Authorization and benefit verification

Verify member benefits and obtain any required prior authorization before ordering or billing for tests related to oral/oropharyngeal cancer. Coverage and authorization depend on the procedure, diagnosis, and the member's state of residence; check the member's specific benefit plan and applicable state/Medicare/Medicaid regulations at time of request.

• Coverage does not guarantee reimbursement; services must meet authorization and medical necessity guidelines for the procedure, diagnosis, and member's state of residence.
• Application of criteria is dependent upon an individual's benefit coverage at the time of the request; Medicare and Medicaid specifications are in the 'Applicable State and Federal Regulations' section.

Procedure code references (reference only)

Procedure and proprietary test codes listed in the policy are provided for reference only. Prior authorization requirements may vary by payer; confirm whether authorization is required for the specific CPT/HCPCS or proprietary test code before performing or billing the service.

• Codes are included as a general reference and may not be all-inclusive.
• Examples listed: 82397, 87624, 87625, 87626, 88341, 88342, 0429U (Omnipathology Oropharyngeal HPV PCR Test).

Order tests consistent with indicated coverage criteria

Ensure tests are ordered only when consistent with the policy's clinical indications (e.g., testing to establish HPV tumor status for oropharyngeal SCC or metastatic SCC of unknown primary); do not use listed adjunctive tests for routine screening, detection, or diagnosis of oral cancer.

• HPV tumor status testing (mRNA E6/E7 or p16 IHC) MEETS CRITERIA for oropharyngeal SCC or metastatic SCC of unknown primary in a cervical lymph node.
• Salivary biomarker testing, HPV genotyping (OraRisk®), gene expression profiling, panels combining genetic and nongenetic biomarkers, and detection of HPV from an oropharyngeal swab (OmniPathology) DO NOT MEET CRITERIA for screening/detection/diagnosis.

Step therapy not specified

There are no step therapy requirements specified in this policy for oral/oropharyngeal cancer–related testing.

Documentation and coding responsibility

Submit complete and accurate clinical documentation and code claims according to industry-standard coding guidelines. Providers are responsible for documentation that supports medical necessity and for appropriate use of CPT/HCPCS/ICD-10 codes when billing.

• Follow Uniform Billing Editor, AMA CPT guidance, HCPCS, ICD-10, CMS NCCI policy, and other applicable coding manuals.
• Accurate documentation must be available to support the services billed.

LDT validation and CLIA documentation

If using laboratory-developed tests (LDTs), ensure they are validated and performed in-house under CLIA high-complexity rules and retain documentation of CLIA validation; LDTs are not FDA-approved/cleared but are regulated under CLIA '88.

• Many labs develop and validate specific LDTs and must perform them in-house under CLIA high-complexity testing requirements.
• Documentation of CLIA validation may be required.

Denial/recoupment risk for coding or medical necessity noncompliance

Claims may be denied or recouped if coding/billing guidelines or current reimbursement policies are not followed or if services do not meet authorization and medical necessity guidelines.

• Failure to follow appropriate coding/billing guidance (CPT, HCPCS, ICD-10, CMS policies, etc.) may result in denial or recoupment.

Coverage/denial risk for procedures not listed

Coverage determinations in this policy exclude procedures or tests not listed in the procedure code section; procedure codes in the policy are provided as a reference and may not represent the full set of billable or covered services.

• Procedure codes appearing in the policy are included only as a general reference tool and may not be all-inclusive.
• Tests/procedures not listed may be excluded from coverage determinations.