CurrentPremera BluecrossPolicy N/A

Pharmacologic Treatment of Clostridioides difficile (CDI)

Policy governing medical necessity and coverage criteria for specific pharmacologic and microbiota-based therapies for Clostridioides difficile infection for Premera Blue Cross members.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Clostridioides difficile (CDI)

Policy CodePolicy N/A

Change TypeAdded coverage (material)

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit office visit notes documenting diagnosis, history, exam, and medication history to demonstrate medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added coverage for Dificid (fidaxomicin) for the treatment of C. difficile associated diarrhea.

Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

Added CPT code 0780T for the administration of Rebyota.

4drugs/products with explicit coverage criteria

18+minimum age for Dificid coverage (months)

2+recurrent CDI episodes required for Rebyota and Vowst

singletreatment course limit for Rebyota, Vowst, and Zinplava

Coverage Criteria for CDI Therapies

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic Treatment of Clostridioides difficile (CDI)

Policy CodePolicy N/A

Change TypeAdded coverage (material)

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain prior authorization and submit office visit notes documenting diagnosis, history, exam, and medication history to demonstrate medical necessity.

SourceLink

On This Page

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Dificid (fidaxomicin) — Initial therapy

Covered when ALL of the following are met

Dificid coverage: The individual is aged 6 months or older; Diagnosed with Clostridioides difficile (C. difficile) associated diarrhea; AND meets ONE of: has tried generic oral metronidazole first and had an inadequate response or intolerance to generic oral metronidazole; has tried generic oral vancomycin first and had an inadequate response or intolerance to generic oral vancomycin; OR there is documented C. difficile resistance to metronidazole AND documented C. difficile resistance to vancomycin; Dose limited to 400 mg per day (taken as 200 mg twice daily).dose_limit=400 mg/day

Follow FDA dosing and prescribing information

Rebyota (fecal microbiota, live-jslm) — Initial therapy for recurrent CDI

Covered when ALL of the following are met

Rebyota coverage: The individual is aged 18 years or older; Has had two or more recurrent Clostridioides difficile infection (CDI) episodes; Positive stool test for toxigenic C. difficile within the last 30 days; Current episode of CDI is controlled (defined as less than three loose stools per day for two consecutive days); Administration will occur within 72 hours following completion of antibacterial treatment for CDI; Limited to a single treatment course.administration_window=within_72_hours

Managed through pharmacy and medical benefit

Vowst (fecal microbiota spores, live-brpk) — Initial therapy for recurrent CDI

Covered when ALL of the following are met

Vowst coverage: The individual is aged 18 years or older; Has had two or more recurrent Clostridioides difficile infection (CDI) episodes; Positive stool test for toxigenic C. difficile within the last 30 days; Current episode of CDI is controlled (defined as less than three loose stools per day for two consecutive days); Administration will occur within 72 hours following completion of antibacterial treatment for CDI; Limited to a single treatment course.administration_window=within_72_hours

Managed through pharmacy benefit

Zinplava (bezlotoxumab) — Adjunct to antibacterial therapy to reduce recurrence risk

Covered when ALL of the following are met

Zinplava coverage: The individual is aged 18 years or older; Has a diagnosis of Clostridioides difficile infection (CDI) confirmed by a positive stool test for toxigenic C. difficile; Is at high risk for CDI recurrence due to at least one of: age >=65 years, immunocompromised status, severe CDI at presentation, or presence of C. difficile ribotype 027; Is currently receiving standard-of-care antibacterial therapy for CDI (fidaxomicin, metronidazole, or vancomycin); Limited to a single treatment course.single_course

Managed through medical benefit

All uses of Dificid (fidaxomicin), Rebyota (fecal microbiota, live-jslm), Vowst (fecal microbiota spores, live-brpk), and Zinplava (bezlotoxumab) that are not explicitly described in this policy are considered investigational and are not covered. The medications are subject to FDA dosing and administration guidance; requests for uses outside the policy may be denied as investigational.

