Nutrient/Nutritional Panel Testing

POLICY NUMBER

A.2.04.136

DESCRIPTION

Multimarker nutritional panel testing is proposed for patients with certain chronic conditions (eg, mood disorders, fibromyalgia, unexplained fatigue) as well as for healthy individuals seeking to optimize health and/or fitness.

Nutritional panel testing aims to identify nutritional deficiencies that will lead to personalized nutritional supplement recommendations. Testing is proposed both for healthy individuals to optimize health and for patients with chronic conditions (eg, mood disorders, fibromyalgia, unexplained fatigue) to specify supplements that will ameliorate symptoms.

Genova Diagnostics offers nutritional/nutrient panel testing. Among the tests this company offers is NutrEval® FMV, which involves analysis of urine and blood samples and provides information on more than 100 markers including organic acids, amino acids, fatty acids, markers of oxidative stress (direct measurement of glutathione and CoQ10, and markers of oxidative injury and DNA damage) and nutrient elements (see the table below). Genova Diagnostics produces a report that includes test results categorized as minimal, moderate, or high need for support, along with recommendations for supplements and dosages for items categorized as high need. NutrEval FMV patient reports can recommend supplementation for any nutrients listed in the table below, if they are found to be areas of high need.

NutrEval Plasma, also by Genova Diagnostics, is a similar test. The only difference between NutrEval FMV and NutrEval Plasma is that the former uses urine (first morning void) whereas the latter uses plasma (fasting sample) to measure amino acids.

SpectraCell Laboratories offers a micronutrient test that measures functional deficiencies at the cellular level. The test assesses how well the body uses 31 vitamins, minerals, amino and fatty acids, antioxidants, and metabolites (see the table below). SpectraCell categorizes test results into adequate, borderline, and deficient, and offers supplementation suggestions based on each patient's deficiencies.

Components of the NutrEval FMV Test and Spectra Cell Tests

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 (CLIA). Nutrient/nutritional panel testing using urine and/or blood samples is offered (eg, NutrEval FMV® and NutrEval Plasma® by Genova Diagnostics; micronutrient testing by SpectraCell) under the auspices of the CLIA. Laboratories that offer LDTs must be licensed by the CLIA for high-complexity testing. To date, the US Food and Drug Administration has chosen not to require any regulatory review of this test.

Related policies –

• Homocysteine Testing in the Screening, Diagnosis, and Management of Cardiovascular Disease and Venous Thromboembolic Disease

• Intracellular Micronutrient Analysis

• Cardiovascular Risk Panels

• Intravenous Nutrient Therapy

POLICY

Nutrient/nutritional panel testing is considered investigational for all indications including but not limited to testing for nutritional deficiencies in individuals with mood disorders, fibromyalgia, or unexplained fatigue, and healthy individuals.

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

11/19/2015: Approved by Medical Policy Advisory Committee.

06/07/2016: Policy number A.2.04.136 added.

01/19/2018: Policy description updated regarding testing. Policy statement unchanged.

01/22/2019: Policy reviewed; no changes.

01/20/2020: Policy reviewed; no changes.

02/03/2021: Policy description updated regarding tests. Policy statement unchanged.

02/03/2022: Policy reviewed; no changes.

01/25/2023: Policy description updated regarding tests and test components. Policy statement updated to change "patients" to "individuals."

01/09/2024: Policy description updated regarding tests. Policy statement unchanged.

02/06/2025: Policy reviewed; no changes.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.04.136

CODE REFERENCE

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

Investigational Codes

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