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

Cigna's specific coverage criteria for inspire hgns 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 Inspire HGNS System as Not FDA-Approved — and Why You Can Appeal

A "not FDA-approved" denial for the Inspire Hypoglossal Nerve Stimulation system is almost always a factual error or a coding mismatch. The Inspire device received FDA approval for obstructive sleep apnea and has been on the market for several years. This denial type typically arises when: (1) the device was coded with a non-specific HCPCS code that Cigna's system did not map to the FDA-approved product; (2) the claim described a component or revision that Cigna's policy associated with an unapproved configuration; or (3) the denial was generated by automated rules that did not correctly identify the device from the submitted claim data.

Because the factual premise of the denial is incorrect, these appeals are among the most straightforward — provided you attach the right documentation upfront.

## Federal Appeal Rights

ACA §2719 entitles you to at least two internal appeals and independent external review for most non-grandfathered plans. ERISA §503 provides full-and-fair review in employer-sponsored plans. You generally have 180 days from the denial notice to request external review — verify the exact deadline on your Explanation of Benefits. Expedited review (approximately 72-hour decision) is available when your health is at serious risk from delay.

## Concrete Appeal Process

1. Identify the exact denial basis: Obtain Cigna's denial letter and call the appeals line to confirm whether the denial is tied to a specific device code, a specific component, or a system-level flag. 2. File a Level 1 internal appeal with the following attachments: (a) the FDA's publicly available approval summary or 510(k)/PMA clearance document for the specific Inspire device model; (b) the operative or implant report identifying the device by model number; (c) a corrected claim or a letter from the billing department confirming the HCPCS code submitted corresponds to the FDA-approved device. 3. If denied again, file a Level 2 internal appeal, then escalate to independent external review and your state insurance commissioner.

## Documentation to Gather

• FDA approval documentation: The device's FDA approval or clearance letter, available from the FDA's publicly searchable device database — include the specific device name and model number that matches what was implanted.
• Operative report: Surgical documentation identifying the implanted device by model and serial number.
• Billing and coding records: The HCPCS/CPT codes submitted with the claim, with a brief explanation of how each maps to the FDA-approved device.
• Cigna coverage policy: The current policy for HGNS, confirming that the FDA-approved device is a covered benefit under the patient's plan.
• Prescriber statement: A brief letter from the implanting surgeon confirming the implanted device is the FDA-approved Inspire system and meets all coverage criteria.

## Criteria-Mapping Structure

This appeal has two tracks. Track 1 — Factual Correction: present the FDA approval document and match the model number to the operative report, resolving the denial's factual premise. Track 2 — Medical Necessity (in case Cigna shifts grounds): map each of Cigna's coverage criteria for HGNS to the corresponding chart finding. Submitting both tracks in one packet prevents the appeal from cycling back on a second denial.