Coverage Policy Manual
Policy #: 2006021
Category: Laboratory
Initiated: July 2006
Last Review: August 2018
  Food and Chemical Sensitivity Testing

Description: Food or food additive intolerance or sensitivity is thought by some to be responsible for symptoms of irritable bowel syndrome, migraine headaches, chronic fatigue syndrome, some dermatologic conditions, and arterial plaquing and calcification.

Adverse reactions to foods may be the result of an IgE-mediated reaction but may also occur due to non-IgE-mediated immunologic and nonimmunologic mechanisms.  Food allergy causes the immune system to synthesize and release reactive chemical agents such as histamines, cytokines, lymphokines, and interferons.

The Academy of Allergy, Asthma and Immunology, in 2006 specifically advise “Other tests have not been adequately studied in the diagnosis of food allergy.  These include the  measurement of food specific total IgG or IgG4 antibody, immune complexes, hair analysis, cytotoxic tests to foods that use automated machinery, and applied kinesiology (muscle strength testing).  These tests should not be used for the diagnosis of food allergy.

There is no specific coding for these services.  CPT 86849-unlisted immunology procedure, should be used.

Policy/
Coverage:
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Laboratory testing, including but not limited to mediator release test or food specific IgG,  to detect food or food additive sensitivity, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
The preponderance of opinion in the medical literature indicates that additional study is necessary before measurement of IgG subtypes, serum antibodies, or serum antigens to various food types can be accepted as standard diagnostic tests for identification of causative agents for cardiac, gastrointestinal, or any other organ system complaint.
 
For members with contracts without primary coverage criteria, laboratory testing other than food challenge, including  but not limited to the mediator release test or food specific IgG, detect food or food additive sensitivity, is considered investigational and is not covered. Investigational services are an exclusion in the member benefit contract.

Rationale:
Few studies have been published in peer-reviewed medical literature involving the use of this test in screening for hypersensitivity reactions to food and chemicals.  There is a paucity of medical literature reporting results of dietary modification as a result of any kind of testing.  The American College of Gastroenterology does not recommend this type of testing for Irritable Bowel Disease.
 
Zar et al reported on 108 IBS patients, many of whom had significantly higher IgG4 titers when compared to a control group to beef, pork, lamb and wheat out of 16 foods that were tested.  They concluded that response to an exclusion diet based on elevated food-specific IgG4 in future studies might be useful in establishing the significance of their findings.
 
In a study of 25 patients Zar et al queried patients at 3 and 6 months after starting an exclusion diet based on results of IgG4 titers.  Significant improvement was reported in pain severity, pain frequency, bloating severity, satisfaction with bowel habits, and the effect of IBS on life in general was reported at 3 months that was maintained at 6 months.  Rectal compliance and sensitivity were measured in 12 patients at baseline and at 6 months.  Rectal compliance increased without change in thresholds for urge to defecate/discomfort.
 
The Food Allergy Practice Parameter by the American College of Allergy, Asthma and Immunology contains the following statements:
    • “The significance of immunoglobulin M (IgM), immunoglobulin G (IgG), and IgG subclass antibodies (e.g., the role of IgG4) in food allergy is less well understood and highly controversial.”
    • “The role of cellular in vitro correlates as diagnostic or prognostic indicators of food allergy is not established.”
    • “The role of specific cytokine profiles in serum or peripheral mononuclear cells of food allergic patients has not been established in the mechanism of food allergy.”
 
2012 Update
A search of the MEDLINE database conducted through July 2012 did not reveal any new information that would prompt a change in the coverage statement.
 
2014 Update
A literature search conducted using the MEDLINE database through July 2014 did not reveal any new information to prompt a change in the coverage statement.
 
2015 Update
A literature search conducted using the MEDLINE database through July 2015 did not reveal any new information to prompt a change in the coverage statement.
 
2016 Update
A literature search conducted through June 2016 did not reveal any new information that would prompt a change in the coverage statement
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2018. No new literature was identified that would prompt a change in the coverage statement.
 

CPT/HCPCS:
86001Allergen specific IgG quantitative or semiquantitative, each allergen
86343Leukocyte histamine release test (LHR)
86849Unlisted immunology procedure

References: American College of Gastroenterology Functional Disorders Task Force.(2002) Evidence-based position statement on the management of irritable bowel syndrome in North America. Am J Gastroenterol 2002; 97 (Suppl):S1-5.

Atkinson W, Sheldon TA, et al.(2004) Food elimination based on IgG antibodies in irritable bowel syndrome: a randomized controlled trial. Gut 2004; 53:1459-64.

Cash BD, Chey WD.(2004) Review article: irritable bowel syndrome – an evidence-based approach to diagnosis. Aliment Pharmacol Ther 2004; 19:1235-45.

Cash BD, Chey WD.(2005) Diagnosis of irritable bowel syndrome. Gastroenterol Clin N Am 2005; 34:205-20.

Chapman JA, Bernstein IL, et al.(2006) Food allergy: a practice parameter. Ann Allergy Asthma Immunol, 2006; 96 (3 Suppl 2):S1-S68.

Floch MH.(2005) Use of diet and probiotic therapy in the irritable bowel syndrome: an analysis of the literature. J Clin Gastroenterol 2005; 39 (5 Suppl):S243-6.

O’Sullivan M, O’Morain C.(2003) Food intolerance: dietary treatments in functional bowel disorders. Curr Treat Options Gastroenterol 2003; 6:339-45.

Signet Diagnostic Corp.(2006) Is your food making you sick. www.nowleap.com, accessed 6/27/2006.

Somers SC, Lembo A.(2003) Irritable bowel syndrome: evaluation and treatment. Gastroenterol Clin N Am 2003; 32:507-29.

Van Ree R, Vieths S, Poulsen LK.(2006) Allergen-specific IgE testing in the diagnosis of food allergy and the event of a positive match in the bioinformatics search. Mol Nutr Food Res 2006 [Epub ahead print].

Whorwell P, Lea R.(2004) Dietary treatment of the irritable bowel syndrome. Curr Treat Options Gastroenterol 2004; 7:307-16.

Zar S, Benson MJ, Kumar D.(2005) Food-specific serum IgG4 and IgE titers to common food antigens in irritable bowel syndrome. Am J Gastroenterol 2005; 100:1550-7.

Zar S, Mincher L, Benson MJ, Kumar D.(2005) Food specific IgG4 antibody-guided exclusion diet improves symptoms and rectal compliance in irritable bowel syndrome. Scand J Gastroenterol 2005; 40:800-7.

Zuo XL, Li YQ, et al.(2007) Alterations of food antigen-specific serum immunoglobulins G and E antibodies in patients with irritable bowel syndrome and functional dyspepsia. Clin Exp Allergy, 2007; 37:823-30.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2019 American Medical Association.