Capital Bluecross Fecal Analysis Coverage Update

Coverage and Medical Necessity Criteria

Coverage and Non-coverage Criteria

Covered and not-covered laboratory assessments prior to FMT donation and for evaluation of intestinal dysbiosis are specified as follows.

Covered by culture prior to FMT donation: Prior to donation for a fecal microbiota transplant (FMT), analysis by bacterial culture of the donor fecal sample for the following microorganisms MEETS COVERAGE CRITERIA: (a) Extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae; (b) Vancomycin-resistant Enterococci (VRE); (c) Carbapenem-resistant Enterobacteriaceae (CRE); (d) Methicillin-resistant Staphylococcus aureus (MRSA); (e) Campylobacter; (f) Shigella; (g) Salmonella.

From policy 'III. Indications and/or Limitations of Coverage'

Covered by NAAT prior to FMT donation: Prior to donation for an FMT, analysis by nucleic acid amplification testing (NAAT) of the donor fecal sample for the following microorganisms MEETS COVERAGE CRITERIA: (a) Clostridium difficile; (b) Campylobacter; (c) Salmonella; (d) Shigella; (e) Shiga toxin-producing Escherichia coli; (f) Norovirus; (g) Rotavirus; (h) COVID-19 (SARS-CoV-2).

From policy 'III. Indications and/or Limitations of Coverage'

NAAT not covered prior to FMT donation: Prior to donation for an FMT, analysis by NAAT of the donor fecal sample for the following microorganisms DOES NOT MEET COVERAGE CRITERIA: (a) Extended spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae; (b) Vancomycin-resistant Enterococci (VRE); (c) Carbapenem-resistant Enterobacteriaceae (CRE); (d) Methicillin-resistant Staphylococcus aureus (MRSA); (e) Any other microorganisms not listed above.at least one listed

Policy explicitly lists these NAATs as not meeting coverage

Fecal analysis components not covered for dysbiosis evaluation: As a diagnostic test for 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; quantification of Lactobacilli, bifidobacteria, and E. coli and other 'potential pathogens' including Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, S. aureus, Vibrio; identification and quantitation of fecal yeast (including C. albicans, C. tropicalis, Rhodotorula and Geotrichum); N-butyrate; beta-glucuronidase; pH; short chain fatty acid distribution; fecal secretory IgA.

Comprehensive list from policy

Recurrent C. difficile infection

Guideline-based coverage considerations

FMT appropriate for recurrent C. difficile infection: Consider FMT or fecal-microbiota-based therapies after completion of standard-of-care antibiotics for patients with recurrent Clostridioides difficile infection (CDI); prevention with fecal microbiota-based therapies can be considered after the second recurrence (third episode) or in select high-risk patients. Careful consideration is advised for patients requiring frequent or long-term antibiotics.clinical judgement per guideline

AGA guidance on fecal-microbiota-based therapies

Non-CDI indications

Situations where FMT is not recommended

FMT not recommended for other GI conditions: FMT should not be offered for functional gastrointestinal symptoms in patients with inflammatory bowel disease (IBD) and is suggested against for ulcerative colitis, Crohn's disease, pouchitis, and irritable bowel syndrome outside of clinical trials; where mentioned, FMT for these indications is considered investigational and appropriate only in the context of clinical research.not applicable

Multiple society guidelines (AGA, BSG) recommend against routine use in these conditions

Donor screening requirements

Donor screening and safety requirements for FMT

Essential donor screening elements: Donor screening should include testing for C. difficile toxin B (or toxins A and B if B unavailable) and routine culture for enteric pathogens; MDRO testing is required and must at minimum include ESBL-producing Enterobacteriaceae, VRE, CRE, and MRSA. Donors and/or stools that test positive for MDROs must be excluded. Consider screening for a broader panel of enteric pathogens per society guidance; bookend testing (no more than 60 days apart) with quarantine of stool until postdonation MDRO tests are confirmed negative is acceptable.laboratory confirmation negative

FDA, BSG/HIS, AGA and FMT Workgroup donor screening recommendations

COVID-19 / SARS-CoV-2 screening

Infectious disease precautions related to emerging pathogens

SARS-CoV-2 precautions: Assess donors for SARS-CoV-2 infection or exposure since December 1, 2019, and consider testing stool donations or donor specimens (upper respiratory, rectal, or stool) for SARS-CoV-2 virus or RNA prior to donation.none stated

FDA COVID-19 related donor screening and testing guidance

The policy explicitly excludes a set of fecal biomarkers and microbial quantifications from coverage when used as diagnostic tests for intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal bacterial overgrowth. The listed components that DO NOT MEET COVERAGE CRITERIA include: triglycerides; chymotrypsin; iso-butyrate, iso-valerate, and n‑valerate; meat and vegetable fibers; long chain fatty acids; cholesterol; total short chain fatty acids; quantification of Lactobacilli, bifidobacteria, and E. coli and other potential pathogens (e.g., Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, S. aureus, Vibrio); identification/quantitation of fecal yeast; N‑butyrate; beta‑glucuronidase; pH; short chain fatty acid distribution; and fecal secretory IgA.

