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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.
The gastrointestinal tract is colonized by a large number and variety of microorganisms including bacteria, fungi, and archaea. The concept of intestinal dysbiosis rests on the assumption that abnormal patterns of intestinal flora, such as overgrowth of some commonly found microorganisms, have an impact on human health. Symptoms and conditions attributed to intestinal dysbiosis include chronic disorders such as irritable bowel syndrome, 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.
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, Genova Diagnostics offers a “Comprehensive Digestive Stool Analysis 2.0” that evaluates a stool sample for the following components:
The comprehensive stool analysis package has an optional parasitology component.
Fecal calprotectin as a stand-alone test is addressed separately in the Fecal Calprotectin Testing medical policy.
A related topic, fecal microbiota transplantation (FMT), the infusion of intestinal microorganisms to restore normal intestinal flora is addressed in the Fecal Microbiota Transplantation medical policy. FMT has been rigorously studied for the treatment of patients with recurrent Clostridium difficile infection (CDI). Use of the procedure to treat any other condition remains controversial and no specific stool testing, other than the identification of CDI, is currently recommended.
Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Act (CLIA). The Genova Diagnostics test is available under the auspices of CLIA. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.
Note: Intestinal dysbiosis may also be considered a manifestation of idiopathic environmental intolerance (i.e., clinical ecology). Idiopathic environmental intolerance is discussed in the Diagnosis and Management of Idiopathic Environmental Intolerance (i.e., clinical ecology) policy.
POLICYFecal analysis of the following components is considered investigational as a diagnostic test for the evaluation of intestinal dysbiosis, irritable bowel syndrome, malabsorption, or small intestinal overgrowth of bacteria:
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY5/2002: Approved by Medical Policy Advisory Committee (MPAC) ), Code Reference section completed, CPT code 82270, 82491, 82710, 82715, 82725, 83986, 84311, 86403, 87045, 87046, 87102, 87177, 89160 added, ICD-9 diagnosis code 564.1, 569.0-569.9, 579.0-579.9 added
11/5/2003: Code Reference section updated, CPT code 82705, 89125 added, ICD-9 diagnosis code range 569.0-569.9, 579.0-579.9 listed separately
8/16/2005: Code Reference section updated, CPT code 82705 deleted, ICD-9 diagnosis code 564.1, 569.0.0, 569.1, 569.2, 569.3, 569.41, 569.42, 569.49, 569.5, 569.60, 569.61, 569.62, 569.69, 569.81, 569.82, 569.83, 569.84, 569.85, 569.86, 569.89, 569.9, 579.0, 579.1, 579.2, 579.3, 579.4, 579.8, 579.9 deleted
2/8/2006: Code Reference table updated: code 82270 deleted
5/14/2007: Policy reviewed; description updated to include stool sample components. Added CPT 83631
8/18/2008: Policy reviewed, no changes
04/30/2010: Policy description and statement unchanged. Revised the description of CPT code 83986.
05/17/2011: Policy reviewed; no changes.
08/11/2011: Added the following CPT codes to the Non-Covered Codes table: 82239, 82240, 82492, 82656, 82705, 82726, 82784, 83993, 84490, 87075, 87106, 87335, and 88313.
03/02/2012: Policy reviewed; no changes.
04/17/2013: Policy reviewed; no changes.
03/13/2014: Policy reviewed; no changes.
03/18/2015: Policy description updated to add information regarding laboratory analysis of fecal samples. Policy statement unchanged.
07/20/2015: Code Reference section updated for ICD-10.
12/31/2015: Investigative definition updated in policy guidelines section. Code Reference section updated to revise code description for CPT 87335 with an effective date of 01/01/2016.
02/12/2016: Policy description updated to remove the proposed patterns of dysbiosis and to add information regarding laboratory-developed tests. Policy statement updated to remove calprotectin from the investigational statement. This is addressed in a separate policy.
Blue Cross Blue Shield Association policy # 2.04.26
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.