Sierra Health and Life Rebyota Coverage Update

Coverage and Medical Necessity Criteria

inv-01: Medically Necessary — Prevention of rCDI

Covered when ALL of the following are met:

Rebyota medical necessity criteria: 1) Diagnosis of recurrent Clostridioides difficile infection defined by both: presence of diarrhea (≥3 loose bowel movements within a 24-hour period for 2 consecutive days) AND a positive stool test for C. difficile toxin; 2) Patient is 18 years of age or older; 3) Patient has had one or more recurrence(s) of CDI following an initial episode of CDI; 4) Both: (a) patient completed at least 10 days of one of the following antibiotic therapies for rCDI between 24 to 72 hours prior to initiating Rebyota: oral vancomycin or fidaxomicin; AND (b) previous episode of CDI is under control (e.g., less than 3 unformed/loose stools/day for 2 consecutive days); 5) Prescribed by or in consultation with a gastroenterologist or an infectious disease specialist; 6) Authorization requested for a single-dose treatment only.

Maintain documentation of stool testing, antibiotic course, symptom control, and specialist involvement.

inv-02: Not Medically Necessary / Unproven Indications

Unproven indications: Rebyota is unproven and not medically necessary for prevention and/or treatment of all other indications including but not limited to Ulcerative Colitis, Crohn's disease, and irritable bowel syndrome due to insufficient evidence of efficacy.

inv-03: Not medically necessary — Ulcerative Colitis

Ulcerative colitis

UC coverage stance: FMT is unproven and not medically necessary for prevention and/or treatment of UC.

Multiple RCTs and meta-analyses show heterogeneous results and limitations; AGA recommends FMT only in clinical trials (see source).

inv-04: Not established — Crohn's Disease

Crohn's disease

CD coverage stance: Evidence is insufficient to support FMT for Crohn's disease; available prospective single-center open-label data report modest responses and potential for harm, and controlled trials are required.

Small sample sizes, open-label design, and safety signals limit applicability.

inv-05: Not medically necessary — Irritable Bowel Syndrome

Irritable bowel syndrome

IBS coverage stance: FMT is unproven and not medically necessary for prevention and/or treatment of IBS; randomized trials and meta-analyses report inconsistent results with significant heterogeneity and route-dependent effects (some benefit reported with lower GI or upper GI delivery), but overall evidence is insufficient.

Subgroup analyses suggest delivery-route differences; well-designed RCTs are needed.

inv-06: Coverage for recurrent CDI / FDA-indicated use

Covered when ALL of the following are met

rCDI indication: Patient has recurrent Clostridioides difficile infection (recurrent CDI) or severe/refractory CDI being considered for FMT or an FDA-approved microbiota product (e.g., Rebyota) after appropriate antibiotic therapy.see guidelines (multiple recurrences)

Supported by guideline recommendations and FDA labeling.

Prior therapy requirement: Documented appropriate antibiotic treatment has been administered per guideline recommendations (typically at least two recurrences, i.e., three total CDI episodes) unless FMT is used as rescue therapy for severe/fulminant refractory cases where surgery is not an option.>=2 recurrences typically

Reflects IDSA-SHEA, ASCRS, and other society guidance.

Delivery methods: Acceptable delivery methods include colonoscopy or oral capsules; enema may be used if other methods are unavailable. FDA-approved formulations may specify route-specific labeling.

inv-07: Investigational / Not standard of care indications

Not routinely covered / investigational when ANY of the following apply

IBS: FMT for irritable bowel syndrome is investigational/not established: randomized trials and meta-analyses show inconsistent results, high heterogeneity, and low to very low quality evidence; benefit may vary by route but overall efficacy for global IBS symptoms is not demonstrated.

See Xu 2019, Laniro 2019, and recent meta-analyses.

Ulcerative colitis and Crohn disease: FMT for ulcerative colitis or Crohn disease is investigational or recommended only in the context of clinical trials due to very low or limited evidence and the need for larger, controlled studies with long-term follow-up.

AGA recommends trial-only for UC; controlled trials are required for CD.

Use of Rebyota or fecal microbiota transplantation (FMT) for indications other than prevention of recurrent Clostridioides difficile infection (rCDI) is considered unproven and not medically necessary. The policy explicitly lists Ulcerative Colitis, Crohn's disease, and irritable bowel syndrome (IBS) among non‑rCDI indications for which evidence is insufficient to support coverage.

Requests for FMT/Rebyota for these non‑rCDI conditions may be denied when submitted for routine treatment because controlled trial evidence is limited, heterogeneous, or of low quality and does not establish clinical benefit for these indications.

