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., Hemoccult® ICT, Instant-View®, 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.
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
Evidence based studies in the published literature that validate the application of immunochemical fecal occult blood tests for other conditions/diseases are lacking.
SOURCES
Allison, J., & Potter, M. B. (2009). New screening guidelines for colorectal cancer: A practical guide for the primary care physician. Primary Care: Clinics in Office Practice, 36 (3), 575-602.
American Cancer Society. (2010, February). Colorectal cancer early detection. What is colorectal cancer? Retrieved January 19, 2011 from http://www.cancer.org/acs/groups/cid/documents/webcontent/003170-pdf.pdf.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2010). Immunochemical fecal occult blood testing (2.01.66). Retrieved January 19, 2011 from BlueWeb. (7 articles and/or guidelines reviewed)
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]. (2010, April). Colorectal cancer screening tests (NCD 210.3, p. 2-162). Ingenix.
Complete Guide to Medicare Coverage Issues [Computer software]. (2010, April). Fecal occult blood test (FOBT) (NCD 190.34, p. 2-156, 2-159). Ingenix.
ECRI Institute. Health Technology Information Service. Evidence Reports. (2006, April). Immunochemical fecal occult blood tests for colorectal cancer screening. Retrieved January 19, 2011 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 Oncology, 7 (2), 127-131. (Level 2 Evidence - Independent study)
Guittet, L., Bouvier, V., Mariotte, N., Vallee, J. P., Levillain, R., Tichet, J., et al. (2009). Comparison of a guaiac and an immunochemical faecal occult blood test for the detection of colonic lesions according to lesion type and location. British Journal of Cancer, 100 (8), 1230-1235. (Level 2 Evidence - Independent study)
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.
Kuriyama, M., Kato, J., Takemoto, K., Hiraoka, S., Okada, H., & Yamamoto, K. (2010). Prediction of flare-ups of ulcerative colitis using quantitative immunochemical fecal occult blood test. World Journal of Gastroenterology, 16 (9), 1110-1114. (Level 4 Evidence - Independent study)
Levi, Z., Rozen, P., Hazazi, R., Vilkin, A., Waked, A., Maoz, E., et al. (2007). A quantitative immunochemical fecal occult blood test for colorectal neoplasia. Annals of Internal Medicine, 146 (4), 244-255. (Level 3 Evidence - Industry sponsored)
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.
Mandel, J. S. (2008). Screening for colorectal cancer. Gastroenterology Clinics of North America, 37 (1), 97-115.
Nadel, M. R., Berkowitz, Z., Klabunde, C. N., Smith, R. A., Coughlin, S. S., & White, M. C. (2010). Fecal occult blood testing beliefs and practices of U.S. primary care physicians: Serious deviations from evidence-based recommendations. Journal of General Internal Medicine, 25 (8), 833-839.
National Cancer Institute. (2010, April). Colorectal Cancer Screening. Retrieved January 19, 2011 from http://www.cancer.gov/cancertopics/pdq/screening/colorectal/Patient/page3.
National Cancer Institute. (2010, December). Colorectal cancer screening (PDQ®) health professional version. Evidence of Benefit. Retrieved January 19, 2011 from http://www.cancer.gov/cancertopics/pdq/screening/colorectal/HealthProfessional/page3/print.
National Guideline Clearinghouse. (2006, March). Practice parameter for the detection of colorectal neoplasms: An interim report. Retrieved January 19, 2011 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2008, May-June). 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. Retrieved January 19, 2011 from http://www.guidelines.gov.
National Guideline Clearinghouse. (2010, May). Colorectal cancer screening. Retrieved January 19, 2011 from http://www.guidelines.gov.
Sanford, K. W., & McPherson, R. A. (2009). Fecal occult blood testing. Clinics in Laboratory Medicine, 29 (3), 523-541.
U. S. Food and Drug Administration. (2007, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070660. Retrieved January 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070660.pdf.
U. S. Food and Drug Administration. (2008, June). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K080812. Retrieved January 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K080812.pdf.
U. S. Food and Drug Administration. (2010, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K101831. Retrieved January 19, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf10/K101831.pdf.
U.S. Department of Health and Human Services. Agency for Healthcare Research and Quality. (2010, September). The guide to clinical preventive services, 2010-2011. Recommendations of the U.S. Preventive Services Task Force. Retrieved January 19, 2011 from http://www.ahrq.gov/clinic/pocketgd1011/pocketgd1011.pdf.
van Rossum, L. G., van Rijn, A. F., van Munster, I. P., Jansen, J. B., Fockens, P., Laheij, R. J., et al. (2009). Earlier stages of colorectal cancer detected with immunochemical faecal occult blood tests. The Netherlands Journal of Medicine, 67 (5), 182-186. (Level 2 Evidence - Independent study)
Zauber, A. G., Lansdorp-Vogelaar, I., Knudsen, A. B., Wilschut, J., van Ballegooijen, M., Kuntz, K. M. (2008). Evaluating test strategies for colorectal cancer screening: A decision analysis for the U.S. Preventive Services Task Force. Annals of Internal Medicine, 149 (9), 659-669.
ORIGINAL EFFECTIVE DATE: 2/1/2004
MOST RECENT REVIEW DATE: 2/10/2011
ID_BT
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