Intracellular Micronutrient Analysis

POLICY NUMBER

A.2.04.73

DESCRIPTION

Commercial laboratories offer panels of tests evaluating intracellular levels of micronutrients (essential vitamins and minerals). Potential uses of these tests include screening for nutritional deficiencies in healthy people or those with chronic disease and aiding in the diagnosis of disease in patients with nonspecific symptoms.

“Micronutrients” collectively refer to essential vitamins and minerals necessary in trace amounts for 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 U. S.; most people 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. Also, some commercial laboratories offer panels of vitamin and mineral testing that also use serum analysis.

Diagnostic Testing

This policy evaluates laboratory tests that measure the intracellular levels of micronutrients. This testing, also known as intracellular micronutrient analysis, micronutrient testing, or functional intracellular analysis, is sometimes claimed to be superior to serum testing because intracellular levels reflect more stable micronutrient levels over longer time periods than serum levels and because intracellular levels are not influenced by recent nutrition intake. However, the relation between serum and intracellular levels of micronutrients is complex. The balance of intracellular and extracellular levels depends 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 various micronutrients (e.g. minerals, vitamins, amino acids, fatty acids). The test offered by IntraCellular Diagnostics (EXA Test®) evaluates epithelial cells from buccal swabs and assesses levels of intracellular mineral electrolyte (ie, magnesium, calcium, potassium, phosphorous, sodium, and chloride). 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 include:

• Vitamins: A, B₁, B₂, B₃, B₆, B₁₂, C, D, K; biotin, folate, pantothenic acid

• Minerals: calcium, magnesium, manganese, zinc, copper

• Antioxidants: alpha lipoic acid, coenzyme Q10, cysteine, glutathione, selenium, vitamin E

• Amino acids: asparagine, glutamine, serine

• Carbohydrate metabolism: chromium, fructose sensitivity, glucose-insulin metabolism

• Fatty acids: oleic acid

• Metabolites: choline, inositol, carnitine.

The SpectraCell micronutrient panel may also include SPECTROX™ for evaluation of the total antioxidant function and IMMUNIDEX™ for immune response score.

Clinical laboratories may develop and validate tests in-house and market them as a laboratory service; laboratory-developed tests (LDTs) must meet the general regulatory standards of the Clinical Laboratory Improvement Amendments. Intracellular micronutrient panel testing is offered by SpectraCell Laboratories and IntraCellular Diagnostics under the auspices of the Clinical Laboratory Improvement Amendments. Laboratories that offer LDTs must be licensed by the Clinical Laboratory Improvement Amendments for high-complexity testing. To date, the U.S. Food and Drug Administration has chosen not to require any regulatory review of this test.

POLICY

Intracellular micronutrient panel testing is considered investigational.

POLICY EXCEPTIONS

None

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative 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. 

POLICY HISTORY

11/17/2011: 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 A.2.04.73 added.

03/27/2017: Policy description updated regarding laboratory testing. Policy statement unchanged.

03/27/2018: Code Reference section updated to add new CPT code 0038U, effective 04/01/2018.

04/05/2018: Policy description updated. Policy statement unchanged.

04/02/2019: Policy description updated regarding micronutrient panels. Policy statement unchanged. Code Reference section updated to add CPT code 86353.

01/20/2020: Policy description updated to remove information regarding vitamin deficiencies. Policy statement unchanged.

02/04/2021: Policy reviewed; no changes.

02/07/2022: Policy description updated regarding micronutrients and laboratory tests. Policy statement unchanged.

01/26/2023: Policy description updated regarding micronutrients and intracellular micronutrient panel testing. Policy statement unchanged.

01/16/2024: Policy reviewed; no changes.

02/14/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.04.73

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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