BlueCross BlueShield of Tennessee Medical Policy Manual

In Vitro Particle Size Measurement for Screening Hypersensitivity Reactions to Foods and Chemicals

DESCRIPTION

In vitro particle size measurement for screening hypersensitivity reactions involves the measurement of the aggregate release of inflammatory mediators from an individual's immunocytes after exposure to various food extracts and chemicals (e.g., food additives). A determination is made of the difference in volume of circulating immunocytes and plasma before and after an in vitro antigen challenge.

An example of this technology is the Mediator Release Test® or MRT®. For this test, portions of an individual's blood sample are incubated with various food extracts and food additives (typically 150 different substances). The degree of reactivity is determined by the degree of mediator release from the cells. A response, change in cellular and plasma volume, is thought to indicate a hypersensitivity reaction and results are used as a basis for modifying an individual’s diet. The MRT® is one component of the Lifestyle Eating and Performance (LEAP®) Program of oligoantigenic dieting. This type of testing has been promoted for individuals with, among other conditions, irritable bowel syndrome, chronic fatigue syndrome, migraine headaches, and dermatologic conditions (e.g., eczema, dermatitis).

POLICY

In vitro particle size measurement for the purpose of screening hypersensitivity reactions to food and chemicals is considered investigational.

IMPORTANT REMINDERS

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.

ADDITIONAL INFORMATION

Well-designed studies in peer-reviewed journals are not available regarding the use of this test in screening for hypersensitivity reactions to foods (e.g., sensitivity to cow's milk) and chemicals. These studies are needed to determine the efficacy of this technology and to substantiate any potential health benefits associated with its use in diet modification.

SOURCES

Don Self & Associates, Inc. An integrated disease management program for irritable bowel syndrome: Taking the "irritable" out of irritable bowel syndrome. Retrieved August 17, 2009 from http://www.donself.com/LEAP/LEAP-doc.ppt.

Pasula, M. J., & Nowak, J. (1999, May). Particle size measurement in suspensions, part 1: A laboratory method for exploring food sensitivities in illness. American Clinical Laboratory, 18 (4), 16-18.

Pasula, M. J., & Nowak, J. (1999, October). Particle size measurement in suspensions, part 2: An in vitro procedure for screening adverse reactions to foods and chemicals. American Clinical Laboratory, 18 (4), 14-15.

Signet Diagnostic Corporation. Mediator Release Test and Lifestyle Eating and Performance (LEAP) information packet received from Signet Diagnostic Corporation on October 8, 2003.

ORIGINAL EFFECTIVE DATE: 5/1/2004

MOST RECENT REVIEW DATE: 6/14/2012

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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.

This document has been classified as public information.