Fecal Analysis in the Diagnosis of Intestinal Dysbiosis

POLICY NUMBER

A.2.04.26

DESCRIPTION

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.

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 below.

Digestion

• Triglycerides

• Chymotrypsin

• Iso-butyrate, iso-valerate, and n-valerate

• Meat and vegetable fibers

Absorption

Microbiology

Metabolic

Immunology

ªFecal calprotectin as a stand-alone test is addressed separately in the Fecal Calprotectin Testing medical policy.

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

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 Amendments. Laboratories that offer laboratory-developed tests must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of comprehensive testing for fecal dysbiosis.

Some U.S. commercially available fecal dysbiosis tests are listed in the table below.

Commercially Available Fecal Dysbiosis Tests by CLIA Certified Laboratories

CLIA: Clinical Laboratory Improvement Amendments

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. Multiple Chemical Sensitivities) (i.e., clinical ecology) policy.

POLICY

Fecal 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:

• 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 Escherichiacoli 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)

• N-butyrate

• Beta-glucuronidase

• 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 immunoglobulin A.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative 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.

POLICY HISTORY

5/2002: 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.

06/06/2016: Policy number A.2.04.26 added.

01/18/2017: Policy description updated regarding gastrointestinal disorders and symptoms. Policy statement unchanged. Code Reference section updated to remove deleted CPT codes 82491 and 82492.

01/16/2018: Policy description updated regarding laboratory testing. Policy statement unchanged.

01/14/2019: Policy description updated regarding conditions attributed to intestinal dysbiosis. Fecal markers of dysbiosis updated. Policy statement unchanged.

01/16/2020: Policy description updated to remove information regarding intestinal dysbiosis. Policy statement unchanged.

10/13/2020: Code Reference section updated to revise the code description for CPT code 87335, effective 10/06/2020.

12/15/2020: Code Reference section updated to add CPT code 83630.

02/01/2021: Policy description updated. Policy statement unchanged.

10/15/2021: Code Reference section updated to remove CPT code 82656.

02/04/2022: Policy reviewed; no changes.

01/25/2023: Policy reviewed; no changes.

12/21/2023: Code Reference section updated to add new 2024 CPT code 0430U, effective 01/01/2024.

01/11/2024: Policy description updated regarding fecal dysbiosis tests. Policy statement unchanged.

02/07/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.04.26

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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