ModifiedUnitedHealthcarePolicy CS2025D00124F

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

Medical policy governing coverage and clinical criteria for Rebyota (fecal microbiota, live-jslm) for prevention of recurrent C. difficile infection (rCDI) in adults; applies to UnitedHealthcare Medical Benefit Drug coverage except where state-specific exceptions noted.

Policy Summary

PayerUnitedHealthcare

PolicyRebyota (fecal microbiota, live-jslm) for prevention of recurrent Clostridioides difficile infection

Policy CodePolicy CS2025D00124F

Change TypeCodes removedevidence and references updated

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for a single-dose Rebyota (J1440) with documentation of rCDI diagnostic criteria, prior antibiotic therapy (≥10 days), age ≥18, and prescribing clinician specialty.

SourceLink

POLICY UPDATE CHANGES

Removed HCPCS code G0455 from applicable codes.

Updated Clinical Evidence and References sections to reflect the most current information.

single doseauthorization issued for

J1440procedure code

A04.71diagnosis code

18+age requirement

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

rCDI recommendedguideline support

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

Initial therapy — medically necessary criteria

Covered when ALL of the following are met:

Rebyota coverage criteria: 1) Diagnosis of recurrent Clostridioides difficile infection defined by BOTH: (a) diarrhea (>=3 loose bowel movements within a 24-hour period for 2 consecutive days) AND (b) a positive stool test for C. 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; 4) BOTH: (a) patient has completed at least 10 days of one of the following antibiotic therapies between 24 to 72 hours prior to initiating Rebyota: oral vancomycin OR fidaxomicin (Dificid); AND (b) the previous episode of CDI is under control (e.g., <3 unformed/loose 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.

All listed conditions must be satisfied for coverage.

Coverage by indication

rCDI (Clostridioides difficile infection): FMT is supported by guideline bodies (AHRQ, ACG) for recurrent CDI and for severe/fulminant CDI refractory to antibiotics; recommended delivery methods include colonoscopy or capsules; consider repeat FMT for recurrence within 8 weeks.guideline-based

AHRQ/ACG recommendations cited

Ulcerative Colitis (UC): Evidence is mixed: several meta-analyses and RCTs show short-term combined clinical and endoscopic benefit in some trials, but heterogeneity, lack of standardized protocols, and inconsistent long-term results lead to FMT being unproven or not medically necessary for UC in some assessments.insufficient evidence

Single-dose FMT RCTs showed no maintenance benefit; pooled RCTs suggest short-term induction benefit but uncertainty remains regarding maintenance, donor selection, dosing, and delivery.

Irritable Bowel Syndrome (IBS): Evidence is inconclusive and modality-dependent: pooled analyses show no overall superiority to placebo, but some delivery routes (upper GI via duodenoscope or naso-jejunal, or colonoscopy in some trials) showed benefit; capsule FMT often did not show benefit. Overall not established for routine use.insufficient/inconclusive evidence

Heterogeneous trial results and low to very low GRADE quality in many analyses.

Guideline-aligned coverage indications

Covered when clinical indications align with major society guidance (examples below reflect guideline positions):

Guideline-based indications

NICE: Adults with two or more previous confirmed episodes of rCDI — FMT recommended as a treatment choice.>=2 recurrences
NICE recommends FMT as a choice for adults with two or more prior confirmed episodes.
ACG: Consider FMT to avoid further recurrence in individuals with a second or more CDI recurrence; colonoscopy or capsules are preferred delivery methods; repeat FMT recommended for recurrence within 8 weeks of first FMT.second or more recurrence
ACG guidance (strong recommendations, variable evidence quality).
IDSA-SHEA:

Rebyota (fecal microbiota, live-jslm) is unproven and not medically necessary for the prevention and/or treatment of indications other than recurrent Clostridioides difficile infection (rCDI), including but not limited to ulcerative colitis, Crohn's disease, and irritable bowel syndrome. The policy explicitly states coverage is limited to the listed rCDI criteria; use for other conditions lacks sufficient evidence of efficacy and is therefore not covered.

Use of fecal microbiota transplantation (FMT) for ulcerative colitis (UC) and irritable bowel syndrome (IBS) is described in the document as having insufficient evidence to support routine clinical use. The policy notes that FMT for UC is considered unproven and not medically necessary, and that pooled analyses for IBS show no overall superiority to placebo with modality-dependent results, so claims for UC or IBS are at risk for denial.

The policy discourages use of FMT outside guideline-recommended sequencing and scenarios. In line with IDSA-SHEA and ESCMID guidance, FMT should be reserved for patients who have completed appropriate antibiotic therapy and, for complex or refractory cases, be considered only after multidisciplinary risk assessment and when standard treatments have failed. Performing FMT before completing recommended antibiotic regimens or without appropriate assessment may be considered investigational or excluded.

