Inspire HGNS denied as not FDA-approved for this use 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 Not FDA-Approved — and Why That Denial Is Incorrect

A "not FDA-approved" denial for Inspire HGNS is factually incorrect, and this is likely the most directly rebutted denial type you will encounter. The Inspire Upper Airway Stimulation system received FDA Premarket Approval (PMA) — the most rigorous FDA pathway for medical devices, requiring demonstration of both safety and effectiveness. This is a matter of public record in the FDA's device database.

Humana may issue this denial due to a coding error (wrong device code submitted), an outdated policy entry, a reviewer error, or because a specific implant component or revision was reviewed under the wrong indication. Before assuming the denial is a simple administrative error, verify that the procedure and device codes submitted in the claim or prior authorization exactly match the FDA-approved Inspire system indication for obstructive sleep apnea. If the codes are correct and the indication matches, the denial rests on a factual error and should be reversed on the first internal appeal.

## Federal Appeal Rights

• Internal appeal: Submit immediately with the FDA approval documentation. This class of denial — based on a factual error — often resolves at the internal level without requiring external review.
• External review (ACA §2719): If the internal appeal is denied, you are entitled to independent external review. An external reviewer applying objective standards will have access to the same public FDA records.
• Timeline: External review requests are generally due within approximately four months of the final internal adverse determination. Check your denial letter for exact deadlines.
• Expedited review: Available for urgent or time-sensitive clinical situations.

## What to Gather

1. FDA PMA approval documentation — the public FDA summary for the Inspire HGNS PMA, available at fda.gov/medical-devices. Print or save the page showing approval status and approved indication. 2. Correct procedure and device codes — confirm with your surgeon's billing office that the CPT, HCPCS, and device codes submitted exactly match the approved Inspire system and its FDA-approved OSA indication. 3. Prescriber letter — a brief letter from your surgeon stating that the specific Inspire system being used holds FDA PMA approval for the indication for which it is prescribed, and citing the approval. 4. Diagnosis documentation — polysomnography confirming OSA diagnosis and severity, and chart documentation of PAP failure, to demonstrate the procedure is being used within its approved indication. 5. Humana's coverage policy — obtain the current published policy from humana.com; if it lists coverage criteria for HGNS, it implicitly acknowledges FDA approval, which directly contradicts the denial.

## Criteria-Mapping Structure

| Denial Basis | Rebuttal Evidence | |---|---| | "Not FDA-approved" assertion | FDA PMA approval summary (fda.gov, public record) | | Correct indication | Prescriber letter confirming on-label use for OSA | | Correct codes submitted | Billing office confirmation of device/procedure codes | | Humana policy acknowledgment | Coverage criteria in Humana's own published policy |

Your appeal letter should open by stating the specific FDA PMA number and approval date for the Inspire system (available on fda.gov), and ask Humana to identify the basis for concluding the device lacks approval in light of that public record. Under ERISA §503 full-and-fair review, Humana must disclose all clinical and factual criteria it relied upon.