BlueCross BlueShield of Tennessee Medical Policy Manual

Fecal Calprotectin Testing

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.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The diagnostic accuracy of fecal calprotectin is uncertain, as are the clinical management changes associated with specific calprotectin levels. The evidence is insufficient to determine the effects of the technology on health outcomes.  

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2017). Fecal Calprotectin Testing (2.04.69). Retrieved December 7, 2017 from BlueWeb. (25 articles and/or guidelines reviewed)

Chey, W., Kurlander, J., & Eswaran, S. (2015). Irritable bowel syndrome, a clinical review. The Journal of the American Medical Association, 313 (9), 949-959. (Level 1 evidence)

Kawashima, K., Ishihara, S., Yuki, T., Fukuba, N., Oshima, N., Kazumori, H., et al. (2016). Fecal calprotectin level correlated with both endoscopic severity and disease extent in ulcerative colitis. BMC Gastroenterology, 16, 47. (Level 3 evidence)

Menees, S., Powell, C., Kurlander, J., Goel, A., & Chey, W. (2015). A meta-analysis of the utility of c-reactive protein, erythrocyte sedimentation rate, fecal calprotectin, and fecal lactoferrin to exclude inflammatory bowel disease in adults with IBS. The American Journal of Gastroenterology, 110, 444-454. (Level 1 evidence)

National Institute for Health and Care Excellence. (2013). Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel. Retrieved February 24, 2016 from http://www.nice.org.uk.

U. S. Food and Drug Administration. (2006, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K050007 (PhiCal®) Retrieved September 15, 2011 from http://www.accessdata.fda.gov.

U. S. Food and Drug Administration. (2014, January). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K130945 (CalPrest®) Retrieved September 15, 2011 from http://www.accessdata.fda.gov.

Winifred S. Hayes, Inc. Medical Technology Directory. (2017, July). Fecal calprotectin assay for monitoring disease activity in Crohn disease. Retrieved December 7, 2017 from www.Hayesinc.com/subscribers. (70 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2017, June). Fecal calprotectin assay for monitoring postoperative recurrence of Crohn disease. Retrieved December 7, 2017 from www.Hayesinc.com/subscribers. (53 articles and/or guidelines reviewed)

Zhuge, Y., Huang, Q.P., Li, Q., & Wang, J.S. (2016). Fecal calprotectin for predicting relapse and activity in patients with Crohn’s disease: a meta-analysis. Euroasian Journal of Hepato-Gastroenterology, 6 (2), 116-124. (Level 2 evidence)

ORIGINAL EFFECTIVE DATE:  1/14/2012

MOST RECENT REVIEW DATE:  1/25/2018

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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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