BlueCross and BlueShield of Montana Medical Policy/Codes
Fecal Analysis in the Diagnosis of Intestinal Dysbiosis
Chapter: Medicine: Tests
Current Effective Date: October 25, 2013
Original Effective Date: August 01, 2012
Publish Date: October 25, 2013
Revised Dates: September 30, 2013
Description

Intestinal dysbiosis may be defined as a state of disordered microbial ecology that causes disease. The concept of dysbiosis rests on the assumption that patterns of intestinal flora, specifically overgrowth of some microorganisms found commonly in intestinal flora, have an impact on human health.  Symptoms and conditions attributed to dysbiosis include chronic intestinal disorders including irritable bowel disease, inflammatory or autoimmune disorders, food allergy, atopic eczema, unexplained fatigue, arthritis and ankylosing spondylitis, malnutrition or neuropsychiatric symptoms including autism, and breast and colon cancer.  Leo Galland, MD, is a researcher who has focused his studies on dysbiosis. Galland has proposed four patterns of dysbiosis:

Putrefaction

Putrefaction dysbiosis results from diet high in fat and animal flesh and low in insoluble fiber, i.e., typical of Western style diet.  It is thought that, a compared to normal pattern of intestinal flora, this diet produces an increased concentration of Bacteriodes sp., and a decreased concentration of bifidiobacteria in stools.  The increased concentration of Bacteriodes sp. is thought to be associated with increased urease, ultimately leading to a rising fecal pH. Bacteriodes sp. is also thought to be associated with increased beta-glucoronidase, which functions to deconjugate bile acids (which are thought to be toxic to the colonic epithelium) causing diarrhea.  Increased levels of beta-glucuronidase may also have an impact on estrogen metabolism.

Fermentation

A fermentation pattern of dysbiosis has been attributed to bacterial overgrowth.  In mild cases, fermentation may be characterized principally by carbohydrate intolerance, manifested by abdominal distention, flatulence, diarrhea, constipation and feelings of malaise.

Deficiency

Antibiotic therapy or decrease in dietary fiber may result in relative deficiencies of normal fecal flora, including bifidiobacteria, lactobacillus, and E. coli.                      

Sensitization

A sensitization pattern of dysbiosis has been characterized as an abnormal immune response to the endotoxins and antigens associated with normal intestinal flora.

Laboratory analysis of both stool and urine has been investigated as markers of dysbiosis.  Reference laboratories specializing in the evaluation of dysbiosis may offer comprehensive testing of various aspects of digestion, absorption, microbiology, and metabolic markers. For example, the Great Smokies Diagnostic Laboratory offers a Comprehensive Digestive Stool Analysis that evaluates a stool sample for the following components;

Laboratory analysis of both stool and urine has been investigated as markers of dysbiosis.  Reference laboratories specializing in the evaluation of dysbiosis may offer comprehensive testing of various aspects of digestion, absorption, microbiology, and metabolic markers. For example, the Great Smokies Diagnostic Laboratory offers a Comprehensive Digestive Stool Analysis that evaluates a stool sample for the following components:

  • Digestion
    1. Triglycerides,
    2. Chymotrypsin,
    3. Iso-butyrate, iso-valerate, and n-valerate,
    4. Meat and vegetable fibers.
  • Absorption                       
    1. Long chain fatty acids,
    2. Cholesterol,
    3. Total fecal fat,
    4. Total short chain fatty acids.
  • Microbiology
    1. Levels of Lactobacilli, bifidobacteria, and E. coli and other potential pathogens, including Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, Staphylococcus aureus, Vibrio.
    2. Identification and quantitation of fecal yeast (including Candida albicans, C. tropicalis, Rhodotorula and Geotrichum.
  • Metabolic Markers
    1. N-butyrate (considered key energy source for colonic epithelial cells), 
    2. Beta-glucoronidase,
    3. ph,
    4. Short chain fatty acid distribution (adequate amount and proportions of the different short chain fatty acids reflect the basic status of intestinal metabolism).
  • Immunology
    1. Fecal secretory IgA (as a measure of luminal immunologic function).

