Inspire HGNS denied as experimental or investigational 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 Experimental — and Why You Can Appeal

Cigna's "experimental or investigational" denial category is applied when the insurer concludes that a treatment has not yet met its internal evidence standard for general medical acceptance. For the Inspire Hypoglossal Nerve Stimulation system — which received FDA approval for obstructive sleep apnea (OSA) — this type of denial is often based on an outdated coverage policy or a policy that has not yet been updated to reflect the device's established clinical profile. It can also occur when a new or expanded indication is being sought and Cigna has not yet made a coverage determination for that specific population.

Because the device is FDA-approved, "experimental" denials are among the most winnable on external review. Independent reviewers apply an objective evidence standard, and FDA approval combined with broad professional society endorsement frequently meets it.

## Federal Appeal Rights

ACA §2719 entitles you to at least two internal appeals and independent external review through an accredited Independent Review Organization (IRO). ERISA §503 provides full-and-fair review rights in employer plans. The external-review deadline is typically 180 days from the denial notice — verify the exact date on your Explanation of Benefits. An expedited review (roughly 72-hour turnaround) is available when your condition is urgent.

## Concrete Appeal Process

1. Request Cigna's current coverage policy for hypoglossal nerve stimulation and the specific evidence criteria the denial is based on. 2. File a Level 1 internal appeal. Lead with the FDA clearance date and indication, then cite relevant professional society guideline endorsements (e.g., the American Academy of Sleep Medicine's position on HGNS). Do not cite specific statistics — let the official documents speak for themselves. 3. If upheld, file a Level 2 internal appeal, then immediately request independent external review, which is particularly favorable for FDA-approved devices denied as experimental. 4. File complaints in parallel with your state insurance commissioner if Cigna's policy does not reflect current FDA status.

## Documentation to Gather

• FDA approval documentation: The FDA's publicly available approval summary for the specific Inspire device model being implanted.
• Professional society guidelines: Current AASM, AAO-HNS, or other applicable specialty-society clinical practice guidelines that include HGNS as a recognized treatment option for OSA.
• Diagnosis and severity confirmation: Polysomnography report with clinical interpretation, and physician notes describing the severity and consequences of OSA.
• PAP-failure documentation: Dated records demonstrating inadequate PAP response or intolerance — establishing that this is not a first-line request.
• Prescriber medical-necessity letter: A detailed letter from the implanting surgeon addressing Cigna's experimental-denial rationale directly, citing FDA status and guideline acceptance.

## Criteria-Mapping Structure

Obtain the exact language from Cigna's coverage policy describing what evidence standard a treatment must meet to move out of the experimental category. List each criterion. In the column beside each, cite the specific document — FDA approval letter, guideline publication, professional society statement — that satisfies it. Framing the appeal as a direct rebuttal to the policy's own evidence standard is more persuasive than a general letter asserting the device "works."