Rebyota denied as not FDA-approved for this use 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 Denied Rebyota as Not FDA-Approved — and Why You Can Appeal

Rebyota (fecal microbiota, live-jslm) has received full FDA approval for the prevention of recurrence of Clostridioides difficile (C. diff) infection following antibiotic treatment in adults. A "not FDA-approved" denial at this stage is almost certainly an administrative error — either the insurer's drug database has not been updated to reflect current FDA status, or a prior-authorization reviewer applied an outdated policy. This is one of the most straightforward denials to challenge because it is based on a factual inaccuracy correctable with publicly available FDA records.

## Why This Denial Is Appealable

The FDA's approval status for Rebyota is a matter of public record, documented in the FDA's drug database and in the product's prescribing information. An insurance denial that contradicts an FDA approval determination can be challenged on its face. Your appeal should lead with the FDA documentation and request that Cigna update its records and coverage determination accordingly. This type of denial frequently resolves at the internal appeal level once the factual record is corrected.

## Federal Appeal Framework

• Internal appeal: File within the deadline on your denial notice. Request that Cigna identify the specific basis for the "not FDA-approved" determination so you can address it directly.
• ERISA Section 503 (employer plans) / ACA Section 2719 (marketplace plans): You are entitled to a full-and-fair review and access to the clinical and administrative criteria used.
• External review: Available after exhausting internal remedies. The standard window is approximately 4 months from the final internal denial. An independent reviewer applying objective standards will have access to the same FDA approval records.
• Expedited review: Available if your health would be seriously jeopardized by the standard timeline.

## Appeal Timeline

1. Download the current Rebyota prescribing information and the FDA approval documentation from the FDA's public website. 2. Request the specific policy language or drug file Cigna used to determine the drug is not FDA-approved. 3. File the internal appeal with the FDA documentation attached. 4. If denied internally (unlikely for a factual-record correction), file for external review immediately.

## Documentation to Gather

• FDA approval documentation: The current FDA-approved prescribing label or product approval letter, demonstrating the approved indication that matches your prescribed use.
• Prescriber letter: Brief letter from your prescriber confirming that Rebyota is being prescribed for its FDA-approved indication and that the denial appears to reflect outdated information.
• Diagnosis records: Lab-confirmed C. diff history establishing that the prescribed use matches the approved indication.

## Criteria-Mapping Structure

Obtain the specific Cigna policy or source document used to make the "not FDA-approved" determination. Map the facts:

| Cigna's Stated Basis | Correcting Evidence | |---|---| | Drug listed as unapproved or investigational | FDA approval documentation with indication statement | | Policy version or database date used | Request the date and version; provide current FDA status | | Proposed use outside the approved indication | Prescribing information confirming use is within the label |

This type of denial is factually correctable and should not require extensive clinical documentation — the FDA approval record does the work.