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

Humana'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 Humana Denied Tumor Genomic Profiling as Not FDA-Approved

A not-FDA-approved denial for tumor genomic profiling means Humana's review found that either (a) the specific assay or laboratory platform lacks the FDA authorization the policy requires, or (b) the test is authorized but is being used for an indication or patient population outside the scope of its FDA clearance. This denial requires careful fact-checking, because many comprehensive genomic profiling platforms do carry FDA authorization — and if the denial is factually incorrect, the appeal is straightforward.

The FDA regulatory pathway for diagnostics involves multiple mechanisms: 510(k) clearance, PMA approval, Breakthrough Device designation, and the companion diagnostic pathway. A coverage policy may require a specific authorization type. Confirming exactly what regulatory status the requested test holds — and whether Humana's policy recognizes that pathway — is the first step in building an appeal.

## Federal Appeal Framework

Under ACA Section 2719, non-grandfathered plans must offer internal appeal and independent external review. FDA-status denials are particularly strong candidates for external review because an accredited IRO evaluates current regulatory and clinical evidence rather than relying solely on the insurer's internal policy interpretation. File your internal appeal within 180 days of the denial. Request external review within approximately 4 months of the final internal denial. Expedited review is available when treatment decisions cannot be delayed. ERISA employer plans carry equivalent rights under Section 503.

## Concrete Appeal Steps

1. Obtain the FDA authorization documentation for the specific assay being requested — your ordering laboratory can provide this directly. 2. Compare the FDA authorization type and intended use against the exact language of Humana's coverage policy. 3. If the authorization exists and covers your indication, the denial may be factually incorrect — document this clearly in your appeal letter. 4. If there is a genuine authorization gap, have your oncologist address clinical utility and guideline support. 5. Engage external review if the internal appeal does not resolve the denial.

## Documentation to Gather

• FDA authorization documentation: The actual FDA letter, 510(k) summary, PMA approval, or companion diagnostic labeling for the specific test.
• Intended use statement: Confirm the FDA-cleared indication encompasses your cancer type and clinical scenario.
• Oncologist medical-necessity letter: Explains why this specific test is required and addresses any gap between FDA authorization scope and Humana's policy requirements.
• Diagnosis confirmation: Pathology, staging, cancer type to confirm the test is being used within its intended use.
• Guideline support: Applicable NCCN or specialty society guidance recommending genomic profiling for your indication.

## Criteria-Mapping Structure

Pull the exact "FDA approval" language from Humana's coverage policy. Map it to the specific FDA document for the requested assay. If there is a mismatch between what the policy requires and what the assay holds, highlight it — and address whether the policy language is consistent with current FDA regulatory practice for laboratory-developed tests and cleared genomic platforms.