Blvr Valves denied as not FDA-approved for this use by Humana?

Humana's specific coverage criteria for blvr valves 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 Denied BLVR Valves as "Not FDA-Approved" — and Why That Is Directly Rebutted

The Zephyr Endobronchial Valve system received FDA De Novo authorization for the treatment of severe emphysema in appropriate patients. A Humana denial on "not FDA-approved" grounds for bronchoscopic lung volume reduction (BLVR) valves is therefore factually incorrect on its face — and this type of denial has among the highest appeal success rates precisely because the rebuttal evidence is a matter of public record.

This kind of denial most often occurs because Humana's coverage policy was not updated after FDA clearance, a reviewer applied a blanket "investigational device" policy without checking the current regulatory status, or the claim was submitted with codes that did not clearly identify the FDA-authorized device.

## Your Federal Appeal Rights

ACA §2719 and ERISA §503 guarantee your right to internal appeal and binding external review by an Independent Review Organization (IRO). Internal appeals must generally be filed within 180 days of the denial notice. If the internal appeal is denied, you may request IRO external review — typically within four months of the final internal adverse decision. Expedited review is available for patients with urgent clinical need.

IROs are required to apply generally accepted standards of medical practice and current regulatory status. When FDA clearance is documented and submitted, IROs routinely overturn "not FDA-approved" denials.

## Documentation to Gather

• FDA De Novo authorization letter: This is the most important document for this appeal. Download the publicly available FDA De Novo authorization for the Zephyr Endobronchial Valve (or the specific cleared valve system your physician is prescribing) directly from the FDA website (fda.gov) and attach it as Exhibit A. This single document directly contradicts the denial rationale.
• Device product labeling: Attach the FDA-cleared labeling for the device, which defines the approved indication. Your prescriber's letter should confirm the patient's clinical situation falls within that approved indication.
• Prescriber medical-necessity letter: A letter from the treating interventional pulmonologist or pulmonologist citing the FDA-cleared indication, confirming the patient meets criteria per chart documentation, and referencing the applicable professional society guideline (ATS/ERS/CHEST) that endorses BLVR for appropriate emphysema patients.
• Humana's denial basis: Quote the exact language from Humana's denial letter and respond to it point by point with the FDA documentation.

## Criteria-Mapping Structure

Organize the appeal as: (1) statement of the denial reason as Humana wrote it; (2) the FDA authorization document rebutting it; (3) the prescriber's confirmation that the proposed use is within the cleared indication; (4) supporting clinical documentation from the chart. Keep it factual and direct — this appeal wins on documented fact, not argument.