CPT 82310, 84590, 82725, 86353, 88348 – Calcium, Vitamin A procedurces

82310 Calcium; total
82725 Fatty acids, nonesterified
84590 Vitamin A
84591 Vitamin, not otherwise specified
84999 Unlisted chemistry procedure
86353 Lymphocyte transformation, mitogen (phytomitogen) or antigen induced blastogenesis
88348 Electron microscopy, diagnostic

Introduction
Micronutrients are essential vitamins and minerals. Getting enough of them is important for good health. It’s rare in the United States to have medical conditions caused by lack of nutrients like vitamins A, B1, B12, C, and D, and selenium. Most people get enough vitamins and minerals through their diet or over-the-counter vitamins. Blood samples are a proven way to measure the level of essential nutrients. Other tests have been created that look at nutrient levels inside cells.

These tests are unproven. There are no published medical studies showing whether the cell tests are more accurate or useful than standard blood tests at measuring levels of vitamins or minerals. There are also no randomized controlled trials — studies that randomly put people in different study groups — exploring whether the cell tests are effective to screen for or diagnose nutrient deficiencies.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

When reviewing intracellular micronutrient panel testing, the entire panel is to be reviewed as a whole versus the individual elements of the panel.

Reference Laboratories (see Benefit Application)
IntraCellular Diagnostics
IntraCellular Diagnostics uses electron microscopy for which CPT code 88348 might be reported.

SpectraCell Laboratories

According to SpectraCell Laboratories, their total antioxidant function testing (SPECTROX®) is reported using CPT code 86353.

Benefit Application

This testing is currently only available through two reference laboratories: SpectraCell Laboratories (Houston, TX) and IntraCellular Diagnostics (Medford, OR).

Evidence Review 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.
Background

Vitamin Deficiencies

“Micronutrients” collectively refer to essential vitamins minerals necessary in trace amounts for health. Clinical deficiency states (states occurring after prolonged consumption of a diet lacking the nutrient and 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 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. In addition, some commercial laboratories offer panels of vitamin and mineral testing that also use serum analysis.

Diagnostic Testing

This policy evaluates novel laboratory tests that measure the intracellular levels of micronutrients. This testing, also known as intracellular micronutrient analysis, micronutrient testing or functional intracellular analysis is 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 intra- 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 a variety of micronutrients (eg, minerals, vitamins, amino acids, fatty acids). The test offered by IntraCellular Diagnostics evaluates epithelial cells from buccal swabs and assesses levels of intracellular mineral electrolyte (ie, magnesium, calcium, potassium, phosphorous, sodium, 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, 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 also includes an evaluation of total antioxidant function.

Summary of Evidence

For individuals who have chronic diseases or nonspecific generalized symptoms who receive intracellular micronutrient analysis, the evidence includes observational studies. Relevant  outcomes are test accuracy, symptoms, and change in disease status. No studies were identified that evaluated 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 other 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 the effects of the technology on health outcomes.

Ongoing snd Unpublished Clinical Trials

A search of ClinicalTrials.gov in January 2018 did not identify any ongoing or unpublished trials that would likely influence this review. Practice Guidelines and Position Statements No guidelines or statements were identified.

Medicare National Coverage

There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.