Fecal calprotectin is a calcium- and zinc-binding protein that is a potential indicator of intestinal inflammation. Fecal calprotectin testing (e.g., PhilCal®, CalPrest®, CalPrest®NG) has been proposed as a noninvasive test to diagnose inflammatory bowel disease (IBD), Crohn’s disease, and ulcerative colitis. A fecal calprotectin level of less than 50 ug/g is suggestive of a low likelihood of inflammatory bowel disease. Other potential uses are to differentiate inflammatory bowel disease (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 individuals with IBD and as a marker of relapse.
Fecal calprotectin testing may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Fecal calprotectin testing for management of inflammatory bowel disease, including active inflammatory bowel disease and surveillance for relapse of disease in remission is considered investigational.
Fecal calprotectin testing is considered medically appropriate when ALL the following are met:
When there is a differential diagnosis of inflammatory bowel disease or non-inflammatory bowel disease (including irritable bowel syndrome)
Endoscopy with biopsy is being considered
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
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.
There is a lack of evidence to support fecal calprotectin testing for the management and surveillance of inflammatory bowel disease.
American College of Gastroenterology. (2018, March). ACG clinical guideline: management of Crohn’s disease in adults. Retrieved October 26, 2018 from https://gastroenterology.acponline.org.
BlueCross BlueShield Association. Evidence Positioning System. (1:2019). Fecal Calprotectin Testing (2.04.69). Retrieved May 14, 2019 from http://www.evidencepositioningsystem.com. (19 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. (2017). Faecal calprotectin diagnostic tests for inflammatory diseases of the bowel. Retrieved May 15, 2019 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; last updated search July 2018). Fecal calprotectin assay for monitoring disease activity in Crohn disease. Retrieved October 26, 2018 from www.Hayesinc.com/subscribers. (70 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2017, June; last updated search June 2018). Fecal calprotectin assay for monitoring postoperative recurrence of Crohn disease. Retrieved May 15, 2019 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: 9/30/2019
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.
This document has been classified as public information.