ModifiedUnitedHealthcarePolicy CS2026D00124H

Rebyota (Fecal Microbiota, Live-Jslm) — Medical Benefit Drug Policy

Defines medical benefit drug coverage criteria for Rebyota for prevention of recurrent Clostridioides difficile infection (rCDI) for UnitedHealthcare Community Plan; includes clinical background, applicable codes, and statements of noncoverage for other indications.

Policy Summary

PayerUnitedHealthcare

PolicyRebyota (Fecal Microbiota, Live-Jslm) — Medical Benefit Drug Policy

Policy CodePolicy CS2026D00124H

Change TypeState applicability language removedprior version archived

Effective DateApril 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documenting recurrent CDI diagnosis, completion of ≥10 days of oral vancomycin or fidaxomicin 24–72 hours prior, and specialist involvement.

SourceLink

POLICY UPDATE CHANGES

Removed language indicating this Medical Benefit Drug Policy does not apply to Indiana and removed content pertaining to Louisiana; prior policy version CS2025D00124G archived.

18+minimum patient age for coverage

≥10 daysprior antibiotic duration

J1440HCPCS code

A04.71diagnosis code

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FDA-approved product

04/01/2026policy revision date

Coverage Criteria and Indications

Coverage criteria for Rebyota

Rebyota is 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 loose bowel movements within a 24-hour period for 2 consecutive days; AND (2) a positive stool test for Clostridioides difficile toxin.

Age and recurrence history: Patient is 18 years of age or older; AND patient has had one or more recurrence(s) of CDI following an initial episode of CDI.

Prior antibiotic therapy and symptom control: Both: (a) patient has completed at least 10 days of oral vancomycin or fidaxomicin between 24 to 72 hours prior to initiating Rebyota; AND (b) previous episode of CDI is under control (e.g., <3 unformed/loose stools/day for 2 consecutive days).

Prescribing clinician: Prescribed by or in consultation with a gastroenterologist OR an infectious disease specialist.

Authorization will be issued for a single dose treatment only.

Unproven / Not Medically Necessary Indications

Not covered indications (unproven/not medically necessary):

Other indications: Rebyota (fecal microbiota, live-jslm) 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.

UC — Not medically necessary (per segment)

Ulcerative colitis — coverage stance from document segment

UC stance: FMT is unproven and not medically necessary for prevention and/or treatment of ulcerative colitis based on insufficient evidence and inconsistent results across studies.

AGA recommends FMT for mild-to-moderate UC only in the context of clinical trials due to very low quality evidence.

CD — Insufficient evidence / investigational

Crohn's disease — evidence summary

CD stance: Evidence is limited and inconsistent: small open-label studies show modest benefit and potential harm; controlled trials are required before considering FMT for Crohn's disease.

Single-center open-label study (10 patients) reported 3 responders and 2 significant adverse events; Cochrane review highlighted low certainty and need for higher-quality studies.

IBS — Insufficient evidence / investigational

Irritable bowel syndrome — coverage stance from document segments

IBS stance: Overall evidence is inconsistent: pooled analyses generally show no clear benefit versus placebo; subgroup analyses suggest benefit for non-oral delivery (colonoscopic, duodenal/nasojejunal) or single stool multiple-donor colonoscopy in some trials.

Capsule (oral) FMT frequently not effective; heterogeneity high and quality of evidence low to very low across systematic reviews and meta-analyses.

Indication: recurrent or refractory CDI

Covered when ALL of the following are met

Primary coverage criteria: 1) Patient has recurrent Clostridioides difficile infection (rCDI) with two or more recurrences (i.e., three CDI episodes) OR severe/fulminant CDI refractory to antibiotics when not a surgical candidate; 2) Appropriate standard-of-care antibiotic treatment has been provided prior to FMT per society guidance (e.g., IDSA-SHEA/ASCRS); 3) Treatment intent is prevention of CDI recurrence or rescue therapy; 4) For use of an FDA-approved product (e.g., Rebyota), indication aligns with labeling (prevention of recurrence following antibiotic treatment for recurrent CDI).recurrence count: >=2 recurrences (3 episodes)

Based on society guidelines (ASCRS, IDSA-SHEA, NICE) and FDA product indication.

Indications not supported by sufficient evidence

Not routinely covered / investigational when used for other indications

Other indications: Use of FMT for irritable bowel syndrome (IBS) or for ulcerative colitis (UC) is considered investigational or should be performed only in clinical trials; routine coverage is not supported by current evidence.

Systematic reviews and AGA guidance indicate inconsistent or very low-quality evidence; further high-quality RCTs are required.

Use of Rebyota (fecal microbiota, live-jslm) for indications other than prevention of recurrent Clostridioides difficile infection (rCDI) is not supported by this policy. The product is considered unproven and not medically necessary for prevention and/or treatment of other conditions, including but not limited to ulcerative colitis, Crohn's disease, and irritable bowel syndrome, due to insufficient evidence of efficacy.

