CurrentCommunity-CarePolicy N/A

Fecal microbiota (live) for prevention of recurrent Clostridioides difficile infection

This medication utilization policy governs authorization, quantity limits, and coverage period for fecal microbiota (live) used to prevent recurrence of Clostridioides difficile infection in adult members of Community-Care.

Policy Summary

PayerCommunity-Care

PolicyFecal microbiota (live) for prevention of recurrent Clostridioides difficile infection

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization for J1440 with documentation of ≥1 recurrent CDI episode, a positive stool test within 30 days, age ≥18, and planned administration 24–72 hours after completing CDI antibiotics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1required prior CDI recurrence episodes

30 dayswindow for positive stool test

18+minimum patient age

150 mLmax package quantity

1 monthauthorization period

Coverage Criteria for Fecal Microbiota (live)

Initial Approval Criteria

Covered when ALL of the following are met:

Authorization limits (if approved)

Quantity: Authorized up to one 150 mL package without renewal150 mL
Authorization period: Coverage allowed for one month if approved1 month
Subject to benefit changes.

No explicit exclusions are listed in this policy for fecal microbiota (live) when used for prevention of recurrent Clostridioides difficile infection.

The document does not specify any conditions or scenarios that are explicitly designated as not medically necessary for this therapy.

Policy Summary

PayerCommunity-Care

PolicyFecal microbiota (live) for prevention of recurrent Clostridioides difficile infection

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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.

Provider Actions, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for fecal microbiota (live) J1440 for prevention of recurrent Clostridioides difficile infection when the coverage criteria are met.

HCPCS: J1440 — Fecal microbiota, live - jslm, per mL
Prior authorization required before administration
If approved, authorized quantity: up to one 150 mL package (no renewal required)
Authorization period if approved: one month

Note

Provider Action

Providers must submit documentation that supports the clinical criteria for approval (see Documentation callout). Ensure prior authorization is obtained before scheduling treatment.

Documentation Required

Required Documentation

Documentation must include: history of at least one recurrent episode of C. difficile infection, a positive stool test for C. difficile within the past 30 days, patient age ≥ 18 years, and plan for administration 24–72 hours after completion of the qualifying antibiotic course.

Confirm and include date of the positive stool test (within 30 days)
Document prior episode(s) of C. difficile infection
Document patient age (≥ 18 years)
Document planned timing of administration (24–72 hours after antibiotic completion)

Denial Risk

Triggers for Denial

Denial may occur if required documentation is missing or criteria are not met.

No documentation of at least one recurrent C. difficile episode
No positive stool test for C. difficile within the past 30 days
Patient age < 18 years
Administration timing not consistent with 24–72 hours after antibiotic completion

Background

Recurrent Clostridioides difficile infection is characterized by return of symptoms after initial treatment and is associated with disrupted gut microbiota. Use of fecal microbiota (live) or fecal microbiota transplantation aims to restore a healthy microbiome and reduce the risk of further CDI recurrence. For prevention of recurrence, this policy requires a diagnosis of at least 1 recurrent episode of CDI, a positive stool test within the past 30 days, patient age of ≥ 18 years, and planned administration 24 to 72 hours after completion of the CDI antibiotic course. If approved, authorization is limited to up to one 150 mL package for a coverage period of 1 month.

OpenPayer

Fecal microbiota (live) for prevention of recurrent Clostridioides difficile infection

Coverage Criteria for Fecal Microbiota (live)

Coding and Quantity Limits

Provider Actions, Documentation, and Authorization

Background

Definitions