Cigna · Rebyota · US health-plan appeal rights

Rebyota denied as not medically necessary by Cigna?

Q: How long do I have to appeal a Cigna Rebyota denial?

Internal appeal window: Typically 180 days from the denial date. External review window: Typically 60–120 days after the final internal denial. The clock starts from the date on the denial letter.

Most insurers reverse a medical-necessity denial when the appeal cites the specific clinical guideline (NCCN, ADA, AACE, etc.) that supports the requested treatment for your indication.

By Michael John Ryan, Founder & Privacy Officer, DenialHelp, LLC

Last reviewed 2026-05-09

Policy data current as of 2026-04-26

US health-plan appeal rights

Cite: Most US health plans have appeal rights under either the ACA, ERISA, or Medicare/Medicaid rules

Most US health plans are required by federal law to give you both an internal appeal (where the insurer reconsiders) and an external review (where an independent reviewer decides). The exact timelines and processes depend on what kind of plan you have — marketplace / employer group, self-funded, Medicare Advantage, or Medicaid MCO — but in every case there's a window after the denial during which you have the right to fight it.

Internal appeal window

Typically 180 days from the denial date

External review window

Typically 60–120 days after the final internal denial

What Cigna typically requires

Adult ≥18 yr. ≥1 CDI recurrence (i.e., 2nd CDI episode or later). Completion of standard-of-care antibacterial therapy for current CDI episode. Single 150 mL rectal administration 24-72 hours after final antibiotic dose. Not for treatment of active CDI.

Source policy: Cigna Coverage Position on Rebyota (Fecal Microbiota, live-jslm)

What works in the appeal

Rebyota was FDA-APPROVED on November 30, 2022 — the FIRST FDA-approved fecal microbiota product. Indication (per FDA label): prevention of recurrence of CDI in individuals ≥18 yr following antibiotic treatment for recurrent CDI (i.e., ≥1 prior recurrence — 2nd episode onward, NOT 3+). Approval based on PUNCH CD3 (Khanna Drugs 2022;82(15):1527-1538) — Phase 3 RCT, n=262, treatment success 70.6% Rebyota vs 57.5% placebo at 8 wk (Bayesian posterior probability of superiority 99.1%). Endorsed by ACG 2021 + AGA Living Guideline 2024 update. Traditional FMT remains investigational under FDA enforcement discretion; Rebyota is the regulatorily approved alternative.

Next steps

Find the date on the denial letter — your appeal window starts there.
Read your plan's Summary of Benefits and Coverage (SBC) for the specific deadlines.
Request the insurer's claim file in writing — they must provide it.
Submit your appeal in writing with new clinical evidence and a physician statement.

Get the letter drafted

DenialHelp drafts your appeal in 5 minutes — $40 list price, $30 for your first letter (use code SEO25). We cite the federal regs and the specific clinical evidence your plan responds to. Your physician signs and sends.

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Related appeal guides

Other Cigna appeals

Other denial reasons for Cigna Rebyota

denied for failing step therapy denied as non-formulary denied for missing prior authorization denied as experimental or investigational denied as not FDA-approved for this use

This guide describes general US federal appeal rights based on Most US health plans have appeal rights under either the ACA, ERISA, or Medicare/Medicaid rules. Your specific plan documents (Summary of Benefits and Coverage, Evidence of Coverage) override anything here. DenialHelp is not your lawyer and not your physician — we draft appeal letters that your physician signs. Outcomes depend on your insurer's decision and factors outside our control. Reviewed by Michael John Ryan on 2026-05-09. Editorial standards: denialhelp.com/authors.