Results are reported both individually or combined into a “dysbiosis risk index,” which is based on gut microbiology, pH, and short chain fatty acids.

Policy

Each benefit plan or contract defines which services are covered, which are excluded, and which are subject to dollar caps or other limits.  Members and their providers have the responsibility for consulting the member's benefit plan or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan or contract, the benefit plan or contract will govern.

Coverage

A fecal analysis panel consisting of ALL the following components is considered experimental, investigational and unproven as a diagnostic test for the evaluation of intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal overgrowth of bacteria:

  • Triglycerides; AND
  • Chymotrypsin; AND
  • Iso-butyrate, iso-valerate and n-valerate; AND
  • Meat and vegetable fibers; AND
  • Long chain fatty acids; AND
  • Cholesterol; AND
  • Total short chain fatty acids; AND
  • Levels of Lactobacilli, bifidobacteria and Escherichia coli(E-coli) and other potential pathogens, including Aeromonas, Bacillus cereus, Campylobacter, Citrobacter, Klebsiella, Proteus, Pseudomonas, Salmonella, Shigella, S. aureus, Vibrio.;AND
  • Identification and quantitation of fecal yeast (including C. albicans, C. tropicalis, Rhodotorula and Geotrichum); AND
  • N-butyrate; AND
  • Beta-glucuronidase; AND
  • pH; AND
  • Short chain fatty acid distribution (adequate amount and proportions of the different short chain fatty acids reflect the basic status of intestinal metabolism); AND
  • Fecal secretory IgA

Policy Guidelines

All laboratory components of the fecal analysis panel must be present on the claim as indicated in the coverage section of this policy before this panel can be identified as Fecal Analysis for the diagnosis of dysbiosis.

Rationale

While the literature includes much discussion regarding the relationship between intestinal microflora and various disorders, intestinal dysbiosis as a specific disorder is poorly defined.  A literature search revealed no published studies establishing diagnostic criteria for this disorder.  The gastrointestinal symptoms attributed to intestinal dysbiosis (i.e., bloating, flatulence, diarrhea, or constipation), overlap in part with either irritable bowel syndrome or small intestinal bacterial overgrowth syndrome.  The diagnosis of irritable bowel syndrome is typically made clinically, based on a set of criteria referred to as the Rome criteria.  The small intestine normally contains a limited number of bacteria, at least in comparison to the large intestine.  Small intestine bacterial overgrowth may occur due to altered motility (including blind loops), decreased acidity, and exposure to antibiotics, or surgical resection of the small bowel. Symptoms include malabsorption, diarrhea, fatigue, and lethargy.  Although the diagnosis of bacterial overgrowth may be made clinically and the condition treated empirically with antibiotics, the laboratory gold standard for diagnosis consists of a culture of a jejunal fluid sample.  Recently, hydrogen breath tests, commonly used to evaluate lactose intolerance, have been adapted for use in diagnosing both small intestinal bacterial overgrowth and irritable bowel disease.  No studies in the published literature were identified that described analysis of a stool sample as a diagnostic technique for irritable bowel syndrome or small intestine bacterial overgrowth.

Measurements of fecal fat (i.e., qualitative, quantitative, and fat differential) are established diagnostic techniques for malabsorption.  In contrast, a literature search did not identify any published studies regarding the diagnostic performance of fecal analysis of digestion, absorption, microbiology, metabolic markers, or immunology as a workup of malabsorption syndrome, small intestine bacterial overgrowth, or intestinal dysbiosis.  Chronic intestinal candidiasis has been linked with various gastrointestinal complaints as well as systemic complaints, such as chronic fatigue syndrome.  Similar to intestinal dysbiosis, chronic intestinal candidiasis is an ill-defined condition without established diagnostic parameters.

2006—2007 Update

A literature search of the MEDLINE database for the period of February 2005 to October 2007 did not identify any published articles on intestinal dysbiosis that would change the above conclusions; thus, the policy statement remains unchanged.

