Blue Cross Blue Shield TN fecal testing Coverage

Coverage Criteria for Fecal Analysis and FMT Screening

inv-01: Covered and Not Covered Stool Tests

Covered and not covered fecal analyses relevant to pre-FMT screening and dysbiosis evaluation

Pre-FMT culture coverage: Prior to fecal microbiota transplant (FMT), fecal analysis by culture MEETS COVERAGE CRITERIA for the following organisms: Extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae; Vancomycin-resistant Enterococci (VRE); Carbapenem-resistant Enterobacteriaceae (CRE); Methicillin-resistant Staphylococcus aureus (MRSA); Campylobacter; Shigella; Salmonella.

From policy Indications and/or Limitations of Coverage.

Pre-FMT NAAT coverage: Prior to FMT, fecal analysis by nucleic acid amplification testing (NAAT) MEETS COVERAGE CRITERIA for: Clostridium difficile; Campylobacter; Salmonella; Shigella; Shiga toxin-producing Escherichia coli; Norovirus; Rotavirus; COVID-19 (SARS-CoV-2).

From policy Reimbursement Policy NAAT list.

Pre-FMT NAAT non-coverage: NAAT for ESBL-producing Enterobacteriaceae, VRE, CRE, MRSA, and any other microorganisms not listed as covered DOES NOT MEET COVERAGE CRITERIA prior to FMT.

Explicit NAAT non-coverage statement in policy.

Dysbiosis diagnostic tests not covered: As diagnostic tests for evaluation of intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal bacterial overgrowth, fecal analysis of the following components DOES NOT MEET COVERAGE CRITERIA: triglycerides; chymotrypsin; iso-butyrate, iso-valerate, and n-valerate; meat and vegetable fibers; long chain fatty acids; cholesterol; total short chain fatty acids; levels of Lactobacilli, bifidobacteria, and E. coli and other potential pathogens (including Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, S. aureus, Vibrio); fecal yeast identification/quantitation; N-butyrate; beta-glucuronidase; pH; SCFA distribution; and fecal secretory IgA.

Listed non-covered fecal biomarkers due to lack of supporting published evidence.

inv-02: Indications for FMT in C. difficile infection

Coverage-related clinical positioning present in the text:

FMT for CDI: For Clostridium difficile infection (CDI), FMT is suggested for patients with severe or fulminant CDI refractory to antibiotic therapy (particularly when patients are poor surgical candidates). For patients experiencing a second or further recurrence of CDI, FMT can be delivered (capsule, colonoscopy, or enema) to prevent further recurrences; repeat FMT is suggested for recurrence within 8 weeks. FMT should be considered for recurrent CDI in patients with inflammatory bowel disease (IBD).

Summarizes ACG recommendations on positioning of FMT in CDI management.

inv-03: FMT donor screening and exclusion

Donor screening and exclusion criteria for FMT:

Donor screening requirements: Donors must complete a donor health questionnaire and undergo laboratory screening including stool assays (e.g., C. difficile toxin B by PCR or toxin A/B EIA if PCR unavailable; routine bacterial culture for enteric pathogens including Campylobacter, Salmonella, Shigella; Shiga toxin-producing E. coli by PCR; stool ova/cyst/parasite analysis including Microsporidia; fecal antigen testing for Cryptosporidium and Giardia; acid-fast stain for Cyclospora/Isospora) and viral PCRs (e.g., Norovirus, Rotavirus). Serum screening is also recommended as per guidelines.

Based on joint guideline and workgroup recommendations.

MDRO testing and exclusion: Donor and/or donor stool testing must include multidrug-resistant organism (MDRO) screening (at minimum ESBL-producing Enterobacteriaceae, VRE, CRE, and MRSA). Donors or stools positive for MDROs should not be used for FMT; culture of nasal or peri-rectal swabs is an acceptable alternative to stool testing for MRSA only.bookend testing acceptable within 60 days

Quarantine stool samples until post-donation MDRO tests are confirmed negative; bookend testing (no more than 60 days apart) before and after multiple donations is acceptable.

inv-04: Stool testing in diagnostic workup

Stool testing for evaluation of patients with suspected IBD/diarrhea:

Stool testing to exclude infection: Perform routine fecal examinations and cultures to exclude bacterial, viral, or parasitic causes of diarrhea; test for Clostridium difficile (testing within 2 hours of stool passage is recommended by WGO); in suspected ulcerative colitis and acute flares, perform stool cultures and C. difficile toxin assays to rule out infective causes.

Reflects WGO, ACG, and BSG recommendations.

Fecal inflammatory markers: Fecal markers such as calprotectin and lactoferrin may be used to assess intestinal inflammation and help distinguish inflammatory bowel disease activity from other causes of diarrhea.

Supported by WGO and ACG guidance on using fecal calprotectin/lactoferrin to detect inflammation.

