ModifiedSelectHealthPolicy 522

Fecal Microbiota Therapy (FMT) Coverage Criteria

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This policy governs coverage determinations for fecal microbiota therapy (including fresh stool and commercially prepared frozen capsules) for SelectHealth members with Clostridioides difficile infection and specifies clinical criteria and applicable delivery methods.

Policy Summary

PayerSelectHealth

PolicyFecal Microbiota Therapy (FMT) Coverage Criteria

Policy CodePolicy 522

Change TypeMaterial revision to commercial episode threshold

Effective DateJan 29, 2023

Last ReviewDec 19, 2024

Next Review DateDec 19, 2024

Key ActionObtain prior authorization and document donor screening, testing, and positive C. difficile test to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

For Commercial Plan Policy, changed required amount of episodes of Clostridioides difficile infection in criterion #1b to qualify for this therapy from three to four.

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ModifiedSelectHealthPolicy 522

Fecal Microbiota Therapy (FMT) Coverage Criteria

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Sign up for SelectHealth Policy 522 alerts

Get alerted when Policy 522 changes without checking for updates manually.

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Policy Summary

PayerSelectHealth

PolicyFecal Microbiota Therapy (FMT) Coverage Criteria

Policy CodePolicy 522

Change TypeMaterial revision to commercial episode threshold

Effective DateJan 29, 2023

Last ReviewDec 19, 2024

Next Review DateDec 19, 2024

Key ActionObtain prior authorization and document donor screening, testing, and positive C. difficile test to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

For Commercial Plan Policy, changed required amount of episodes of Clostridioides difficile infection in criterion #1b to qualify for this therapy from three to four.

92.5%mean response rate

30capsules per treatment

≈6 monthsshelf-life

2013–2024implementation span

Coverage Criteria for Fecal Microbiota Therapy (FMT)

Coverage Criteria for Fecal Microbiota Therapy

Select Health covers FMT for members with C. difficile infection when the following criteria are met:

Primary diagnostic requirement: Member has a positive Clostridioides difficile PCR or toxin assaypositive test

Documented positive test required

Recurrent CDI indication (mild-to-moderate): For mild-to-moderate Clostridioides difficile infection: after three episodes of C. difficile infection>=3 episodes

Applies to recurrent mild-to-moderate disease

Fulminant or non-responsive disease: Fulminant Clostridioides difficile infection (recurrent infection that is fulminant) OR patient not improving after three days of antibiotic therapy3 days

Either condition qualifies

Product parity: Commercially prepared OpenBiome capsules and frozen preparations are covered in the same circumstances as fresh stool transplantation

Coverage parity between fresh stool and commercially prepared products

Episode Count Requirement (Commercial Plans)

Commercial plan requirement (revision effective 1/15/25):

Commercial plan episode requirement: For Commercial plan members, the required number of C. difficile infection episodes to qualify under the recurrent CDI criterion was changed from three to four>=4 episodes

Change recorded in Revision History dated 1/15/25

Select Health covers fecal microbiota therapy (FMT) only for members with Clostridioides difficile infection (CDI) when the policy's specific coverage criteria are met. Use of FMT for any indication other than the CDI scenarios described in the criteria is considered investigational and is not covered.

Inclusion of a procedure, diagnosis, or device code in this policy does not guarantee that a given member will have coverage for that service. Coverage and reimbursement are determined by the member's individual benefit plan and eligibility at the time of service; providers should verify benefits and authorizations for each member before proceeding.

Consistent with the policy's coverage stance, use of fecal microbiota therapy for conditions other than recurrent or fulminant CDI as specified in the coverage criteria is considered investigational and is not covered under Select Health.

The provided excerpt does not include an explicit statement framed as 'not medically necessary.' Instead, the policy emphasizes investigational noncoverage for non‑CDI indications and instructs that benefit determinations depend on the member's contract and eligibility.

Coding and Billing References

CPT CodesCPT

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

HCPCS / Drug CodesHCPCS

G0455	Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen
J3490	Unclassified drugs
J3590	Unclassified biologics

Procedure Coding Referencemixed

CPT Only

Document indicates CPT coding referenced (specific CPT codes not listed in this excerpt)

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for fecal microbiota transplantation (FMT) services. SelectHealth covers FMT (including commercially prepared products such as OpenBiome capsules) only in limited circumstances for treatment of Clostridioides difficile infection (CDI). Providers must obtain prior authorization before scheduling or performing FMT to confirm medical necessity and coverage.

Applies to fresh stool preparations and commercially prepared FMT capsules (e.g., OpenBiome).
Prior authorization must be obtained prior to service date.
Coverage limited to CDI indications described in the policy (see coverage criteria).

Prior Authorization

Prior Authorization and Benefit Verification

Providers must verify member benefits and eligibility at the time of service and submit documentation supporting medical necessity with the prior authorization request. Coverage and reimbursement depend on the member's individual benefit plan and eligibility in effect on the date services are rendered.

Verify eligibility and benefits using the member ID and plan details prior to authorization submission.

