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

UnitedHealthcare'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 UnitedHealthcare Issues a "Not FDA-Approved" Denial for Inspire HGNS

This denial type is often a documentation or coding error rather than a substantive clinical dispute. Inspire HGNS (hypoglossal nerve stimulation) has received FDA approval/clearance for its indicated use in obstructive sleep apnea. When UnitedHealthcare issues a "not FDA-approved" denial, it typically means one of the following: (1) the claim was submitted with a procedure or device code that UHC's system does not map to an FDA-approved device; (2) the clinical documentation did not clearly identify the specific device and its cleared indication; or (3) the coverage policy requires documentation of FDA clearance that was not included in the submission.

## Why This Denial Is Appealable

Because FDA clearance for this device is a matter of public record, a "not FDA-approved" denial is highly appealable:

• Internal appeal (ACA §2719 / ERISA §503): Submit a full-and-fair internal appeal within the timeframe on your denial letter. Include explicit documentation of FDA clearance.
• External review: If the internal appeal is denied, request independent external review. Under ACA §2719, the external reviewer's decision is binding on the insurer. The external-review request window is generally within four months of the final internal denial.
• Expedited review applies when clinical urgency exists.

## Documentation to Gather

1. FDA clearance documentation: Download the FDA's publicly available clearance/approval letter or 510(k) summary for the Inspire device from the FDA's website (fda.gov) and attach it directly to the appeal. 2. Device identification: Confirm with the prescribing surgeon that the specific device model implanted or ordered is the FDA-cleared version, and include the device name, model number, and cleared indication in the appeal. 3. Correct procedure and device codes: Work with the ordering facility or billing department to verify that the CPT/HCPCS code submitted accurately reflects the FDA-cleared device. If a coding error caused the denial, a corrected claim may resolve the issue without a full appeal. 4. Diagnosis and indication match: Document that the patient's diagnosis matches the FDA-cleared indication, supported by sleep study results and specialist notes. 5. Prescriber attestation letter: The ordering physician should state explicitly that the device ordered is FDA-cleared for this patient's diagnosed condition.

## Criteria-Mapping Structure

This appeal is primarily about establishing an established fact — FDA clearance — rather than mapping complex clinical criteria. Structure it simply:

| UHC Denial Basis | Rebuttal Evidence | |---|---| | Device not FDA-approved | FDA clearance letter (attached); device model and cleared indication confirmed by prescriber | | [Any additional criteria from UHC's denial letter] | [Corresponding chart or regulatory evidence] |

Also obtain UHC's current published medical policy for hypoglossal nerve stimulation to confirm whether there are additional coverage requirements beyond FDA clearance, and address each of those in the same appeal package.