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Date Printed: October 23, 2017: 07:26 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

05-82000-33

Original Effective Date: 12/15/03

Reviewed: 02/23/17

Revised: 03/15/17

Subject: Fecal Analysis in the Diagnosis of Intestinal Dysbiosis

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
           
Other References Updates    
           

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.

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 (e.g., irritable bowel syndrome (IBS), inflammatory or autoimmune disorders, food allergy, atopic eczema, unexplained fatigue, arthritis and ankylosing spondylitis), malnutrition or neuropsychiatric symptoms (e.g., 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.

POSITION STATEMENT:

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

The evidence is insufficient to determine the effects of the technology on health outcomes.

BILLING/CODING INFORMATION:

There are no specific CPT or HCPCS codes to report fecal analysis of intestinal dysbiosis.

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

No National Coverage Determination (NCD) and/or Local Coverage Determination (LCD) were found at the time of the last guideline reviewed date

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Other names used to report fecal analysis of intestinal dysbiosis:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Comprehensive Digestive Stool Analysis

Comprehensive Digestive Sool Analysis/Parasitology

Digestive Stool Analysis 2.0

Fecal Analysis, Intestinal Dysbiosis

Genova Diagnostics, Comprehensive Digestive Stool Analysis

Great Smokies Diagnostic Laboratory, Comprehensive Digestive Stool Analysis

Intestinal Dysbiosis.

REFERENCES:

  1. Barclay AR, Morrison DJ, Weaver LT, What is the Role of the Metabolic Activity of the Gut Microbiota in Inflammatory Bowel Disease? Probing for Answers with Stable Isotopes, J Pediatr Gastroenterol Nutr. 2008 May; 46(5): 486-95.
  2. Blue Cross Blue Shield Association Medical Reference Policy Manual -2.04.26 Fecal Analysis in the Diagnosis of Intestinal Dysbiosis, 12/16. ClinicalTrials.gov, Diagnostic Strategies in Patients Suspected of Irritable Bowel Syndrome, sponsored by University Hospital Koge, Statens Serum Institute, University of Copenhagen, accessed 07/17/09.
  3. ClinicalTrials.gov, Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients, sponsored by Assistance Publique- Hospital of France, accessed 10/13/08.
  4. ClinicalTrials.gov, Evaluation of Intestinal Microbiome in Obese Kids, sponsored by Medical College of Wisconsin, accessed 07/17/09.
  5. ClinicalTrials.gov, Immune System and Gut Abnormalities in Patients with Common Variable Immunodeficiency With and Without Gastrointestinal Symptoms, sponsored by National Institute of Allergy and Infectious Diseases, accessed 07/17/09.
  6. ClinicalTrials.gov, Manipulation of Visceral Sensitivity and Immune System in IBS, sponsored by North West London Hospitals NHS Trust, accessed 07/17/09.
  7. 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.
  8. Fumi AL, Trexler K, Rifazimin Treatment for Symptoms of Irritable Bowel Syndrome, Ann Pharmacother. 2008 Mar; 42(3): 408-12.
  9. Komanduri S, Gillevet PM, Sikaroodi M, Mutlu E, Keshavarzian A, Dysbiosis in Pouchitis: Evidence of Unique Microfloral Patterns in Pouch Inflammation, Clin Gastroenterol Hepatol, 2007 Mar;5(3):352-60.
  10. McFarland LV, Dublin S, Meta-Analysis of Probiotics for the Treatment of Irritable Bowel Syndrome, World J Gastroenterol. 2008 May 7; 14(17): 2650-61.
  11. Nikfar S, Rahimi R, Rahimi F, Derakhshani S, Abdollahi M, Efficacy of Probiotics in Irritable Bowel Syndrome: A Meta-Analysis of Randomized, Controlled Trials, Dis Colon Rectum. 2008 May 9.
  12. Packey CD, Sartor RB, Commensal Bacteria, Traditional and Opportunistic Pathogens, Dysbiosis and Bacterial Killing in Inflammatory Bowel Diseases, Curr Opin Infect Dis, 2009 June; 22(3): 292-301.
  13. Packey CD, Sartor RB, Interplay of Commensal and Pathogenic Bacteria, Genetic Mutations, and Immunoregulatory Defects in the Pathogenesis of Inflammatory Bowel Diseases, J Intern Med, 2008 Jun; 263(6): 597-606.
  14. Roediger WE, Nitric Oxide From Dysbiotic Bacterial Respiration of Nitrate in the Pathogenesis and as a Target for Therapy of Ulcerative Colitis, Aliment Pharmacol Ther. 2008 Apr 1; 27(7): 531-41.
  15. Swidsinski A, Loening-Baucke V, Verstraelen H, Osowska S, Doerffel Y, Biostructure of Fecal Microbiota in Health Subjects and Patients with chronic Idiopathic Diarrhea, Gastroenterology, 2008 Aug; 135(2): 568-579.
  16. Whelan K, Judd PA, Tuohy KM, et al. Fecal Microbiota in Patients Receiving Enteral Feeding are Highly Variable and May Be Altered in Those Who Develop Diarrhea, Am J Clin Nutr 89: 240-247, 2009.
  17. Wilhelm SM, Brubaker CM, Varcak EA, Kale-Pradhan PB, Effectiveness of Probiotics in the Treatment of Irritable Bowel Syndrome, Pharmacotherapy, 2008 Apr; 28(4): 496-505.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 02/23/17.

GUIDELINE UPDATE INFORMATION:

12/15/03

New Medical Coverage Guideline.

12/15/04

Reviewed; no change in investigational status.

01/01/06

Annual review; no change in investigational status.

11/15/06

Annual review; no change in investigational status.

07/15/07

Annual review, investigational status maintained, guideline reformatted, references updated.

11/15/08

Annual review: position statement maintained, references updated.

09/15/09

Annual review: position statement maintained, description section and references updated.

05/11/14

Revision: Program Exceptions section updated.

03/15/17

Revision; Investigational position statement maintained; description section and references updated.

Date Printed: October 23, 2017: 07:26 AM