073 Form

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Medical Policy Intracellular Micronutrient Analysis Table of Contents • Policy: Commercial • Description • Information Pertaining to All Policies
• Authorization Information • Policy History • References
• Coding Information

Policy Number: 073

BCBSA Reference Number: 2.04.73 (For Plans internal use only) NCD/LCD: N/A Related Policies
None Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Intracellular micronutrient panel testing is INVESTIGATIONAL.
Prior Authorization Information Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.

Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service. CPT Codes / HCPCS Codes / ICD Codes Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

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Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable.

CPT Codes There is no specific CPT code for this service.

ICD-10 Diagnosis Codes Investigational for all diagnoses.

Description “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 evidence review 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 2 commercial laboratories offer intracellular testing for micronutrients. Laboratories perform a panel of tests evaluating the intracellular level of various micronutrients (eg, 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, phosphorus, sodium, chloride).1,SpectraCell Laboratories offers a panel of tests that evaluates the intracellular status of micronutrients within lymphocytes in blood samples.2, 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: a-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 also may include SPECTROX™ for evaluation of the total antioxidant function and IMMUNIDEX™ for immune response score.

Summary 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

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healthy people or those with chronic disease and aiding in the diagnosis of disease in patients with nonspecific symptoms. Summary of Evidence For individuals who have chronic diseases or nonspecific generalized symptoms who receive intracellular micronutrient analysis, the evidence includes an observational study. Relevant outcomes are symptoms and change in disease status. No studies were identified that evaluated the clinical validity or clinical utility of intracellular micronutrient testing compared with standard testing for vitamin or mineral levels. Limited data from observational studies are available on correlations between serum and intracellular micronutrient levels. No randomized controlled trials or comparative studies were identified evaluating the direct health impact of intracellular micronutrient testing. Moreover, there are insufficient data to construct a chain of evidence that intracellular micronutrient testing would likely lead to identifying patients whose health outcomes would be improved compared with alternative approaches to patient management. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome. Policy History Date Action 2/2025 Annual review. References updated. Policy statements unchanged. 1/2024 Annual review. References updated. Policy statements unchanged. 2/2023 Annual review. Description, summary, and references updated. Policy statements unchanged. 2/2022 Annual review. Description, summary, and references updated. Policy statements unchanged. 2/2021 Annual review. Description, summary, and references updated. Policy statements unchanged. 1/2020 Annual review. Description, summary, and references updated. Policy statements unchanged. 2/2019 Annual review. Description, summary, and references updated. Policy statements unchanged. 11/2011- 4/2012 Medical policy ICD 10 remediation: Formatting, editing and coding updates.
No changes to policy statements.
7/1/2012 New policy, effective 7/1/2012 describing ongoing non-coverage. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

References

1. IntraCellular Diagnostics. Mitochondria: Exploration of Intracellular Space. Accessed November 25,
2. https://www.exatest.com/
3. SpectraCell Laboratories. Micronutrient Test. Accessed November 25, 2024. https://spectracell.sitewrench.com/search-tests
4. Houston MC. The role of cellular micronutrient analysis, nutraceuticals, vitamins, antioxidants and minerals in the prevention and treatment of hypertension and cardiovascular disease. Ther Adv Cardiovasc Dis. Jun 2010; 4(3): 165-83. PMID 20400494