Fertility Germline Testing denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for fertility germline testing 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 May Deny Germline Testing as "Not FDA-Approved" — and Why That Framing Is Often Incorrect

Genetic laboratory tests, including germline panels used in fertility settings, are regulated by the FDA under a distinct pathway from pharmaceutical drugs. Many high-complexity germline tests operate as laboratory-developed tests (LDTs) under CLIA certification rather than holding a standalone FDA approval or clearance. When Cigna's automated review flags a test as "not FDA-approved," it may be misapplying a drug-approval standard to a regulated laboratory service — a factual error that is directly appealable.

## Why This Denial Is Appealable

This denial type is often based on a coding or policy-application error. If the laboratory is CLIA-certified, if the test has been reviewed or cleared by the FDA (or falls under a recognized regulatory pathway), or if Cigna's own medical policy does not require FDA approval for this test category, the denial lacks a valid foundation. Regulatory-error denials have a strong track record on appeal.

## Your Federal Appeal Rights

• Internal appeal: ERISA §503 (employer plans) or applicable state law gives you the right to a full-and-fair internal review. File within the deadline on your EOB — typically 180 days.
• External review: ACA §2719 provides access to binding independent external review once internal remedies are exhausted. The total window is roughly four months from denial. Expedited external review (72-hour turnaround) is available when delay poses serious health risk.

## Concrete Appeal Steps and Timeline

1. Obtain the specific denial language — confirm the exact regulatory standard Cigna applied. 2. Request Cigna's written medical policy for the test code billed, including what regulatory status the policy actually requires. 3. Obtain CLIA certification and FDA documentation from the performing laboratory. 4. File internal appeal within the EOB deadline with the documentation below. 5. Escalate to external review if upheld.

## Documentation to Gather

• CLIA certificate: Confirms the laboratory's regulatory standing for high-complexity testing.
• FDA clearance, approval, or De Novo grant documentation (if applicable): The performing laboratory can provide this.
• Laboratory regulatory summary letter: Many labs provide a written summary of their regulatory status for exactly this purpose — request it directly from the lab's medical affairs team.
• Cigna policy text: Print the exact policy language and highlight what standard it actually requires versus what Cigna applied.
• Ordering physician letter: States the test's clinical necessity and regulatory standing in lay terms accessible to a non-specialist reviewer.

## Criteria-Mapping Structure

Side-by-side in your appeal letter: (1) the regulatory standard Cigna's policy actually requires, and (2) the documented regulatory status of the test as performed. If Cigna's policy does not require FDA approval for laboratory-developed tests of this category, cite that policy language verbatim. Reviewers who see the policy's own text contradicting the denial basis are far more likely to overturn.