Allergy Testing - Cytotoxic Food Tests
DESCRIPTION
Cytotoxic food tests involve observation of the response of specific allergens on collected white blood cells. The response is due to the presence of food extracts to which an individual is allergic.
POLICY
Cytotoxic food tests for the diagnosis of an allergy are considered investigational.
See also: General Policy for Allergy Testing and Treatment
ADDITIONAL INFORMATION
No randomized controlled trials have established the efficacy for cytotoxic food testing in the diagnosis of food allergies.
Cytotoxic food tests do not meet the following technology evaluation criteria:
The technology must have final approval from the appropriate government regulatory bodies.
The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
The technology must improve the net health outcome.
The technology must be as beneficial as any established alternatives.
The improvement must be attainable outside the investigational settings.
SOURCES
Allergy & Allergies Agency. BBC Allergy Online. (2006, March). Complementary and alternative allergy tests. Retrieved April 18, 2006 from http://www.allergy-network.co.uk/index.html.
American Academy of Allergy, Asthma & Immunology. (2006). Tips to remember: What is allergy testing? Retrieved April 18, 2006 from http://www.aaaai.org/patients/publicedmat/tips/whatisallergytesting.stm.
American Academy of Allergy, Asthma & Immunology. (1996). Position statement 8. Controversial techniques. Retrieved April 14, 2006 from http://web.archive.org/web/19970510224735/www.aaaai.org/profinfo/publicat/position/ps08.html.
Beyer, K., & Teuber, S. S. (2005). Food allergy diagnostics: Scientific and unproven procedures. Current Opinion in Allergy and Clinical Immunology, 5 (3) 261-266. Abstract retrieved April 17, 2006 from PubMed database.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2003). Allergy testing (2.01.23). Retrieved July 22, 2003 from BlueWeb.
Complete Guide to Medicare Coverage Issues [Computer software]. (2005, November). Food allergy testing and treatment - not covered (NCD 110.11, p. 2-52). St. Anthony Publishing.
Quackwatch. (2003, March). Cytotoxic testing. Retrieved April 14, 2006 from http://www.quackwatch.org/01QuackeryRelatedTopics/Tests/cyto.html.
U. S. Food and Drug Administration. (2004, December). Center for Food Safety and Applied Nutrition. Food allergies rare but risky. Retrieved April 14, 2006 from http://www.cfsan.fda.gov.
U. S. Food and Drug Administration. (2004, July). Office of Regulatory Affairs. Chapter 3, Devices, Contents FDA/ORA Compliance Policy Guides. Sec. 370.100 Cytotoxic testing for allergic diseases (CPG 7124.27). Retrieved April 14, 2006 from http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg370-100.html.
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EFFECTIVE DATE |
5/25/2006 |
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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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