556 Form

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Medical Policy Fecal Analysis in the Diagnosis of Intestinal Dysbiosis Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 556 BCBSA Reference Number: 2.04.26 (For Plan internal use only) Related Policies
• Fecal Calprotectin #329 • Fecal Microbiota Transplantation #682 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Fecal analysis of the following components used as a diagnostic test for the evaluation of intestinal dysbiosis, irritable bowel syndrome, malabsorption or small intestinal overgrowth of bacteria is
INVESTIGATIONAL:

• 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 • Identification and quantitation of fecal yeast (including C. albicans, C. tropicalis, Rhodotorula, and Geotrichum) • N-butyrate
• Beta-glucoronidase
• pH • Short--chain fatty acid distribution (adequate amount and proportions of the different short-chain fatty acids reflect the basic status of intestinal metabolism) • Fecal secretory IgA.

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Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

CPT Codes There is no specific CPT code for this service.

Description Fecal Markers of Dysbiosis Laboratory analysis of both stool and urine has been investigated as markers of dysbiosis. Commercial laboratories may offer testing for comprehensive panels or individual components of various aspects of digestion, absorption, microbiology, and metabolic markers. Representative components of fecal dysbiosis testing are summarized in Table 1.

Table 1. Components of the Fecal Dysbiosis Marker Analysis Markers Analytes Digestion • Triglycerides • Chymotrypsin • Iso-butyrate, iso-valerate, and n-valerate • Meat and vegetable fibers Absorption • Long-chain fatty acids • Cholesterol • Total fecal fat • Total short-chain fatty acids Microbiology • Levels of Lactobacilli, bifidobacteria, and Escherichia coli and other “potential pathogens,” including Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, Staphylococcus aureus, and Vibrio • Identification and quantitation of fecal yeast (including Candida albicans, Candida tropicalis, Rhodotorula, and Geotrichum) (optional viral and/or parasitology components) Metabolic • N-butyrate (considered key energy source for colonic epithelial cells) • β-glucuronidase • pH

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• Short-chain fatty acid distribution (adequate amount and proportions of the different short-chain fatty acids reflect the basic status of intestinal metabolism) Immunology • Fecal secretory immunoglobulin A (as a measure of luminal immunologic function) • Calprotectina a Fecal calprotectin as a stand-alone test is addressed in policy #329.

A related topic, fecal microbiota transplantation, the infusion of intestinal microorganisms to restore normal intestinal flora, is addressed in policy #682. Fecal microbiota transplantation has been rigorously studied for the treatment of patients with recurrent Clostridioides difficile infection.

Summary Intestinal dysbiosis may be defined as a state of disordered microbial ecology that is believed to cause disease. Laboratory analysis of fecal samples is proposed as a method of identifying individuals with intestinal dysbiosis and other gastrointestinal disorders. Summary of Evidence For individuals with gastrointestinal conditions such as suspected intestinal dysbiosis, irritable bowel syndrome (IBS), malabsorption, or small intestinal bacterial overgrowth who receive fecal analysis testing, the evidence includes several cohort and case-control studies comparing fecal microbiota in patients who had a known disease with healthy controls. The relevant outcomes are test validity, symptoms, and functional outcomes. The available retrospective cohort studies on fecal analysis have suggested that some components of the fecal microbiome and inflammatory markers may differ across patients with IBS subtypes. No studies were identified on the diagnostic accuracy of fecal analysis versus another diagnostic approach or that compared health outcomes in patients managed with and without fecal analysis tests. No studies were identified that directly informed the use of fecal analysis in the evaluation of intestinal dysbiosis, malabsorption, or small intestinal bacterial overgrowth. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 2/2025 Annual policy review. References updated. Policy statements unchanged. 1/2024 Annual policy review. References updated. Policy statements unchanged. 2/2023 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 2/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 2/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 2/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 1/2017 Annual policy review. New references added. 3/2015 Annual policy review. New references added. 5/2014 Annual policy review. New references added. 4/2013 Annual policy review. New references added. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
10/2011 Reviewed - Medical Policy Group - GI, Nutrition and Organ Transplantation. No changes to policy statements. 5/2011 New policy effective 5/2011 describing ongoing non-coverage.
Information Pertaining to All Blue Cross Blue Shield Medical Policies

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Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. Emmanuel A, Landis D, Peucker M, et al. Faecal biomarker patterns in patients with symptoms of irritable bowel syndrome. Frontline Gastroenterol. Oct 2016; 7(4): 275-282. PMID 27761231
2. Genova Diagnostics. 2024; https://www.gdx.net/tests/prep/gi-stool-profiles. Accessed October 22,
4. Goepp J, Fowler E, McBride T, et al. Frequency of abnormal fecal biomarkers in irritable bowel syndrome. Glob Adv Health Med. May 2014; 3(3): 9-15. PMID 24891989
5. Jeffery IB, Das A, O'Herlihy E, et al. Differences in Fecal Microbiomes and Metabolomes of People With vs Without Irritable Bowel Syndrome and Bile Acid Malabsorption. Gastroenterology. Mar 2020; 158(4): 1016-1028.e8. PMID 31843589
6. Andoh A, Kuzuoka H, Tsujikawa T, et al. Multicenter analysis of fecal microbiota profiles in Japanese patients with Crohn's disease. J Gastroenterol. Dec 2012; 47(12): 1298-307. PMID 22576027
7. Sobhani I, Tap J, Roudot-Thoraval F, et al. Microbial dysbiosis in colorectal cancer (CRC) patients. PLoS One. Jan 27 2011; 6(1): e16393. PMID 21297998
8. Joossens M, Huys G, Cnockaert M, et al. Dysbiosis of the faecal microbiota in patients with Crohn's disease and their unaffected relatives. Gut. May 2011; 60(5): 631-7. PMID 21209126
9. Langhorst J, Elsenbruch S, Koelzer J, et al. Noninvasive markers in the assessment of intestinal inflammation in inflammatory bowel diseases: performance of fecal lactoferrin, calprotectin, and PMN- elastase, CRP, and clinical indices. Am J Gastroenterol. Jan 2008; 103(1): 162-9. PMID 17916108
10. Smalley W, Falck-Ytter C, Carrasco-Labra A, et al. AGA Clinical Practice Guidelines on the Laboratory Evaluation of Functional Diarrhea and Diarrhea-Predominant Irritable Bowel Syndrome in Adults (IBS-D). Gastroenterology. Sep 2019; 157(3): 851-854. PMID 31302098
11. Quigley EMM, Murray JA, Pimentel M. AGA Clinical Practice Update on Small Intestinal Bacterial Overgrowth: Expert Review. Gastroenterology. Oct 2020; 159(4): 1526-1532. PMID 32679220