ModifiedCignaPolicy IP0556

Rebyota (fecal microbiota, live-jslm) coverage — prevention of recurrent Clostridioides difficile infection

Defines Cigna's coverage criteria for Rebyota to prevent recurrent Clostridioides difficile infection (CDI) in adults, including dosing logistics, prior authorization and coding guidance; applies to health plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyRebyota (fecal microbiota, live-jslm) coverage — prevention of recurrent CDI

Policy CodePolicy IP0556

Change TypeRevised positive stool test timingremoved documentation requirements

Effective DateAug 1, 2025

Next Review DateJun 6, 2025

Key ActionSubmit prior authorization with documentation that the patient is ≥18, has a positive stool test for the current CDI episode, ≥2 prior recurrences (≥3 total episodes), administration planned 24–72 hours after antibiotics, and that an ID or GI specialist prescribed or consulted.

SourceLink

POLICY UPDATE CHANGES

Updated positive stool test criteria with addition of 'for current episode' and removed 'within the previous 30 days'.

Removed documentation requirements.

≥18minimum patient age

≥3required total CDI episodes

24–72hadmin timing after antibiotics

150 mL

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1 moinitial auth duration

Coverage Criteria for Rebyota (Prevention of Recurrent CDI)

Initial Authorization (Prevention of CDI recurrence)

Rebyota is considered medically necessary when the individual meets ALL of the following criteria:

Initial authorization criteria

Age 18 years or older>=18 yrs
B: Clostridioides difficile infection (CDI) confirmed by positive stool test for the current episodepositive stool test
C: At least 2 recurrent CDI episodes (>=3 total CDI episodes)>=3 total episodes
D: Administration will occur 24-72 hours following completion of antibiotic course for CDI treatment24-72 hours
E: Medication is prescribed by or in consultation with an infectious disease or gastrointestinal specialistspecialist involvement

Policy note: When coverage is available and medically necessary, dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature; adjust based on severity, alternative treatments, and previous response

Receipt of sample product does not satisfy criteria

Prevention of recurrence of CDI (criteria update)

Updated criteria for prevention of recurrent CDI

Positive stool test requirement: Positive stool test criteria updated to require a positive test 'for current episode' (phrase 'within the previous 30 days' removed)for current episode

Documentation requirements were removed in this revision

Rebyota for any use other than the prevention of recurrence of Clostridioides difficile infection (CDI) as described in this policy is considered not medically necessary. The policy will be updated if new published data support additional indications.

The provided revision chunks do not list specific exclusion conditions beyond the general not-medically-necessary statement; no explicit, itemized exclusions are present in these sections.

Use of Rebyota for indications other than prevention of CDI recurrence as specified in this policy is considered not medically necessary.

The revision details and updated criteria language included in these chunks do not contain additional explicit statements labeling other uses as not medically necessary.

Coding and Administration Details

Considered medically necessary when policy criteria metmixedCovered

44705	Preparation of fecal microbiota for instillation, including assessment of donor specimen.
0780T	Instillation of fecal microbiota suspension via rectal enema into lower gastrointestinal tract
C9399	Unclassified drugs or biologicals (Code effective until 06/30/2023)
G0455	Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen.
J1440	Fecal microbiota, live-jslm, 1 ml (Code effective 07/01/2023)
J3490	Unclassified drugs (Code effective until 06/30/2023)
J3590	Unclassified biologics (Code effective until 06/30/2023)

inv-08: Administration timing — 24-72 hours after completion of antibiotic course

Administration timing24–72 hours after completion of antibiotic course for CDI treatment

Timing contextSpecified as following completion of the antibiotic course for the current CDI treatment episode

Authorization linkageAdministration timing is a required element of the initial authorization criteria (must occur 24–72 hours after antibiotics)

inv-09: Dose volume — 150 mL single rectal dose

Dose volumeSingle rectal dose of 150 mL

Route associatedDelivered rectally as the product administration method per dosing instructions

Provider Requirements, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization required. Rebyota is a prior authorization medication for prevention of recurrent Clostridioides difficile infection (CDI). Approvals are for a 1 month authorization period when medical necessity criteria are met.

Prior authorization required prior to administration
Authorization period: 1 month

Prior Authorization

Prior Authorization for Prevention of Recurrent CDI

Prior authorization criteria specifically address use for prevention of recurrent CDI. Coverage is for patients meeting all coverage criteria (age ≥18, positive stool test for the current CDI episode, ≥2 prior recurrences [≥3 total episodes], timing of administration after completion of antibiotics, and prescription by or in consultation with an ID or GI specialist).