Fecal microbiota transplantation (including Rebyota) is explicitly considered unproven and not medically necessary for the prevention and/or treatment of ulcerative colitis (UC) and irritable bowel syndrome (IBS). Systematic reviews and meta-analyses of randomized trials report inconsistent results and overall insufficient evidence to support routine clinical use for these indications.

Per the American Gastroenterological Association (AGA) guidance, use of fecal microbiota transplantation for individuals with mild-to-moderate ulcerative colitis without concomitant CDI should be performed only in the context of a clinical trial. Current evidence was rated very low and larger, long-term studies are needed.

Fecal microbiota transplantation is considered unproven and not medically necessary for Crohn's disease based on limited and inconsistent evidence. Small cohort studies and the available randomized data do not provide sufficient, high-quality evidence to support routine therapeutic use of FMT for Crohn's disease.

FMT is regarded as unproven and not medically necessary for ulcerative colitis in this policy. Although some randomized trials have evaluated FMT in UC, results are inconsistent and evidence for maintenance of remission or standardized protocols is insufficient to support routine coverage outside of clinical studies.

Use of fecal microbiota transplantation for irritable bowel syndrome is considered unproven and not medically necessary due to inconsistent randomized trial results, substantial heterogeneity across studies, and low to very low quality of evidence in systematic reviews and meta-analyses.

Routine treatment of IBS with FMT is not supported. Meta-analyses show no consistent overall benefit versus placebo; although some delivery methods (for example, colonoscopic or upper GI delivery) showed benefit in subgroup analyses, the overall evidence is heterogeneous and insufficient to recommend FMT as a standard therapy for IBS.

Applicable Codes and Key Coding Details

Applicable HCPCS CodesHCPCSCovered

J1440

Fecal microbiota, live-jslm, 1 ml (Rebyota)

Applicable Diagnosis CodesICD-10Covered

A04.71

Enterocolitis due to Clostridium difficile, recurrent

Referenced ProductmixedCovered

Rebyota

fecal microbiota, live-jslm — FDA indicated for prevention of recurrent CDI after antibiotic treatment (single-dose authorized)

Prior Authorization

Prior authorization: single-dose Rebyota

Authorization will be issued for a single dose treatment only. Prior authorization is required for ulcerative colitis (UC) and irritable bowel syndrome (IBS) when requested for FMT/Rebyota — these indications are not FDA indications for Rebyota and UC is considered not medically necessary for this therapy in this policy. Providers must confirm prior antibiotic treatment and recurrence count when requesting authorization; failure to follow pre-treatment guidance (antibiotic type/duration and timing, and documentation that prior CDI episode is under control) may result in denial.

Prior authorization required: single-dose Rebyota (J1440)
Prior authorization expectations for UC and IBS: prior auth required; UC requests are considered not medically necessary under this policy
Prior authorization must confirm: documented prior antibiotic therapy (agent, >=10 days, completed 24–72 hours prior) and number of CDI recurrences

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization unlikely for UC or IBS indications

Do not expect coverage for FMT (including Rebyota) when requested for ulcerative colitis or irritable bowel syndrome; these indications are stated as unproven and not medically necessary in the policy.

Prior Authorization

Confirm prior antibiotic treatment and recurrence history

Prior authorization must document that the patient has had prior CDI antibiotic therapy and meets recurrence criteria (history of one or more recurrences or multiple recurrences per guideline recommendations).

Step Therapy

Document required prior antibiotic therapy (≥10 days)

Patient must have completed at least 10 days of oral vancomycin or fidaxomicin between 24–72 hours prior to initiating Rebyota; include records showing the antibiotic course and timing relative to Rebyota administration.

Clinical Background and Rationale

Clostridioides difficile is an anaerobic, gram-positive bacillus that causes Clostridioides difficile infection (CDI). Recurrent CDI (rCDI) is characterized by return of diarrhea together with a positive stool test for C. difficile toxin occurring within weeks after treatment. Fecal microbiota transplantation aims to restore gut microbial diversity and has been incorporated into management of rCDI; society guidance (including IDSA-SHEA and ASCRS) and regulatory approval for specific products support use of FMT/Rebyota for prevention of CDI recurrence in appropriately selected patients.

Key Definitions and Product Details

inv-34: Episode of CDI

Clinical definitionClinical findings compatible with CDI plus microbiologic evidence of C. difficile toxin (eg, positive enzyme immunoassay) or a positive NAAT/toxigenic culture or pseudomembranous colitis on endoscopy/autopsy, in combination with a positive test for toxigenic C. difficile

Symptom criteriaDiarrhea defined as passage of ≥3 loose bowel movements within a 24‑hour period for 2 consecutive days

Diagnostic preferenceNAAT preferably with low cycle threshold (Ct) value when used

inv-35: Recurrent CDI (rCDI)

Definition (rCDI)Recurrence 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

Typical timing

Policy Revision History

04/01/2026policy_revisionLatest

Application/state applicability language updated: language excluding Indiana and content pertaining to Louisiana were removed; prior policy version CS2025D00124G archived.

