Epifix denied for failing step therapy by Blue Cross Blue Shield?

Blue Cross Blue Shield's specific coverage criteria for epifix 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 BCBS Requires Step Therapy for EpiFix — and How to Override It

EpiFix is a dehydrated human amnion/chorion membrane allograft used in the management of chronic, non-healing wounds. BlueCross BlueShield plans commonly require step therapy before approving EpiFix, meaning the plan expects documentation that a defined sequence of less costly wound-care treatments was tried and failed before an advanced biologic membrane is covered. This requirement is driven by BCBS's internal medical policy, and it can be overridden when the record clearly shows that standard-of-care therapies have been exhausted or are clinically inappropriate.

## Why This Denial Is Appealable

Step-therapy denials are highly appealable when you can demonstrate one or more of the following: (a) the required prior-step treatments were already tried and failed, (b) those treatments are contraindicated or clinically inappropriate for your specific wound type, or (c) the wound's acuity or complexity makes bypassing standard step therapy medically necessary. Many states have also enacted step-therapy override protections for commercially insured patients — your attorney or patient advocate can confirm whether your state's law applies.

## Your Federal Appeal Rights

• Internal appeal: ACA §2719 and ERISA §503 guarantee a full-and-fair internal review. The deadline to file is in your denial letter; act promptly.
• External review: If the internal appeal is upheld, you have approximately four months to request independent external review by a certified IRO (independent review organization).
• Expedited option: If the wound poses an imminent threat to limb or life, request expedited review for a 72-hour turnaround.

## Documentation to Gather

1. Step-therapy history with dates and outcomes: A chronological list of every wound-care therapy attempted — debridement approaches, advanced dressings, compression, offloading, negative pressure wound therapy, or other modalities — with start/stop dates and the clinical result documented in the chart. 2. Reasons for therapy failure or contraindication: Physician notes or letters explaining why each required prior step did not achieve wound closure or was not appropriate for this patient. 3. Wound trajectory documentation: Serial measurements and photographs showing wound status over time, demonstrating the wound remained open despite prior interventions. 4. Diagnosis and severity confirmation: Notes establishing the wound's etiology, duration, and complicating clinical factors. 5. Prescriber medical-necessity letter: A letter from your wound-care clinician explaining why EpiFix is now the appropriate next step and why further delay poses clinical risk.

## Criteria-Mapping Structure

Download BCBS's published coverage policy for amniotic membrane allografts from the plan's policy portal. List every step-therapy requirement stated in that policy and map each one to your chart:

| Policy Step Requirement | Chart Documentation | |---|---| | [Prior therapy A required] | [Date tried, duration, outcome per chart note] | | [Prior therapy B required] | [Date tried, duration, outcome per chart note or contraindication documented] | | Wound remains non-healing | [Serial measurements with dates] | | Prescriber attestation of necessity | [Medical-necessity letter from clinician] |

Submit this mapping alongside your appeal letter. A structured, requirement-by-requirement response significantly increases the likelihood of overturn.