ModifiedUnitedHealthcarePolicy 202 5 D0124D

Rebyota (Fecal Microbiota, Live‑Jslm) — coverage criteria for prevention of recurrent Clostridioides difficile infection

Defines medical necessity, coverage criteria, and coding references for Rebyota (RBX2660) as a single-dose, rectally administered fecal microbiota product to prevent recurrence of Clostridioides difficile infection in adults with prior rCDI; applies to UnitedHealthcare commercial plans and directs prior authorization and specialty prescribing considerations.

Policy Summary

PayerUnitedHealthcare

PolicyRebyota (Fecal Microbiota, Live-Jslm) — coverage criteria for prevention of rCDI

Policy CodePolicy 202 5 D0124D

Change TypeAdministrative wording and reference updates

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization and document diagnosis of recurrent CDI, age ≥18, prior CDI episodes, and completion of at least 10 days of oral vancomycin or fidaxomicin 24–72 hours before Rebyota.

SourceLink

POLICY UPDATE CHANGES

Coverage Rationale: Replaced reference to ' Dificid (fidaxomicin)' with 'fidaxomicin'.

Supporting Information: Updated References section to reflect the most current information.

single doseauthorization issued for

18+age requirement

J1440listed HCPCS code for Rebyota

A04.71listed diagnosis code

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10+ daysminimum antibiotic therapy

CD & IBSinsufficient evidence for

Coverage Criteria for Rebyota and Fecal Microbiota Transplantation

inv-01: Medical Necessity Criteria — Prevention of rCDI

Covered when ALL of the following are met:

Rebyota initial coverage criteria: 1) Diagnosis of recurrent Clostridioides difficile infection (rCDI) defined by both: presence of diarrhea (≥3 loose bowel movements in 24 hours for 2 consecutive days) AND a positive stool test for Clostridioides difficile toxin; 2) Patient is 18 years of age or older; 3) Patient has had one or more recurrence(s) of CDI following an initial episode of CDI; 4) BOTH: (a) patient has completed at least 10 days of one of the following antibiotic therapies for rCDI between 24 to 72 hours prior to initiating Rebyota: oral vancomycin or fidaxomicin; AND (b) previous episode of CDI is under control (e.g., <3 unformed stools/day for 2 consecutive days); 5) Prescribed by or in consultation with a gastroenterologist or infectious disease specialist; 6) Authorization will be issued for a single dose treatment only.

From policy Coverage Rationale

inv-02: Coverage statements by indication

Coverage stance summarized from evidence sections:

Ulcerative colitis (UC) induction: Some randomized controlled trials and meta-analyses report short-term clinical and endoscopic remission benefit for FMT in active UC; evidence is heterogeneous and protocols (route, donor type, frequency) are not standardized—consider only in research protocols or with clear supporting evidence.evidence variable; consider for induction only within protocols or clinical trials

supported by chunks 21,22

Ulcerative colitis (UC) maintenance: RCTs of single-dose FMT did not demonstrate maintenance of remission and overall evidence is insufficient; FMT for UC maintenance is not recommended as medically necessary.not recommended for maintenance

supported by chunk 20

Crohn's disease (CD): Available studies are small, uncontrolled, or single-center with inconsistent results; evidence is insufficient and FMT is considered unproven for Crohn's disease outside clinical trials.not recommended outside trials

supported by chunk 18

Irritable bowel syndrome (IBS): Randomized trials and meta-analyses show inconsistent results for IBS; some delivery routes (upper GI or colonoscopic) show benefit in subgroups but overall evidence quality is low—FMT for IBS is unproven and not medically necessary except in research settings.not recommended except in research settings

supported by chunks 28,36,37

inv-03: FMT for recurrent or refractory Clostridioides difficile infection (rCDI)

Covered when ALL of the following are met

rCDI coverage: 1) Adult patient with recurrent or refractory CDI; 2) Documentation of prior appropriate antibiotic treatment for CDI, with guideline-based consideration for FMT after at least two recurrences (i.e., three CDI episodes) or per specialist assessment; 3) FMT used to prevent further recurrence after antibiotic therapy or as rescue therapy when medical management has failed; 4) Indication consistent with FDA-labeled use (Rebyota) or specialty society guidance (e.g., ACG, ASCRS, IDSA-SHEA, ESCMID, NICE); 5) Prescribed or managed by appropriate specialist and supported by documentation of prior CDI episodes and treatments.

Sourced from specialty society guidelines and FDA product information.

inv-04: FMT for irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD)

Not routinely covered / investigational unless in context of clinical trial or strong supporting evidence

IBS/IBD evidence: Randomized trials and meta-analyses demonstrate inconsistent and low-quality evidence for FMT in IBS and IBD. AGA recommends FMT for ulcerative colitis only in the context of clinical trials; overall, current data are insufficient to support routine coverage for IBS, Crohn's disease, or UC maintenance.

