Rebyota denied for missing prior authorization 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 Prior Authorization for Rebyota — and How to Navigate It

Rebyota (fecal microbiota, live-jslm) is an FDA-approved therapy for preventing recurrence of Clostridioides difficile (C. diff) infection. Cigna requires prior authorization (PA) for Rebyota, meaning coverage is available but the prescription must be reviewed and approved before it is filled. A PA denial — as distinct from a coverage denial — means the initial submission did not satisfy Cigna's documentation requirements. This is routinely resolved by resubmitting with complete clinical documentation, or by filing a formal appeal if the PA is denied after resubmission.

## Why This Is Appealable

Prior-authorization denials carry full appeal rights. If Cigna denied the PA on clinical grounds — for example, asserting the documentation of prior C. diff recurrences was insufficient — that clinical determination is subject to internal appeal and, if internally denied, to independent external review. Because PA decisions are made quickly and often by reviewers without full clinical context, the appeal process frequently produces a different outcome when the prescriber's complete record is presented in a structured format.

## Federal Appeal Framework

• Internal appeal: File within the deadline on the PA denial notice. Under ERISA Section 503 and ACA Section 2719, you are entitled to the specific clinical criteria Cigna applied and a full-and-fair review.
• Urgent/concurrent review: If C. diff is causing active or serious harm, request an expedited PA review or expedited appeal — these must be decided within a compressed timeline.
• External review: Available after exhausting internal PA appeal remedies. The standard external-review window is approximately 4 months from the final internal denial.
• State protections: Many states have enacted prior-authorization reform laws imposing additional timelines and transparency requirements; confirm your state's rules if your plan is state-regulated.

## Appeal Timeline

1. Obtain the PA denial notice and the specific criteria Cigna states were not met. 2. Request Cigna's coverage policy for Rebyota to see all PA requirements. 3. Have your prescriber compile records addressing each unmet criterion. 4. Resubmit the PA with complete documentation; if denied again, file the formal internal appeal. 5. If internally denied, file for external review immediately.

## Documentation to Gather

• C. diff diagnosis confirmation: Lab results (PCR or toxin test positive) with dates for each episode.
• Prior treatment history: Records of each prior C. diff antibiotic course — agent, dates, and outcome — demonstrating recurrence despite treatment.
• Clinical notes: Specialist (gastroenterology or infectious disease) notes documenting the diagnosis, treatment history, and clinical rationale for Rebyota.
• Prescriber PA letter: A structured letter from your prescriber that addresses each of Cigna's stated PA criteria, references the FDA-approved indication, and cites applicable professional society guidance.

## Criteria-Mapping Structure

Obtain Cigna's PA criteria for Rebyota. Map each requirement to your documentation:

| PA Criterion | Chart Evidence | |---|---| | Confirmed C. diff diagnosis | Lab results with dates | | Prior recurrences meeting policy definition | Episode dates and lab confirmations | | Prior antibiotic treatment completed | Prescription and treatment records | | Prescriber specialty (if required) | Prescribing physician's credentials |

A PA appeal with a complete, criterion-mapped submission resolves the majority of Rebyota PA denials.