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    v1.0.28
    OpenPayerPolicy UpdatesGenetic & Molecular TestingHighmark PA tumor marker coverage update | OpenPay…
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    CurrentHighmark PennsylvaniaPolicy N/A

    Tumor marker and somatic molecular testing for cancer

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    Coverage guidance for tumor marker and somatic molecular testing associated with common metastatic cancers, specifying tests tied to therapeutic decisions (companion diagnostics) and prognostic markers. Applies to Highmark Pennsylvania members and providers ordering tumor marker molecular tests.

    Policy Summary
    PayerHighmark Pennsylvania
    PolicyTumor marker and somatic molecular testing for cancer
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument linkage of the ordered tumor marker or molecular test to the cancer diagnosis and, when applicable, the associated FDA‑labeled therapy or prognostic intent.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    multipleCancer types listed
    linked testsCompanion markers

    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.

    listed
    Example CPTs

    Coverage Criteria for Tumor Marker and Somatic Molecular Testing

    Medically necessary testing

    Covered when ALL of the following are met:

    Companion diagnostic requirement: Test is for a tumor marker that has an associated FDA-labeled therapy for that cancer type (results are necessary for the safe or effective use of the associated therapy).

    Supported by table entries indicating associated treatments; therapies and tumor markers are included only for cancer types approved according to FDA labeling.

    Prognostic marker allowance: Test is ordered for prognostic purposes in metastatic disease when the marker is specifically listed as prognostic for that cancer type (e.g., BRAF for metastatic, stage IV colorectal cancer).

    Identified in the table as prognostic for colorectal metastatic BRAF.

    Tests that are not linked to an associated FDA‑labeled therapy for the specific cancer type and are not documented in the policy table as having prognostic value are not supported as companion diagnostics. When an associated treatment exists, the policy treats the tumor marker result as necessary for the safe or effective use of that therapy, and only tests tied to FDA‑labeled indications listed in the table meet that companion‑diagnostic rationale.

    Ordering tumor marker or somatic molecular tests when the results are not necessary for the safe or effective use of a listed therapy (for example, when no associated treatment is listed in the policy table or there is no FDA labeling linking the test to therapy selection) may be considered not medically necessary. The policy assumes companion status only when an associated FDA‑labeled therapy is present and identified in the table.

    Covered Indications and Listed Markers

    Metastatic cancers and listed tumor markers

    Covered metastatic cancer-marker pairs

    • Colorectal (metastatic): KRAS (CPT 81275) — associated treatments include cetuximab, panitumumab; NRAS (CPT 81311); BRAF (CPT 81210) — listed for prognostic purposes in stage IV colorectal.

      From table: colorectal metastatic entries for KRAS, NRAS, BRAF.

    • Melanoma (metastatic): BRAF — associated treatments include vemurafenib, dabrafenib, trametinib/dabrafenib, vemurafenib/cobimetinib; (CPT codes shown in table where applicable).

      Melanoma metastatic BRAF listed in table with associated targeted therapies.

    • Non-small cell lung cancer (metastatic): EGFR (CPT 81235) and ALK (CPT 81401 or 81479 for broad or unlisted molecular testing) — associated treatments include crizotinib, ceritinib, alectinib for ALK.

    Example CPT Codes and Coding References

    Example covered CPT codes listed in tableCPT
    81210BRAF
    81275KRAS
    81311NRAS
    81235EGFR
    Additional CPT codes referencedCPT
    81401broad molecular test (listed for ALK/NSCLC row)
    81479Unlisted molecular pathology procedure (listed for ALK/NSCLC row)

    Provider Actions, Prior Authorization, and Documentation

    Prior Authorization

    Prior Authorization for Listed Molecular Tests

    Prior authorization may be required for some listed molecular tests, particularly when used to determine eligibility for FDA‑labeled targeted therapies (companion diagnostics). Providers should verify prior authorization requirements with Highmark Pennsylvania before ordering these tests.

