Inspire HGNS denied for failing step therapy 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 Under Step Therapy — and Why You Can Appeal

Cigna's step-therapy (also called "fail-first") protocols require patients to try and fail one or more specified prior therapies before a higher-tier intervention will be authorized. For the Inspire Hypoglossal Nerve Stimulation system — an implantable device for obstructive sleep apnea (OSA) — Cigna's step-therapy requirement typically centers on documented inadequacy or intolerance of positive airway pressure (PAP) therapy. A denial under this category means either that PAP failure was not documented in the submitted records, or that the documentation submitted did not satisfy Cigna's specific evidentiary standard for what constitutes failure.

This is one of the most successfully appealed denial types for HGNS, because the device's own FDA-approved indication requires exactly the prior-therapy history Cigna is asking for. When records are complete and well-organized, step-therapy denials often reverse at the first internal level.

## Federal Appeal Rights

ACA §2719 guarantees at least two internal appeal levels and access to independent external review for most non-grandfathered plans. ERISA §503 provides full-and-fair review rights for employer-plan participants. External review must typically be requested within 180 days of the denial notice — confirm the exact date on your Explanation of Benefits. Expedited review (approximately 72-hour decision) is available when delay poses a serious health risk.

## Concrete Appeal Process

1. Pull Cigna's current coverage policy for hypoglossal nerve stimulation and identify the precise step-therapy requirements — including how long a PAP trial must have lasted and what constitutes documented failure or intolerance. 2. File a Level 1 internal appeal organized around each step-therapy gate. For each gate, present the corresponding medical record with a specific date, objective data point, and physician interpretation. 3. If Cigna upheld the denial at Level 1, file a Level 2 internal appeal with additional specialist commentary — particularly from the sleep medicine physician who managed the PAP trial. 4. If internal appeals are exhausted, request independent external review. IRO reviewers apply objective clinical standards and frequently overturn step-therapy denials when the underlying record is sound.

## Documentation to Gather

• PAP prescription and initiation records: Date the device was prescribed and first dispensed, with the prescribing physician's contact information.
• Objective adherence data: Download reports from the PAP device showing usage hours, residual AHI, mask-leak data, and any compliance flags — across the full trial period.
• Follow-up clinic notes: Dated notes from every follow-up visit during the PAP trial, capturing the physician's assessment of therapeutic response and the patient's reported experience.
• Failure/intolerance narrative: A physician-authored explanation — ideally from the sleep medicine specialist — describing why PAP was not clinically adequate, referencing specific objective and subjective findings.
• Anatomical evaluation: Drug-induced sleep endoscopy (DISE) or ENT exam results, if completed, confirming suitability for HGNS and absence of contraindicated findings.
• Prescriber medical-necessity letter: A structured letter from the implanting surgeon or sleep medicine physician that walks through each of Cigna's step-therapy criteria and matches each to a specific record entry.

## Criteria-Mapping Structure

Create a two-column table with Cigna's step-therapy requirements in the left column and the exact document, date, and finding satisfying each requirement in the right column. Append the underlying records as numbered exhibits and cross-reference them in the table. This format leaves no room for the reviewer to claim a criterion was unaddressed and is the most effective structural approach for step-therapy appeals.