Fscig Hyqvia denied as experimental or investigational 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 Denies HyQvia as Experimental

Cigna's "experimental or investigational" denial is applied when the plan's medical policy concludes that the evidence for a treatment is not yet sufficient to meet their internal standard for general medical use. For HyQvia — an FDA-approved subcutaneous immunoglobulin product with recombinant hyaluronidase — this denial is most commonly issued when: (1) the patient's specific diagnosis is not listed in Cigna's medical policy as a covered indication; (2) Cigna's policy predates or does not reflect the current evidence base; or (3) there was a documentation gap in the original submission that left the clinical indication unclear.

## Why This Denial Is Appealable

HyQvia has received FDA approval for its labeled indication in adult patients with primary immunodeficiency (PI). An "experimental" denial for an FDA-approved drug used within its labeled indication is a specific, contestable factual claim. The appeal requires demonstrating that the use is within the FDA-approved indication, that professional society guidance from organizations such as the Clinical Immunology Society or equivalent body supports immunoglobulin replacement for your condition, and that Cigna's own policy — read carefully — may actually cover the indication when proper documentation is provided.

## Federal Appeal Framework

• Internal appeal: File under ERISA §503 or ACA §2719 within the deadline on your denial notice. Request a copy of Cigna's current medical policy for HyQvia and the exact language they applied.
• External review: Experimental denials are expressly subject to independent external review under ACA §2719; approximately four months to file after internal exhaustion. This is one of the strongest external-review scenarios because an independent clinical reviewer, not Cigna, decides whether the evidence is sufficient.
• Expedited review: Request immediately if your immunodeficiency places you at risk of serious infection without treatment.

## Documentation to Gather

1. FDA approval and labeled indication — print the FDA prescribing information confirming HyQvia's approved indication; attach to the appeal to rebut the "experimental" characterization. 2. Diagnosis confirmation — immunology records documenting your specific diagnosis and confirming it falls within the FDA-approved or guideline-supported use. 3. Professional society guideline reference — your prescribing immunologist should cite the relevant guideline organization's recommendation for immunoglobulin therapy in your condition (without reproducing specific numeric thresholds; reference the organization and document type). 4. Prior immunoglobulin treatment history — records showing prior immunoglobulin use (if any), confirming the treatment category is already accepted for your diagnosis. 5. Prescriber medical-necessity letter — a letter from your immunologist addressing Cigna's experimental criteria directly and citing FDA approval, guideline support, and your individual clinical need.

## Criteria-Mapping Structure

Obtain Cigna's medical policy for HyQvia. For each criterion listed under the experimental or coverage determination section, provide the specific chart fact or published authority that satisfies it. Where Cigna's policy cites a lack of evidence, respond with the FDA approval date, indication, and any guideline reference your prescriber can provide.