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

Cigna's specific coverage criteria for apligraf 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 Apligraf as "Not FDA-Approved" — and Why That's Likely Wrong

Apligraf (becaplermin-free living bilayered cellular construct) has held FDA clearance as a medical device since the late 1990s for specific chronic wound indications. A "not FDA-approved" denial for Apligraf almost always reflects a coding or documentation mismatch rather than a genuine regulatory status problem — the reviewer may have applied a drug-approval standard to a 510(k)-cleared device, or the claim may have been submitted under an incorrect product code.

## Why This Denial Is Appealable

FDA device clearance is a matter of public record. If Cigna's denial letter cites lack of FDA approval, you can refute it directly with the product's FDA 510(k) clearance number (available on the FDA device database at fda.gov). The appeal should also demonstrate that the device was used within its cleared indication — confirm this with the prescribing clinician's documentation and the manufacturer's current FDA-cleared labeling.

## Federal Appeal Framework

You have layered appeal rights: - Internal appeal: Submit within the timeframe shown on your denial letter (commonly 180 days for ERISA plans, though Cigna's plan documents govern). - ACA §2719 / ERISA §503 external review: If the internal appeal is denied, you may request independent external review through a Cigna-designated Independent Review Organization (IRO). For most plans this window is approximately four months from the final internal denial. An expedited external review is available if your condition is urgent. - State insurance department complaint: Available for fully-insured plans if the IRO process does not resolve the dispute.

## What to Gather

• Wound diagnosis documentation: Pathology, wound-care notes, and photographs confirming the diagnosis that falls within Apligraf's cleared indication.
• FDA clearance record: Print the device listing from the FDA 510(k) database showing cleared indication and status.
• Prescriber medical-necessity letter: The treating clinician should explicitly state that Apligraf is being used within its FDA-cleared indication and explain why it is medically necessary for this patient.
• Prior treatment history: Dates, durations, and outcomes of all wound-care interventions attempted before Apligraf was prescribed (standard wound care, offloading, infection management, etc.).
• Applicable guideline reference: The prescriber should note which wound-care society guideline (e.g., the relevant Wound Healing Society or Society for Vascular Surgery guidance) supports use of bioengineered skin substitutes in this clinical context.

## Criteria-Mapping Structure

In your appeal letter, create a two-column table: left column lists each requirement from Cigna's denial and from Apligraf's FDA-cleared labeling; right column provides the specific chart fact or document that satisfies it. Address the "not FDA-approved" basis head-on in the opening paragraph with the clearance citation.