The policy explicitly excludes a broad set of fecal biomarker assays and microbial profiling components from coverage when used to diagnose intestinal dysbiosis, IBS, malabsorption, or small intestinal bacterial overgrowth (SIBO). Examples listed as not meeting coverage criteria include fecal measurements of triglycerides, chymotrypsin, iso-butyrate/iso-valerate/n‑valerate, meat and vegetable fibers, long chain fatty acids, cholesterol, total short chain fatty acids, and microbial quantitation such as levels of Lactobacilli, bifidobacteria, E. coli and other named potential pathogens, as well as fecal yeast identification/quantitation, N‑butyrate, beta‑glucuronidase, pH, short chain fatty acid distribution, and fecal secretory IgA.

Society guidance cited in the policy indicates that fecal microbiota transplantation (FMT) remains an investigational therapy for inflammatory bowel disease (IBD) and should only be used in the context of clinical trials. The British Society of Gastroenterology notes there is currently no place for FMT in the management of IBD outside clinical trials unless complicated by C. difficile infection, and recommends FMT as investigational for use only in clinical studies.

The policy references FDA safety communications that have identified the risk of serious adverse events from transmission of multidrug‑resistant organisms (MDROs) and other pathogenic organisms via FMT. Where donor screening cannot mitigate the risk of MDRO transmission, these safety alerts may lead to restriction or exclusion of FMT use; the policy emphasizes adherence to recommended donor screening and testing to reduce this risk.

As a coverage rationale, the policy states that fecal analysis aimed at diagnosing dysbiosis, IBS, malabsorption, or SIBO is not supported because the listed tests lack sufficient published evidence of clinical utility. Consequently, assays such as microbial profiling or quantitation and indirect metabolic/enzymatic markers (for example, SCFA measurements, fecal yeast quantitation, beta‑glucuronidase, pH, and similar biomarkers) do not meet coverage criteria for these diagnostic indications.

The policy notes alignment with external guidance (including NICE) that routine fecal testing such as ova and parasite exams and other investigations are not necessary to confirm a diagnosis in people who meet diagnostic criteria for IBS. NICE guidance explicitly lists tests that are unnecessary to confirm IBS in patients who meet diagnostic criteria, including faecal ova and parasite testing.

Provider Actions, Documentation, and Screening Requirements

Prior Authorization

Prior authorization: Not specified in the extracted policy text. Providers should verify member benefit coverage and prior authorization requirements at the time of request with the member's plan before scheduling FMT, as coverage determinations are dependent on individual benefits.

Check member benefits for prior authorization requirements
Contact the payer's provider services or use the payer portal to confirm

Documentation Required

Donor Screening Components

Donor screening components: Donor evaluation must include a donor health questionnaire, serum testing, and stool testing to minimize risk of transmissible infection. Stool testing should include culture for enteric pathogens and testing for C. difficile toxin B. Serum testing and other laboratory assays should follow current consensus guidance and institutional protocols.

Donor health questionnaire completed prior to donation

Background and Scope

Background: Intestinal dysbiosis is defined as a disruption or imbalance of the gut microbial ecology and has been associated with conditions such as IBS, IBD, celiac disease, and metabolic and autoimmune disorders. Assessment methods range from direct microbial profiling (culture, sequencing, NAAT) to indirect fecal biomarkers (enzymes, pH, short chain fatty acids), but normative ranges and clear clinical utility are limited. Fecal microbiota transplantation (FMT) is the transfer of stool from a screened donor to a recipient to restore microbial balance and is an established treatment for recurrent or severe Clostridioides difficile infection, but it requires careful donor screening to prevent transmission of infectious agents including MDROs. The policy therefore governs coverage for fecal analyses used to evaluate dysbiosis and the required stool testing prior to FMT.

Key Definitions

inv-23: Intestinal dysbiosis — definition of dysbiosis

DefinitionIntestinal dysbiosis is a disruption or imbalance of the intestinal microbial ecology.

Associated conditionsLinked with IBS, IBD, celiac disease, multiple sclerosis, Sjogren's syndrome, obesity, allergy, and diabetes.

Clinical relevanceAssessment methods include microbial profiling and fecal biomarkers, but normative ranges and clinical utility are limited.

inv-24: FMT — definition of fecal microbiota transplantation

DefinitionFecal microbiota transplantation (FMT) is the infusion/transfer of stool from a screened healthy donor to a recipient to restore gut microbiome balance.

PurposeIntended to restore microbial balance and used clinically for recurrent or severe C. difficile infection after antibiotic therapy failure.

OpenPayer

Fecal Analysis in the Diagnosis of Intestinal Dysbiosis and Fecal Microbiota Transplant Testing

Coverage Criteria for Fecal Analysis and FMT Screening

Provider Actions, Documentation, and Screening Requirements

Background and Scope

Key Definitions