Currentblue cross blue shield - tennesseePolicy N/A

Oral Cancer Screening and Testing

Defines coverage for tests used to establish HPV tumor status in oropharyngeal squamous cell carcinoma and states which salivary/genetic screening tests do not meet coverage criteria; applies to members of the payer when benefits and applicable regulations permit.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyOral Cancer Screening and Testing

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionRequesters must document medical necessity and member benefit coverage at time of request; prior authorization follows member benefits and applicable regulations.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Covered indication for HPV tumor status testing in oropharyngeal squamous cell carcinoma

4Types of tests listed as not meeting coverage criteria for screening/diagnosis

9Procedure codes listed in policy

FDA/CLIA noteLDTs regulated as high-complexity under CLIA; not FDA-approved

Coverage Criteria

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Covered indication

Covered when ALL of the following are met

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

From policy indications; supports clinical HPV status determination.

Not medically necessary / Not covered tests

Not covered for screening/diagnosis

Non-covered screening/diagnostic tests: The following tests do not meet coverage criteria for screening, detection, or diagnosis of oral cancer: (a) Salivary biomarker testing (e.g., peptides/proteins, nucleic acids, metabolites); (b) Genotyping of HPV (e.g., OraRisk® HPV); (c) Gene expression profiling; (d) Panels that incorporate genetic risk factors with nongenetic biomarkers (e.g., mRNA CancerDetect™).

Policy states lack of published scientific literature confirming these tests are required and beneficial.

This policy addresses several laboratory approaches related to oral and oropharyngeal cancer evaluation. High‑risk HPV testing to establish tumor HPV status in individuals with oropharyngeal squamous cell carcinoma is covered when performed by either mRNA expression testing for HPV E6/E7 or p16 immunohistochemistry, as these methods meet coverage criteria to determine HPV tumor status. By contrast, the policy identifies multiple technologies that lack sufficient published evidence to support their use for screening, detection, or diagnosis of oral cancer. Specifically, salivary biomarker testing (for example, assays of peptides/proteins, nucleic acids, or metabolites), HPV genotyping such as OraRisk® HPV, gene expression profiling, and combined panels that mix genetic risk factors with nongenetic biomarkers (e.g., mRNA CancerDetect™) are listed as not meeting the coverage criteria for screening, detection, or diagnosis.

Use of the listed salivary and genetic tests for screening, detection, or diagnosis of oral cancer is considered not medically necessary because there is a lack of published scientific literature demonstrating that these tests are required and beneficial for diagnosis or treatment. Examples explicitly named in the policy include salivary biomarker testing, HPV genotyping (OraRisk® HPV), gene expression profiling, and combined genetic/nongenetic biomarker panels (e.g., mRNA CancerDetect™).

Procedure Codes

Applicable CPT/HCPCS Procedure Codesmixed

81599	Unlisted multianalyte assay with algorithmic analysis.
82397	Chemiluminescent assay.
87624	Infectious 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).
87625	Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), types 16 and 18 only, includes type 45, if performed.
88341	Immunohistochemistry or immunocytochemistry, per specimen; each additional single antibody stain procedure (List separately in addition to code for primary procedure).
88342	Immunohistochemistry or immunocytochemistry, per specimen; initial single antibody stain procedure.
0296U	Oncology (oral and/or oropharyngeal cancer), gene expression profiling by RNA sequencing at least 20 molecular features (eg, human and/or microbial mRNA), saliva, algorithm reported as positive or negative for signature associated with malignancy (Proprietary test: mRNA CancerDetect™; Lab/Manufacturer: Viome Life Sciences, Inc.).
0429U	Human 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; Lab/Manufacturer: OmniPathology Solutions, Medical Corporation).

Provider Actions and Requirements

Documentation Required

Benefit and Regulatory Documentation

Application of coverage criteria is dependent upon an individual's benefit coverage at the time of the request. Specifications pertaining to Medicare and Medicaid follow applicable government policies (see 'Applicable State and Federal Regulations'). Documentation must support medical necessity and member benefit coverage. If there is a conflict between this policy and any relevant government policy (e.g., Local Coverage Determinations or National Coverage Determinations for Medicare, or state Medicaid rules), the government policy will govern the determination.

Prior authorization requirements follow the member's benefit plan and may be required per the payer or applicable government program.
Clinical documentation should justify medical necessity (diagnosis, clinical findings, prior therapies, and how results will influence management).
Medicare/Medicaid determinations supersede this policy when applicable.

Prior Authorization

Provider Action Callouts

Providers should follow these actionable rules when ordering or billing for oral/oropharyngeal cancer testing.

Requests to establish HPV tumor status for oropharyngeal squamous cell carcinoma: testing for high-risk HPV by mRNA E6/E7 expression or p16 immunohistochemistry meets coverage criteria — include supporting pathology and clinical documentation.
The following tests DO NOT meet coverage criteria and may be denied: salivary biomarker testing (peptides/proteins, nucleic acids, metabolites); HPV genotyping tests marketed for oral/oropharyngeal screening (e.g., OraRisk® HPV); gene expression profiling tests for saliva (e.g., mRNA CancerDetect™/0429U/0296U); and panels combining genetic and nongenetic biomarkers.
Procedure codes listed in the policy (e.g., 81599, 82397, 87624, 87625, 88341, 88342, 0296U, 0429U) are provided for billing reference only and do not guarantee coverage — prior authorization and coverage are subject to member benefits and applicable regulations.

Denial Risk

Denial Risk for Noncovered Tests

Denial triggers: requests for tests that do not meet coverage criteria are at risk for denial. Ensure documentation demonstrates medical necessity and that the requested test is recognized as covered under the member's specific benefit or by applicable Medicare/Medicaid guidance.

Salivary biomarker testing for screening/diagnosis of oral cancer — commonly denied (no established clinical utility).
HPV genotyping for oral/oropharyngeal screening (e.g., OraRisk® HPV) — commonly denied.
Gene expression profiling of saliva (e.g., mRNA CancerDetect™, CPT/HCPCS 0296U) — commonly denied.
Combined genetic/nongenetic biomarker panels for oral cancer risk — commonly denied.

Background

Oral cancer refers to malignancies of the oral cavity and adjacent structures, most commonly squamous cell carcinoma. Determination of HPV tumor status is clinically relevant in oropharyngeal squamous cell carcinoma; the policy specifies that testing for high‑risk HPV using either mRNA expression testing for HPV E6/E7 or p16 immunohistochemistry meets coverage criteria to establish tumor HPV status. Multiple adjunctive and salivary biomarker tests have been studied but, according to the policy, lack sufficient published evidence to support use for screening or diagnosis.

OpenPayer

Oral Cancer Screening and Testing

Coverage Criteria

Procedure Codes

Provider Actions and Requirements

Background

Definitions