Indication: Prevention of recurrence of CDI
Must meet ALL coverage criteria listed in policy

Clinical Background

Clostridioides difficile is a spore-forming, gram-positive bacterium that commonly causes antibiotic-associated diarrhea and can lead to substantial morbidity, mortality, and healthcare costs. Recurrent CDI is common and the risk of subsequent recurrences increases after each episode, making prevention of recurrence a key clinical objective. Rebyota (a rectally administered fecal microbiota suspension) is indicated to prevent recurrence of CDI in adults following antibiotic treatment for recurrent CDI; it is given as a single 150 mL rectal dose typically administered 24–72 hours after completion of the antibiotic course.

Definitions and Product Information

inv-19: Rebyota — product description and indication (rectal fecal microbiota suspension to prevent recurrence of CDI in adults)

Generic name and formulationRebyota (fecal microbiota, live-jslm) — a fecal microbiota suspension for rectal administration

IndicationIndicated to prevent recurrence of Clostridioides difficile infection (CDI) in adults (≥18 years) following antibiotic treatment for recurrent CDI

Limitation of useNot indicated for treatment of active CDI

inv-20: FMT (fecal microbiota transplantation) — definition and delivery routes

DefinitionFecal microbiota transplantation (FMT) is the placement of stool from a healthy donor into a patient’s gastrointestinal tract to alter the recipient’s gut microbiota composition

Purpose

Policy Revision Notes

2025-08-01policy_effective_dateLatest

Policy updated with revised positive stool test criteria ('for current episode') and removal of prior documentation requirements; changes effective 8/1/2025.

2025-06-06policy_revision_review

Revision reviewed: updated positive stool test criteria to require 'for current episode' and deletion of prior documentation requirements.

Policy Summary

PayerCigna

PolicyRebyota (fecal microbiota, live-jslm) coverage — prevention of recurrent CDI

Policy CodePolicy IP0556

Change TypeRevised positive stool test timingremoved documentation requirements

Effective DateAug 1, 2025

Next Review DateJun 6, 2025

SourceLink

On This Page

Dose frequencySingle administration (one-time dose) for the indicated prevention of recurrence

Denial Risk

Positive Stool Test Timing

Positive stool test must be for the current CDI episode. The policy was revised to add the phrase 'for the current episode' and removed the prior requirement that the positive test be 'within the previous 30 days'. Coverage may be denied if the positive stool test criterion for the current CDI episode is not met.

Positive stool test required: explicitly 'for the current episode'
Removed: 'within the previous 30 days' timing requirement

Documentation Required

Documentation Requirements Removed — Submit Clinical Evidence

Documentation requirements that were previously specified have been removed from the policy. Submitters must still provide sufficient medical information to demonstrate that the member meets the current medical necessity criteria in the policy (age, positive stool test for current episode, ≥2 recurrences, administration timing, specialty involvement). Receipt of sample product does not satisfy coverage requirements.

Previously required documentation fields removed
Provide evidence supporting ALL medical necessity criteria at time of prior authorization submission
Receipt of samples does not satisfy criteria

Step Therapy

Place in Therapy and Prior Therapies

Place in therapy: Rebyota is positioned as a preventive option to reduce recurrence after at least two prior CDI recurrences (i.e., three total CDI episodes). Clinical guidelines recommend other treatment options for recurrent CDI (e.g., fidaxomicin [Dificid], oral vancomycin, and fecal microbiota transplantation [FMT]) before or alongside FMT per guideline recommendations; FMT is generally recommended after appropriate antibiotic treatments for at least two recurrences. Rebyota administration must follow completion of CDI antibiotic therapy and be prescribed by or in consultation with an ID or GI specialist.

Place in therapy: prevention of recurrence after ≥2 recurrences (≥3 total episodes)
Prior therapies per guidelines include fidaxomicin, oral vancomycin, and FMT (FMT generally after at least two recurrences)
Administration timing: 24–72 hours after completion of antibiotic course

Note

Guideline References and Safety Guidance

Guideline and safety references inform step-therapy and safety expectations. IDSA/SHEA and ACG guideline recommendations (2021) and NCCN guidance note preferred and alternative antibiotic choices and the role of FMT for recurrent CDI. FDA safety communications regarding FMT (risk of transmission of multidrug-resistant and other pathogenic organisms) are referenced and should be considered when evaluating prior therapies.

Key guideline sources: IDSA/SHEA 2021 focused update; ACG 2021; ASCRS 2021; NCCN Prevention and Treatment of Cancer-Related Infections v1.2025
Safety alerts: FDA communications on FMT risks and additional safety protections (2019–2022)

Used to restore or normalize gut microbiota composition, commonly used for recurrent CDI

Delivery routesVarious preparations and routes exist (including rectal/instillation methods); specific route depends on product and clinical context

inv-21: Rebyota suspension for rectal use as referenced in prescribing information

Reference product descriptionRebyota suspension for rectal use as described in prescribing information

Admin instructions (per PI)Administered rectally via gravity flow using the Rebyota bag and tube tip with patient positioned left-side or knee-chest and bladder/bowel emptied if possible

Source citationPrescribing information: Rebyota suspension for rectal use (Ferring; December 2022)