CurrentExcellus Health Plan IncPolicy 2.01.48

Fecal Microbiota Transplantation

Customize your policy alerts

Sign up for excellus_health_plan_inc Policy 2.01.48 alerts

Get alerted when Policy 2.01.48 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs medical necessity and investigational status for fecal microbiota transplantation (FMT). FMT is medically appropriate for adults with recurrent Clostridioides difficile infection who meet recurrence and donor-stool-screening criteria; other indications are investigational.

Policy Summary

PayerExcellus Health Plan Inc

PolicyFecal Microbiota Transplantation

Policy CodePolicy 2.01.48

Change TypeAnnual reviewno material change

Effective DateSeptember 17, 2026

Next Review DateSeptember 1, 2027

Key ActionDocument at least two CDI recurrences despite standard antibiotic treatment and completion of appropriate donor stool screening before FMT.

SourceLink

POLICY UPDATE CHANGES

The policy underwent an annual review on September 17, 2026, with policy intent unchanged.

2+Required CDI recurrences after the initial episode

3+Total CDI episodes for the recurrence requirement

BothRecurrence and donor screening criteria required

All otherOther indications, including first-line CDI treatment, are investigational

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentExcellus Health Plan IncPolicy 2.01.48

Fecal Microbiota Transplantation

Customize your policy alerts

Sign up for excellus_health_plan_inc Policy 2.01.48 alerts

Get alerted when Policy 2.01.48 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerExcellus Health Plan Inc

PolicyFecal Microbiota Transplantation

Policy CodePolicy 2.01.48

Change TypeAnnual reviewno material change

Effective DateSeptember 17, 2026

Next Review DateSeptember 1, 2027

Key ActionDocument at least two CDI recurrences despite standard antibiotic treatment and completion of appropriate donor stool screening before FMT.

SourceLink

POLICY UPDATE CHANGES

The policy underwent an annual review on September 17, 2026, with policy intent unchanged.

2+Required CDI recurrences after the initial episode

3+Total CDI episodes for the recurrence requirement

BothRecurrence and donor screening criteria required

All otherOther indications, including first-line CDI treatment, are investigational

4Code entries or ranges listed

UnchangedPolicy intent at annual review

Medical Necessity and Investigational Use

Medically appropriate recurrent CDI

FMT is considered medically appropriate for adults with recurrent CDI when BOTH criteria are met.

Medically appropriate recurrent CDI FMT

Recurrent CDI after standard treatment: The individual is an adult with a history of two (2) or more recurrences of Clostridioides difficile infection after the initial episode, despite standard antibiotic treatment.Total of three (3) or more CDI episodes
Appropriate donor screening: Appropriate donor stool screening has been completed.
Screening should include infectious diseases and pathogens.

Investigational indications

FMT is considered investigational for all other indications.

First-line CDI treatment: FMT is used as first-line treatment for CDI.
Inflammatory bowel disease: FMT is used to treat inflammatory bowel disease.

Recurrent or refractory C. difficile infection

Professional guideline-supported use for recurrent or refractory C. difficile infection.

Qualifying CDI scenario

Multiple recurrent CDI: The patient has multiple CDI recurrences and has failed appropriate antibiotic treatments.Typically at least 2 recurrences, representing 3 CDI episodes
Supported by IDSA/SHEA, ASCRS, ACG, and AGA recommendations.
Severe or fulminant refractory CDI: The patient has severe or fulminant CDI that has not responded to antimicrobial therapy, particularly when the patient is a poor surgical candidate.
Supported by AGA and ACG recommendations.
Recurrent CDI in IBD: The patient has IBD with at least one recurrence of CDI and microbiome-based therapy is being used to prevent future infection.

Immune-status considerations

AGA recommendations vary by immune status.

Recurrent CDI and immune status: After completion of standard-of-care antibiotics for recurrent CDI, fecal microbiota-based therapy is suggested for immunocompetent adults and mildly or moderately immunocompromised adults.

The AGA suggests against fecal microbiota-based therapy in severely immunocompromised adults with recurrent CDI. This is a conditional recommendation with low certainty of evidence for use and very low certainty against use in severely immunocompromised adults.

Non-CDI gastrointestinal conditions

Use outside CDI is restricted by professional guidelines.

Clinical trial restriction: Conventional FMT for ulcerative colitis, Crohn's disease, pouchitis, or irritable bowel syndrome should generally be limited to the context of a clinical trial.

The ACG recommends against FMT for global IBS symptoms and for adult ulcerative colitis.

Adult recurrent CDI

Potential adult candidates for FMT generally have recurrent CDI despite CDI-directed antibiotic treatment.

Adult recurrent CDI candidate: The patient has multiple recurrences of CDI and has failed to resolve the infection despite treatment attempts with antibiotic agents targeting CDI.At least 2 appropriate antibiotic-treated recurrences, approximately 3 CDI episodes

Appropriate antibiotic treatment attempts for at least 2 recurrences should generally be tried before referral for FMT.

