Allergy Testing - Cytotoxic Food Tests
DESCRIPTION
Cytotoxic food tests involve the response of specially collected white blood cells to the presence of food extracts to which an individual is allergic. A technician observes the unstained cells for changes in shape and appearance of the leukocytes. Cytotoxic changes in cell morphology (e.g., shrinking, swelling) are being investigated as an indication of allergy to the food.
POLICY
Cytotoxic food tests for the diagnosis of an allergy is considered investigational.
See also: General Policy for Allergy Testing and Treatment
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
Randomized controlled trials are not available to establish the efficacy for cytotoxic food testing in the diagnosis of food allergies.
SOURCES
American Academy of Allergy, Asthma & Immunology. (2007). Tips to remember: What is allergy testing? Retrieved February 2, 2009 from http://www.aaaai.org/patients/publicedmat/tips/whatisallergytesting.stm.
American College of Allergy, Asthma, & Immunology. (2006). Food allergy: A practice parameter. Annals of Allergy, Asthma & Immunology, 96 (3 Suppl. 2), S1-S68.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, August). Cytotoxic food tests (NCD 110.13, p. 2-60). Ingenix.
National Guideline Clearinghouse. (2006, March). Food allergy: A practice parameter. Retrieved February 2, 2009 from http://www.guidelines.gov.
U. S. Food and Drug Administration. (2004, December). Center for Food Safety and Applied Nutrition. Food allergies rare but risky. Retrieved February 3, 2009 from http://www.cfsan.fda.gov.
U. S. Food and Drug Administration. (1995, March). Office of Regulatory Affairs. Sec.370.100 Cytotoxic testing for allergic diseases (CPG 7124.27). Retrieved February 2, 2009 from http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg370-100.html.
Wuthrich, B. (2005). Unproven techniques in allergy diagnosis. Journal of Investigational Allergology & Clinical Immunology, 15 (2), 86-90.
ORIGINAL EFFECTIVE DATE: 10/12/1998
MOST RECENT REVIEW DATE: 12/8/2011
ID_BT
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.