    • Affected examples include tumor marker tests tied to specific therapies (see policy code lists).
    • Prior authorization status may vary by test and cancer type.
    Documentation Required

    Link Test Order to Diagnosis and Therapy

    Documentation for ordered tumor marker or molecular tests must clearly link the test to the patient’s cancer diagnosis and, when applicable, to the specific FDA‑labeled therapy it will inform. This linkage supports medical necessity and appropriate use as a companion diagnostic.

    • Include cancer type, staging (when relevant), and the intended associated therapy (if known).

    Key Definitions

    Companion diagnostic — definition and policy implications
    DefinitionA test whose results are necessary for the safe or effective use of a specific FDA-labeled therapy; when an associated treatment exists, test results are necessary for therapy use.
    Key implication for coverageWhen an associated FDA‑labeled treatment exists, the test is considered a companion diagnostic and results are necessary for safe/effective use of that therapy.
    Scope of applicationApplies to tumor marker tests listed for cancer types approved for treatment according to FDA labeling.
    Documentation requirementTesting must be linked to the specific cancer type and associated FDA‑labeled therapy to meet companion diagnostic rationale.
    Denial riskTests not linked to an associated FDA‑labeled therapy may be excluded from coverage as not medically necessary.

    Not Covered Tests and Indications

    NOT COVERED — Tests or clinical indications that have no associated FDA‑labeled treatment and are not identified as prognostic in the policy table may be excluded from coverage as not necessary for therapy decisions. The policy limits companion diagnostic coverage to tumor markers and cancer types that are explicitly linked to FDA‑labeled therapies or noted as prognostic in the table.

    Background

    Tumor marker and somatic molecular testing identifies genetic alterations in metastatic cancers that can be prognostic or can guide targeted therapies when an associated FDA‑labeled treatment exists. For cancer types listed with an associated therapy (for example, ALK testing in non‑small cell lung cancer with associated treatments such as crizotinib, ceritinib, and alectinib), the policy considers those tests as companion diagnostics, meaning results are necessary for the safe or effective use of the specified therapy. Tests not tied to such FDA‑labeled indications are not treated as companion diagnostics under this policy.

    Policy Summary
    PayerHighmark Pennsylvania
    PolicyTumor marker and somatic molecular testing for cancer
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective DateN/A
    Next Review DateN/A
    Key ActionDocument linkage of the ordered tumor marker or molecular test to the cancer diagnosis and, when applicable, the associated FDA‑labeled therapy or prognostic intent.
    SourceLink
    On This Page
    Coverage Criteria for Tumor Marker and Somatic Molecular TestingCovered Indications and Listed MarkersExample CPT Codes and Coding ReferencesProvider Actions, Prior Authorization, and DocumentationKey DefinitionsNot Covered Tests and IndicationsBackground

    NSCLC entries and associated ALK therapies listed in source table and chunk 2.

    Documentation requirement: Medical record documents the cancer diagnosis (metastatic site/stage) and links the ordered molecular/tumor marker test to the intended therapeutic decision or prognostic intent.

    Documentation should link the ordered test to the cancer type and, when applicable, to the associated FDA-labeled therapy or prognostic intent as shown in the table.

  1. If the test result will guide use of an FDA‑approved targeted agent, note the agent name and indication in the order or clinical notes.
    2. Denial Risk

    Denial Risk for Non‑Companion or Undocumented Testing

    Testing that is not aligned with an FDA‑labeled therapy or that lacks documentation tying the test to an associated treatment may be denied as a non‑companion test or not medically necessary. When a tumor marker is listed with an associated treatment in the policy, results are considered necessary for the safe and effective use of that therapy.

    • Examples: KRAS/NRAS testing for metastatic colorectal cancer when used to determine eligibility for cetuximab or panitumumab.
    • Tests lacking an FDA‑labeled associated treatment or missing documentation linking the test to a treatment plan are at higher risk for denial.
    Note

    Provider Action Summary

    Providers should ensure prior authorization (when required) and adequate documentation are obtained and submitted with claims to reduce the risk of denial or claim delay.

    • Check Highmark Pennsylvania prior authorization lists and submit clinical notes/orders showing diagnosis, stage (if relevant), and intended treatment.
    • If test is ordered for prognostic or investigational purposes without an associated FDA‑labeled therapy, note that it may be considered not medically necessary per policy.