DESCRIPTION
Fecal calprotectin is a calcium- and zinc-binding protein that is a potential marker of intestinal inflammation. Fecal calprotectin testing has been proposed as a noninvasive test to diagnose inflammatory bowel disease (IBD), Crohn’s disease and ulcerative colitis. Other potential uses are to differentiate IBD from irritable bowel syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. This test has also been proposed to evaluate response to treatment for patients with IBD and as a marker of relapse.
PhiCal™ (Genova Diagnostics) is a commercially available enzyme-linked immunosorbent assay (ELISA) test measuring fecal calprotectin levels. This test is indicated to aid in the diagnosis of IBD and to differentiate IBD from IBS; it is intended to be used in conjunction with other diagnostic testing and clinical considerations.
POLICY
Fecal calprotectin testing for the diagnosis and management of intestinal conditions, including, but not limited to inflammatory bowel disease is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
There is a lack of controlled trials evaluating the clinical utility of fecal calprotectin testing to improve patient management decisions or to predict or improve health outcomes.
SOURCES
Bennett, W. E., Gonzalez-Rivera, R. Puente, B. N., Shaikh, N., Stevens, H. J., Mooney, J. C., et al. (2010). Proinflammatory fecal mRNA and childhood bacterial enteric infections. Gut Microbes, 1 (4), 209-212. (Level 2 evidence - Independent study)
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). Fecal Calprotectin (2.04.69). Retrieved September 12, 2011 from BlueWeb. (16 articles and/or guidelines reviewed)
Furman, D. L. & Cash, B. D. (2011). The role of diagnostic testing in irritable bowel syndrome. Gastroenterology Clinics of North American, 40, 105-119. (Level 5 evidence)
Shastri, Y. M., Bergis, D., Povse, N., Schafer, V., Shastri, S., Weindel, M., et al. (2008). Prospective multicenter study evaluating fecal calprotectin in adult acute bacterial diarrhea. The American Journal of Medicine, 121 (12). (Level 2 evidence)
U. S. Food and Drug Administration. (2006, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K050007. Retrieved September 15, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf5/k050007.pdf.
Van Rheenen, P. F., Van de Vijver, E., & Fidler, V. (2010). Faecal calprotectin for screening of patients with suspected inflammatory bowel disease: Diagnostic meta-analysis. BMJ, 341 (c3369). (Level 1 evidence - Independent study)
World Gastroenterology Organisation. (2009, April). Global guideline: Irritable bowel syndrome: A global perspective. Retrieved September 12, 2011 from http://www.guideline.gov/content.aspx?id=15232&search=fecal+calprotectin.
World Gastroenterology Organisation. (2009, June). Global guideline: Irritable bowel disease: A global perspective. Retrieved September 12, 2011 from http://www.guideline.gov/content.aspx?id=15231&search=fecal+calprotectin.
ORIGINAL EFFECTIVE DATE: 1/14/2012
MOST RECENT REVIEW DATE: 1/14/2012
ID_BA
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