CurrentMolina HealthcarePolicy G2099

Intracellular Micronutrient Analysis

Defines Molina Healthcare's coverage stance for intracellular micronutrient panel testing (proprietary lymphocyte/buccal cell-based assays) and describes clinical background, limitations, and applicable procedure codes for providers and payers.

Policy Summary

PayerMolina Healthcare

PolicyIntracellular Micronutrient Analysis

Policy CodePolicy G2099

Change TypeNo material change

Effective DateSep 18, 2015

Next Review Date

Key ActionDo not submit prior authorization requests expecting coverage for proprietary intracellular micronutrient panel testing; these tests do not meet coverage criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredCoverage stance

31SpectraCell analytes

≈40Other vendors' analytes

NumerousProcedure codes

NoneCoverage changes

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Coverage Criteria

inv-01: Not medically necessary / Does not meet coverage criteria

Not covered when the following condition is met:

Primary exclusion: Intracellular micronutrient panel testing (e.g., SpectraCell, Cell Science Systems cell micronutrient assay, ExaTest) does not meet coverage criteria

Policy states lack of available published scientific literature confirming these tests are required and beneficial for diagnosis or treatment

Intracellular micronutrient panel testing, including proprietary assays such as SpectraCell, Cell Science Systems (cell micronutrient assay), and ExaTest, is explicitly stated in this policy to not meet coverage criteria due to a lack of available published scientific literature demonstrating that these tests are required and beneficial for diagnosis or treatment.

A recent literature review was performed and the policy was updated for background and evidence references; however, the review did not change the coverage determination and no modifications to the existing coverage criteria were made.

The rationale for noncoverage is that no studies were identified that reliably evaluate the accuracy of intracellular micronutrient tests compared with standard serum or established testing, nor controlled studies demonstrating that use of these tests changes patient management or improves health outcomes. Limited correlation data exist between serum and intracellular levels, and no practice guidelines endorsing these assays were found.

In conclusion, the updated evidence review reinforced the original determination: available literature updates did not provide sufficient new evidence to warrant changes to the policy, and the prior coverage stance remains intact.

Covered Indications and Contexts

inv-19: Note on covered indications

Tests are commercially available and performed in CLIA‑accredited laboratories, but no covered clinical indications are specified in this policy:

Service description: Intracellular micronutrient testing (examples: SpectraCell, IntraCellular Diagnostics ExaTest, Cell Science Systems CMA) are offered by commercial laboratories and are performed as laboratory‑developed tests in CLIA‑accredited facilities

These assays have not been through FDA approval and are regulated as high‑complexity LDTs under CLIA; CLIA status should be documented when submitted

Coverage status note: This policy does not list any specific covered clinical indications for intracellular micronutrient panel testing

Absence of listed covered indications indicates services are not supported by the policy's medical necessity criteria

inv-20: Clinical contexts referenced in document (pregnancy iodine, diabetes vitamin C, cardiovascular disease, liver fibrosis)

The document references clinical contexts in the literature but does not establish them as covered indications:

Not Covered Services

Intracellular micronutrient panel testing (for example, SpectraCell, Cell Science Systems CMA, and ExaTest) is not covered by this policy due to insufficient published scientific evidence demonstrating analytical validity, clinical validity, or clinical utility.

This document does not introduce new, specific test exclusions beyond the existing policy language. Any test-specific exclusions or additional details are maintained elsewhere in the full policy and remain unchanged after the most recent review.

Procedure and Billing Codes

Procedure / CPT codes referencedCPT

82128	Amino acids; multiple, qualitative, each specimen.
82136	Amino acids, 2 to 5 amino acids, quantitative, each specimen.
82180	Ascorbic acid (vitamin c), blood.
82310	Calcium; total.
82379	Carnitine (total and free), quantitative each specimen.
82495	Chromium.
82525	Copper.
82607	Cyanocobalamin (Vitamin B-12);.
82652	Vitamin D; 1, 25 dihydroxy, includes fraction(s), if performed.
82725	Fatty acids, nonesterified.

1–10 of 26

1/3

Provider Actions and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for intracellular micronutrient panel testing. Requests for coverage must follow the payer's prior authorization process; obtaining prior authorization does not make tests that do not meet medical necessity criteria payable.

Affected procedure codes include, but may not be limited to: 82128, 82136, 82180, 82310, 82379, 82495, 82525, 82607, 82652, 82725, 82746, 82748, 82978, 83735, 83785, 84207, 84252, 84255, 84425, 84446, 84590, 84591, 84597, 84630, 84999, 86353, 88348.

Note

Literature Review Outcome

Literature review and evidence update were performed; the review did not necessitate any changes to coverage criteria. Existing authorization and coverage rules remain in effect.

Ordering and Documentation Requirements

Note

Ordering: tests are LDTs performed by CLIA-accredited commercial labs (no provider restriction stated)

No specific ordering-provider restrictions are stated in the policy; these proprietary intracellular tests are performed as LDTs by commercial laboratories with CLIA accreditation.

Order these tests through the performing commercial CLIA-accredited laboratory according to the lab's ordering procedures.
Policy does not specify provider licensure or specialty requirements for ordering.

Note

No specific ordering-provider requirements specified in policy sections

The policy does not specify additional ordering provider requirements in the referenced sections; follow the laboratory's own ordering instructions and the member's benefit coverage.

Check member benefits and the performing lab's requisition requirements when ordering.
No policy-level ordering provider restrictions are documented in these sections.

Definitions

CMA / Cellular micronutrient assay definition

TermCMA (Cellular Micronutrient Assay)

DefinitionCellular micronutrient assay (CMA) — laboratory-developed test intended to assess intracellular micronutrient status by measuring nutrient uptake/retention in cultured cells or cellular components.

Common vendors/examplesCell Science Systems (CMA), SpectraCell (cellular micronutrient panel)

ASEM / EXA definition

TermASEM / EXA

DefinitionASEM: analytical scanning electron microscopy; EXA: energy dispersive x-ray analysis — techniques used by some buccal epithelial cell mineral/elemental tests (for example ExaTest).

Background

Micronutrients — vitamins and trace elements — are essential dietary components that can be measured in serum or, in the case of proprietary assays, in intracellular compartments. Commercial vendors offer proprietary intracellular or cellular tests (lymphocyte culture–based assays or buccal cell elemental analyses) such as SpectraCell, Vibrant, Genova, ExaTest, and Cell Science Systems. These assays are performed as laboratory-developed tests in CLIA-accredited laboratories and are marketed as reflecting intracellular stores or longer-term nutritional status, but the policy finds insufficient evidence of their accuracy or clinical utility compared with standard testing.

Frequency Limits

Frequency limits data placeholder

Presence in policyFrequency limits section included for laboratory tests, but no explicit frequency rules are specified in the policy for intracellular micronutrient assays.

Implication for claimsBecause no frequency period is defined, requests should reference general medical necessity criteria and existing prior authorization rules when applicable.

Related codingProcedure codes for related analytes are listed elsewhere in the policy (see applicable CPT/HCPCS codes).

Frequency limits data placeholder

Inventory noteFrequency limits inventory item present but policy does not specify test-specific retest intervals for proprietary intracellular micronutrient panels.

RecommendationFollow standard clinical practice and benefit plan rules; absence of stated frequency limits does not imply coverage.