CurrentAnthemPolicy CC-0233

Rebyota (fecal microbiota, live - jslm) — Medical Necessity and Prior Authorization

Medical necessity and prior authorization criteria for Rebyota (fecal microbiota, live - jslm) administered as a single rectal dose to prevent recurrence of Clostridioides difficile infection in adults; applies to Anthem members and providers submitting requests under the medical benefit.

Policy Summary

PayerAnthem

PolicyRebyota (fecal microbiota, live - jslm) — Medical Necessity and Prior Authorization

Policy CodePolicy CC-0233

Change TypeNo material change

Effective Date

Next Review DateSep 8, 2025

Key ActionSubmit prior authorization with documentation of age ≥18, ≥3 CDI episodes treated with antibiotics, positive stool toxin test, and plan to administer Rebyota within 24–72 hours after completing antibiotics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum age

≥3prior CDI episodes

1 dosequantity limit

J1440HCPCS

A04.71ICD-10

Coverage and Approval Criteria

Approval criteria

Requests for Rebyota may be approved if ALL of the following are met:

Rebyota approval criteria: I. Individual is 18 years of age or older; AND II. Individual is requesting Rebyota for prevention of recurrence of Clostridiodes difficile infection; AND III. Individual has had at least three episodes of Clostridiodes difficile infection (initial episode and two recurrences) treated with antibiotic therapy (including Dificid, metronidazole or oral vancomycin); AND IV. Current episode of Clostridiodes difficile infection has been verified with a positive stool test for Clostridiodes difficile toxin; AND V. Rebyota will be administered within 24 to 72 hours of completing antibiotic treatment for the current Clostridiodes difficile infection episode.

Follow IDSA/SHEA guidance referenced in policy.

Requests for Rebyota may be denied when used to treat an active Clostridioides difficile infection rather than to prevent recurrence. Use of Rebyota in combination with Vowst or Zinplava during the same CDI episode is not approved. In addition, requests that do not meet the policy’s specified clinical criteria (age, number of prior CDI episodes, positive stool toxin test, and timing of administration) or that are submitted for any other indications outside the criteria will not be approved.

Rebyota is not approved for treatment of an active CDI episode. The policy explicitly states that requests for use of Rebyota to treat active C. difficile infection (rather than to prevent recurrence) are not approved.

Policy Summary

PayerAnthem

PolicyRebyota (fecal microbiota, live - jslm) — Medical Necessity and Prior Authorization

Policy CodePolicy CC-0233

Change TypeNo material change

Effective Date

Next Review DateSep 8, 2025

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.

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior authorization required — approval conditions

Prior authorization is required. Requests may be approved only when all approval criteria are met: patient is 18 years or older; request is for prevention of recurrence of CDI; patient has had at least three CDI episodes (initial + two recurrences) treated with antibiotic therapy (e.g., Dificid, metronidazole, or oral vancomycin); the current episode is verified with a positive stool test for C. difficile toxin; and Rebyota will be administered within 24–72 hours after completing antibiotic treatment. Quantity limit: one 150 mL dose, one time.

Age ≥ 18 years
Indication: prevention of CDI recurrence
≥3 CDI episodes treated with antibiotics (initial + 2 recurrences)
Positive stool test for C. difficile toxin verifying current episode
Administration within 24–72 hours after completing antibiotics
Limit: one 150 mL dose, one time (J1440)

Step Therapy

Context of prior treatments — IDSA/SHEA 2021 guidance

Policy references the IDSA/SHEA 2021 guidance: preferred and alternative antibiotic options are specified for initial and recurrent CDI, and fecal microbiota transplant is listed as an option for second or subsequent recurrence. For recurrent CDI, recommended antibiotic strategies include Dificid (preferred), vancomycin (standard or tapered/pulsed), vancomycin followed by Xifaxan, or fecal microbiota transplant as appropriate.

IDSA/SHEA 2021 recommends Dificid as preferred for initial and first recurrence; vancomycin (standard or tapered/pulsed) as alternative.
For second or subsequent recurrence, options include Dificid (standard/extended-pulse), tapered/pulsed vancomycin, vancomycin followed by Xifaxan, or fecal microbiota transplant.

Documentation Required

Required clinical documentation

Document the current CDI episode with a positive stool test for C. difficile toxin, record prior CDI episodes and the antibiotic treatments used, and include a plan showing Rebyota will be administered within 24 to 72 hours after completion of the current antibiotic course.

Positive stool test result for C. difficile toxin verifying current episode
History documenting at least three CDI episodes and prior antibiotic therapies (e.g., Dificid, metronidazole, oral vancomycin)
Administration timing plan: Rebyota to be given within 24–72 hours after completing antibiotics

Denial Risk

Denial triggers — common reasons for non-approval

Denials may be issued when the request is for treatment (rather than prevention) of active CDI, when Rebyota is requested in combination with Vowst or Zinplava during the same CDI episode, or when the specified clinical criteria for approval are not met.

Requests to treat active CDI (not to prevent recurrence) are not approved
Concurrent use with Vowst or Zinplava during the same CDI episode is not approved
Requests failing to meet all listed approval criteria may be denied

OpenPayer

Rebyota (fecal microbiota, live - jslm) — Medical Necessity and Prior Authorization

Coverage and Approval Criteria

Billing Codes and Quantity Limits

Prior Authorization, Documentation, and Provider Requirements

Background and Indication

Key Definitions