CurrentCignaPolicy 0604

Laboratory Testing Services (Mm_0604_Coveragepositioncriteria_Labtesting)

Defines general criteria for when laboratory tests or panels are considered medically necessary, not medically necessary, experimental/investigational/unproven, and lists many specific CPT/PLA/U codes and panels with coverage stance or notes. Applies to lab testing services across Cigna-administered health benefit plans, with cross-references to more specific Cigna policies.

Policy Summary

PayerCigna

PolicyMm_0604_Coveragepositioncriteria_Labtesting

Policy CodePolicy 0604

Change TypeFocused review additions and code updates

Effective DateMay 15, 2026

Next Review DateMar 15, 2027

Key ActionIf the test, condition, or indication is addressed by another Cigna Coverage Policy, use the more specific policy for coverage determinations.

SourceLink

POLICY UPDATE CHANGES

Added policy statement for not covered or reimbursable tests and specific codes added.

Policy updated and codes added on multiple focused review dates.

Annual Review dated 3/15/2026 notes no clinical policy statement changes.

Initial policy created on 3/15/2025.

>200Listed Specific CPT/PLA/U Codes Mentioned

8Explicitly Experimental Tests Listed

13Not Covered Epigenetic Tests Listed

Panel definitions specified

multipleTimed-sample multipliers present

3Focused reviews in 2025-2026

Coverage Summary

This policy defines general criteria used to determine when laboratory tests or panels are clinically useful and eligible for coverage under Cigna-administered health benefit plans. It applies across laboratory testing services and cross-references more specific Cigna Coverage Policies when a test, condition, or indication is addressed elsewhere.

High-level coverage stance is mixed: tests meeting the General Criteria for Medically Necessary Lab Testing are covered; many tests or code-specific categories are identified as experimental/investigational/unproven or not covered/not reimbursable (see detailed code lists).

Policy effective date / last review: Effective 5/15/2026; Last Review 5/15/2026. The policy notes focused reviews and code additions (see related revision history) and directs users to use more specific Cigna policies when available.

Key facts

Policy number0604

Effective date2026-05-15

Last review2026-05-15

Next review2027-03-15

Coverage stancemixed

Medical-Necessity Criteria

General Criteria for Medically Necessary Lab Testing

A laboratory test or panel of tests that is required to prevent, evaluate, diagnose or treat an illness, injury, disease or its symptoms is considered medically necessary if ALL of the following criteria are met:

ALL of the following

the testing method for each single test or test in a panel is scientifically valid (analytical validity: accuracy, precision, sensitivity, specificity, reproducibility) based on published, peer-reviewed prospective evidence
ordered and performed according to test manufacturer's intended indications for use
ordered by a qualified health care practitioner, practicing within the scope of their license and who is actively managing the individual's care
US Food and Drug Administration (FDA) cleared or approved and/or performed in an appropriately credentialed and certified laboratory setting

Experimental / Not Covered

Experimental, Investigational, or Unproven (Not Covered for ANY Indication)

Each of the following laboratory tests listed below is considered experimental, investigational, or unproven for ANY indication:

ANY of the following

PreTRM ® (CPT ® 0247U)
Immunoscore (CPT ® 0261U)
NaviDKD TM Predictive Diagnostic Screening for Kidney Health (CPT ® 0384U)
IGoCheck™ (CPT ® 0558U)
MammoCheck™ (CPT ® 0559U)

Coding

Experimental/Investigational/Unproven Codes (Not Covered for ANY Indication)CPTExperimental

0247U	PreTRM®
0261U	Immunoscore
0384U	NaviDKD™ Predictive Diagnostic Screening for Kidney Health
0558U	IGoCheck™
0559U	MammoCheck™
0458U	Auria Home Breast Health Assessment
0385U	Promarker® D
0574U	NanoDetect-TB

Considered Experimental/Investigational/Unproven (specific U-codes)CPTExperimental

0059U	Specific Proprietary Test (0059U)
0060U	Specific Proprietary Test (0060U)
0061U	Specific Proprietary Test (0061U)
0065U	Specific Proprietary Test (0065U)
0067U	Specific Proprietary Test (0067U)
0068U	Specific Proprietary Test (0068U)
0069U	Specific Proprietary Test (0069U)
0077U	Specific Proprietary Test (0077U)
0079U	Specific Proprietary Test (0079U)
0082U	Specific Proprietary Test (0082U)

1–10 of 19

1/2

Not Covered or Reimbursable (specific U-codes and DNA methylation tests)CPTNot Covered

0616U	TruD MDS Alzheimer's & MC™
0617U	TruD MDS ASCVD™
0618U	TruD MDS Bipolar™
0619U	TruD MDS COPD™
0620U	TruD MDS Hepatocellular Carcinoma™
0621U	TruD MDS Lyme Disease™
0622U	TruD MDS Major Depressive Disorder™
0623U	TruD MDS Multiple Sclerosis™
0624U	TruD MDS NASH™
0625U	TruD MDS Osteoporosis™

1–10 of 12

1/2

Epigenetic Risk/Susceptibility Tests (Not Covered / Not Reimbursable)CPTNot Covered

