ModifiedUnitedHealthcarePolicy IEXD00124.03

Rebyota (Fecal Microbiota, Live-Jslm) — Coverage Criteria

Defines UnitedHealthcare coverage criteria for Rebyota (an FDA-approved standardized fecal microbiota product) for prevention of recurrent C. difficile infection (rCDI) in adults and states when it is considered not medically necessary for other indications.

Policy Summary

PayerUnitedHealthcare

PolicyRebyota (Fecal Microbiota, Live-Jslm) — Coverage Criteria

Policy CodePolicy IEXD00124.03

Change TypeRemoved HCPCS codeupdated evidence/references

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for a single-dose Rebyota treatment when all coverage criteria are met.

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 permitted per patient

J1440HCPCS code included for Rebyota

>=18patient age requirement

>=1required prior CDI recurrence(s)

A04.71

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.

Coverage Criteria and Policy Positions

inv-01: Medically necessary for prevention of rCDI

Covered when ALL of the following are met:

Diagnostic criteria: Diagnosis of recurrent Clostridioides difficile infection (rCDI) defined by BOTH: (1) presence of diarrhea defined as passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days; AND (2) a positive stool test for C. difficile toxin.

Age: Patient is 18 years of age or older.

Prior recurrence: Patient has had one or more recurrence(s) of CDI following an initial episode of CDI.>=1 recurrence

Antibiotic therapy and disease control: 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) previous episode of CDI is under control (e.g., less than 3 unformed/loose stools/day for 2 consecutive days).

Prescriber specialty: Prescribed by or in consultation with a gastroenterologist OR an infectious disease specialist.

Authorization limit: Authorization will be issued for a single dose treatment only.single dose

inv-02: Not medically necessary / unproven indications

Other indications: Rebyota (FMT) is unproven and not medically necessary for prevention and/or treatment of all other indications, including but not limited to ulcerative colitis, Crohn's disease, and irritable bowel syndrome, due to insufficient evidence of efficacy.

inv-03: Ulcerative Colitis — Not Medically Necessary

Policy stances in this segment:

Ulcerative Colitis (UC): FMT is considered unproven and not medically necessary for prevention and/or treatment of ulcerative colitis (UC).

Systematic reviews and RCT meta-analyses report some short-term induction benefit in active UC but heterogeneity, small study numbers, and lack of standardized protocols support an NMN designation; AGA recommends FMT for UC only in the context of clinical trials.

inv-04: IBS — Not Medically Necessary

IBS evidence summary and stance:

Irritable Bowel Syndrome (IBS): There is insufficient and inconsistent evidence to support FMT for IBS; FMT is unproven and not medically necessary for prevention and/or treatment of IBS.

Some RCTs and meta-analyses report benefit for specific delivery routes (e.g., duodenoscope or naso-jejunal tube) or single-dose multiple-donor colonoscopic preparations, but overall evidence is low quality and heterogeneous, limiting routine coverage.

inv-05: Crohn Disease — Evidence Uncertain

Crohn disease evidence:

Crohn disease (CD): Available evidence is limited and of low certainty; Cochrane and other reviews conclude no solid conclusions can be drawn regarding FMT efficacy for Crohn disease and more high-quality studies are needed.

No explicit coverage decision is provided in this segment; document classifies non-rCDI indications generally as unproven.

inv-06: CDI — Consider FMT for multiple recurrences

CDI recommendation:

Clostridioides difficile infection (CDI): AHRQ proposes FMT should be considered for children and adults with multiple CDI recurrences; Rebyota is indicated to prevent recurrence of CDI in adults following antibiotic treatment for recurrent CDI when criteria are met.multiple recurrences

Policy supports consideration of FMT for multiple recurrences per guideline recommendations, with coverage limited to indicated population and prior authorization requirements.

inv-07: Coverage context and evidence-based positions

Coverage aligned to evidence and guideline positions:

FDA Indication: Rebyota is indicated for prevention of recurrence of CDI in individuals 18 years and older following antibiotic treatment for recurrent CDI.

FDA indication supports coverage for the specified population when plan criteria and prior authorization are satisfied.

Guideline-supported FMT use for CDI: AHRQ and ESCMID acknowledge FMT for multiple recurrent CDI and as rescue therapy for severe complicated CDI; AGA restricts FMT for UC to clinical trials.

Guidelines support FMT primarily for recurrent CDI; other indications remain experimental or trial-based.

IBS evidence: Systematic reviews and meta-analyses for IBS show mixed and low-quality evidence with small RCTs; any demonstrated benefit appears route- and preparation-dependent.

Coverage for IBS indications would be limited by low-quality evidence and is classified as unproven or not medically necessary absent stronger evidence or plan-specific allowances.

Rebyota and other fecal microbiota transplantation (FMT) preparations are not covered for the treatment or prevention of conditions other than recurrent Clostridioides difficile infection (rCDI). This includes, but is not limited to, ulcerative colitis, Crohn's disease, and irritable bowel syndrome, owing to insufficient evidence of efficacy for these indications.

