
    Next Review DateN/A
    Key ActionObtain prior authorization for companion diagnostic biomarker testing and submit supporting clinical information for medical director review.
    SourceLink
    On This Page
    Coverage CriteriaCovered IndicationsEligibility RequirementsProvider ActionsBackgroundDefinitionsNot Covered
  1. The companion drug or therapy is listed on the Maryland Medicaid Fee Schedule.
    • Confirm whether the requested laboratory is a preferred vendor before ordering.
    • Redirection may be made to an MCO-preferred test when it is consistent with NCCN recommendations.
    Documentation Required

    Supporting Clinical Documentation

    Submit documentation supporting the member’s established cancer diagnosis or substantiated suspicion of cancer, including abnormal cancer-related findings from histologic and/or cytologic examination. Requests for repeat measurable residual disease (MRD) testing must also include the supporting medical literature and clinical evidence.

    • Histologic and/or cytologic examination results showing abnormal findings related to cancer or a substantiated suspicion of cancer.
    • Clinical documentation supporting the diagnosis, clinical evaluation, and intended cancer treatment.
    • For MRD testing, include relevant medical literature and clinical evidence.
    Denial Risk

    FDA or NCCN Criteria Not Met

    Coverage may be denied when the biomarker test is not FDA approved for the member’s specific cancer and intended use, or when it is not recommended by current NCCN guidelines at the required evidence level.

    • The test must have current FDA approval for its intended and specific use, including the type of cancer being treated.
    • The test must be recommended under current NCCN guidelines for the intended use.
    • NCCN evidence must be Category 1 or Category 2A; Category 2B or Category 3 does not meet the criterion.
    Denial Risk

    Laboratory or Companion Therapy Requirements

    Coverage may be denied when the biomarker testing facility does not meet Clinical Laboratory Improvement Amendments (CLIA) standards or when the companion drug or therapy is not FDA approved for the specific cancer treatment.

    • The testing facility must meet CLIA standards.
    • The companion drug or therapy must be FDA approved for the specific cancer treatment.
    • The companion drug or therapy must be listed on the Maryland Medicaid Fee Schedule.
    Denial Risk

    Uncovered Testing Purpose or Clinical Context

    Biomarker testing used for research is not covered. Testing may not be covered for asymptomatic members undergoing screening, including screening of members or their relatives, or when there is neither an established cancer diagnosis nor a substantiated suspicion supported by clinical evaluation and abnormal histologic or cytologic findings.

    • Research-only testing is not covered.
    • Screening biomarkers for asymptomatic members or their relatives are not covered under this clinical criterion.
    • A qualifying cancer diagnosis or substantiated suspicion of cancer, with supporting abnormal histologic and/or cytologic results, is required.
    Billing Rule

    Lifetime Frequency Limit

    Testing to identify companion biomarkers may be performed once per lifetime as a routine utilization limit. Exceptions may apply when the member has more than one primary cancer, develops a new primary cancer, or requires repeat MRD testing supported by medical literature and clinical evidence.

    • Routine companion biomarker testing is limited to once per lifetime.
    • Exceptions include more than one primary cancer diagnosis or development of a new primary cancer diagnosis.
    • Repeat MRD testing requires submitted medical literature and clinical evidence.
    Note

    Ordering Provider Requirement

    Biomarker testing must be ordered by a hematology/oncology specialist.

    • Verify that the ordering provider is a hematology/oncology specialist before submitting the request.