The document explicitly states that FMT is unproven and not medically necessary for both prevention and treatment of ulcerative colitis (UC) and irritable bowel syndrome (IBS). For UC, randomized data and systematic reviews fail to provide consistent, durable benefit; for IBS, pooled RCT evidence shows no overall superiority to placebo with substantial heterogeneity and route‑dependent effects.

Per the American Gastroenterological Association (AGA) guidance, FMT for mild‑to‑moderate ulcerative colitis should be performed only in the context of a clinical trial. The policy follows this recommendation and does not endorse routine use of FMT for mild‑to‑moderate UC outside research settings due to very low quality and heterogeneous evidence.

Rebyota is indicated and considered medically necessary only for prevention of recurrence of CDI under the policy criteria; use of Rebyota for prevention or treatment of other conditions (for example, ulcerative colitis, Crohn's disease, or IBS) is not medically necessary because evidence does not demonstrate efficacy for these indications.

The policy states that FMT is unproven and not medically necessary for the prevention and/or treatment of ulcerative colitis and irritable bowel syndrome. Systematic reviews and RCTs for these conditions show inconsistent findings, significant heterogeneity, and generally low certainty of evidence, supporting the non‑coverage stance for these indications.

For irritable bowel syndrome (IBS), FMT is considered not established as medically necessary. Randomized trials and meta‑analyses report inconsistent results and substantial heterogeneity; while some subgroup analyses suggest benefit for specific delivery routes (e.g., colonoscopy or upper GI delivery), the overall body of RCT evidence does not demonstrate a consistent, reproducible benefit to support routine clinical use.

Billing and Coding

Applicable HCPCS CodeHCPCSCovered

J1440

Fecal microbiota, live - jslm, 1 ml

Relevant Diagnosis CodesICD-10

A04.71

Enterocolitis due to Clostridium difficile, recurrent

Dose CFU and PEG content

Dose volume150 mL per single rectal dose

Colony forming units (CFU) rangeContains between 1x10^8 and 5x10^10 CFU per mL

Bacteroides content>1x10^5 CFU/mL of Bacteroides spp.

Polyethylene glycol (PEG 3350) contentNot greater than 5.97 grams PEG3350 per 150 mL dose

Preparation matrixFiltrate prepared with PEG 3350 and saline

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior authorization — single dose (J1440)

Prior authorization is required for fecal microbiota transplantation (FMT) when requested for prevention of recurrent Clostridioides difficile infection (rCDI), including use of the FDA-approved product Rebyota (HCPCS J1440). Authorization will be issued for a single-dose treatment only when all medical necessity criteria are met.

Prior authorization required for single-dose Rebyota (HCPCS J1440).
Authorization issued for a single dose only.

Documentation Required

Prior authorization expectation — document indication and evidence

Prior authorization requests for FMT must document the clinical indication and supporting evidence. FMT is considered medically necessary for prevention of recurrent CDI only; requests for other indications (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome) are considered unproven and not medically necessary.

FMT is unproven and not medically necessary for UC and IBS.

Clinical Background and Product Information

Clostridioides difficile (formerly Clostridium difficile) is an anaerobic, gram‑positive bacillus that causes Clostridioides difficile infection (CDI). Recurrent CDI (rCDI) is defined by recurrence of diarrhea together with a positive stool test for C. difficile toxin occurring within the typical post‑treatment window (commonly considered within 8 weeks) after a prior CDI episode. FMT, including the FDA‑approved microbiota product Rebyota, is used as a microbial‑based therapy to prevent rCDI in adults after appropriate antibiotic therapy; clinical trials demonstrated reductions in recurrence but evidence and applicability vary by study design and population.

Definitions and Clinical Endpoints

Episode of CDI

Clinical definitionClinical findings compatible with CDI plus microbiological evidence of C. difficile toxin by EIA without another cause, or compatible clinical picture with positive NAAT (preferably low Ct) or positive toxigenic culture or pseudomembranous colitis

Typical presentationDiarrhea with supporting laboratory evidence for C. difficile toxin

Alternative diagnostic evidencePositive toxigenic culture or endoscopic/pathologic evidence of pseudomembranous colitis in combination with a positive test for toxigenic C. difficile

Exclusion of other causesDiagnosis requires reasonable exclusion of other causes of diarrhea

Recurrent CDI (rCDI)

DefinitionRecurrence of diarrhea and a positive stool test for C. difficile toxin occurring within 8 weeks following treatment or as diagnosed by a GI or ID specialist; recurrences can occur later than 8 weeks

OpenPayer

Rebyota (fecal microbiota, live-jslm) — coverage criteria for prevention of recurrent Clostridioides difficile infection

Coverage and Medical Necessity Criteria

Billing and Coding

Provider Requirements, Prior Authorization, and Documentation

Clinical Background and Product Information

Definitions and Clinical Endpoints