Apligraf denied as experimental or investigational 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 Denies Apligraf as Experimental or Investigational

Cigna's experimental/investigational denial for Apligraf (a bilayered living cell-based wound therapy for chronic wounds) typically occurs when the clinical documentation submitted does not clearly establish that the patient's wound meets the specific indications listed in Cigna's coverage policy, or when the policy itself has not been updated to reflect the current body of evidence. Because Apligraf is FDA-cleared and has been in clinical use for treating chronic venous leg ulcers and diabetic foot ulcers that fail to respond to conventional care, this denial is often successfully challenged when the appeal is built on the clinical record and the relevant coverage criteria.

## Why This Denial Is Appealable

An experimental designation is a coverage determination, not a clinical fact. Cigna's own coverage policy will list the clinical criteria under which Apligraf is considered medically necessary and no longer experimental. If the patient's wound meets those criteria and the documentation supports it, the denial rests on a documentation gap, not on the drug's regulatory or evidentiary status. Additionally, recognized wound-care guidelines from bodies such as the Wound Healing Society or the Society for Vascular Surgery may be cited generically to support the clinical appropriateness of the treatment.

## Federal Appeal Framework

• Internal appeal (ERISA §503 / ACA §2719): Submit within the timeframe on the denial letter.
• External review: Available through an accredited IRO after final internal denial, generally within four months of that decision. IRO reviewers are independent clinicians who evaluate the evidence on the merits, not Cigna's coverage criteria alone.
• Expedited review: Request if wound deterioration poses an imminent risk of limb-threatening infection or hospitalization.

## Concrete Appeal Steps and Timeline

1. Obtain Cigna's current coverage policy for Apligraf and identify the criteria under which it is considered covered (non-experimental). 2. Compare those criteria to the patient's documented wound history, prior treatment record, and current wound status. 3. Have the treating wound-care specialist write a detailed letter addressing each coverage criterion and citing chart evidence. 4. Submit the internal appeal with wound-care notes, wound measurements and photographs, prior-treatment history, and the prescriber letter. 5. Request expedited review if wound acuity supports it. 6. If denied internally, file for external IRO review immediately.

## Documentation to Gather

• Wound history and measurements: Serial wound photographs, surface-area measurements, and wound-bed descriptions showing chronicity and inadequate response to prior treatment.
• Prior conservative treatment record: Documentation that standard wound care (debridement, compression, offloading, moist wound therapy) was attempted for the required duration without adequate healing — with dates and recorded outcomes.
• Diagnosis confirmation: Chart notes or specialist report confirming the wound type (e.g., venous leg ulcer, diabetic foot ulcer) and any relevant comorbidities.
• Prescriber medical-necessity letter: Must address each criterion in Cigna's coverage policy and cite the specific chart findings that satisfy it.
• Cigna coverage policy: The current document, including the section listing covered indications.

## Criteria-Mapping Structure

List each criterion from Cigna's "covered" threshold in a table. In the adjacent column, cite the specific chart fact — measurement date, wound size, prior-treatment dates, recorded outcomes — that satisfies it. Attach the supporting chart pages as labeled exhibits.