Fecal microbiota transplantation for recurrent Clostridioides difficile infection
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This policy governs medical necessity and prior authorization requirements for fecal microbiota-based therapies (including conventional FMT and FDA-approved products Rebyota and VOWST) to prevent recurrent C. difficile infection for Fallon Health members and selected Fallon products.
Prior authorization is required for Rebyota (fecal microbiota, live - jslm) suspension, rectal use (HCPCS code J1440) effective for dates of service on or after September 1, 2026.
Conventional fecal microbiota transplant remains medically necessary under specified criteria and FDA-approved therapies are addressed separately.
Revised coverage criteria to indicate that fecal microbiota transplantation is covered after ≥ 2 episodes of C. difficile.
Added new sections for Medicare Variation and MassHealth Variation and coding/billing guidance for Rebyota (J1440 and 0780T) and HCPCS G0455.
CPT 44705 is nonpayable for Medicare and will deny vendor liable for all plan members; use HCPCS G0455 for Medicare purposes.
Coverage Criteria for Fecal Microbiota Transplantation
Medical necessity criteria for fecal microbiota transplantation
Covered when ALL of the following are met:
Clinical note on severe/fulminant hospitalized patients
Situations where conventional FMT may be considered:
Indications and recommended sequencing
Society guideline–based recommendations for use of FMT / fecal microbiota-based therapies
Initial coverage criteria for FMT
Covered when ALL of the following are met
Fecal microbiota transplantation (FMT) is considered experimental or investigational for all indications other than those expressly covered by this policy. Examples include, but are not limited to, Crohn's disease and other forms of inflammatory bowel disease; use of FMT for these conditions is not supported by current evidence and is excluded from coverage.
FMT and fecal microbiota–based therapies are not recommended for the prevention or routine treatment of conditions other than Clostridioides difficile infection (CDI) outside of clinical trials. Guideline panels (AGA, IDSA/SHEA, ASCRS, ACG) advise against routine use of FMT for inflammatory bowel disease (including ulcerative colitis) and irritable bowel syndrome, and recommend that non‑CDI indications be limited to research settings.
Do not bill HCPCS G0455 for preparation of a donor specimen if the donor specimen is not ultimately used for the treatment of a member. Per CMS and Plan guidance, G0455 describes preparation with instillation and the Plan does not pay for services that are not directly related to the diagnosis or treatment of the member; billing for specimen preparation that is not used may be denied.
FDA-approved fecal microbiota products such as Rebyota and VOWST are indicated for the prevention of recurrence of CDI following antibiotic treatment and are not indicated for the treatment of active C. difficile infection. Rebyota is administered rectally as a single-dose enema within 24–72 hours after completing antibiotic therapy; VOWST is oral and also indicated for prevention of recurrence only.
Reiterating guideline-based recommendations: FMT is not recommended for conditions such as inflammatory bowel disease (including ulcerative colitis) or irritable bowel syndrome except within clinical trials. Major society guidance emphasizes use of fecal microbiota therapies primarily for recurrent or refractory CDI and advises against routine application for non‑CDI gastrointestinal diseases.
CPT 44705 is nonpayable and will deny (vendor liable) for Medicare purposes and therefore is not covered for Plan members effective for the dates cited. For Medicare reporting, CMS created HCPCS G0455 to describe preparation with instillation of fecal microbiota; use of CPT 44705 is not valid for Medicare and will be denied.
Coding and Diagnosis Codes
| J1440 | Rebyota (fecal microbiota, live - jslm) suspension, for rectal use |
| 0780T | Instillation of fecal microbiota suspension via rectal enema into lower gastrointestinal tract |
| G0455 | Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen |
| G0455 | Preparation and instillation of fecal microbiota by any method, including assessment of donor specimen (per CMS). |
| 0780T | CPT code for instillation of Rebyota (fecal microbiota, live-jslm). |
| J1440 | HCPCS code for Rebyota (fecal microbiota, live - jslm) product (paid separately on OPPS/ASC fee schedule). |
| 44705 | CPT 44705 noted as not valid for Medicare purposes for preparation of fecal microbiota for instillation. |
| 44705 | Preparation of fecal microbiota for instillation, including assessment of donor specimen |
| G0455 | Preparation with instillation of fecal microbiota by any method, including assessment of donor specimen |
| 0780T | Instillation of fecal microbiota suspension via rectal enema into lower gastrointestinal tract |
| J1440 | Fecal microbiota, live - jslm, 1 mL billed as 150 mL |
| A04.71 | Enterocolitis due to Clostridium difficile, recurrent |
| A04.72 | Enterocolitis due to Clostridium difficile, not specified as recurrent |
Provider Actions and Prior Authorization Requirements
Prior authorization required for Rebyota (J1440) effective 09/01/2026
Prior authorization is required for Rebyota (fecal microbiota, live - jslm) suspension for rectal use (HCPCS J1440) effective for dates of service on or after September 1, 2026. CPT 0780T and G0455 do not require prior authorization.
