Bezlotoxumab denied for missing prior authorization by Aetna?

Aetna's specific coverage criteria for bezlotoxumab 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 Aetna Denied Bezlotoxumab for Prior Authorization

Aetna requires prior authorization for bezlotoxumab before the drug is administered or dispensed. A prior-auth-required denial typically means the drug was furnished without obtaining advance approval, or a retroactive authorization request was submitted and denied because the required clinical criteria were not documented at the time. Prior authorization for bezlotoxumab is common across commercial insurers because the drug is a specialty biologic used in a specific subset of patients and carries significant cost.

## Why This Denial Is Appealable

Even when prior authorization was not obtained in advance, appeals succeed when the clinical record demonstrates that authorization would have been granted had it been requested. The appeal essentially re-creates the prior-authorization decision retroactively with full documentation. If the prior authorization was requested and denied, the appeal challenges the criteria applied. Either way, the clinical foundation is the same: thorough documentation that the patient met Aetna's published coverage criteria at the time of treatment.

## Federal Appeal Framework

• Internal appeal (ERISA §503 / ACA): File within the deadline on the denial notice. Request Aetna's full prior-authorization criteria for bezlotoxumab as part of your appeal preparation.
• External review (ACA §2719): If the internal appeal is denied, an IRO can review whether the denial was consistent with generally accepted medical practice. File within approximately four months of the final internal denial.
• Expedited review: If the patient's clinical situation is urgent, request expedited review with prescriber certification.

## Concrete Appeal Steps

1. Request Aetna's current prior-authorization criteria document for bezlotoxumab. 2. Request the FDA-approved prescribing label (Zinplava) to verify the approved indication and population. 3. Have your prescriber complete a retrospective prior-authorization letter that addresses every criterion in Aetna's policy with specific chart references. 4. Compile the supporting clinical records (labs, prior treatment notes, risk-factor documentation). 5. Submit the internal appeal in writing within the required timeframe.

## Documentation to Gather

• Diagnosis confirmation: Laboratory-confirmed C. difficile infection with dates of diagnosis and treatment.
• Prior recurrence history: All documented C. difficile episodes, antibiotic courses, and outcomes with dates.
• Concurrent antibiotic documentation: Name and course of the antibiotic being used at the time of bezlotoxumab administration, per the FDA label's use context.
• Recurrence risk factors: Any clinical factors present in the chart that correspond to elevated recurrence risk as described in the FDA label's indicated population.
• Prescriber prior-auth support letter: Addressing each of Aetna's stated authorization criteria with specific chart citations, and confirming the prescription was medically necessary at the time of treatment.

## Criteria-Mapping Structure

Obtain Aetna's prior-authorization criteria for bezlotoxumab — this is typically a page or two in their clinical policy bulletin. Create a table: left column = each criterion verbatim from the policy; right column = the chart fact, lab result, or prescriber attestation that satisfies it. Note the date each fact was established in the record to demonstrate that criteria were met at the time of treatment. This retroactive mapping is the core of a successful prior-auth appeal.