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    v1.0.28
    OpenPayerPolicy UpdatesOtorhinolaryngology (ENT)Blue Cross Blue Shield Tennessee HPV Testing Cover…
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    Currentblue cross blue shield - tennesseePolicy N/A

    Oral Cancer Screening and Testing

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    Defines coverage stance for tests used to establish HPV tumor status in oropharyngeal squamous cell carcinoma and exclusions for various oral cancer screening tests (salivary biomarkers, genotyping, gene expression panels, etc.), and lists applicable CPT/HCPCS/Proprietary procedure codes. Applies to BlueCross BlueShield of Tennessee members, subject to individual benefit coverage and federal/state regulations.

    Policy Summary
    Payerblue cross blue shield - tennessee
    PolicyOral Cancer Screening and Testing
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective Date
    Next Review Date
    Key ActionProviders must document that the individual has oropharyngeal squamous cell carcinoma when ordering testing to establish HPV tumor status (p16 IHC or HPV E6/E7 mRNA testing).
    SourceLink

    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.

    POLICY UPDATE CHANGES

    No material clinical/coverage changes

    1Covered Indication (HPV testing for OPSCC)
    4Not covered test categories (listed)
    9Procedure codes referenced

    Coverage Summary

    Scope: Defines coverage stance for tests used to establish HPV tumor status in oropharyngeal squamous cell carcinoma (OPSCC) and exclusions for various oral cancer screening tests (salivary biomarkers, genotyping, gene expression panels). Lists applicable CPT/HCPCS/Proprietary procedure codes and notes application is subject to individual benefit coverage and federal/state regulations.

    Coverage stance: Mixed — HPV testing to determine tumor status in individuals with confirmed OPSCC is covered when criteria are met, while salivary biomarker tests, HPV genotyping assays, and gene expression profiling panels (e.g., mRNA CancerDetect™) are identified as not meeting coverage criteria.

    Key statistics and referenced codes
    Covered Indication (count)1
    Not covered test categories (count)4
    Procedure codes referenced (count)9

    Medical-Necessity Criteria

    Coding

    Covered / Relevant procedure codes (reference list)mixed
    82397Chemiluminescent assay
    87624Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types
    87625Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed
    88342Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure
    88341Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure
    0296UOncology (oral and/or oropharyngeal cancer), gene expression profiling by RNA sequencing at least 20 molecular features, saliva, algorithm reported as positive or negative for signature associated with malignancy (Proprietary test: mRNA CancerDetect™; Viome Life Sciences, Inc.)
    0429UHuman papillomavirus (HPV), oropharyngeal swab, 14 high-risk types
    81599Unlisted multianalyte assay with algorithmic analysis
    Codes associated with non-covered tests (listed for billing reference)CPTNot Covered
    0296UProprietary test: mRNA CancerDetect™ (listed in policy as an example of gene expression profiling — policy states panels such as mRNA CancerDetect™ DO NOT MEET COVERAGE CRITERIA)
    81599Unlisted multianalyte assay with algorithmic analysis (may be used for proprietary saliva/genetic panel tests that are not covered)

    Provider Actions

    Documentation Required

    Confirm oropharyngeal squamous cell carcinoma diagnosis

    Providers must document that the individual has oropharyngeal squamous cell carcinoma when ordering testing to establish HPV tumor status (p16 IHC or HPV E6/E7 mRNA testing).

    • 88342
    • 88341
    • 87624
    • 0429U
    Prior Authorization

    Coverage dependent on member benefits and regulations

    Application of coverage criteria is dependent upon an individual's benefit coverage at the time of the request; federal and state (Medicare/Medicaid) regulations may supersede this policy and must be followed.

    Background & Evidence

    Epidemiology: Oral cavity and oropharyngeal cancers are common; the American Cancer Society estimated approximately 58,450 diagnoses and 12,230 deaths in 2024 for oral cavity and oropharyngeal cancers. Oral squamous cell carcinoma (OSCC) is the predominant histology.

    Diagnostic considerations: Early detection often depends on conventional oral examination (COE) and scalpel biopsy with histology; many cases arise from potentially malignant disorders. Adjunctive tests (vital staining, brush cytology, chemiluminescence, autofluorescence, salivary biomarkers) have variable sensitivity and specificity across studies and are not recommended as replacements for COE followed by biopsy.

    HPV and tumor testing: Human papillomavirus (HPV) is a major contributor to oropharyngeal cancers. Major professional organizations endorse using p16 immunohistochemistry (IHC) as a widely available surrogate marker with very good agreement with HPV E6/E7 mRNA to establish tumor HPV status for oropharyngeal cancers; alternate validated HPV nucleic acid assays may be used per guidance and confirmation practices.

    SourceSummary
    NCCN/ASCO/CAP guidanceSupport p16 IHC as surrogate for HPV E6/E7 mRNA for oropharyngeal cancer
    Systematic reviews/meta-analysesVariable sensitivity/specificity for adjunctive screening tests; overall insufficient evidence to support salivary/genotyping/gene expression panels for screening

    Oral cancer: Cancer occurring in the oral cavity between the vermilion border of the lips and the junction of the hard and soft palates or the posterior one third of the tongue.

    HPV testing for tumor status: Testing to establish HPV tumor status using high-risk HPV E6/E7 mRNA expression testing or p16 immunohistochemistry (IHC) as a surrogate.

    Revision History

    Policy Summary
    Payerblue cross blue shield - tennessee
    PolicyOral Cancer Screening and Testing
    Policy CodePolicy N/A
    Change TypeNo material changes
    Effective Date
    Next Review Date
    Key ActionProviders must document that the individual has oropharyngeal squamous cell carcinoma when ordering testing to establish HPV tumor status (p16 IHC or HPV E6/E7 mRNA testing).
    SourceLink
    On This Page
    Coverage SummaryMedical-Necessity CriteriaCodingProvider ActionsBackground & EvidenceRevision History
    Billing Rule

    Procedure code use for proprietary/nonstandard tests

    Use unlisted or appropriate CPT/HCPCS/PLA procedure codes for proprietary multianalyte or gene expression saliva tests; examples of such codes include unlisted multianalyte assay with algorithmic analysis and specific PLA codes. Proprietary saliva/gene-expression tests (for example, mRNA CancerDetect™ and OraRisk®) are identified in this policy as not meeting coverage criteria and may be denied.

    • 81599
    • 0296U