Fecal microbiota transplantation (FMT) is reserved for established indications and remains investigational for inflammatory bowel disease (IBD). The BSG states that FMT remains an investigational treatment for use only in clinical trials in IBD, and that there is currently no place for FMT in routine management of IBD unless complicated by C. difficile infection outside of clinical trials. The AGA similarly advises that FMT should not be offered for functional GI symptoms in IBD outside of research contexts.

Regulatory safety communications highlight the risk of transmission of pathogenic and multidrug‑resistant organisms with FMT. The FDA has issued safety communications and alerts noting risk of serious adverse reactions due to transmission of multidrug‑resistant organisms and provided additional recommendations on donor screening and testing. Providers and donor programs should follow these FDA recommendations; donors or stool testing positive for MDROs must be excluded.

The policy considers a broad range of specific fecal analysis components as not medically necessary (DO NOT MEET COVERAGE CRITERIA) for diagnosing intestinal dysbiosis due to insufficient validated clinical utility. The non‑covered items include measurements of fecal lipids and fats, specified short‑chain and long‑chain fatty acids, targeted quantification of bacterial genera/species and potential enteric pathogens, fecal yeast identification, enzymatic markers (e.g., beta‑glucuronidase), pH, short chain fatty acid distribution, and fecal secretory IgA.

For patients who meet diagnostic criteria for irritable bowel syndrome (IBS), selected tests are unnecessary to confirm the diagnosis. NICE specifies that faecal ova and parasite testing and hydrogen breath testing (for lactose intolerance and bacterial overgrowth) are not necessary to confirm IBS in people who otherwise meet IBS diagnostic criteria. The BSG notes limited clinical value for many fecal tests in malabsorption and recommends established approaches (e.g., faecal elastase for pancreatic insufficiency) rather than broad fecal panels.

Procedure and Billing Codes

Applicable CPT/HCPCS Procedure CodesCPT

82542	Column chromatography, includes mass spectrometry, if performed (e.g., HPLC, LC, LC/MS, LC/MS-MS, GC, GC/MS-MS, GC/MS, HPLC/MS), non-drug analyte(s) not elsewhere specified, qualitative or quantitative, each specimen.
82705	Fat or lipids, feces; qualitative.
82710	Fat or lipids, feces; quantitative.
82715	Fat differential, feces, quantitative.
83986	pH; body fluid, not otherwise specified.
84311	Spectrophotometry, analyte not elsewhere specified.
87045	Culture, bacterial; stool, aerobic, with isolation and preliminary examination (e.g., KIA, LIA), Salmonella and Shigella species.
87046	Culture, bacterial; stool, aerobic, additional pathogens, isolation and presumptive identification of isolates, each plate.
87075	Culture, bacterial; any source, except blood, anaerobic with isolation and presumptive identification of isolates.
87076	Culture, bacterial; anaerobic isolate, additional methods required for definitive identification, each isolate.

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Provider Requirements, Documentation, and Billing Guidance

Documentation Required

Donor stool testing requirements

Donor stool must be tested by bacterial culture for the listed enteric pathogens and by nucleic acid amplification testing (NAAT) for specified organisms prior to FMT donation to meet coverage criteria. Providers must submit documentation of these donor stool test results with the prior authorization request or claims as applicable.

Bacterial culture required prior to donation: ESBL-producing Enterobacteriaceae; VRE; CRE; MRSA; Campylobacter; Shigella; Salmonella.
NAAT required prior to donation: C. difficile; Campylobacter; Salmonella; Shigella; Shiga toxin–producing E. coli; Norovirus; Rotavirus; SARS‑CoV‑2 (COVID‑19).

Billing Rule

Use listed CPT/HCPCS codes for billing

Use the CPT/HCPCS procedure and laboratory codes listed in the policy when billing for FMT procedures and donor stool testing. These are the billable codes to be used; procedure codes in the policy are provided as a billing reference and may not be all‑inclusive.

Background and Scope

Intestinal dysbiosis refers to a disruption or imbalance of the gut microbial ecology implicated in multiple clinical contexts, including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), celiac disease, and metabolic or autoimmune disorders. Fecal microbiota transplantation (FMT) transfers stool from a healthy donor to a recipient with the intent of restoring microbial balance and is an established therapy for recurrent Clostridioides difficile infection but remains investigational for many other indications such as IBD outside of clinical trials.

Key Definitions

Intestinal dysbiosis — definition

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

Associated conditionsLinked with IBS, IBD, celiac disease, metabolic and autoimmune disorders (policy lists examples including multiple sclerosis, Sjogren's, obesity, allergy, diabetes).

Role in policyUsed as the clinical concept underlying guidance on fecal analysis and FMT donor screening; diagnostic fecal analyses for dysbiosis are largely not covered per policy.

Fecal microbiota transplantation (FMT) — definition

DefinitionFecal microbiota transplantation (FMT) is the infusion of stool from a healthy donor to a patient with presumed gut dysbiosis, intended to restore microbiome balance.

Indications

OpenPayer

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

Coverage and Medical Necessity Criteria

Procedure and Billing Codes

Provider Requirements, Documentation, and Billing Guidance

Background and Scope

Key Definitions