CurrentUnitedHealthcarePolicy 2025D0124C

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

Defines UnitedHealthcare medical policy coverage and medical necessity criteria for Rebyota to prevent recurrence of Clostridioides difficile infection (rCDI) in adults; states FMT is not covered for other indications such as ulcerative colitis, Crohn's disease, and IBS.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy 2025D0124C

Change TypeNo material changes

Effective DateJan 1, 2025

Next Review Date

Key ActionObtain prior authorization for a single-dose Rebyota treatment only after documenting age ≥18, recurrent CDI with positive stool toxin test, completion of at least 10 days of oral vancomycin or fidaxomicin 24–72 hours prior, and clinician consultation with GI or ID.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

single doseauthorized treatment courses

>=18 yrsminimum patient age for coverage

10 daysantibiotic therapy prior

1+ rCDIrequired history of CDI recurrence

150 mL

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Coverage Criteria for Rebyota (fecal microbiota, live-jslm)

Initial therapy (medical necessity)

Covered when ALL of the following are met:

Rebyota medical necessity criteria: 1) Diagnosis of recurrent Clostridioides difficile infection (rCDI) defined by BOTH: (a) presence of diarrhea defined as passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days; AND (b) 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 (Dificid); AND (b) the previous episode of CDI is under control (for example, less than 3 unformed/loose stools/day for 2 consecutive days); 5) Prescribed by or in consultation with a gastroenterologist or an infectious disease specialist; 6) Authorization will be issued for a single-dose treatment only.

Exact temporal window for antibiotics: 24–72 hours prior to Rebyota; single-dose authorization only.

Indication-specific coverage stance

Coverage stance and evidence summary by indication

Ulcerative colitis (UC): There is insufficient evidence for the efficacy of treating UC with FMT. Trials and systematic reviews report mixed results; single-dose RCTs did not demonstrate maintenance benefit and meta-analyses show heterogeneity and low certainty. Therefore FMT (including Rebyota) is considered unproven and not medically necessary for prevention and/or treatment of UC.

Lahtinen RCT (single-dose) did not show difference in maintenance of remission; meta-analyses report heterogeneity and low certainty.

Crohn's disease (CD): The evidence base for FMT in Crohn's disease is small with low-certainty data; existing reviews conclude insufficient evidence to support routine use. FMT for CD is therefore considered unproven and not medically necessary.

Cochrane and other reviews found limited data and low certainty.

Irritable bowel syndrome (IBS): Systematic reviews and RCTs show no consistent overall benefit of FMT for IBS. Some delivery routes (upper-GI or endoscopic) showed benefit in subgroup analyses, but overall evidence is inconsistent, with low-quality data and heterogeneity. FMT for IBS is considered unproven and not medically necessary.

Meta-analyses (Rokkas & Hold; Halkjær et al.) found no overall advantage; subgroup signals for upper-GI delivery require further study.

Rebyota (fecal microbiota, live-jslm) and fecal microbiota transplantation (FMT) are considered not medically necessary and unproven for prevention and/or treatment of indications other than prevention of recurrent Clostridioides difficile infection (rCDI). This includes, but is not limited to, Ulcerative Colitis (UC), Crohn's disease (CD), and Irritable Bowel Syndrome (IBS) due to insufficient evidence of efficacy.

For Crohn's disease, available systematic reviews and pooled data include small cohorts and at least one randomized trial; while some short-term signals for remission have been reported, authors conclude that higher-quality, placebo-controlled randomized trials with long-term follow-up are needed before FMT can be recommended.

For ulcerative colitis and IBS, randomized trials and meta-analyses have produced mixed and heterogeneous results, with single-dose FMT trials failing to demonstrate consistent maintenance benefit; therefore routine use for UC or IBS is not supported.

FMT is considered unproven and not medically necessary for prevention and/or treatment of ulcerative colitis (UC) and irritable bowel syndrome (IBS). Evidence from randomized trials and meta-analyses is heterogeneous and of low certainty, and single-dose FMT trials have not demonstrated clear maintenance or durable benefit in UC.

