Apligraf denied for failing step therapy 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 Applies Step Therapy to Apligraf

Cigna's coverage policy for advanced wound-care products such as Apligraf typically requires that a patient first attempt and fail a defined course of conventional wound care before a bioengineered skin substitute will be authorized. This "step-therapy" or "fail-first" requirement reflects the insurer's position that standard care (debridement, appropriate offloading, moisture-balance dressings, infection control, and compression where indicated) should be exhausted before a higher-cost product is used. A denial citing step therapy means Cigna's records did not show adequate documentation of those prior steps.

## Why This Is Appealable

Step-therapy denials are among the most successfully overturned on appeal, because the required prior treatment often has in fact been attempted — it simply was not documented in the format the insurer expects. If the patient has a documented history of conventional wound care that failed, the appeal is largely a documentation exercise. Additionally, many states have enacted step-therapy exception laws requiring insurers to grant exceptions when prior therapy is contraindicated, previously tried and failed, or when the time required to complete it would cause irreversible harm.

## Federal Appeal Framework

• Internal appeal: File within the deadline shown on the denial letter. This is where the prior-treatment history evidence is most impactful.
• Step-therapy exception request: Many Cigna plans have a separate exception pathway; ask the prescriber to submit a formal exception request alongside the appeal.
• ACA §2719 external review: Available after exhausting internal appeals. The IRO will assess whether the step-therapy requirement was clinically appropriate given the documented history. Window is approximately four months from final internal denial.
• ERISA §503: For employer-sponsored plans, requires full disclosure of the criteria used and a full-and-fair review of the clinical record.

## What to Gather

• Chronological prior-treatment log: A table listing every wound-care intervention attempted — product or technique, start date, end date, and documented outcome — covering the period specified in Cigna's policy.
• Wound progression records: Measurements and photographs showing the wound's course during prior treatment.
• Prescriber attestation: A letter from the treating clinician attesting that standard wound-care steps have been completed, identifying what was tried, for how long, and why Apligraf is now the appropriate next step.
• Applicable guideline reference: Reference to the relevant wound-care specialty society guideline supporting escalation to a bioengineered skin substitute after standard-care failure.
• Exception basis (if applicable): If any required step was contraindicated (e.g., compression contraindicated due to arterial insufficiency), document that contraindication with objective clinical findings and reference to the FDA labeling and Cigna's own policy for exceptions.

## Criteria-Mapping Structure

Obtain Cigna's current medical policy for Apligraf or bioengineered skin substitutes and list each step-therapy requirement. For each requirement, provide the chart evidence that it was met, including specific dates and outcomes. Address any gaps honestly and explain them with supporting clinical rationale.