Immunochemical Fecal Occult Blood Tests
DESCRIPTION
Colorectal cancer is a common cause of death in Western countries. The focus is on the prevention and screening for early signs of this disease. If detected by screening, small asymptomatic polyps can be removed from the colon before they develop into tumors. Some precancerous polyps bleed into the colon. Early detection of blood in the stool suggests the presence of a polyp that can be confirmed by a colonoscopy.
Currently, guaiac and immunochemical are the two main types of tests used to examine stool for the presence of blood. The guaiac stool tests are the most commonly used tests and can yield false-positive results if certain foods, vitamins or drugs are consumed days prior to the exam.
Immunochemical fecal occult blood tests (e.g., HemeSelect®, Immudia®, InSure™) detect the globin portion of the hemoglobin molecule from blood in fecal samples. Theoretically, this test is more specific for detecting loss of blood from the lower intestine because this blood is less degraded during transit. Dietary restrictions are not necessary for these tests. Generally, the individual collects the sample at home, but the tests must be performed in a certified clinical laboratory.
POLICY
Immunochemical fecal occult blood tests, for routine physical examinations and in screening for colorectal cancer or other sources of lower gastrointestinal bleeding are considered medically necessary.
Immunochemical fecal occult blood tests for other conditions / diseases are considered investigational.
ADDITIONAL INFORMATION
Evidence based studies in the published literature that validate the application of immunochemical fecal occult blood tests for other conditions / diseases are lacking.
SOURCES
American Cancer Society (National Guideline Clearinghouse. (2007, February). Can colorectal polyps and cancer be found early? Retrieved July 19, 2005 from http://www.cancer.org/docroot/CRI/content/CRI_2_4_3X_Can_colon_and_rectum_cancer_be_found_early.asp?sitearea.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2009). Immunochemical fecal occult blood testing (2.01.66). Retrieved March 16, 2007 from BlueWeb.
Cappell, M.S. (2008) Reducing the incidence and mortality of colon cancer: mass screening and colonoscopic polypectomy. Gastroenterology Clinics of North America, 37 (1), 129-160
Complete Guide to Medicare Coverage Issues [Computer software]. (2009, April). Colorectal cancer screening tests. (NCD 210.3, p. 2-160). The Ingenix Complete Guide to Medicare Coverage Issues.
ECRI Institute. Health Technology Assessment Information Service. Evidence Reports. (2006, April). Immunochemical fecal occult blood tests for colorectal cancer screening. Retrieved March 16, 2007 from ECRI Institute. (106 articles and/or guidelines reviewed)
Frazer, C.G., Matthew, C.M., Mowat, N.A.G., Wilson, J.A., Carey, F.A., & Steele, R.J.C. (2006). Immunochemical testing of individuals positive guaiac faecal occult blood test in a screening programme for colorectal cancer: an observational study. The Lancet, 7 (2), 127-131.
Hewitson P, Glasziou P, Irwig L, Towler B, Watson E. Screening for colorectal cancer using the faecal occult blood test, Hemoccult. Cochrane Database of Systematic Reviews 2007, Issue 1. Art. No.: CD001216. DOI: 10.1002/14651858.CD001216.pub2.
Levi, Z., Rozen, P., Hazazi, R., Vilkin, A., Waked, A., Maoz, E., Birkenfeld, S. et al. (2007). A quantitative immunochemical fecal occult blood test for colorectal neoplasia. Annals of Internal Medicine, 146 (4), 244-255.
Levin, B. Lieberman, D.A., McFarland, B., Smith, R.A., Brooks, D., Andrews, K.S., et al. Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology. CA: A Cancer Journal for Clinicians, 58 (1), 130-160.
Levin, B., Brooks, D., Smith, R. A., & Stone, A. (2003). Emerging Technologies in Screening for Colorectal Cancer: CT Colonography, Immunochemical Fecal Occult Blood Tests, and Stool Screening Using Molecular Markers. CA: A Cancer Journal for Clinicians, 3 (53). 44-55.
The Technology Evaluation Center. (2004, July). Immunochemical versus guaiac fecal occult blood tests (Vol. 19, No. 5). Chicago: BlueCross BlueShield Association.
U. S. Food and Drug Administration. ( 2001, January). Center for Devices and Radiological Health. 510 (K) Summary of safety and effectiveness. Retrieved September 5, 2003 from http://www.fda.gov/cdrh/pdf/k002457.pdf.
U. S. Preventative Services Task Force. (2008, October). Screening for Colorectal Cancer. Recommendation statement. Agency for Healthcare Research and Quality, Rockville, MD. Retrieved May 21, 2009 from http://www.ahrq.gov/clinic/uspstf08/colocancer/colors.htm.
Van Ballegooijen, M., Habbema, J. D. F., Boer, R., Zauber, A. G., & Brown, M. L. (2003). Report to the Agency for Healthcare Research and Quality: A comparison of the cost-effectiveness of fecal occult blood tests with different test characteristics in the context of annual screening in the Medicare population. Retrieved September 5, 2003 from www.cms.hhs.gov/coverage/download/id87.zip.
ORIGINAL EFFECTIVE DATE: 2/1/2004
MOST RECENT REVIEW DATE: 7/9/2009
ID_BT
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