BRCA Single Gene denied as not FDA-approved for this use by Aetna?

Aetna's specific coverage criteria for brca single gene 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 Aetna Denied Your BRCA Single-Gene Test — and Why You Can Appeal

Aetna sometimes issues a "not FDA-approved" denial for BRCA single-gene testing because the FDA regulates laboratory-developed tests (LDTs) differently from standard drug approvals, and some testing platforms carry a different regulatory designation than others. This framing can be misleading: many BRCA single-gene assays are performed in CLIA-certified laboratories under an established regulatory framework, and clinical-guideline bodies such as NCCN and ACMG have long endorsed hereditary BRCA testing for appropriate candidates. A denial rooted in FDA-approval language deserves a careful, documented challenge.

## Your Federal Appeal Rights

You have the right to both an internal appeal and an external review:

• Internal appeal: Submit within the timeframe stated in your Explanation of Benefits (typically 180 days). Aetna must respond within 30 days for pre-service requests and 60 days for post-service claims.
• External review (ACA §2719): After exhausting the internal process — or if Aetna fails to meet its own deadlines — you may request an independent external review through your state's Insurance Commissioner or the federal ERISA external-review process. The window to request external review is generally four months from receipt of the final internal denial.
• Expedited review: If the denial affects urgent care or ongoing treatment, request expedited external review; a decision is typically required within 72 hours.
• ERISA §503: If your plan is employer-sponsored and governed by ERISA, you have a right to a full-and-fair review with access to the clinical basis for the denial.

## What to Gather

1. Diagnosis documentation — pathology reports, clinical notes confirming personal or family history of BRCA-related cancers. 2. Ordering clinician's letter — a detailed medical-necessity letter explaining why BRCA single-gene testing (rather than a broader panel) is the clinically indicated choice for this patient at this time. 3. Guideline support — reference the applicable NCCN or ACMG hereditary-cancer guideline (by name and version) to establish that this test is the recognized standard of care. 4. Laboratory certification — documentation that the performing lab holds CLIA certification and, where applicable, CAP accreditation. 5. Aetna's published policy — obtain Aetna's current Clinical Policy Bulletin for hereditary cancer genetic testing and cross-reference its stated criteria against your clinical record.

## Criteria-Mapping Structure

Copy each requirement listed in Aetna's coverage policy into a table. For every row, identify the exact chart entry or clinical note that satisfies it. Where the denial cites a specific regulatory standard, your clinician's letter should explain how the ordered test meets or exceeds that standard. If the denial references an FDA-approval pathway, request Aetna's clinical reviewer to specify which regulatory designation they require and provide evidence that the ordered assay meets it.

## Bottom Line

"Not FDA-approved" language applied to BRCA single-gene testing frequently rests on a mischaracterization of laboratory-test regulation. A well-documented appeal tying your clinical picture to published guidelines and the lab's regulatory standing has a strong factual basis. Engage your ordering clinician early — their letter is often the single most important document in the file.