LCD L34063

Coverage Guidance

Language quoted from Centers for Medicare and Medicaid Services (CMS). National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862 (a)(1)(A)allows coverage and payment for only those services considered medically reasonable and necessary.

Section 1833 (e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Indications and Limitations of Coverage

Abstract:

Radioallergosorbent test (RAST), fluoroallergosorbent test (FAST), and multiple antigen simultaneous tests are in vitro techniques for determining whether a patient's serum contains IgE antibodies against specific allergens of clinical importance. As with any allergy testing, the need for such tests is based on the findings during a complete history and physical examination of the patient.

The multiple antigen simultaneous testing technique is similar to the RAST/FAST techniques in that it depends upon the existence of allergic antibodies in the blood of the patient being tested. With the multiple antigen simultaneous test system, several antigens may be used to test for specific IgE simultaneously.

ELISA (enzyme-linked immunosorbent assay) is another in vitro method of allergy testing for specific IgE antibodies against allergens. This method is also a variation of RAST.

Limitations:

The following tests are considered to be not medically necessary and will be denied.

• ELISA/Act qualitative antibody testing

This testing is used to determine in vitro reaction to various foods and relies on lymphocyte blastogenesis in response to certain food antigens.

• LMRA (Lymphocyte Mitogen Response Assays) by ELISA/Act

• IgG ELISA, indirect method

• Qualitative multi-allergen screen

This is a non-specific test that does not identify a specific antigen.

• IgG and IgG subclass antibody tests for food allergy do not have clinical relevance, are not validated, lack sufficient quality control, and should not be performed.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Bibliography

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