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    v1.0.28
    OpenPayerPolicy UpdatesHematology/OncologyBlue Cross Blue Shield Tennessee ctDNA Coverage Pr…
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    Currentblue cross blue shield - tennesseePolicy N/A

    Circulating tumor DNA (liquid biopsy) companion diagnostic assays

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    Defines medical necessity criteria for use of circulating tumor DNA (liquid biopsy) companion diagnostic assays to guide prescribing of FDA‑approved companion diagnostic‑linked medications in advanced/metastatic solid tumors, and states that tumor‑informed ctDNA testing using Signatera™ is investigational.

    Policy Summary
    Payerblue cross blue shield - tennessee
    PolicyCirculating tumor DNA (liquid biopsy) companion diagnostic assays
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 31, 2026
    Last ReviewFeb 25, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization confirming all medical appropriateness criteria are met before covering a circulating tumor DNA companion diagnostic assay.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    4medical appropriateness criteria bullet points
    2distinct policy stances

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    FDAFDA‑cleared companion diagnostics (examples)
    7/31/2026effective date

    Coverage Criteria for Circulating Tumor DNA Companion Diagnostics

    Companion diagnostic ctDNA — Medical Appropriateness

    Covered when ALL of the following are met:

    Companion diagnostic ctDNA coverage criteria

    • Diagnosis of advanced or metastatic cancer (solid tumors).
    • Treatment with a medication in which there is a liquid biopsy-based FDA-approved companion diagnostic being considered (e.g., FoundationOne® Liquid CDx, Guardant360® CDx).
    • FDA label for the drug and indication being considered states companion diagnostic testing is necessary.
    • Individual has not had previous somatic tumor testing to identify genetic changes required to prescribe the medication.

    Tumor‑informed circulating tumor DNA testing using Signatera™ is considered investigational for all indications.

    Covered and Investigational Regimens

    Test / ExampleIntended useCoverage statusCoverage conditions
    FoundationOne® Liquid CDxFDA‑cleared liquid biopsy companion diagnostic to identify genomic alterations from circulating tumor DNA for guiding targeted therapy selectionCoveredCovered when ALL of the following are met: 1) diagnosis of advanced or metastatic solid tumor; 2) treatment with a medication for which a liquid biopsy‑based FDA‑approved companion diagnostic is being considered; 3) FDA label for the drug/indication states companion diagnostic testing is necessary; 4) no prior somatic tumor testing has been performed to identify required genetic changes.
    Guardant360® CDxFDA‑cleared liquid biopsy companion diagnostic to detect tumor genomic alterations from circulating tumor DNA to inform prescribing of companion diagnostic‑linked therapiesCoveredCovered when ALL of the following are met: 1) diagnosis of advanced or metastatic solid tumor; 2) treatment with a medication for which a liquid biopsy‑based FDA‑approved companion diagnostic is being considered; 3) FDA label for the drug/indication states companion diagnostic testing is necessary; 4) no prior somatic tumor testing has been performed to identify required genetic changes.
    TestDescriptionCoverage statusRationale / Notes
    Signatera™A personalized, tumor‑informed ctDNA assay that uses prior tumor sequencing to track individualized tumor‑specific variants (designed to detect molecular residual disease).Not CoveredConsidered investigational for all indications per policy; not covered as a tumor‑informed ctDNA test.

    Referenced FDA‑cleared Tests and Codes

    Referenced FDA-cleared tests (examples)mixed
    FoundationOne® Liquid CDxFoundationOne® Liquid CDx
    Guardant360® CDxGuardant360® CDx

    Provider Actions, Prior Authorization, and Documentation

    Prior Authorization

    Prior Authorization Required

    Prior authorization is required for coverage of circulating tumor DNA (liquid biopsy) companion diagnostic assays. Prior authorization confirms that all medical appropriateness criteria are met before the assay is covered.

    • Applies when a liquid biopsy companion diagnostic assay (e.g., FoundationOne Liquid CDx, Guardant360 CDx) is being used to guide prescribing of a medication.
    • Prior authorization must verify that the member has an advanced or metastatic solid tumor, the drug under consideration has an FDA‑approved liquid biopsy companion diagnostic for the specific indication, the FDA label states companion diagnostic testing is necessary, and no prior somatic tumor testing has already identified the required genetic changes.
    Step Therapy

    Step Therapy

    No step therapy requirements apply for liquid biopsy companion diagnostic assays.