Pediatric CDI

In children, FMT may be considered for recurrent or refractory CDI in the following situations.

Pediatric FMT consideration

Recurrent mild-to-moderate CDI: The child has at least 3 episodes of mild to moderate CDI and has failed a 6- to 8-week vancomycin taper, with or without an alternative antibiotic such as rifaximin or nitazoxanide.At least 3 episodes; failed 6- to 8-week vancomycin taper
Recurrent severe CDI: The child has at least 2 episodes of severe CDI resulting in hospitalization and associated with significant morbidity.At least 2 severe episodes requiring hospitalization
Moderate CDI refractory to standard therapy: Moderate CDI has not responded to standard therapy, including vancomycin, for at least 1 week.

FMT is investigational when used as first-line treatment for CDI or to treat inflammatory bowel disease. These uses do not meet the policy’s medically appropriate indication for recurrent CDI.

The AGA suggests against conventional FMT outside a clinical trial for ulcerative colitis, Crohn’s disease, pouchitis, and irritable bowel syndrome. The ACG also recommends against FMT for global IBS symptoms and adult ulcerative colitis.

FMT for diabetes, obesity, metabolic syndrome, neurological disorders, and other difficult-to-treat conditions is not established as a treatment regimen because available evidence is largely limited to case reports, case series, and cohort studies. Additional randomized controlled trials and longer-term studies are needed to establish efficacy and safety.

FMT is strongly recommended against in children with cancer and in pediatric hematopoietic stem-cell transplantation patients.

FMT is not recommended for the clinical treatment of pediatric conditions other than moderate to severe or recurrent CDI. Controlled pediatric trials are not available, and the long-term effects of FMT remain unknown.

FMT for other indications supported only by case reports, case series, or cohort studies is not established as medically necessary. Current evidence is insufficient to demonstrate the treatment’s efficacy and safety for routine implementation.

Pediatric FMT outside moderate to severe or recurrent CDI is not recommended for clinical treatment. Pediatric evidence remains limited, with no available controlled or prospective clinical trials establishing use for other conditions.

Codes and Clinical Thresholds

CPT CodesCPT

44705	Preparation of fecal microbiota for instillation, including assessment of donor specimen
0780T	Instillation of fecal microbiota suspension via rectal enema into lower gastrointestinal tract

HCPCS CodesHCPCS

G0455

Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen

ICD10 CodesICD-10

A04.7 - A04.72

Enterocolitis due to Clostridium difficile (code range)

Adult recurrent CDI before FMT referral

Required recurrencesAt least 2 appropriate antibiotic-treated recurrences

Total CDI episodes3 CDI episodes

Before referralAppropriate antibiotic treatments should be tried before referral for FMT

Pediatric recurrent mild-to-moderate CDI

CDI episodesAt least 3 episodes of mild-to-moderate CDI

Vancomycin treatmentFailure of a 6- to 8-week taper with vancomycin

Documentation and Referral Requirements

Documentation Required

Antibiotics Before FMT

Before referring an adult for FMT, confirm that appropriate conventional antibiotic treatment for CDI has been attempted and failed. Professional recommendations generally support antibiotic treatment through at least two recurrences, representing three or more CDI episodes, before FMT is offered.

Document the antibiotic agents used to target CDI and the response or failure of each course.
Confirm treatment attempts covered at least two recurrences before referral for FMT.

Documentation Required

Prior CDI Antibiotic Treatment

Document prior CDI treatment attempts before adult FMT referral. The supporting professional opinion is that appropriate antibiotic treatment should be tried for at least two recurrences, or three CDI episodes total.

Include the dates, agents, and outcomes of prior CDI-directed antibiotic courses.
Record persistent or recurrent infection despite those treatment attempts.

Clinical Background

Fecal microbiota transplantation (FMT) administers intestinal microorganisms from a healthy, appropriately screened donor into a patient’s gastrointestinal tract to restore a stable microbial community and address dysbiosis. FMT may be delivered by colonoscopy, oral capsules, nasogastric or nasoduodenal tube, or rectal enema. Its primary clinical application is recurrent Clostridioides difficile infection, which can follow antibiotic-related disruption of normal colonic flora and may cause severe colitis, toxic megacolon, or perforation. Donor screening is important because transmission of infectious agents is a principal risk of FMT.

Key Terms

Fecal microbiota transplantation (FMT)

DefinitionAdministration of intestinal microorganisms from a healthy, screened donor into a patient's gastrointestinal tract

PurposeTo restore normal colonic flora and replace disordered native microbiota with a stable donor microbial community

Other namesAlso called fecal bacteriotherapy or intestinal microbiota transplantation

Recurrent Clostridioides difficile infection (CDI)

DefinitionReappearance of CDI symptoms after resolution on appropriate therapy

Typical intervalTypically within 8 weeks of treatment completion

Policy Summary

PayerExcellus Health Plan Inc

PolicyFecal Microbiota Transplantation

Policy CodePolicy 2.01.48

Change TypeAnnual reviewno material change

Effective DateSeptember 17, 2026

Next Review DateSeptember 1, 2027

Key ActionDocument at least two CDI recurrences despite standard antibiotic treatment and completion of appropriate donor stool screening before FMT.