Recent literature has focused on the role of bacterial overgrowth of the small bowel in the pathogenesis of irritable bowel syndrome (IBS).  These studies have used the hydrogen breath test to diagnose bacterial overgrowth, and have reported mixed results.  Cuoco and Salvagnini reported that 45.8% (44/96) of patients with IBS had abnormal breath tests.  In contrast, Walters and Vanner reported that only 10%–13% of patients with IBS had an abnormal breath test, and that this percentage of abnormal results did not differ from a group of healthy controls.

A number of clinical trials have been published that evaluate treatment of IBS patients with nonabsorbable antibiotics and/or probiotics.  Two recent randomized, controlled trials of rifaximin versus placebo reported improvement in IBS symptoms following antibiotic treatment. Sharara and colleagues performed a hydrogen breath test pre- and post-treatment and found that response to treatment correlated with a change in the breath test.

Trials of treatment with probiotics have been less successful.  Whorwell and colleagues treated IBS with the probiotic Bifidobacterium infantis and reported that there was symptom improvement with one of three doses, but no improvement with the other two doses.  Niv and colleagues used the probiotic Lactobacillus reuteri in patients with IBS and did not find any significant reduction in symptoms compared with placebo.

In summary, some evidence is accumulating to suggest that bacterial overgrowth has a role in IBS, and that treatment with non-absorbable antibiotics may have a benefit in reducing symptoms for these patients.  However, none of these studies has used fecal analysis to select patients or to monitor response to treatment.  Therefore, the role of fecal analysis in evaluating and or treating intestinal dysbiosis remains uncertain, and there is no evidence to suggest that fecal analysis leads to improved health outcomes.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
Investigational for all diagnosis codes.
ICD-10 Codes
Investigational for all diagnosis codes.
References
  1. Vanner, S.J., Depew, W.T., et al.  Predictive value of the Rome criteria for diagnosing the irritable bowel syndrome.  American Journal of Gastroenterology (1999) 94(10):2912-7.
  2. Pimentel, M., Chow, E.J.  Eradication of small intestinal bacterial overgrowth reduces symptoms of irritable bowel syndrome.  American Journal of Gastroenterology (2000) 95(12):3503-6.
  3. Lacour, M., Zunder, T., et al.  The pathogenetic significance of intestinal Candida colonization--a systematic review from an interdisciplinary and environmental medical point of view. International Journal of Hygiene and Environmental Health (2002) 205(4):257-68.
  4. Cuoco, L., Salvagnini, M.  Small intestine bacterial overgrowth in irritable bowel syndrome: a retrospective study with rifaximin.  Minerva Gastroenterologica e Dietologica (2006) 52(1):89-95.
  5. Walters, B., Vanner, S.J.  Detection of bacterial overgrowth in IBS using the lactulose H2 breath test: comparison with 14C-D-xylose and healthy controls. American Journal of Gastroenterology (2005) 100(7):1566-70.
  6. Pimentel, M., Park, S., J et al.  The effect of a nonabsorbed oral antibiotic (rifaximin) on the symptoms of the irritable bowel syndrome: a randomized trial.  Annals of Internal Medicine (2006) 145(8):557-63.
  7. Sharara, A.I., Aoun ,E., et al.  A randomized double-blind placebo-controlled trial of rifaximin in patients with abdominal bloating and flatulence.  American  Journal of Gastroeneterology (2006) 101(2):326-33.
  8. Whorwell, P.J., Altringer, L., et al.  Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome.  American Journal of Gastroenterology (2006) 101(7):1581-90.
  9. Niv, E., Naftali, T., et al.  The efficacy of Lactobacillus reuteri ATCC 55730 in the treatment of patients with irritable bowel syndrome – a double blind, placebo-controlled, randomized study. Clinical Nutrition (2005) 24(6):925-31.
  10. Fecal Analysis in the Diagnosis of Intestinal Dysbiosis.  Chicago, Illinois: Blue Cross Blue Shield Association Medical Policy Reference Manual. (2007 April)  Medicine 2.04.26.
History
May 2012  New policy for BCBSMT; Investigational
October 2013 Policy formatting and language revised.  Policy statement unchanged.
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Fecal Analysis in the Diagnosis of Intestinal Dysbiosis