Lymphocytic Mitogen Response Assay for the Diagnosis of Vitamin, Mineral, and Antioxidant Functional Deficiencies
DESCRIPTION
The lymphocytic mitogen response assay measures the integrity of an early proliferative response. Lymphocyte proliferation normally occurs early in an immune response. Mitogens are potent stimulants for the proliferation. An absent or poor mitogen response suggests a severe defect in cell-mediated immunity. This test is designed to detect and classify congenital or acquired immunodeficiency disorders, study the integrity of lymphokine production, and monitor immunosuppress or immunoenhancing therapy. This test is being investigated for the diagnosis of intracellular vitamin, mineral, and antioxidant functional deficiencies.
This policy does not address the use of this technology to assess lymphocytic function in the diagnosed immunodeficiency disease, to monitor immunotherapy, or the treatment of cancer.
POLICY
Lymphocyte mitogen response assay for the diagnosis of intracellular vitamin, mineral, and antioxidant functional deficiencies is considered investigational.
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
Well-designed studies published in peer-reviewed literature that validates the use of lymphocyte mitogen response assay, for the diagnosis of intracellular vitamin, mineral, and antioxidant functional deficiencies are lacking.
SOURCES
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Lymphocyte mitogen response assays (NCD 190.8, p. 2-92). Ingenix.
Galan, P., Kesse-Guvot, E., Czernichow, S., Briancon, S., Blacher, J., et al. (2010). Effects of B vitamins and omega 3 fatty acids on cardiovascular diseases: A randomised placebo controlled trial. BMJ, 341 (c6273), 1-9. (Level 1 Evidence - Industry sponsored)
Shojaei, M. H., Djalali, M., Siassi, F., Khatami, M. R., Bouroumand, M. A., Eshragian, M. R., et al. (2009). Serum levels of lipoprotein(a) and homocysteine in patients on hemodialysis who take hydroxymethylglutaryl-CoA reductase inhibitors, vitamin B6, and folic acid. Iranian Journal of Kidney Diseases, 3 (3), 141-144. (Level 2 Evidence - Independent study)
Sidani, M., & Ziegler, C. (2008). Preventing heart disease: Who needs to be concerned and what to do. Primary Care Clinics in Office Practice, 35 (4), 589-607.
Wald, D. S., Morris, J. K., & Wald, N. J. (2011). Reconciling the evidence on serum homocysteine and ischaemic heart disease: A meta-analysis. PLoS ONE, 6 (2), e16473.
ORIGINAL EFFECTIVE DATE: 4/1/2005
MOST RECENT REVIEW DATE: 8/11/2011
ID_BT
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