Clinical Background

Clostridioides difficile infection typically presents with watery diarrhea and can range in severity from mild or moderate illness to life‑threatening, complicated disease (e.g., hypotension, ileus, or megacolon). Standard treatment is antibiotic therapy (for example, metronidazole, vancomycin, or fidaxomicin), but relapses are common. Fecal microbiota therapy (FMT) restores healthy fecal bacteria from a screened donor into the recipient's gastrointestinal tract and has demonstrated high efficacy for recurrent or refractory CDI in the literature.

Key Definitions and Severity

inv-19: Fecal Microbiota Therapy (FMT) — definition and delivery routes summary

DefinitionReintroduction of healthy fecal bacteria from a donor into the gastrointestinal tract of a patient diagnosed with C. difficile infection (also called fecal biotherapy, fecal bacteriotherapy, fecal microbiota transplantation, fecal flora reconstitution, fecal transfer, or stool transplantation).

Common delivery routesColonoscopy (proximal colon), enema (rectal), nasoduodenal (upper GI) tube infusion, or oral frozen capsules.

Products referencedFresh donor stool preparations and commercially prepared frozen capsules (e.g., OpenBiome capsules) are used; commercially prepared products are kept frozen until administration.

inv-20: Severity definitions for CDI — mild/moderate, severe, complicated thresholds

Mild or moderate CDILeukocytosis with WBC ≤ 15,000 cells/µL and serum creatinine < 1.5× premorbid level.

Policy Summary

PayerSelectHealth

PolicyFecal Microbiota Therapy (FMT) Coverage Criteria

Policy CodePolicy 522

Change TypeMaterial revision to commercial episode threshold

Effective DateJan 29, 2023

Last ReviewDec 19, 2024

Next Review DateDec 19, 2024

Key ActionObtain prior authorization and document donor screening, testing, and positive C. difficile test to support medical necessity.

SourceLink

On This Page

Include member-specific benefit information when available to avoid delayed or denied claims.

Coverage determination is subject to the member's contract and benefit limitations.

Denial Risk

Non‑covered Indications — Investigational Use

FMT is covered only for specific CDI scenarios; use of FMT for other conditions is considered investigational and is not covered. Do not submit prior authorization requests for non-CDI indications.

FMT is NOT covered for indications other than Clostridioides difficile infection (investigational).
Requests for off-label or investigational uses will be denied.

Documentation Required

Required Procedure Documentation

Providers must supply complete documentation to support the prior authorization and claims, including confirmation of CDI diagnosis, prior treatment history, and donor screening/preparation details.

Confirmatory positive C. difficile PCR or toxin assay must be included.
Document prior antibiotic therapies and response (see referenced prior therapies).
Provide donor screening results, donor relationship (if applicable), preparation method (fresh vs. frozen/capsules), and route of administration.
Include informed consent and evidence of discontinuation of recipient antibiotics when applicable.

Step Therapy

Therapy Sequence — Place in Treatment Pathway

FMT is reserved for patients who have failed appropriate antibiotic therapy for CDI or who have fulminant disease meeting policy criteria. Ensure the documented therapy sequence and antibiotic treatment failures are present in the record and prior authorization submission.

FMT should be considered after documented failure of standard antibiotic therapy per policy-defined sequence.
For recurrent CDI: typically after at least three episodes or as otherwise specified in policy.
For fulminant CDI: document lack of improvement after three days of antibiotic therapy when applicable.

Note

Referenced Prior Therapies

Document prior antibiotic therapies used to treat the current CDI episode(s). This information is required to demonstrate that standard therapies were attempted before FMT.

Common referenced prior therapies include oral vancomycin, metronidazole, and fidaxomicin (Dificid).
List dates, doses, duration, and clinical response to each antibiotic course in the prior authorization submission.

Denial Risk

Verify Benefits and Eligibility — Benefit Determination Risk

Verify benefits and eligibility and include supporting clinical documentation to justify medical necessity. Benefit determination may vary by member and plan; final coverage is based on the member's plan provisions at time of service.

Contact Member Services using the number on the member ID card for specific benefit questions.
Submit all supporting records with the prior authorization request to expedite review.
SelectHealth may deny services if eligibility or benefit coverage does not support payment.

Leukocytosis with WBC ≥ 15,000 cells/µL or serum creatinine > 1.5× premorbid level.

Severe, complicated (fulminant) CDIHypotension or shock, ileus, or megacolon (features of complicated/fulminant disease).

inv-21: Fecal Microbiota Transplantation (FMT) — alternate definition and delivery methods referenced in literature

Alternate term and scopeFecal Microbiota Transplantation (FMT) is described in the literature as transfer of processed donor fecal material to a recipient's GI tract to treat recurrent or refractory C. difficile infection.

Documented delivery methods in literatureColonoscopy, duodenal/duodenal (upper GI) infusion (including nasoduodenal or duodenal routes), and oral capsulized frozen preparations have been used and reported in clinical series and trials.

Key evidence sourcesMultiple clinical reports and trials (e.g., van Nood et al. duodenal infusion, JAMA 2014 oral capsulized frozen FMT, and several case series/systematic reviews) support these methods.