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Commercial laboratories offer panels of tests evaluating intracellular levels of micronutrients (essential vitamins and minerals). Potential uses of this test include screening for nutritional deficiencies in healthy individuals or those with chronic disease, and aiding in the diagnosis of disease in patients with generalized symptoms.
“Micronutrients” is a collective term used to describe essential vitamins and minerals. Adequate intake of micronutrients is important to the maintenance of health. Clinical deficiency states (states occurring after prolonged consumption of a diet lacking the nutrient that is treated by adding the nutrient to the diet) have been reported for vitamins A, B1, B12, C and D, selenium, and other micronutrients. Classic nutritional deficiency diseases are uncommon in the United States; most individuals derive sufficient nutrition from their diets alone or in combination with over-the-counter multivitamins.
Laboratory tests are available for individual micronutrients and are generally used to confirm suspected micronutrient deficiencies. Testing is performed by serum analysis using standardized values for defining normal and deficient states. In addition, some commercial laboratories offer panels of vitamin and mineral testing that also use serum analysis.
This policy addresses a novel laboratory test that measures the intracellular levels of micronutrients. This testing is known as intracellular micronutrient analysis and is also called micronutrient testing and functional intracellular analysis. Advocates claim that intracellular nutrient status is superior to serum testing. This is because intracellular levels may reflect more stable micronutrient levels over longer time periods compared to serum levels because intracellular levels are not influenced by recent nutrition intake. However, this is not a widely accepted view, as the relationship between serum and intracellular levels of micronutrients is complex. The balance of intra- and extracellular levels depend on a number of factors, including the physiology of cellular transport mechanisms and the individual cell type.
At least two commercial laboratories offer intracellular testing for micronutrients. Laboratories perform a panel of tests evaluating the intracellular level of a variety of micronutrients (e.g. minerals, vitamins, amino acids, fatty acids). The test offered by IntraCellular Diagnostics evaluates epithelial cells from buccal swabs and assesses levels of magnesium, calcium, potassium, phosphorous, sodium and chloride as well as ratios between various combinations of these minerals. SpectraCell Laboratories offers a panel of tests that evaluates the intracellular status of micronutrients within lymphocytes in blood samples. The micronutrients measured by the test are as follows:
The SpectraCell micronutrient panel also includes an evaluation of total antioxidant function.
Intracellular micronutrient testing is offered by companies SpectraCell and IntraCellular Diagnostics, which have Clinical Laboratories Improvement Amendments (CLIA) accredited laboratories. SpectraCell’s micronutrient panel test and the IntraCellular Diagnostics ExaTest® have not been through the FDA approval process.
POLICYIntracellular micronutrient panel testing is considered investigational.
POLICY GUIDELINESInvestigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY11/17/2011: Approved by Medical Policy Advisory Committee.
09/25/2012: Policy reviewed; no changes.
11/06/2013: Policy reviewed; no changes.
08/20/2014: Policy reviewed; description updated. Policy statement unchanged. Sources section updated to change "9.03.26" to "2.04.73."
07/30/2015: Code Reference section updated for ICD-10.
10/29/2015: Policy description updated. Policy statement unchanged. Investigative definition updated in policy guidelines section.
06/06/2016: Policy number added.
SOURCE(S)Blue Cross Blue Shield Association policy # 2.04.73
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.