Future re-authorization following an initial, completed course is restricted. Future re-authorization of Rebyota and Vowst after one treatment course is considered investigational and will not be approved. Likewise, future re-authorization of Zinplava after one dose is considered investigational. Dificid re-authorization for treatment of C. difficile associated diarrhea will be reviewed as a new initial request. Non-formulary exception reviews for these products may be approved up to 12 months; other approvals are generally limited to 1 month per the policy.

Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Dificid (fidaxomicin), Rebyota (fecal microbiota, live-jslm), Vowst (fecal microbiota spores, live-brpk), and Zinplava (bezlotoxumab) when used for indications covered by this policy. Initial approvals for non‑formulary exception reviews may be granted for up to 12 months; all other initial approvals may be granted for up to 1 month. Re-authorization of fidaxomicin for C. difficile–associated diarrhea will be reviewed as an initial request. Re-authorization after one treatment course for Rebyota or Vowst, or after one dose of Zinplava, is considered investigational and is not routinely covered.

Initial approval durations: non‑formulary exception reviews up to 12 months; other initial approvals up to 1 month
Re-authorization: fidaxomicin reviewed as initial request; Rebyota/Vowst/Zinplava following single course/dose considered investigational

Step Therapy

Step Therapy Required for Fidaxomicin

Fidaxomicin (Dificid) requires a step-therapy trial of alternate therapies prior to approval. Specifically, the member must be aged 6 months or older, have a diagnosis of Clostridioides difficile–associated diarrhea, and have tried and had an inadequate response to or intolerance of generic oral metronidazole OR generic oral vancomycin. Additionally, documented C. difficile resistance to metronidazole and vancomycin must be provided when applicable. The dose is limited to 400 mg per day (200 mg twice daily).

Age requirement: ≥ 6 months
Diagnosis: Clostridioides difficile–associated diarrhea
Step requirement: trial of generic oral metronidazole and/or generic oral vancomycin with documented inadequate response or intolerance
Dose limit: 400 mg/day (200 mg twice daily)

Documentation Required

Required Medical Record Documentation

Submit complete medical records to support medical necessity. Documentation should include office visit notes with diagnosis, relevant history, physical examination, and a detailed medication history. For C. difficile therapies, include stool testing results (eg, positive toxigenic C. difficile test within 30 days when applicable), documentation of prior antimicrobial treatments and responses/intolerances, and any microbiology demonstrating resistance if claimed.

Office visit notes with diagnosis, history, physical exam, medication history
Stool test results for toxigenic C. difficile when applicable
Documentation of prior therapies, responses, or intolerances
Microbiology results showing resistance if asserted

Denial Risk

Investigational Uses — Likely Denial

Uses of Dificid (fidaxomicin), Rebyota, Vowst, or Zinplava that are not specifically described in this policy are considered investigational and are not covered. Future re‑authorization requests following a single course of Rebyota or Vowst, or a single dose of Zinplava, are considered investigational.

All uses not outlined in this policy are investigational
Re-authorization after one treatment course/dose for Rebyota, Vowst, or Zinplava considered investigational

Policy Revision History

2025-09-01interim_review_material_changeLatest

Added coverage for Dificid (fidaxomicin) for the treatment of C. difficile–associated diarrhea.

2025-04-01annual_review_clarification

Clarified that non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months and that medications are subject to FDA dosing and administration information.

2024-09-01annual_review_no_policy_change

Annual review completed with no changes to clinical policy statements.

2024-01-01coding_update

Coding update and correction: Vowst removed from HCPCS code J1440 and added to HCPCS code J3590.

2023-08-01interim_review_addition

Interim review added Vowst (fecal microbiota spores) coverage criteria and linked Vowst to HCPCS code J1440.

2023-07-06policy_effective_new_policy

New policy effective; added Rebyota and Zinplava coverage criteria and initial HCPCS/claims coding entries.

J0565	Injection, bezlotoxumab (Zinplava), 10 mg.
J1440	Fecal microbiota, live jslm (Rebyota), ml.
J3590	Unclassified biologics (use to report: Vowst).

OpenPayer

Pharmacologic Treatment of Clostridioides difficile (CDI)

Coverage Criteria for CDI Therapies

Coding and Age Limits

Authorization, Documentation, and Provider Requirements

Background and Scope

Definitions and Clinical Thresholds

Policy Revision History