Linx denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for linx 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 Denied the LINX Device as Not FDA-Approved

This denial category — not FDA-approved — is factually incorrect for the LINX Reflux Management System. LINX received FDA premarket approval (PMA) for the treatment of gastroesophageal reflux disease. When a payer issues a "not FDA-approved" denial for a device that has received FDA clearance or approval, the denial is based on either a factual error in the reviewer's record or an outdated coverage policy. This is one of the most straightforward denial categories to overturn because the correction requires only factual documentation, not clinical argumentation.

## Why This Denial Is Appealable

A denial predicated on a factual inaccuracy — that an FDA-cleared device lacks FDA approval — is not a defensible clinical determination. Under ERISA §503 and ACA §2719, the plan is required to conduct a full and fair review that considers the actual evidence. Presenting the FDA's own documentation directly contradicts the basis for denial and frequently results in reversal at the internal appeal stage without the need for external review.

## Federal Appeal Framework

• Internal appeal: File immediately, attaching the FDA approval documentation as Exhibit A. Request the specific coverage policy language Cigna applied and demand a written explanation of why FDA clearance was disregarded.
• External review: If the internal appeal is denied despite the FDA documentation, escalate to external review under ACA §2719. The general window is 4 months from the final internal denial notice.
• Expedited option: If your condition is urgent, request expedited review at both stages.
• State insurance department complaint: A denial based on a demonstrably false factual premise is also appropriate to report to your state's insurance regulator, which can compel re-review.

## Documentation to Gather

1. FDA approval/clearance printout — go to fda.gov, locate the LINX PMA or 510(k) clearance record, and print the full approval summary page. This is your primary exhibit. 2. Device labeling — the FDA-approved indications for use from the official labeling, showing the specific condition and patient population for which the device is cleared. 3. Prescriber letter — confirming that the device is being used within its FDA-cleared indications for your specific diagnosis. 4. Objective GERD diagnosis records — pH monitoring, manometry, and endoscopy supporting that your use case falls within the approved indication. 5. Prior treatment history — documentation that you meet the clinical prerequisites stated in the device labeling and Cigna's own policy.

## Criteria-Mapping Structure

Lead your appeal letter with a single, direct paragraph: state that the denial cites "not FDA-approved" for a device that received FDA PMA clearance on [date — obtain from fda.gov], attach the FDA record as Exhibit A, and request immediate reversal on that basis alone. Then provide the full clinical criteria mapping as a secondary argument to address any residual medical-necessity concerns the reviewer may raise on re-review.