Loading...

    Explore
    • Policy Monitoring
    • Live Policy Feed
    • Billing Codes
    • NPI Medicare & Medicaid
    • Healthcare Providers
    • Health Insurance Payers
    • States
    • Service Lines
    • Taxonomy Codes
    Lookup tools
    • Billing Code Lookup
    • CPT Modifier Lookup
    • Provider Taxonomy Code Lookup
    • Healthcare Provider & Facility Lookup
    • Health Insurance Payer Lookup
    • Payer Contact Directory

    Policy & Benchmark Tools

    • Prior Authorization Lookup
    • Coverage Criteria Lookup
    • Timely Filing Lookup
    • Billing Code Reimbursement Rates
    • Payer Comparison Dashboard
    • Facility Comparison Dashboard
    • All tools

    Company

    • About OpenPayer
    • Data Sources
    • Trek Health
    OpenPayerby Trek Health
    LinkedInYouTube

    © 2026 Trek Health. All rights reserved.

    OpenPayer is built and maintained by Trek Health.

    v1.0.28
    OpenPayerPolicy UpdatesOtorhinolaryngology (ENT)Blue Cross Blue Shield TN HPV tumor-status Coverag…
    Ask Trek AI about this page
    CurrentBlue Cross Blue Shield - TennesseePolicy N/A

    Oral Cancer Screening and Testing — HPV Tumor-Status and Noncovered Screening Tests

    Customize your policy alerts

    Sign up for all blue cross blue shield - tennessee policy alerts

    Know when blue cross blue shield - tennessee releases new policies or updates existing guidance.

    Monitor payer policy activity

    Receive email alerts as soon as relevant payer policies are published or updated.

    Defines coverage for tests to establish HPV tumor status in oropharyngeal squamous cell carcinoma and states which salivary/genomic screening tests for oral cancer are not covered; applies to BlueCross BlueShield of Tennessee members.

    Policy Summary
    PayerBlue Cross Blue Shield - Tennessee
    PolicyOral Cancer Screening and Testing — HPV Tumor-Status and Noncovered Screening Tests
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionWhen submitting for coverage of HPV testing to establish tumor HPV status in oropharyngeal SCC, include documentation of test type (mRNA E6/E7 or p16 IHC), relevant specimen information, and use the listed CPT/HCPCS/proprietary codes.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    1Covered clinical indication

    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.

    4Noncovered test types
    9Procedure codes listed
    FDA/CLIALDT/CLIA note

    Coverage Criteria

    HPV testing to establish tumor status (Covered)

    Covered when ALL of the following are met

    HPV tumor-status testing: Testing for high-risk HPV using either mRNA expression testing for HPV E6/E7 or immunohistochemistry for p16 expression to establish HPV tumor status for individuals with oropharyngeal squamous cell carcinoma.

    Meets coverage criteria per policy.

    Not medically necessary / Not covered screening tests

    The following DO NOT MEET COVERAGE CRITERIA for screening, detection, or diagnosis of oral cancer

    Noncovered screening/diagnostic tests: Salivary biomarker testing (e.g., peptides/proteins, nucleic acids, metabolites).

    Listed explicitly as not meeting coverage criteria due to lack of evidence.

    Noncovered screening/diagnostic tests: Genotyping of HPV (e.g., OraRisk® HPV).

    Listed explicitly as not meeting coverage criteria due to lack of evidence.

    Noncovered screening/diagnostic tests: Gene expression profiling.

    Listed explicitly as not meeting coverage criteria due to lack of evidence.

    Noncovered screening/diagnostic tests: Panels that incorporate genetic risk factors with nongenetic biomarkers (e.g., mRNA CancerDetect™).

    Listed explicitly as not meeting coverage criteria due to lack of evidence.

    Salivary biomarker tests, HPV genotyping assays, gene expression profiling, and combined genetic/nongenetic biomarker panels are specifically listed in this policy as not meeting coverage criteria for the screening, detection, or diagnosis of oral cancer. Examples called out in the policy include salivary tests for peptides/proteins, nucleic acids, or metabolites; HPV genotyping such as OraRisk® HPV; gene expression profiling; and multi-marker panels that combine genetic risk factors with nongenetic biomarkers (for example, mRNA CancerDetect™).

    By contrast, testing intended to establish tumor HPV status in oropharyngeal squamous cell carcinoma is covered when performed using one of the supported methods: high-risk HPV mRNA E6/E7 expression testing or p16 immunohistochemistry. The policy distinguishes these clinically directed, tumor-based assays from the excluded screening/detection tests listed above.

    Use of salivary biomarker tests and panels for routine oral cancer screening or to make a diagnosis is considered not medically necessary under this policy because there is insufficient published scientific evidence demonstrating that these tests are required and beneficial for patient diagnosis or treatment. Requests for such testing for screening or diagnostic purposes are therefore at risk for denial.

    Providers should ensure that any HPV testing submitted for coverage is clearly documented as intended to establish tumor HPV status for an existing diagnosis of oropharyngeal squamous cell carcinoma and that the method used is one of the covered methods (mRNA E6/E7 expression testing or p16 immunohistochemistry). The policy does not endorse use of salivary biomarker or combined panels for screening, detection, or diagnostic decision‑making for oral cancer.