Use of FMT for ulcerative colitis (UC) and irritable bowel syndrome (IBS) is described in this policy as unproven and not medically necessary for prevention or treatment, based on available systematic reviews and randomized trials that show inconsistent benefit, heterogeneity of methods, and low-quality evidence.

The American Gastroenterological Association (AGA) recommends that FMT for individuals with mild-to-moderate ulcerative colitis be performed only in the context of a clinical trial; routine clinical use for induction or maintenance of UC is not supported by the AGA due to very low–quality evidence.

Use of Rebyota for indications other than prevention of rCDI is considered unproven and not medically necessary because evidence is insufficient to establish efficacy for other diseases; coverage is limited to the FDA‑indicated population and the documented medical necessity criteria for rCDI.

FMT is designated unproven and not medically necessary for the prevention and/or treatment of ulcerative colitis (UC) in this policy, reflecting trial results and systematic reviews that do not consistently demonstrate benefit for maintenance or induction of remission.

FMT is designated unproven and not medically necessary for the prevention and/or treatment of irritable bowel syndrome (IBS); systematic reviews and network meta-analyses show no consistent overall benefit and heterogeneity across trials.

The evidence base for FMT in IBS is of low quality and heterogeneous. Meta-analyses include small RCTs with differing delivery routes and preparations; while some subgroup analyses suggest benefit for specific routes (e.g., duodenoscope or naso-jejunal delivery), overall results are inconsistent and routine clinical use is not established.

Applicable Codes and Product Coding

HCPCSHCPCS

J1440

Fecal microbiota, live - jslm, 1 ml

Diagnosis CodesICD-10

A04.71

Enterocolitis due to Clostridium difficile, recurrent

Removed Applicable CodesHCPCSNot Covered

G0455

HCPCS code G0455 (removed from Applicable Codes)

Referenced Drug ProductNDCCovered

NDC	Rebyota prescribing information (see package insert)

Rebyota CFU concentration — technical specifications

CFU concentration rangeEach 150 mL dose contains fecal microbes at a concentration between 1x10^8 and 5x10^10 colony forming units (CFU) per mL.

Bacteroides minimum>1x10^5 CFU/mL of Bacteroides per mL in the preparation.

PEG3350 contentContains not greater than 5.97 grams of PEG3350 in saline per dose.

Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Authorization will be issued for a single dose treatment only. Submit a prior authorization request that documents the diagnosis and meets the medical necessity criteria for Rebyota (prevention of recurrent CDI) and ensure the request indicates a single-dose administration.

Single dose only
PA required for Rebyota (fecal microbiota, live-jslm) — HCPCS J1440 listed for reference
Include prescribing clinician specialty (gastroenterologist or infectious disease specialist)

Note

Ulcerative Colitis (UC) — Not Medically Necessary

Rebyota is unproven and not medically necessary for the prevention or treatment of ulcerative colitis (UC). Do not submit prior authorization requests for UC indications; such requests should be denied as not medically necessary.

UC indications are not covered — insufficient evidence of efficacy

Clinical Background

Clostridioides difficile infection (CDI) can recur after initial treatment; recurrent CDI (rCDI) is defined by recurrence of diarrhea plus a positive stool toxin test and is the indication supported for therapy with Rebyota. Rebyota is an FDA‑approved, standardized rectally administered fecal microbiota product intended to prevent recurrence of CDI in adults. Coverage for Rebyota is limited to members who meet the policy criteria, including being age 18 years or older, documentation of one or more CDI recurrence(s), completion of at least 10 days of oral vancomycin or fidaxomicin within the specified 24–72 hour window prior to administration, and other required documentation; authorization is issued for a single dose only.

Key Definitions

Episode of CDI — clinical and microbiological criteria

Clinical criteriaClinical findings compatible with CDI (e.g., diarrhea) without reasonable alternate cause.

Microbiological evidencePositive test for toxigenic Clostridioides difficile: enzyme immunoassay (EIA) toxin, or positive NAAT preferably with low cycle threshold, or positive toxigenic culture; pseudomembranous colitis on endoscopy/pathology in combination with positive test also qualifies.

Symptom thresholdDiarrhea defined as passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days (used in policy diagnostic node).

Recurrent CDI (rCDI) — timing and diagnostic definition

Timing definitionRecurrence of diarrhea and a positive stool test for C. difficile toxin occurring within 8 weeks following treatment or as diagnosed by a GI or ID specialist.

Policy Revision History

2025-01-01removed_applicable_codeLatest

Removed HCPCS code G0455 from Applicable Codes.

2025-01-01updated_supporting_information

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

Policy Summary

PayerUnitedHealthcare

PolicyRebyota (Fecal Microbiota, Live-Jslm) — Coverage Criteria

Policy CodePolicy IEXD00124.03

Change TypeRemoved HCPCS codeupdated evidence/references

Effective DateJan 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for a single-dose Rebyota treatment when all coverage criteria are met.