For ulcerative colitis, the policy summarizes available trials as insufficient to demonstrate a clear benefit: randomized data (for example, single-dose FMT trials) have not shown maintenance benefit and meta-analyses report heterogeneity and inconsistent long-term outcomes. Because of these limitations, FMT (including Rebyota) is considered unproven and not medically necessary for UC.

Overall, the document treats FMT as unproven and not medically necessary for both ulcerative colitis (UC) and irritable bowel syndrome (IBS). UC trial results are inconsistent and do not support routine maintenance use, while IBS trials show no consistent overall benefit and efficacy that depends on delivery modality; therefore routine coverage for these indications is not supported.

FMT for indications outside recurrent CDI (for example, routine use in other gastrointestinal conditions) is not supported by the policy and is considered unproven. The ESCMID and other guideline summaries emphasize reserving FMT for multiple recurrent or severely refractory CDI and recommend standardized product preparation and multidisciplinary risk assessment before use in complex cases.

Coding and Billing

Procedure/Billing CodesHCPCS

J1440

Fecal microbiota, live-jslm, 1 ml.

Diagnosis CodesICD-10

A04.71

Enterocolitis due to Clostridium difficile, recurrent

Previously applicable HCPCS codes (removed)HCPCSNot Covered

G0455

HCPCS code noted as removed from applicable codes

Prior antibiotic therapy duration — key facts

Minimum prior antibiotic therapy duration>= 10 days of oral vancomycin or fidaxomicin completed between 24 to 72 hours prior to Rebyota

Acceptable antibioticsOral vancomycin; Dificid (fidaxomicin)

Timing requirementAntibiotic course must be completed 24–72 hours before Rebyota administration

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rebyota (single-dose J1440). Be prepared to provide documentation demonstrating the member meets diagnostic and treatment sequencing criteria for recurrent CDI before authorization is approved.

Single dose authorization only
Verify current billing codes prior to submission (policy removed G0455 as of 01/01/2025)

Documentation Required

Documentation Required for rCDI

Document the diagnosis of recurrent CDI and prior therapy thoroughly. Include stool testing results, stool frequency/duration, age, and detailed recurrence history to demonstrate medical necessity.

Stool test positive for C. difficile toxin
Diarrhea: ≥3 loose stools in 24 hours for ≥2 consecutive days
Patient age ≥ 18 years

Background and Clinical Context

Recurrent C. difficile infection (rCDI) occurs when diarrhea returns after initial treatment and is confirmed with a positive stool test for C. difficile toxin; rCDI commonly presents within weeks of initial therapy. FMT aims to restore normal gut microbiota and Rebyota is an FDA-approved, standardized fecal microbiota suspension delivered rectally as a single 150 mL dose for prevention of rCDI. Clinical use and coverage are limited to adults meeting diagnostic criteria (diarrhea defined as ≥3 loose stools/24 hours for 2 consecutive days with a positive toxin test), age ≥18 years, documented recurrence(s), and appropriate antibiotic pretreatment per policy requirements.

Definitions and Product Characteristics

Episode of CDI — clinical + microbiological evidence

Clinical criteria for an episode of CDIClinical findings compatible with CDI (e.g., ≥3 loose stools/24 hr for 2 consecutive days) without another cause of diarrhea

Microbiological evidencePositive test for toxigenic Clostridioides difficile (toxin EIA, positive NAAT preferably with low Ct, or toxigenic culture) or endoscopic/pathologic evidence (pseudomembranous colitis)

Combined requirementAn episode requires both compatible clinical findings and microbiologic evidence of toxigenic C. difficile

Recurrent CDI (rCDI) — definition and timing

Definition of recurrence (rCDI)Recurrence of diarrhea plus a positive stool test for C. difficile toxin occurring within 8 weeks following treatment or as diagnosed by a GI or ID specialist

Typical timing

Policy Summary

PayerUnitedHealthcare

PolicyRebyota (fecal microbiota, live-jslm) for prevention of recurrent Clostridioides difficile infection

Policy CodePolicy CS2025D00124F

Change TypeCodes removedevidence and references updated

Effective DateJan 1, 2025

Next Review DateN/A

SourceLink

On This Page

Reserve FMT for individuals who have established proper antibiotic treatment for at least two episodes of recurrence (or three CDI episodes) due to potential adverse events and transmission risks.

antibiotic treatment for at least two recurrences

IDSA-SHEA sequencing recommendation.

