Currentblue cross blue shield - tennesseePolicy N/A

Intracellular Micronutrient Analysis

This policy defines coverage and limitations for intracellular micronutrient panel testing (laboratory-developed panels such as SpectraCell, ExaTest, Cell Science Systems) for Blue Cross Blue Shield of Tennessee members.

Policy Summary

Payerblue cross blue shield - tennessee

PolicyIntracellular Micronutrient Analysis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDo not submit claims for intracellular micronutrient panel testing because it does not meet coverage criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Not coveredPrimary coverage determination

24+Scientific citations

25+Procedure codes listed

Coverage Determination

Not covered: Intracellular micronutrient panel testing

Covered when ALL of the following are met

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Covered indications

No covered indications are listed; the policy explicitly states intracellular micronutrient panel testing is not covered.

Covered indications: The document does not list any covered indications for intracellular micronutrient panel testing; the policy states these tests do not meet coverage criteria.

No clinical indications are accepted for coverage.

Not Covered Services

Not covered: Intracellular micronutrient panel testing includes, but is not limited to, vendor-specific or laboratory-developed panel assays such as SpectraCell, IntraCellular Diagnostics ExaTest, and the Cell Science Systems Cellular Micronutrient Assay. These tests do not meet the plan’s coverage criteria and are excluded from reimbursement.

Applicable Procedure Codes

Applicable CPT Codes (listed)CPT

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 24

1/3

Additional procedure codes referencedCPT

86353	Lymphocyte transformation, mitogen (phytomitogen) or antigen induced.
88348	Electron microscopy, diagnostic (blastogenesis).

Provider Action & Billing Guidance

Denial Risk

Intracellular Micronutrient Panels — Not Covered

Intracellular micronutrient panel testing (e.g., SpectraCell, Cell Science Systems cell micronutrient assay, ExaTest) does not meet coverage criteria. Submitters should not bill for these panels as covered services.

Applies to tests marketed as intracellular micronutrient panels (SpectraCell, IntraCellular Diagnostics ExaTest, Cell Science Systems CMA, Genova NutrEval FMV)
Action: Do not bill as covered services; expect denial if submitted for coverage

Documentation Required

Lab Certification & Documentation Required

Laboratory-developed intracellular micronutrient tests are high-complexity LDTs regulated under CLIA. Providers must document CLIA accreditation and the laboratory's validation/verification procedures when submitting testing for consideration. If the performing laboratory is CLIA-certified, include the CLIA number and documentation of analytic validation and clinical justification in the medical record.

Required documentation for submissions: CLIA certificate number for performing lab; summary of analytic validation/verification (precision, accuracy, reference ranges); clinical rationale linking test results to patient management
Note: LDTs are not FDA-cleared/approved; FDA clearance is not required for clinical use but does not change coverage determination

Billing Rule

Billing/Coding Guidance — CPT/HCPCS

Use the listed CPT/HCPCS codes for itemized analytes if any component testing is performed and billed individually; the panel itself is not covered. Confirm coding matches the specific analyte(s) performed and supported by documentation.

If individual analytes are performed and medically supported, bill the appropriate CPT code(s) from the listed set
Common applicable codes include: 82128, 82136, 82180, 82310, 82379, 82495, 82525, 82607, 82652, 82725, 82746, 82978, 83735, 83785, 84207, 84252, 84255, 84425, 84446, 84590, 84591, 84597, 84630, 84999
Do not use a panel CPT or expect panel reimbursement; unsupported panel claims are subject to denial

Denial Risk

Denial Trigger — Panels

Denials will be issued for intracellular micronutrient panel testing when submitted for coverage because the service does not meet coverage criteria due to insufficient evidence of clinical benefit.

Expect claim denials for panels (SpectraCell, ExaTest, Cell Science Systems CMA, NutrEval FMV) billed as covered services
Providers may appeal with supporting clinical evidence and documentation of individual analyte medical necessity; include CLIA and validation documentation as noted above

Ordering and Test Provider Requirements

Note

Ordering requirements and lab accreditation

No specific ordering provider restrictions are listed in the policy. Laboratories offering intracellular micronutrient panels operate as CLIA-accredited LDT providers.

Policy notes SpectraCell, IntraCellular Diagnostics, and Cell Science Systems maintain CLIA-accredited labs
No requirement in the policy limiting which provider types may order these tests is specified

Background and Scope

Background: Micronutrients (vitamins and trace elements) are dietary components required in small amounts for normal growth and physiologic function. Intracellular micronutrient assays purport to measure cellular nutrient status; however, the policy concludes these panel tests have insufficient published evidence to demonstrate that their use improves diagnosis or guides treatment decisions, and therefore they are not covered.

Definitions

Micronutrients — definition and examples (boron, iron, zinc, etc.)

DefinitionMicronutrients are dietary vitamins and trace elements required in small amounts and obtained from the diet.

Trace element examplesBoron; iron; zinc; selenium; manganese; iodine; copper; molybdenum; cobalt; chromium.

Vitamin examplesVitamins A, B, C, D, K.

Clinical contextEssential for healthy development, disease prevention, and overall wellbeing; not synthesized by the body.

Laboratory-developed test (LDT) — definition and regulatory context (CLIA, not FDA-approved)

DefinitionLaboratory‑developed tests (LDTs) are tests developed, validated, and performed in‑house by clinical laboratories.

Regulatory oversightLDTs are regulated by CMS as high‑complexity tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88).

FDA statusLDTs are not approved or cleared by the U.S. Food and Drug Administration; FDA clearance/approval is not currently required for clinical use.

Examples in policySpectraCell, IntraCellular Diagnostics ExaTest, Genova Diagnostic's NutrEval FMV, Cell Science Systems Cellular Micronutrient Assay (CMA) are cited as LDTs not through FDA approval.

Frequency Limits

Frequency limits — inventory placeholder (no chunk indices); render if present in source

Frequency limits presentNone specified in the policy.

Default actionNo frequency or timing restrictions are defined for intracellular micronutrient panel testing in this document.

ImplicationBecause the test is not covered, frequency limits are not applicable to coverage determinations.