Fscig Hyqvia denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for fscig hyqvia 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 HyQvia as "Not FDA-Approved" — and Why That Is Appealable

HyQvia (immune globulin infusion 10% with recombinant human hyaluronidase) is FDA-approved for the treatment of primary immunodeficiency in adults. A "not FDA-approved" denial from Cigna almost always means the insurer is contending that your specific indication — the exact diagnosis on the claim — falls outside the labeled indication, or that the claim was coded in a way that obscured the approved use. It does not necessarily mean the drug itself lacks FDA approval.

## Why This Denial Is Frequently Overturned

If your prescriber ordered HyQvia for an FDA-approved indication and the claim coding accurately reflects that diagnosis, the denial is factually incorrect on its face. Insurers occasionally issue these denials when prior-authorization paperwork is missing, when a diagnosis code is ambiguous, or when an internal formulary system misclassifies the product. Each of these is correctable on appeal.

## Federal Appeal Framework

You have layered protections:

• Internal appeal — You must typically exhaust one level of internal appeal first. Submit within the timeframe shown on your Explanation of Benefits (often 180 days from the denial date).
• ACA §2719 external review — For non-grandfathered plans, after an adverse internal decision you may request an Independent Review Organization (IRO) review. The standard external-review window is approximately four months from the internal denial; verify the exact deadline on your denial letter.
• Expedited external review — Available when a delay would seriously jeopardize your health; an IRO decision is typically required within 72 hours.
• ERISA §503 (self-funded plans) — Requires a "full and fair review" with access to the criteria used; the plan must provide the specific clinical guidelines it relied on.

## Documentation to Gather

• Diagnosis confirmation — Office notes, lab results, or specialist letters confirming the primary immunodeficiency diagnosis with ICD-10 coding that matches the FDA-approved indication.
• Prescriber medical-necessity letter — A signed letter from your immunologist explaining why HyQvia (specifically the subcutaneous route with recombinant hyaluronidase) is medically necessary for your condition, referencing the FDA-approved indication.
• Prior treatment history — Dates, outcomes, and documented tolerability issues with any prior immunoglobulin therapy, including intravenous formulations.
• FDA label — Print the current FDA-approved prescribing information for HyQvia and attach it; highlight the indication section that covers your diagnosis.

## Criteria-Mapping Structure

For each requirement in Cigna's published medical coverage policy for immune globulin therapy, create a two-column table:

| Policy Requirement | Chart Evidence Meeting It | |---|---| | FDA-approved indication (list exact language from the label) | Diagnosis code + specialist note confirming the diagnosis | | Each additional criterion in the policy | Specific date-stamped chart entry or lab result |

Obtain Cigna's current coverage policy from the provider portal or by written request under ERISA, then map every criterion individually. A point-by-point response is far more effective than a narrative letter alone.