References: systematic reviews and AGA guidance.

Rebyota (fecal microbiota, live-jslm) is not medically necessary for prevention or treatment of indications other than prevention of recurrent Clostridioides difficile infection. The policy specifies that Rebyota is unproven and not medically necessary for all other indications, including but not limited to Ulcerative Colitis (UC), Crohn's disease, and irritable bowel syndrome (IBS) due to insufficient evidence of efficacy.

Fecal microbiota transplantation (FMT) is considered unproven and not medically necessary for the prevention or treatment of ulcerative colitis, Crohn's disease, and irritable bowel syndrome outside of approved indications or clinical trials. The evidence summaries and systematic reviews report heterogeneous and overall insufficient data to support routine clinical use for these conditions.

The American Gastroenterological Association (AGA) recommends that FMT for individuals with mild-to-moderate ulcerative colitis without C. difficile infection be performed only in the context of a clinical trial. AGA rated the evidence as very low and called for larger, long-term studies before routine clinical adoption.

For Crohn's disease, available studies are limited (small cohorts and a single randomized trial) and while some short-term signals exist, the overall evidence is insufficient. Therefore, FMT is described as unproven and not medically necessary for prevention or treatment of Crohn's disease outside of research settings.

Routine use of FMT for maintenance therapy in ulcerative colitis, for Crohn's disease, or for irritable bowel syndrome is not medically necessary given inconsistent and insufficient evidence. Randomized trials and RCT meta-analyses have not demonstrated consistent maintenance benefit in UC, and studies of IBS and CD are heterogeneous in method and outcomes, precluding support for routine coverage.

Use of FMT for irritable bowel syndrome (IBS) is not supported by consistent, high-quality evidence. Systematic reviews and randomized trials report overall no clear advantage of FMT over placebo, with subgroup analyses suggesting route-dependent effects; consequently, FMT for IBS is considered unproven and not medically necessary except in well-designed clinical trials.

Coding and Product References

Applicable HCPCS CodesHCPCS

J1440

Fecal microbiota, live - jslm, 1 ml.

Applicable Diagnosis CodesICD-10

A04.71

Enterocolitis due to Clostridium difficile, recurrent

Product referencesmixed

Rebyota (fecal microbiota, live-jslm)

Indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI. Note: NDC/HCPCS not specified in this section.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rebyota and for fecal microbiota transplantation (FMT) when used to treat recurrent CDI. Single‑dose authorization will be issued for Rebyota (one dose only). Verify the requested service aligns with the FDA‑labeled indication for Rebyota or with guideline-supported use for rCDI.

Prior authorization required for Rebyota (single dose authorization only).
Prior authorization recommended/likely required for FMT when used for non‑rCDI indications (e.g., UC, Crohn's, IBS) — these uses are considered unproven or not medically necessary.
Confirm indication: Rebyota only for prevention of rCDI in adults following appropriate antibiotic treatment.

Documentation Required

Suggested Clinical Documentation to Support Medical Necessity

Requests for Rebyota and FMT must include documentation supporting medical necessity. Provide clinical records that demonstrate the diagnosis, prior therapies, and relevant test results to justify use.

Background and Context

Clostridioides difficile infection (CDI) can recur after initial therapy; fecal microbiota transplantation (FMT) aims to restore gut microbial diversity to prevent recurrence. Rebyota is an FDA-licensed, donor-derived microbiota product administered rectally as a single dose for prevention of recurrent CDI in adults following antibiotic treatment. The policy requires documentation of prior CDI episodes, age ≥18 years, and completion of recommended antibiotic therapy prior to Rebyota use.

Definitions and Product Description

rCDI / Episode of CDI — definition for recurrent CDI

DefinitionRecurrent CDI (rCDI): recurrence of diarrhea plus a positive stool test for Clostridioides difficile toxin occurring within 8 weeks following treatment or as diagnosed by a gastroenterology or infectious disease specialist.

Episode of CDIAn episode requires compatible clinical findings and microbiologic evidence (toxin EIA or positive NAAT with corroborating findings) or endoscopic/pathologic evidence of pseudomembranous colitis.

Typical timingMost recurrences occur within 2–8 weeks after treatment, although later recurrences are possible.

FMT / Rebyota product description

DefinitionFecal Microbiota Transplantation (FMT): transfer of prepared donor stool (saline-diluted fecal suspension) into the gastrointestinal tract to restore fecal composition and microbial diversity.

Rebyota product summary

Policy Revision History

2025-12-01revisionLatest

Coverage Rationale wording updated: replaced reference to 'Dificid (fidaxomicin)' with 'fidaxomicin'; Supporting Information: References section updated to reflect current information; previous policy version 2025D0124C archived.