SourceLink

On This Page

At least 1 CDI recurrence

AGA best practice advice.

No response for at least 1 week

Repeated testing for etiologies other than CDI, such as inflammatory bowel disease, is advised.

Severe or fulminant CDI refractory to standard therapy: Severe CDI or fulminant C. difficile colitis has not responded to standard therapy after 48 hours.No response after 48 hours

Alternative antibiotic

The vancomycin taper may be used with or without an alternative antibiotic, such as rifaximin or nitazoxanide

Pediatric recurrent severe CDI

Severe CDI episodesAt least 2 episodes of severe CDI

HospitalizationEpisodes resulting in hospitalization

Clinical impactEpisodes associated with significant morbidity

Pediatric moderate CDI nonresponse

ConditionModerate CDI

Standard therapyNo response to standard therapy, including vancomycin

Required durationFor at least 1 week

Pediatric severe or fulminant CDI nonresponse

ConditionSevere CDI or fulminant C. difficile colitis

Standard therapyNo response to standard therapy

Required intervalAfter 48 hours

Documentation Required

Recurrent CDI History

For adult recurrent CDI, document a history of at least two recurrences after the initial episode despite standard antibiotic treatment, for a total of at least three CDI episodes.

The recurrence history and failure of standard treatment must be documented before FMT is considered medically appropriate.

Documentation Required

Donor Stool Screening

Confirm and document that the donor stool has undergone appropriate screening before FMT. Screening should include evaluation for infectious diseases and relevant pathogens to reduce the risk of transmitting infection.

Document infectious-disease screening of the donor.
Document pathogen screening of the donor stool and any required donor or specimen evaluation.

Documentation Required

Recurrent CDI Treatment History and Donor Screening

The record must support recurrent CDI, failure of appropriate antibiotic treatment, and completion of appropriate donor and donor-specimen screening before FMT is performed.

Document multiple CDI recurrences and failed appropriate antibiotic treatments.
Document completion of appropriate donor and donor fecal-specimen screening in accordance with applicable FDA recommendations.

Unsupported block type: denial_riskұassistant_dirty code pineq (format issue?)

Denial Risk

Criteria Not Met

If the adult recurrent-CDI criteria are not met, FMT does not qualify as medically appropriate under this policy.

Document at least two recurrences after the initial episode despite standard antibiotic treatment.
Document completion of appropriate donor stool screening.

Denial Risk

Insufficient Evidence for Other Indications

Evidence is insufficient to establish FMT as a treatment regimen for other difficult-to-treat conditions, including diabetes, obesity or metabolic syndrome, and neurologic disorders.

These uses remain unsupported by sufficient evidence and should not be represented as medically necessary under this policy.

Denial Risk

Non-CDI Gastrointestinal Indications

Professional guidance recommends against conventional FMT for ulcerative colitis, Crohn's disease, pouchitis, and irritable bowel syndrome except in the context of a clinical trial, where specified.

Do not submit conventional FMT for these non-CDI gastrointestinal indications as routine medically necessary treatment.
For ulcerative colitis, Crohn's disease, pouchitis, and IBS, document clinical-trial context when applicable.

Denial Risk

Pediatric Non-CDI Use

FMT is not recommended for pediatric conditions other than moderate to severe or recurrent CDI. The long-term effects remain unknown, and controlled pediatric trials are lacking.

Do not use FMT for other pediatric medical conditions under the cited AAP guidance.
For pediatric CDI, document that the condition is moderate to severe or recurrent.

Initial treatment context

Recurrence follows resolution of the infection on appropriate therapy

Severely immunocompromised

Cancer treatmentActive cytotoxic therapy for solid tumors or hematologic malignancies

Cellular or transplant therapyPrior chimeric antigen receptor T-cell therapy or hematopoietic cell transplant when neutropenic

Other qualifying conditionsAny neutropenia, severe primary immunodeficiency, or advanced or untreated HIV infection

HIV criteriaCD4 count below 200/mm³, an AIDS-defining illness without immune reconstitution, or symptomatic HIV

Mildly or moderately immunocompromised

DefinitionAn immunocompromised patient who does not meet the definition of severely immunocompromised

Immune statusThe patient is immunocompromised

Severity distinctionThe patient does not meet the criteria for severe immunocompromise

Fecal microbiota-based therapies

TimingAfter completion of standard-of-care antibiotics

Clinical useFor recurrent C. difficile infection

Recommendation factorsRecommendations differ according to immune status and disease severity