CurrentPremera BluecrossPolicy 2.01.92

Pharmacologic treatment of Clostridioides difficile infection (CDI)

Defines medical necessity criteria, benefit application, and coding for fidaxomicin (Dificid and generic), fecal microbiota products (Rebyota, Vowst), and bezlotoxumab (Zinplava) for treatment or prevention of recurrent CDI for Premera Bluecross members.

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic treatment of Clostridioides difficile infection (CDI)

Policy CodePolicy 2.01.92

Change TypeAdded fidaxomicinrevised Zinplava age criterion

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis, history, exam, and medication history to demonstrate that medical necessity criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added fidaxomicin to the policy with same criteria as Dificid (fidaxomicin).

Updated Zinplava (bezlotoxumab) age requirement from aged 18 years or older to aged 1 year or older.

400 mg/dayfidaxomicin dosing limit

single courseRebyota/Vowst treatment limit

>=2 recurrencesRebyota/Vowst eligibility

single doseZinplava treatment

pharmacy & medical

Policy Summary

PayerPremera Bluecross

PolicyPharmacologic treatment of Clostridioides difficile infection (CDI)

Policy CodePolicy 2.01.92

Change TypeAdded fidaxomicinrevised Zinplava age criterion

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis, history, exam, and medication history to demonstrate that medical necessity criteria are met.

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.

Coverage Criteria

inv-01: Fidaxomicin (Dificid/generic) — Initial therapy criteria

Dificid (fidaxomicin) tablets/granules and generic fidaxomicin are covered when ALL of the following are met:

fidaxomicin_criteria: Patient aged 6 months or older

fidaxomicin_criteria: Diagnosed with Clostridioides difficile (C. difficile)–associated diarrhea

fidaxomicin_prior_therapy: Has tried and had an inadequate response or intolerance to generic oral metronidazole

fidaxomicin_prior_therapy: Has tried and had an inadequate response or intolerance to generic oral vancomycin

fidaxomicin_prior_therapy: Documented C. difficile resistance to metronidazole AND documented C. difficile resistance to vancomycin

fidaxomicin_criteria: Dose limited to 400 mg per day (taken as 200 mg twice daily)<= 400 mg/day

inv-02: Rebyota — Coverage criteria

Rebyota (fecal microbiota, live-jslm) is covered when ALL of the following are met:

rebyota_criteria: Patient aged 18 years or older

rebyota_criteria: Has had two or more recurrent Clostridioides difficile infection (CDI) episodes

rebyota_criteria: Positive stool test for toxigenic C. difficile within the last 30 days<= 30 days

rebyota_criteria: Current episode controlled (less than three loose stools per day for two consecutive days)

inv-03: Vowst — Coverage criteria

Vowst (fecal microbiota spores, live-brpk) is covered when ALL of the following are met:

vowst_criteria: Patient aged 18 years or older

vowst_criteria: Has had two or more recurrent Clostridioides difficile infection (CDI) episodes

vowst_criteria: Positive stool test for toxigenic C. difficile within the last 30 days<= 30 days

vowst_criteria: Current episode controlled (less than three loose stools per day for two consecutive days)

inv-04: Zinplava — Coverage criteria

Zinplava (bezlotoxumab) is covered when ALL of the following are met:

zinplava_criteria: Patient aged 1 year or older

zinplava_criteria: Diagnosis of Clostridioides difficile infection (CDI) confirmed by positive stool test for toxigenic C. difficile

At high risk for CDI recurrence due to one of the following

zinplava_risk: Age ≥ 65 years

zinplava_risk: Immunocompromised

zinplava_risk:

All uses of Dificid (fidaxomicin), generic 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 may be denied. These medications are subject to FDA dosing and administration instructions; requests outside the policy’s specified indications should be supported with documentation and will be reviewed as investigational.

Re-authorization of Rebyota and Vowst after completion of one treatment course is considered investigational (not medically necessary) and will not be approved. Initial non-formulary exception reviews for these microbiota products may be approved for up to 12 months, but any subsequent re-treatment requests following a completed single course will be evaluated as investigational and are generally not eligible for coverage.

Coding

Covered CPT CodesCPT

0780T

Instillation of fecal microbiota suspension via rectal enema into lower gastrointestinal tract

Covered HCPCS CodesHCPCS

J0565	Injection, bezlotoxumab (Zinplava), 10 mg
J1440	Fecal microbiota, live - jslm (Rebyota), 1 ml
J3590	Unclassified biologics (use to report: Vowst)

inv-09: fidaxomicin daily dose limit

Daily maximum dose400 mg per day (200 mg twice daily)

Route and formulationOral fidaxomicin (Dificid tablets/granules or generic fidaxomicin)

Age eligibilityPatient aged 6 months or older

Dose administration noteTaken as 200 mg twice a day to not exceed daily limit

Provider Actions / Authorization

Prior Authorization

Prior Authorization and Length of Approval

Prior authorization is required for Dificid (fidaxomicin), fidaxomicin, Rebyota (fecal microbiota, live-jslm), Vowst (fecal microbiota spores, live-brpk) and Zinplava (bezlotoxumab) when coverage is sought under this policy. Non‑formulary exception reviews for these products may be approved for a length of up to 12 months. All other approvals (routine reviews not granted as a non‑formulary exception) may be approved for up to 1 month. Future re‑authorization of Dificid (fidaxomicin) and fidaxomicin for the treatment of C. difficile associated diarrhea will be reviewed as an initial request. Future re‑authorization of Rebyota and Vowst following administration of one treatment course is considered investigational. Future re‑authorization of Zinplava following administration of one dose is considered investigational.

Non‑formulary exception approvals: up to 12 months
Standard approvals (non‑exception): up to 1 month
Re‑authorization of Dificid/fidaxomicin: reviewed as initial request
Re‑authorization of Rebyota or Vowst after one treatment course: investigational
Re‑authorization of Zinplava after one dose: investigational

Background

Clostridioides difficile infection (CDI) is a toxin-producing, spore-forming bacterium that causes antibiotic-associated diarrhea and colitis and is a common healthcare-associated infection. CDI results in substantial disease burden in the United States, with many cases occurring in hospitalized or recently hospitalized patients. Recognized risk factors include prior antibiotic exposure, recent gastrointestinal surgery, prolonged healthcare exposure, immunocompromised status, and advanced age (particularly patients aged >65 years).

Definitions

inv-15: Recurrent Clostridioides difficile infection (CDI) — definition / episode thresholds

Policy definitionRecurrent CDI = multiple episodes of C. difficile infection; policy requires two or more recurrent CDI episodes for fecal microbiota products (Rebyota, Vowst)

Clinical test requirementPositive stool test for toxigenic C. difficile within the last 30 days

Control of current episodeCurrent episode controlled defined as less than three loose stools per day for two consecutive days

Timing for administrationAdministration within 72 hours following completion of antibacterial treatment for CDI

Typical risk factors (context)Risk factors include prior antibiotics, GI surgery, prolonged healthcare exposure, immunocompromise, and age >65