    Coding

    Applicable CPT/HCPCS/Proprietary codes listedmixed
    81599Unlisted multianalyte assay with algorithmic analysis.
    82397Chemiluminescent assay.
    87624Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68).
    87625Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed.
    88341Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure (List separately in addition to code for primary procedure).
    88342Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure.
    0429UHuman papillomavirus (HPV), oropharyngeal swab, 14 high-risk types (ie, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). Proprietary test: Omnipathology Oropharyngeal HPV PCR Test.

    Provider Actions / Billing Notes

    Billing Rule

    Procedure codes for HPV and related assays

    Use the listed CPT/HCPCS and proprietary codes when submitting claims for HPV testing to establish tumor HPV status in oropharyngeal squamous cell carcinoma: 81599, 82397, 87624, 87625, 88341, 88342, and 0429U. Include the appropriate code for the test method performed (for example, 87624/87625 for nucleic acid detection, 88342/88341 for p16 immunohistochemistry, 0429U for the proprietary Omnipathology oropharyngeal HPV PCR test, or 81599 for unlisted algorithmic assays).

    • 87624 — HPV, high-risk nucleic acid detection
    • 87625 — HPV types 16/18 (includes 45 if performed)
    • 88342 — Initial single antibody immunohistochemistry (e.g., p16)
    • 88341 — Each additional single antibody stain (if applicable)
    • 0429U — Omnipathology Oropharyngeal HPV PCR Test (14 high-risk types)
    • 82397 — Chemiluminescent assay (if applicable)
    • 81599 — Unlisted multianalyte assay with algorithmic analysis

    Definitions

    Oral cancer — definition
    DefinitionOral 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.
    Most common histologySquamous cell carcinoma is the most common type of oral cancer.
    Anatomic scopeIncludes malignancy of the oral cavity and the posterior one third of the tongue within the described boundaries.
    HPV tumor-status testing (covered) — acceptable methods
    Covered test methodsHigh‑risk HPV testing using mRNA expression testing for HPV E6/E7 or immunohistochemistry (IHC) for p16 expression to establish tumor HPV status in individuals with oropharyngeal squamous cell carcinoma.
    Clinical purposeTo establish HPV tumor status for individuals with oropharyngeal squamous cell carcinoma (meets coverage criteria).

    Background

    Oral cancer in this policy context refers to malignancies arising in the oral cavity and adjacent structures, with squamous cell carcinoma being the most common histologic type encountered. Determination of tumor human papillomavirus (HPV) status is clinically relevant for oropharyngeal squamous cell carcinoma and is supported when performed by validated tumor-based methods such as high-risk HPV mRNA E6/E7 expression testing or p16 immunohistochemistry.

    Policy Summary
    PayerBlue Cross Blue Shield - Tennessee
    PolicyOral Cancer Screening and Testing — HPV Tumor-Status and Noncovered Screening Tests
    Policy CodePolicy N/A
    Change TypeNo material change
    Effective DateN/A
    Next Review DateN/A
    Key ActionWhen submitting for coverage of HPV testing to establish tumor HPV status in oropharyngeal SCC, include documentation of test type (mRNA E6/E7 or p16 IHC), relevant specimen information, and use the listed CPT/HCPCS/proprietary codes.
    SourceLink
    On This Page
    Coverage CriteriaCodingProvider Actions / Billing NotesDefinitionsBackground
    Note

    LDTs: CLIA high-complexity and laboratory validation

    Laboratory-developed tests (LDTs) used for HPV or other biomarker testing are regulated by CMS as CLIA high-complexity tests and are not FDA-approved or cleared; performing laboratories must validate these in-house LDTs per CLIA requirements.

    • LDTs are regulated by CMS as high-complexity tests under CLIA '88.
    • LDTs are not approved or cleared by the FDA and require laboratory validation for clinical use.
    Documentation Required

    Documentation required to support HPV tumor-status testing

    Document in the medical record that HPV testing is being performed to establish tumor HPV status for oropharyngeal squamous cell carcinoma, and record the test type and relevant pathology specimen information (e.g., mRNA E6/E7 testing or p16 immunohistochemistry). Reference the applicable CPT/HCPCS/proprietary test code(s) used for the submitted test.

    • Specify clinical indication: to establish tumor HPV status in oropharyngeal SCC.
    • Record test method (mRNA E6/E7 or p16 immunohistochemistry) and specimen details.
    • Include the applicable procedure code(s) from the policy when submitting the claim.
    Denial Risk

    Noncovered oral cancer screening tests — denial risk

    Requests for the following oral cancer screening/diagnostic tests do not meet coverage criteria and are at risk for denial: salivary biomarker testing, HPV genotyping (for example, OraRisk®), gene expression profiling, and panels combining genetic and nongenetic biomarkers.

    • Salivary biomarker testing (peptides/proteins, nucleic acids, metabolites)
    • Genotyping of HPV (e.g., OraRisk® HPV)
    • Gene expression profiling
    • Panels that combine genetic risk factors with nongenetic biomarkers (e.g., mRNA CancerDetect™)
    Documentation noteDocumentation should identify the test type performed (e.g., HPV E6/E7 mRNA or p16 IHC) and relevant pathology specimen information when submitting for coverage.