Coding — pair G0455, CPT 0780T and J1440 as specified
For Fallon Medicare Plus, NaviCare, PACE and specified Fallon plans, use HCPCS G0455 for preparation with instillation of fecal microbiota; for Rebyota instillation providers must report CPT 0780T and HCPCS J1440 together on the same claim per payer guidance.
Required antibiotic trial — fidaxomicin and vancomycin
Before FMT is considered, there must have been an inadequate response or adverse reaction to both fidaxomicin (Dificid) and vancomycin (capsule or oral solution) unless contraindicated.
- Document inadequate response or adverse reaction to both agents.
Antibiotic therapy sequencing per specialty guidance
Society guidance recommends that appropriate antibiotic treatments generally be tried before offering FMT, typically after at least two recurrences (i.e., three CDI episodes) in many guidelines.
- IDSA/SHEA panel opinion: appropriate antibiotic treatments for at least 2 recurrences (3 CDI episodes) should be tried prior to FMT.
- ASCRS and other societies similarly recommend antibiotic therapy before FMT.
Treatment sequencing — FMT after ≥ 2 C. difficile episodes
Coverage was revised to require fecal microbiota transplantation only after at least two total episodes of C. difficile infection (initial infection plus ≥1 recurrence).
- Minimum threshold for coverage: ≥ 2 total episodes of C. difficile infection.
Required clinical documentation to establish medical necessity
Clinical documentation must include evidence of at least two total C. difficile infection episodes, specialist involvement (infectious disease or gastroenterology or consult notes), age ≥18, and documentation of inadequate response or adverse reaction to both fidaxomicin and vancomycin; requests should indicate this is for a single treatment.
- Number and dates of CDI episodes (showing ≥ 2 total episodes).
- Specialist consult notes or prescriber specialty listed.
- Age confirmation (≥ 18 years).
- Documentation of failure or adverse reaction to fidaxomicin and vancomycin.
- Statement that request is for a single FMT treatment.
Required diagnosis codes — use A04.71 or A04.72
Claims must be associated with ICD-10 diagnosis code A04.71 (recurrent C. difficile) or A04.72 (C. difficile not specified as recurrent); only these codes will be considered for coverage.
PA required for rectal administration of Rebyota (J1440); lack of PA risks denial
Requests for Rebyota administered rectally (HCPCS J1440) require prior authorization; failure to obtain required prior authorization may result in denial.
G0455 not payable when donor specimen unused
Do not bill HCPCS G0455 for preparation of a donor specimen if the donor specimen is not ultimately used for treatment; billing for an unused donor specimen may be denied because the Plan does not pay for services not directly related to treatment.
- G0455 should not be billed if the donor specimen is not used for the member's treatment.
Billing rule — bill G0455 only if donor specimen used
Do not bill G0455 for preparation of a donor specimen if the specimen is not ultimately used; G0455 is payable only when the specimen is used for treatment of the member.
- Only bill G0455 when donor specimen was used for the member's FMT procedure.
Definitions and Product Descriptions
Background and Context
Clostridioides difficile infection (CDI) ranges from mild diarrhea to life‑threatening colitis. Recurrent CDI is defined as an episode occurring within 8 weeks after a prior episode that had resolved. Oral antibiotics are first‑line therapy; fecal microbiota therapies (conventional FMT or FDA‑approved products) aim to restore the gut microbiome and are intended primarily to prevent further recurrences, particularly for patients with multiple recurrences.
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