SourceLink

On This Page

Reference clinical rationale in policy when issuing denials for UC

Note

Irritable Bowel Syndrome (IBS) — Not Medically Necessary

Rebyota is unproven and not medically necessary for the prevention or treatment of irritable bowel syndrome (IBS). Prior authorization requests for IBS should be denied as not medically necessary.

IBS indications are not covered — insufficient evidence of efficacy
Reference clinical rationale in policy when issuing denials for IBS

Documentation Required

CDI Documentation Requirements

Documented recurrent CDI is required. Provide clinical documentation that meets the policy definition of recurrent CDI: presence of diarrhea (≥3 loose stools per 24 hours for 2 consecutive days) and a positive stool test for C. difficile toxin, plus documentation of prior episodes and treatment response.

Document number and dates of prior CDI episodes and treatments
Include stool frequency documentation and positive toxin test results
Note clinical status of prior episode (e.g., <3 unformed stools/day for 2 consecutive days to show prior episode under control)

Step Therapy

Required Antecedent Antibiotic Therapy / CDI Step Requirement

Member must have completed antecedent antibiotic therapy for recurrent CDI prior to receiving Rebyota. Ensure documentation shows completion of at least 10 days of oral vancomycin or fidaxomicin between 24 to 72 hours prior to administration.

Minimum 10 days of oral vancomycin or fidaxomicin
Antibiotic course completed 24–72 hours prior to proposed Rebyota administration
Consider FMT only after multiple recurrences per AHRQ/ESCMID guidance — include prior recurrence history

Denial Risk

Denial Triggers

Triggers for denial include lack of documented recurrent CDI as defined in the policy, patient age under 18, and absence of completed antecedent antibiotic therapy (≥10 days oral vancomycin or fidaxomicin between 24–72 hours prior).

No documentation of recurrent CDI (diarrhea criteria and positive toxin test)
Patient < 18 years of age
No documentation of completed antecedent antibiotic therapy (10 days of oral vancomycin or fidaxomicin within required timeframe)
Requests for UC or IBS indications

Documentation Required

Reference Member-Specific Plan

Always reference the member-specific benefit plan document when making coverage determinations. This policy provides guidance but the member's plan terms and any applicable federal or state mandates govern coverage.

Check member-specific benefits and any applicable mandates before approving or denying coverage
In case of conflict, the member specific benefit plan document governs

Billing Rule

Billing Code Update — Verify Codes

Removal of HCPCS code G0455 from the policy's applicable codes list may affect billing practices. Verify billing codes on the claim and ensure use of appropriate, currently listed codes (e.g., J1440) to avoid claim denials.

G0455 removed from policy — verify current billing codes
Use HCPCS J1440 (fecal microbiota, live - jslm, 1 ml) as referenced where applicable

Typical timing window

Although most recurrences occur within two to eight weeks after treatment, recurrences can occur later than that time frame.

Clinical requirementDocumentation should confirm recurrent episode (symptoms plus positive toxin test) to meet rCDI definition.

Rebyota (RBX2660 / fecal microbiota, live-jslm) — product description and administration

Product name and codeRebyota (fecal microbiota, live-jslm; RBX2660) — standardized fecal microbiota suspension approved by the FDA for prevention of rCDI.

Formulation and preparationPrepared from screened donor stool processed in a predefined ratio with polyethylene glycol (PEG) 3350 and saline to produce a filtrate (fecal microbiota suspension).

Route and dosingAdministered rectally as a single 150 mL dose (single-dose administration).

Donor testingHuman donor stool is tested for a panel of transmissible pathogens; donors do not have dietary restrictions for allergens per product description.

Clinical remission — trial-defined remission endpoints

Trial-defined remission conceptClinical remission defined as improvement in symptoms to predefined trial-specific thresholds (e.g., combined clinical and endoscopic remission or Mayo score below trial-specific cutoff).

Outcome measuresRemission endpoints in UC trials included combined clinical and endoscopic remission, clinical remission or response, and endoscopic remission or response.

Assessment timingRemission assessed at defined follow-up intervals in RCTs (examples include 8 or 12 weeks in analyzed studies).

Rebyota (fecal microbiota, live-jslm) — FDA-indicated product statement

FDA-indicated useRebyota is 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.

Age restrictionIndicated for adults 18 years of age and older.

Context of useUse is specified following antibiotic treatment for recurrent CDI (per FDA product statement).

FMT (Fecal Microbiota Transplantation) — definition and delivery routes

DefinitionFecal Microbiota Transplantation (FMT) is the transfer of prepared stool from a healthy donor to a patient to restore gut microbiota and increase microbial diversity.

Common delivery routesDelivery routes include rectal administration/enema (including standardized rectal products), colonoscopy, nasojejunal tube, and oral capsules.

Purpose in CDIUsed extensively to treat recurrent CDI with the intent of reestablishing a more normal fecal composition and suppressing C. difficile overgrowth.