0616U	TruD MDS Alzheimer's & MC™
0617U	TruD MDS ASCVD™
0618U	TruD MDS Bipolar™
0619U	TruD MDS COPD™
0620U	TruD MDS Hepatocellular Carcinoma™
0621U	TruD MDS Lyme Disease™
0622U	TruD MDS Major Depressive Disorder™
0623U	TruD MDS Multiple Sclerosis™
0624U	TruD MDS NASH™
0625U	TruD MDS Osteoporosis™

1–10 of 12

1/2

Specific Multi-gene Panel Not CoveredCPTNot Covered

0628U

RenaDx™ multi-gene NGS panel

Listed Considered Not Medically Necessary when performed as screening in general populationCPTNot Covered

0002M	Liver disease, ten biochemical assays, prognostic algorithm for fibrosis/steatosis/ASH
0003M	Liver disease, ten biochemical assays, prognostic algorithm for fibrosis/steatosis/NASH
0002U	Oncology (colorectal), quantitative assessment of three urine metabolites, algorithm reported as likelihood of adenomatous polyps
0003U	Oncology (ovarian), biochemical assays of five proteins, algorithm reported as likelihood score

Common Laboratory Panel CPT Codes (Panel composition specified)CPT

80000	General health panel codes (see constituent analytes below)
81000	Urinalysis, by dip stick or tablet reagent; automated
81001	Urinalysis, by reagent strip (ie, dip stick)
81002	Urinalysis, by reagent strip (ie, dip stick) with microscopy
81003	Urinalysis, by dip stick; single
81005	Urinalysis, by dip stick; multiple
81007	Urinalysis; reagent strip for pH

Panel Definitions and Constituent Analytes (Informational)mixed

82009	Bilirubin conjugated (direct)
82010	Bilirubin total
82013	Bilirubin fractionation
82016	Iron, serum
82017	Iron binding capacity (TIBC)
82030	Calcium, total
82042	Phosphorus; inorganic
82043	Magnesium, serum
82044	Cortisol

Extensive Individual Chemistry/Analyte Codes (Informational)CPT

81508	Protein-based assay (specific)
81510	Protein-based assay (specific)
81512	Protein-based assay (specific)
81517	Protein-based assay (specific)
81539	Proprietary algorithm/assay (81539)
81560	Proprietary algorithm/assay (81560)
80181	Therapeutic drug assay
80183	Therapeutic drug assay
80184	Therapeutic drug assay
80185	Therapeutic drug assay

1–10 of 21

1/3

Hematology / Coagulation (Informational)CPT

85032	Hematocrit
85044	Hemoglobin
85045	CBC with automated differential
85048	Reticulocyte count
85049	Blood cell morphology
85060	Hemoglobin A1c
85397	Hematology panel component
85379	Platelet function tests

Molecular and Genetic Codes (Informational)CPT

81371	SMN1 deletion analysis
81372	SMN1 point mutation analysis
81373	Genetic assay, specific
81375	Genetic assay, specific
81376	Genetic assay, specific
81378	Genetic assay, specific
81379	Genetic assay, specific
81380	Genetic assay, specific
81382	Genetic assay, specific

Coagulation / Platelet Function / Hemostasis (Informational)CPT

85652	Platelet aggregation
85670	Fibrinogen assay
85675	Thrombin time
85705	Erythrocyte sedimentation rate
85732	Platelet count
85810	Hemoglobin electrophoresis

Immunology / Serology / Allergy (Informational)CPT

86000	TB antigen tests
86001	Allergen-specific IgE
86005	Immunoassay for analyte
86008	Immunoassay for analyte
86015	Immunoassay, therapeutic drug
86021	Antibody screen
86022	Antibody screen
86023	Antibody screen

Serology / Viral / Bacterial (Informational)CPT

86146	Toxoplasma antibody
86147	Cytomegalovirus antibody
86148	Epstein-Barr virus antibody
86200	Hepatitis serology
86231	HIV antibody
86235	Hepatitis B surface antigen

Microbiology Culture and Identification (Informational)CPT

87003	Culture, bacterial; blood
87015	Culture, bacterial; sterile body fluid
87045	Screening culture
87046	Culture, bacterial; any other source
87070	Anaerobic culture
87071	Clostridium difficile organism
87073	Culture, feces

Molecular Pathogen and NAAT (Informational)CPT

87400	Infectious agent detection by nucleic acid
87640	HPV types detection
87641	HPV types detection
87650	Chlamydia trachomatis NAAT
87651	Neisseria gonorrhoeae NAAT

Cytology / Pathology / Surgical Path (Informational)CPT

88106	Cytopathology, cervical or vaginal
88108	Cytopathology, cervical or vaginal
88112	Cytopathology, cervical or vaginal
88120	Cytopathology, cervical or vaginal
88300	Surgical pathology, gross and microscopic examination
88304	Surgical pathology
88307	Surgical pathology

Miscellaneous Codes and HCPCS/S Codes (Informational)mixed

G0327	Prostate cancer screening; PSA, with physician order
S3630	Lab test, proprietary
S3650	Lab test, proprietary
S3652	Lab test, proprietary
S3708	Lab test, proprietary
S3722	Lab test, proprietary

Provider Actions & Billing Rules

Documentation Required

Use specific Cigna Coverage Policy if available

Use the specific Cigna Coverage Policy for the test or indication when one exists. If a more specific Cigna Coverage Policy applies to the test, condition, or indication, follow that policy rather than this general laboratory testing policy. This ensures the most relevant coverage criteria, documentation requirements, and billing guidance are applied.