Policy Summary

PayerUnitedHealthcare

PolicyRebyota (Fecal Microbiota, Live-Jslm) — coverage criteria for prevention of rCDI

Policy CodePolicy 202 5 D0124D

Change TypeAdministrative wording and reference updates

Effective DateDec 1, 2025

Next Review Date

SourceLink

On This Page

Diagnosis: documentation of recurrent Clostridioides difficile infection (rCDI) — clinical notes showing ≥3 loose stools/day and clinical assessment.
Positive stool toxin test for C. difficile documented in the record.
Patient age (≥18 years for Rebyota).
Prescribing clinician specialty (gastroenterologist or infectious disease specialist) or documented consultation.
Record of prior CDI episodes and treatments (dates and agents used).
For Rebyota: documentation that prior episode is under control (e.g., <3 unformed stools/day for 2 consecutive days).
If submitting for FMT outside rCDI, include supporting literature/rationale; note these indications are generally unproven and at higher denial risk.

Documentation Required

Antibiotic Completion Requirement

Patient must have completed an appropriate antibiotic regimen prior to Rebyota or FMT for rCDI. For Rebyota, completion of at least 10 days of oral vancomycin or fidaxomicin is required 24–72 hours before administration.

Antibiotic completion requirement for Rebyota: ≥10 days of oral vancomycin or fidaxomicin completed 24–72 hours prior to Rebyota administration.
For FMT in rCDI, follow guideline-recommended antibiotic pre‑treatment (IDSA‑SHEA and ASCRS recommend antibiotic therapy for recurrent episodes prior to FMT).
Include antibiotic treatment records (agent, start/stop dates, response) with the authorization request.

Step Therapy

Step Therapy: Require Prior Antibiotic Management

Step therapy is required: conventional antibiotic management must be tried and documented before FMT/Rebyota for rCDI. FMT should be reserved for individuals with multiple recurrences or refractory disease after appropriate antibiotics per society guidelines.

Require documentation of prior antibiotic management for at least two recurrences (three CDI episodes) or other guideline‑specified thresholds before approving FMT in many cases.
Consider FMT for rCDI after failure of standard-of-care antibiotics and/or when recurrence prevention is the goal (Rebyota indication).
Denials likely if proper stepwise antibiotic therapy is not documented.

Rebyota (fecal microbiota, live-jslm) is an FDA-approved standardized, donor-derived FMT suspension administered rectally as a single 150 mL dose for prevention of rCDI; prepared from qualified donors with transmissible pathogen testing.

Dose compositionEach 150 mL dose contains between 1x10^8 and 5x10^10 CFU per mL (including >1x10^5 CFU/mL of Bacteroides) and contains ≤5.97 g of PEG 3350 in saline.

Preparation and administrationThe fecal suspension is the filtrate generated by processing stool with polyethylene glycol 3350 (PEG 3350) and saline and is administered rectally as a single dose.

Clinical and endoscopic remission — outcome definitions used in trials

Combined outcomeCombined clinical and endoscopic remission: a trial endpoint measuring both patient-reported clinical indices and endoscopic healing to assess treatment effect.

Clinical indicesExamples of patient-reported clinical indices used in trials include the Mayo score for ulcerative colitis and the Harvey–Bradshaw Index for Crohn's disease.

Endoscopic assessmentEndoscopic remission/response is used alongside clinical measures to determine mucosal healing and overall treatment efficacy in randomized trials.

Recurrent CDI (rCDI) — definition referenced by guideline groups

Guideline-referenced rCDI populationGuideline groups commonly reference individuals with two or more recurrences (i.e., three CDI episodes) or those with a second or more recurrence as candidates for FMT.

Antibiotic treatment prerequisiteIDSA‑SHEA recommends reserving FMT for individuals who have established proper antibiotic treatment for at least two recurrences (three CDI episodes).

Delivery recommendationsACG endorses colonoscopy or capsules as preferred delivery methods for rCDI and suggests enemas only if other methods are unavailable; repeat FMT may be recommended for recurrence within 8 weeks.

Rebyota (fecal microbiota, live-jslm) — FDA-licensed product description

FDA indicationRebyota (fecal microbiota, live-jslm) is indicated to prevent recurrence of Clostridioides difficile infection in individuals 18 years and older following antibiotic treatment for recurrent CDI.

Product natureAn FDA‑licensed, standardized microbiota-based product prepared from donor stool and administered rectally as a single-dose enema (150 mL).

Manufacturing/testingPrepared from qualified donors with testing for a panel of transmissible pathogens; formulated as a PEG 3350 and saline filtrate.

Mechanism of actionMechanism of action has not been established.