Systematic reviews of IBS trials show no overall advantage of FMT over placebo in pooled analyses; some subgroup analyses suggest benefit with specific upper-GI delivery methods, but these findings are inconsistent and insufficient to support routine clinical use.

Requests for FMT for UC or IBS should be evaluated in the context of this policy stance and are subject to denial unless supported by compelling, high-quality evidence consistent with covered indications.

Use of Rebyota or other FMT preparations for indications other than prevention of recurrent CDI—such as Ulcerative Colitis (UC), Crohn's disease (CD), and Irritable Bowel Syndrome (IBS)—is considered not medically necessary / unproven because current evidence does not reliably demonstrate efficacy for these conditions.

Although some cohort studies and small randomized trials report short-term improvements in inflammatory bowel disease measures, the overall evidence base is limited by small sample sizes, heterogeneity of FMT methods, and low certainty; more rigorous placebo-controlled RCTs with longer follow-up are required before these indications can be considered for coverage.

FMT is unproven and not medically necessary for prevention and/or treatment of ulcerative colitis (UC) and irritable bowel syndrome (IBS). Meta-analyses and randomized trials provide inconsistent results and substantial heterogeneity, and findings do not support routine clinical application for these conditions.

Because evidence does not meet the threshold for medical necessity, clinical requests for FMT to treat UC or IBS should be considered experimental and are not covered under this policy.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rebyota (fecal microbiota, live-jslm). Authorization will be issued for a single-dose treatment only when medical necessity criteria are met.

Authorization: single-dose treatment only
Policy Number: 2025D0124C
Effective Date: 2025-01-01

Documentation Required

Required Diagnostic Documentation

Documentation must demonstrate the diagnosis of recurrent Clostridioides difficile infection (rCDI). Required clinical evidence includes both: presence of diarrhea defined as 3 or more loose stools within a 24-hour period for 2 consecutive days; and a positive stool test for C. difficile toxin.

Clinical criteria: ≥3 loose stools/day for 2 consecutive days
Laboratory: positive stool C. difficile toxin test

Background and Context

Clostridioides difficile infection (CDI) is a toxin-mediated diarrheal disease often associated with prior antibiotic exposure. Recurrent CDI (rCDI) is defined as recurrence of diarrhea plus a positive stool test for C. difficile toxin occurring within 8 weeks after treatment or as diagnosed by gastroenterology or infectious disease specialists.

Fecal microbiota transplantation (FMT) aims to restore normal gut microbiota. Rebyota is an FDA-approved standardized fecal microbiota suspension administered rectally as a single-dose enema; each 150 mL dose contains a specified bacterial colony-forming unit (CFU) range and is produced from screened donor stool.

This policy covers Rebyota only for prevention of rCDI in adults meeting the medical necessity criteria, and it explicitly excludes coverage for treatment or prevention of other conditions such as Ulcerative Colitis, Crohn's disease, and Irritable Bowel Syndrome because current evidence is insufficient.

Definitions and Product Characteristics

inv-16: Episode of CDI — Clinical findings compatible with CDI plus microbiological evidence of C. difficile toxins by enzyme immunoassay or positive NAAT (prefer...).

DefinitionClinical findings compatible with CDI plus microbiological evidence of C. difficile toxins by enzyme immunoassay or a positive NAAT (preferably with a low cycle threshold), positive toxigenic culture, or pseudomembranous colitis on endoscopy.

Clinical criteriaSymptoms: diarrhea consistent with CDI (e.g., ≥3 unformed/loose stools within 24 hours for 2 consecutive days).

Microbiological evidencePositive stool test for toxigenic C. difficile by enzyme immunoassay or NAAT (preferably low Ct) or positive toxigenic culture.

Alternate diagnostic findingPseudomembranous colitis diagnosed on endoscopy (with supporting positive test for toxigenic C. difficile).

Contextual noteEpisode of CDI requires absence of reasonable alternative causes of diarrhea when interpreting test results.

Policy Revision History

2025-07-01template_updateLatest

Template update with revisions to the Benefit Considerations section.

2025-01-01policy_effective_and_content_update

Policy effective date established; Applicable Codes updated (HCPCS code G0455 removed), Clinical Evidence and References sections updated, and previous policy version 2024D00124B archived.