    Tumor Genomic Alterations and Biomarker Requirements

    General tumor genomic alterations — companion diagnostic ctDNA context
    Relevant genomic alterationsTumor genomic alterations required are those genetic changes used to prescribe medications that have FDA‑approved liquid biopsy companion diagnostics (e.g., alterations targeted by FoundationOne® Liquid CDx or Guardant360® CDx)
    Clinical contextAlterations must be assessed in individuals with advanced or metastatic solid tumors being considered for a therapy with an FDA‑cleared liquid biopsy companion diagnostic
    Prior testing considerationIndividuals must not have had prior somatic tumor testing to identify the genetic changes required to prescribe the medication
    Regulatory linkageAlterations must correspond to biomarkers specified as necessary in the FDA drug label for the given drug and indication

    Definitions

    Liquid biopsy (definition and context)
    DefinitionAnalysis of circulating tumor DNA (ctDNA) or circulating tumor cells from peripheral blood to characterize tumors and tumor genomes noninvasively, using single‑gene or multi‑gene panels.
    Biologic sourceCell‑free tumor DNA originates largely from apoptotic or necrotic tumor cells from primary or metastatic sites and is detectable in peripheral blood.
    Clinical usesCan be used serially to monitor molecular changes in a tumor and potentially determine sensitivity to certain treatments.
    Examples of assaysExamples include FoundationOne® Liquid CDx and Guardant360® CDx as liquid biopsy companion diagnostics.
    Signatera™ (tumor‑informed ctDNA assay)
    Definition of Signatera™A personalized, tumor‑informed ctDNA assay that uses prior sequencing of an individual's tumor to identify individualized tumor‑specific variants and monitors plasma samples for these variants over time.

    Background

    Liquid biopsy analyzes circulating tumor DNA (ctDNA) or circulating tumor cells from peripheral blood to noninvasively characterize tumor genomics and can be used serially to monitor tumor molecular changes. Cell‑free tumor DNA originates from apoptotic or necrotic tumor cells released from primary or metastatic sites. A personalized, tumor‑informed ctDNA assay such as Signatera™ uses prior tumor sequencing to track individualized variants and is currently offered as a laboratory‑developed test; its use for tumor‑informed ctDNA testing is considered investigational.

    Revision History

    2026-07-31policy_effective_dateLatest

    Policy approved and effective date set; do not implement until 7/31/26.

    2025-02-28source_reference_update

    FDA 510(k) database entry for Guardant360® (P200010) referenced in supporting documentation (retrieved 2025-02-28).

    2025-02-21source_reference_update
    Policy Summary
    Payerblue cross blue shield - tennessee
    PolicyCirculating tumor DNA (liquid biopsy) companion diagnostic assays
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateJul 31, 2026
    Last ReviewFeb 25, 2025
    Next Review DateN/A
    Key ActionObtain prior authorization confirming all medical appropriateness criteria are met before covering a circulating tumor DNA companion diagnostic assay.
    SourceLink
    On This Page
    Coverage Criteria for Circulating Tumor DNA Companion DiagnosticsCovered and Investigational RegimensReferenced FDA‑cleared Tests and CodesProvider Actions, Prior Authorization, and DocumentationTumor Genomic Alterations and Biomarker RequirementsDefinitionsBackgroundRevision History
    Documentation Required

    Required Documentation

    Documentation submitted with the prior authorization request must demonstrate medical necessity, including diagnosis and clinical context.

    • Diagnosis confirming advanced or metastatic solid tumor (specify primary site and stage).
    • Evidence that a medication with an FDA‑approved liquid biopsy companion diagnostic is being considered for treatment (drug name and indication).
    • Copy or reference to the FDA label or companion diagnostic approval showing the liquid biopsy is required for the drug/indication.
    • Documentation that the member has not previously had somatic tumor testing identifying the actionable genetic alteration.
    • Relevant clinical notes, imaging, pathology, and prior test results as applicable.
    Denial Risk

    Denial Triggers / Risk

    Requests will be denied when medical appropriateness criteria are not met.

    • Use of a liquid biopsy companion diagnostic for non‑advanced or non‑metastatic disease.
    • Drug considered does not have an FDA approval that relies on a liquid biopsy companion diagnostic for the specific indication.
    • Lack of documentation that testing is necessary per the FDA label or that prior somatic testing has not already identified the required genetic change.
    • Insufficient clinical documentation to support the diagnosis of advanced/metastatic solid tumor or the clinical intent to prescribe the companion‑diagnostic‑linked medication.
    Intended purposeDesigned to detect molecular residual disease following treatment by tracking tumor‑specific variants.
    Regulatory statusOffered as a laboratory‑developed test; FDA review for a companion diagnostic indication is ongoing.
    Coverage stanceTumor‑informed ctDNA testing using Signatera™ is considered investigational for all indications per this policy.

    FDA 510(k) database entry for FoundationOne® Liquid CDx (P190032) referenced in supporting documentation (retrieved 2025-02-21).