Appeal type: Experimental/Investigational
Decision: Upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement for Genova diagnostics allergy test provided. Findings:  The physician reviewer found that the current literature and guidelines that address immunoglobulin G  (IgG) diagnostic testing like the Genova diagnostics, do not consider IgG food sensitivity testing clinically useful, relevant, or a valid method for evaluating for food allergy or food intolerance that may be contributing to celiac disease or any other condition. As such, the guidelines do not recommend testing for IgG and IgG subclass antibody. IgG signifies exposure to a food, not allergy to a food. IgG antibodies to food are commonly detectable in healthy individuals, independent of the presence or absence of food related symptoms. Since a normal immune system should make IgG antibodies to foreign proteins, a positive IgG test to a food is a sign of a normal immune system. IgG4 against foods indicates that the organism has been repeatedly exposed to food components, recognized as foreign proteins by the immune system. A study notes that its presence should not be considered as a factor, which induces hypersensitivity, but rather as an indicator for immunological tolerance, linked to the activity of regulatory T cells.  Testing for blood IgG against different foods is performed with large scale screening for hundreds of foods. However, many serum samples show positive IgG results without corresponding clinical symptoms. These findings, combined with the lack of convincing evidence for histamine releasing properties of IgG in humans, and lack of any controlled studies on the diagnostic value of IgG testing in food allergy, do not support these tests in this clinical setting. There is a lack of strong evidence that measuring IgG antibodies is useful for diagnosing food allergy or intolerance. There is also a lack of evidence that IgG antibodies cause symptoms. IgG antibodies reflect exposure to allergen but not the presence of disease. At present, there is a lack of reliable and validated clinical tests for the diagnosis of food intolerance. While intolerances are nonimmune by definition, IgG testing is not clinically validated to guide management of this patients medical condition. IgG testing lacks both a sound scientific rationale and evidence of effectiveness. The lack of correlation between results and actual symptoms, and the risks resulting from unnecessary food avoidance, escalate the potential for harm from this test. Further, there is a lack of published clinical evidence to support the use of IgG tests to determine the need for vitamins or supplements or dietary modifications.  In light of the lack of clinical relevance, and the potential for harm resulting from their use, Genova Diagnostics allergy testing performed was not likely to have been more effective than the standard modalities for the evaluation of this patients medical condition. Final Result: The all  three reviewers determined that the services at issue were not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be upheld. Credentials/Qualifications: Physician reviewers are  board certified in allergy and immunology and are actively practicing. The reviewers are experts in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.