Policy Summary

PayerUnitedHealthcare

PolicyRebyota (Fecal Microbiota, Live-Jslm) — Medical Benefit Drug Policy

Policy CodePolicy CS2026D00124H

Change TypeState applicability language removedprior version archived

Effective DateApril 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documenting recurrent CDI diagnosis, completion of ≥10 days of oral vancomycin or fidaxomicin 24–72 hours prior, and specialist involvement.

SourceLink

On This Page

Step Therapy

Document failure/intolerance of conventional therapy before FMT

Document failure or intolerance of conventional therapies (e.g., diet, pharmacotherapy, probiotics) when FMT is being considered for non‑rCDI indications or investigational uses.

Step Therapy

Step requirement: complete guideline‑recommended antibiotic trials

Follow the step requirement that conventional antibiotic treatment be used for at least two recurrences (i.e., three CDI episodes) before offering FMT when guideline‑concordant care is expected.

Documentation Required

Required documentation to support authorization

Required documentation includes clinical evidence of recurrent CDI (diarrhea frequency and positive stool toxin test), patient age, history of prior recurrences, completion and timing of ≥10 days of oral vancomycin or fidaxomicin, evidence prior episode is controlled, and gastroenterology or infectious disease specialist involvement.

Documentation Required

Suggested outcome documentation (research/investigational)

When available, provide outcome measures reported in studies (for research/investigational uses) such as disease‑specific indices and microbiome profiling (e.g., Harvey‑Bradshaw Index, 16S rRNA sequencing) to support efficacy assessments.

Documentation Required

Support indication consistent with FDA‑approved use

When using an FDA‑approved product (e.g., Rebyota), include documentation that the intended use aligns with the FDA indication — prevention of CDI recurrence following antibiotic treatment for recurrent CDI in adults ≥18 years.

Denial Risk

Triggers for denial — common causes

Denial may be triggered if the patient does not meet diagnostic criteria for rCDI (≥3 loose stools/day for 2 consecutive days plus positive stool toxin), is under 18 years old, has not completed required antibiotics, prior episode is not controlled, or Rebyota is prescribed for non‑rCDI indications.

Denial Risk

Ulcerative colitis — not medically necessary

FMT (including Rebyota) is considered unproven and not medically necessary for prevention and/or treatment of ulcerative colitis; prior authorization for UC indications should be expected to be denied absent compelling trial evidence.

Denial Risk

Irritable bowel syndrome — not medically necessary

FMT is unproven and not medically necessary for prevention and/or treatment of irritable bowel syndrome; prior authorization for IBS indications should be expected to be denied absent strong supporting evidence.

Denial Risk

Risk of denial if pre‑treatment guidance not followed

Use of FMT before completing appropriate antibiotic treatment for at least two recurrences (or three CDI episodes) may be contrary to guideline recommendations (IDSA‑SHEA) and could lead to denial if the plan requires guideline‑concordant care.

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

Diagnostic componentsRequires both compatible clinical picture and microbiologic evidence of toxigenic C. difficile

inv-36: Rebyota formulation/dose

Dose volume and routeSingle 150 mL dose administered rectally as a single‑dose enema

Microbial contentEach mL contains between 1x10^8 and 5x10^10 CFU/mL of fecal microbes, including >1x10^5 CFU/mL of Bacteroides

ExcipientsContains polyethylene glycol (PEG) 3350 in saline with not greater than 5.97 g of PEG 3350 per 150 mL dose

Regulatory statusRebyota is an FDA‑approved standardized FMT product for prevention of rCDI

inv-37: Clinical response (Crohn's disease)

Clinical response measureDecrease in Harvey‑Bradshaw Index score by ≥3 at one month post‑FMT

Study contextMeasured in a prospective open‑label single‑center study of 10 individuals with Crohn's disease

Limitations notedStudy was small, open‑label, lacked control arm, and showed modest benefit with potential for harm

inv-38: Maintenance of remission (UC)

Maintenance of remission (trial definition)Fecal calprotectin <200 μg/g AND clinical Mayo score <3 throughout 12‑month follow‑up

RCT outcomeIn the cited RCT, 54% (13/24) in FMT vs 41% (10/24) in placebo met the primary endpoint (no significant difference)

ConclusionResults did not support use of single‑dose FMT for maintenance of remission in UC in that trial

inv-39: Recurrent CDI (rCDI) definition / multiple recurrences

rCDI definition for FMT considerationRecurrent CDI refers to infection that recurs after initial treatment; multiple recurrences generally means two or more recurrences (three CDI episodes)

Guideline thresholdASCRS and IDSA‑SHEA recommend reserving FMT for patients with multiple (≥2) recurrences or after at least two recurrences (three episodes)

NICE guidanceNICE recommends FMT as a choice for adults with two or more previous confirmed episodes of rCDI

Risk considerationsGuidelines note potential adverse events (including pathogen transmission) as rationale to limit FMT to multiple‑recurrence patients