Tumor Genomic Profiling denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for tumor genomic profiling are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Cigna Denies Tumor Genomic Profiling as Not FDA-Approved — and How to Appeal

Tumor genomic profiling spans a wide range of testing approaches — from FDA-approved companion diagnostic assays and in vitro diagnostic devices to laboratory-developed tests (LDTs) that operate under CLIA/CAP certification without separate FDA pre-market approval. Cigna may deny a genomic test on "not FDA-approved" grounds when the specific test or assay requested is a laboratory-developed test rather than an FDA-cleared or FDA-approved test, or when the indication submitted does not match the FDA-cleared intended use of an approved assay.

### Why This Denial Happens

The FDA has cleared or approved a number of companion diagnostic tests tied to specific cancer types and specific targeted therapies. When a broader or different panel is ordered — or when a test is ordered for an indication not covered by the FDA approval — Cigna may characterize the request as outside approved use. Many leading oncology laboratories use LDTs precisely because they cover a broader range of genes and indications than currently approved companion diagnostics. These tests are regulated under CLIA and often endorsed by professional oncology societies even without FDA pre-market approval.

### Why It Is Appealable

FDA approval status for a diagnostic test is different from clinical evidence of utility and standard of care. CLIA-certified LDTs are lawfully performed and are widely used as the clinical standard at major cancer centers. Professional society guidelines — including applicable NCCN guideline categories — often endorse specific LDTs or genomic profiling broadly, independent of FDA approval status. Appeals that clearly document the regulatory status of the test, its CLIA/CAP certification, and its guideline endorsement frequently succeed.

### Federal Appeal Framework

• Internal appeal: File within the timeframe on your denial notice (typically 180 days for ACA-compliant plans). Cigna must respond within 30 days for pre-service or 60 days for post-service.
• External review (ACA §2719): After an adverse internal decision, you have approximately four months to request independent external review by an IRO. The IRO's decision is binding on Cigna.
• ERISA §503: Employer-plan enrollees are entitled to full-and-fair review and may request the complete administrative record.
• Expedited review: Available when delay would seriously jeopardize health; decisions are generally required within 72 hours.

### Documentation to Gather

1. Test regulatory status — documentation of the specific assay: whether it holds FDA approval or clearance, or is a CLIA-certified LDT; the laboratory's CLIA and CAP accreditation certificates. 2. FDA-approved companion diagnostic context — if the test is being ordered instead of or in addition to an FDA-approved companion diagnostic, the ordering oncologist should explain what additional clinical information the broader panel provides. 3. Professional society guideline support — citation from the ordering oncologist of the applicable NCCN guideline category or equivalent professional society recommendation that endorses this testing approach for the patient's cancer type and clinical situation. 4. Diagnosis and clinical necessity documentation — current pathology report, clinical notes, and a clear explanation of how the test result will inform treatment decisions. 5. Ordering oncologist's medical-necessity letter — a signed letter addressing the regulatory status issue directly: why this test, at this laboratory, is the appropriate clinical choice, and how it complies with applicable regulatory standards.

### Criteria-Mapping Structure

Obtain the current Cigna medical coverage policy for the specific test code at cigna.com. Many Cigna policies distinguish between FDA-approved tests and LDTs and set separate criteria for each. Map the patient's chart documentation to every criterion, and explicitly address the FDA-approval criterion by documenting the test's regulatory and accreditation status. Frame the appeal around the distinction between FDA pre-market approval and clinical validity under CLIA, supported by professional guideline endorsement.