ESCMID: FMT may be considered as rescue therapy for severely complex CDI that has declined despite antibiotics and when surgery is not an option; requires multidisciplinary risk assessment and standardized product preparation/screening.severe refractory CDI

ESCMID recommends multidisciplinary assessment and standardized product availability.

Record number and dates of prior CDI episodes

Documentation Required

Document CDI Recurrence and Prior Therapy

Show evidence of CDI recurrence and prior antibiotic therapy. The record should demonstrate prior episode control and the sequence of treatments tried before FMT/Rebyota.

Evidence prior episode under control (e.g., <3 unformed stools/day for 2 consecutive days)
Dates and agents of prior antibiotic courses for CDI
Specialist involvement: gastroenterologist or infectious disease consultation

Step Therapy

Antibiotic Lead-In Requirement

Antibiotic lead-in is required: the patient must have completed at least 10 days of a specified antibiotic (oral vancomycin or fidaxomicin) between 24 to 72 hours prior to FMT/Rebyota administration.

Allowed lead-in agents: oral vancomycin or fidaxomicin (Dificid)
Duration: ≥10 days completed 24–72 hours before FMT/Rebyota

Step Therapy

Step Therapy Expectations for CDI

Step therapy / sequencing expectations: FMT/Rebyota should be reserved for individuals who have failed appropriate antibiotic therapy per guideline-recommended sequencing — typically after multiple recurrences or when standard management has failed.

Document at least two episodes of recurrence (or three CDI episodes) when applicable per IDSA-SHEA
Record failure or intolerance of appropriate antibiotic regimens prior to FMT/Rebyota

Note

Antibiotic Trial Before FMT

Antibiotic trial before FMT: consider FMT/Rebyota after failure of appropriate antibiotic therapy for multiple recurrences; repeat FMT may be considered for recurrence within guideline-specified timeframes.

Consider FMT/Rebyota for patients with multiple recurrences despite guideline-directed antibiotics
Note guidance on repeat FMT for recurrence within 8 weeks of prior FMT

Denial Risk

Triggers for Denial

Triggers for denial: authorization may be denied if the member does not meet recurrent CDI diagnostic criteria, lacks documented appropriate antibiotic lead-in/sequence, is under age 18, or if FMT/Rebyota is requested for unproven indications (e.g., UC, IBS).

Missing stool toxin positive test or insufficient diarrhea documentation
No documentation of ≥10-day antibiotic lead-in completed 24–72 hours prior
No evidence of required number of recurrences or failed antibiotic courses
Requests for indications considered unproven (Ulcerative Colitis, Crohn's disease, IBS)

Billing Rule

Verify Current Applicable Codes

Verify current applicable codes before submitting authorization or claims. Code lists may change; the policy removed HCPCS code G0455 effective 01/01/2025 — confirm use of J1440 and appropriate diagnosis codes.

Current product HCPCS: J1440 (Fecal microbiota, live-jslm, 1 ml)
Example ICD-10: A04.71 (Enterocolitis due to Clostridium difficile, recurrent)
Providers should verify payer-specific billing guidance prior to submission

Most recurrences occur within 2–8 weeks after treatment, though later recurrences can occur

Diagnostic confirmationRequires positive stool toxin test in the context of compatible clinical symptoms

Rebyota product characteristics

Dose and routeSingle 150 mL rectal dose

Product compositionProcessed donor fecal microbiota in PEG 3350 and saline; each 150 mL dose contains 1x10^8 to 5x10^10 CFU/mL (including >1x10^5 CFU/mL of Bacteroides)

Donor screeningPrepared from stool donated by qualified individuals; donor stool tested for a panel of transmissible pathogens

Combined clinical and endoscopic remission — UC trial outcome

Combined clinical and endoscopic remission definitionOutcome combining clinical symptom remission and endoscopic evidence of mucosal healing used in UC trials

Measured endpointsIncludes clinical remission/response and endoscopic remission/response as reported in RCTs and meta-analyses

Context of useUsed as a primary outcome in UC RCTs/meta-analyses assessing short-term induction benefit

FMT delivery modalities

Common delivery modalitiesColonoscopy, upper GI routes (naso-jejunal tube or duodenoscope), and oral capsules

Rebyota deliveryRebyota is administered rectally as a single 150 mL dose (enema/rectal instillation), not oral capsules

Multiple recurrences (rCDI) — guideline context

Guideline context for multiple recurrencesGuidelines support considering FMT for adults with multiple (>=2) confirmed CDI recurrences

ACG positionACG recommends FMT to avoid further recurrence in individuals with a second or more CDI recurrence; colonoscopy or capsules preferred

NICE positionNICE recommends FMT for adults with two or more previous confirmed episodes of rCDI