Rebyota denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for rebyota 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 Requires Step Therapy for Rebyota — and Why You Can Appeal

Rebyota (fecal microbiota, live-jslm) is FDA-approved to prevent recurrence of Clostridioides difficile (C. diff) infection following antibiotic treatment in adults. Cigna's step-therapy requirement typically means the plan requires documentation that one or more prior antibiotic courses for C. diff have been completed before Rebyota will be authorized. In most cases, patients prescribed Rebyota have already completed the required prior antibiotic treatments — making this a documentation gap rather than a clinical failure. When the step-therapy requirement is genuinely inappropriate for a specific patient, a step-therapy exception is available.

## Why This Denial Is Appealable

Step-therapy requirements for Rebyota are intended to confirm that the prior antibiotic steps have been taken — not to deny a therapy that is clinically appropriate after those steps have been completed. If your records document the required prior antibiotic courses and their outcomes, the step-therapy requirement should be satisfied on appeal. If your prescriber has determined that additional antibiotic courses would be clinically harmful or futile, many states and federal guidelines allow a step-therapy exception on that basis. Applicable professional society guidelines (such as those from the Infectious Diseases Society of America) can support the prescriber's rationale.

## Federal Appeal Framework

• Internal appeal / step-therapy exception: File a step-therapy exception request simultaneously with the internal appeal, citing prior steps completed or clinical reasons steps cannot be taken.
• ACA Section 2719 external review: Available after exhausting internal remedies for non-grandfathered plans. The standard external-review window is approximately 4 months from the final internal denial.
• ERISA Section 503: Employer-sponsored plans must provide access to the specific step-therapy criteria and a full-and-fair review.
• State step-therapy laws: Many states have enacted step-therapy reform laws with mandatory exception timelines; confirm your state's protections if applicable.
• Expedited review: Request if recurrent C. diff is causing urgent health risk.

## Appeal Timeline

1. Obtain the step-therapy policy language from Cigna — specifically, which prior steps are required. 2. Compile records documenting completion of each required prior step. 3. Submit the internal appeal and step-therapy exception request with full documentation. 4. If denied, file for external review immediately.

## Documentation to Gather

• Prior C. diff antibiotic treatment records: For each required step, document the specific antibiotic course used (generic name), the dates of treatment, completion of the course, and the clinical outcome (recurrence).
• Lab confirmation of recurrence: Positive C. diff test results following each prior treatment course, confirming the step-therapy sequence has been completed without durable success.
• Prescriber medical-necessity letter: Should document each completed prior step, explain why Rebyota is now appropriate consistent with the FDA-approved indication and applicable professional society guidance, and request an exception if any step cannot be completed due to clinical concerns.
• Clinical severity documentation: Notes documenting the impact of recurrent C. diff and the clinical rationale for proceeding to Rebyota.

## Criteria-Mapping Structure

Obtain Cigna's step-therapy policy for Rebyota. Map each required step:

| Required Step | Documentation | |---|---| | Step 1 antibiotic course completed | Prescription record, treatment dates, outcome | | Step 2 antibiotic course completed (if required) | Prescription record, treatment dates, outcome | | Recurrence confirmed after each step | Lab results with dates | | Exception basis (if steps cannot be completed) | Prescriber letter with clinical rationale and guideline reference |

Patients who have already completed the required prior antibiotic courses frequently win this appeal at the internal level with complete documentation.