Inspire HGNS denied as experimental or investigational by Humana?

Humana'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 Humana Denies Inspire HGNS as Experimental

An "experimental or investigational" denial means Humana's medical policy team has determined — or has applied a blanket policy determining — that hypoglossal nerve stimulation does not yet meet its evidentiary threshold for coverage as an established treatment. This is one of the most commonly appealed and reversed denial categories for Inspire HGNS, because the device has FDA approval and a substantial published evidence base recognized by major sleep medicine professional societies.

The key facts to establish on appeal:

• Inspire HGNS received FDA premarket approval (PMA) for the treatment of moderate-to-severe OSA. FDA PMA requires demonstration of safety and effectiveness — it is the highest level of FDA device clearance. A treatment with PMA approval is, by definition, not unapproved or purely investigational.
• Major professional medical organizations — including the American Academy of Sleep Medicine (AASM) and the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) — have issued position statements or clinical practice guidance acknowledging HGNS as an evidence-based treatment option for selected OSA patients.
• Humana's own published medical coverage policy for HGNS may in fact list coverage criteria (meaning the procedure is covered when criteria are met), which directly contradicts a blanket "experimental" denial. Obtain that policy and compare it to your denial letter.

## Federal Appeal Rights

• Internal appeal: Submit a written appeal with supporting clinical documentation within the timeframe on your denial notice (typically 180 days).
• External review (ACA §2719): After exhausting internal appeals, you are entitled to independent external review. The external reviewer is not bound by Humana's internal policies and applies objective clinical standards.
• Timeline: The external review request window is approximately four months from your final adverse determination. Expedited review is available for urgent clinical situations.

## What to Gather

1. FDA approval documentation — the FDA's public summary of the Inspire HGNS PMA approval (publicly available at fda.gov). 2. Professional society guidance — a copy of the relevant AASM or AAO-HNS position statement or clinical practice guideline acknowledging HGNS. 3. Prescriber letter — your surgeon or sleep physician should explicitly rebut the "experimental" characterization by citing FDA approval status and society guidance, and by explaining how your case meets the criteria in the peer-reviewed literature. 4. Diagnosis and severity documentation — polysomnography results confirming OSA type and severity, and chart notes documenting PAP failure or intolerance. 5. Humana's coverage policy — download the current policy from humana.com and note any criteria listed; if criteria exist, argue the treatment is covered (not experimental) when criteria are met, and demonstrate your case meets them.

## Criteria-Mapping Structure

| Humana Experimental/Coverage Criterion | Your Supporting Evidence | |---|---| | [Copy each criterion or exclusion language from the policy verbatim] | [Chart note, date, prescriber statement addressing it] |

Your appeal should conclude: the device holds FDA PMA approval, is endorsed by applicable professional society guidelines, and Humana's own policy reflects coverage criteria — meaning the procedure is an established, covered treatment when criteria are met, not an experimental one. Request the specific clinical or evidentiary basis for the experimental determination, as ERISA §503 full-and-fair review requires Humana to disclose all clinical criteria and evidence relied upon.