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

Aetna'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 Aetna Denied Inspire HGNS as "Not FDA-Approved" — and Why You Can Fight It

Inspire Upper Airway Stimulation (hypoglossal nerve stimulation, HGNS) received FDA premarket approval (PMA) as a Class III medical device for the treatment of moderate-to-severe obstructive sleep apnea in adults who cannot tolerate CPAP therapy. A denial coded as "not FDA-approved" almost always reflects an administrative error — a miscoded billing identifier, an outdated clinical policy that has not been refreshed since approval, or a mismatch between the device code submitted and the code Aetna's system expects. This type of denial is highly appealable because the factual predicate of the denial is verifiable and wrong.

## Federal Appeal Framework

For most employer-sponsored (ERISA) plans, ERISA §503 guarantees a full-and-fair internal review. ACA §2719 adds an independent external review right. You typically have 180 days from the denial notice to file an internal appeal, and if that fails, an external review request must generally be submitted within four months of the final internal denial. An expedited (72-hour) review is available when a standard timeline would seriously jeopardize your health. State-regulated individual and small-group plans follow your state's external-review rules, which are at least as protective.

## Your Concrete Appeal Steps

1. Request the denial letter and clinical criteria — ask Aetna in writing for the specific clinical policy number and the exact language under which the claim was denied. 2. Obtain device FDA approval documentation — download the FDA PMA approval letter and approval order for Inspire HGNS directly from the FDA's PMA database at accessdata.fda.gov and include it as Exhibit A in your appeal. 3. Confirm the procedure/device codes — have your surgeon or sleep specialist's billing team verify that the ICD-10 diagnosis code, CPT procedure code, and device HCPCS code on the claim exactly match Aetna's current coverage policy requirements. 4. File a written internal appeal — submit within Aetna's stated deadline (check your Summary Plan Description), attach the FDA approval letter, and explicitly state that the denial reason is factually incorrect. 5. Request external review if denied again — if Aetna upholds the denial internally, immediately file for independent external review.

## Documentation to Gather

• FDA PMA approval letter for Inspire HGNS (from fda.gov)
• Your treating physician's letter confirming the device is FDA-approved and medically indicated for your diagnosis
• Operative/implant report or pre-authorization request showing the specific device and codes
• Your sleep study results confirming the diagnosis
• Records documenting CPAP intolerance

## Criteria-Mapping Structure

In your appeal letter, create a table with three columns: Aetna's stated requirement | Your supporting document | Exact chart fact. Pull each requirement verbatim from Aetna's published coverage policy (available at aetna.com/cpb). For the FDA-approval requirement specifically, cite the PMA number, approval date, and indication language from the FDA letter. This structured mapping prevents Aetna from shifting to a new objection without addressing your evidence.