Documentation Required

Coverage determination considerations

When making a coverage determination, consider the applicable benefit plan language, the clinical indication and documentation provided, FDA status and intended use of the test, published evidence and professional society guidance, and whether results will directly impact clinical management for the member.

Background & Evidence

Policy basis for coverage decisions requires demonstration of analytical validity (accuracy, precision, sensitivity, specificity, reproducibility) and clinical validity/utility in published, peer-reviewed evidence; tests must be ordered per manufacturer indications and by qualified clinicians, and be FDA cleared/approved or performed in appropriately credentialed laboratories (CLIA).

The policy gives weight to authoritative guidance: the USPSTF A/B recommendations and published professional society/organization guidance can satisfy evidentiary requirements for screening or other uses.

Laboratory Developed Tests (LDTs) lacking adequate evidence or regulatory clearance may be considered unproven. Tests lacking sufficient evidence that results improve health outcomes are classified as experimental/investigational/unproven and not covered.

Screening of asymptomatic general population is considered Not Medically Necessary unless the screening test is specifically recommended by USPSTF Grade A or B or is addressed by another Cigna Coverage Policy.

Evidence	Value
Systematic review prevalence of overuse	Mean over- and underutilization 20.6% and 44.8% (Zhi et al. 2013)
Overuse diagnostic testing review	Majority of included assessments report overuse below 25% (Müskens et al. 2022/2021)

Definitions

Panel must include the following: Indicates that all listed constituent test CPT codes (and specified multiples) are required for the panel CPT code to be billed as that panel (see panel composition rules).

Experimental/Investigational/Unproven: Tests lacking sufficient peer-reviewed evidence to demonstrate safety, effectiveness, or improvement in health outcomes (examples: PreTRM ® , Immunoscore, PromarkerD — see policy code lists).

LDT (Laboratory Developed Test): An in vitro diagnostic test designed, manufactured, and used within a single CLIA-certified laboratory; may lack FDA clearance and may be considered unproven if clinical utility evidence is lacking.

USPSTF Grade A & B: Task Force recommendations with high/moderate certainty of net benefit; screening tests are acceptable only when recommended as Grade A or B.

Revision History

03/15/2025Initial publication

Initial policy created on 3/15/2025.

11/15/2025Focused review

Policy updated and codes added on 11/15/2025.

02/15/2026Focused review

Policy updated and codes added on 2/15/2026.

Policy Summary

PayerCigna

PolicyMm_0604_Coveragepositioncriteria_Labtesting

Policy CodePolicy 0604

Change TypeFocused review additions and code updates

Effective DateMay 15, 2026

Next Review DateMar 15, 2027

Key ActionIf the test, condition, or indication is addressed by another Cigna Coverage Policy, use the more specific policy for coverage determinations.

SourceLink

On This Page

not primarily for the convenience of the individual or Health Care Professional

the type, frequency, extent, site and duration of testing is consistent with the need to obtain laboratory information to assess and/or manage the clinical needs of the individual

each single test or test in a panel should not be duplicative or overlap in clinical intent with other services previously or currently being performed

AND ANY of the following

The USPSTF has designated use of the test as a Level A or B recommendation
There is published, evidence-based Professional Society/Organization guidance specifically addressing the test's use to treat or diagnose a specific illness, injury, disease or clinical symptoms exhibited by the specific individual for whom the test is ordered
There is sufficient published, evidence-based literature that each test has clinical usefulness to drive clinical decision making, resulting in improved health outcomes of the individual for whom testing is proposed

Not Medically Necessary

A laboratory test is considered not medically necessary for ANY of the following:

ANY of the following

testing intervals or indications performed outside of published A & B recommendations of the USPSTF and/or published professional society/organization guidelines
absence of documented changes in the condition of the individual, requiring further evaluation
results of the test will not directly impact the clinical management of the individual
screening in the general population without specific signs or symptoms or an existing diagnosis that suggests the clinical need for the test (unless addressed by another Cigna Coverage Policy)

General Criteria for Laboratory Testing (Medically Necessary)

Covered when ALL of the following are met:

ALL of the following

Test demonstrated in peer-reviewed scientific literature to have analytical and clinical validity (preferably prospective clinical trial data).
Test used to prevent illness or assist in evaluation, diagnosis, or management of an existing illness, injury or disease, or its symptoms.
Results of testing directly impact clinical management of the individual for whom testing is requested.
Test performed in an FDA-approved/cleared assay and/or in a CLIA-certified laboratory appropriate for the complexity.
Panel testing acceptable when sequential single tests are not feasible (eg, limited specimen) or when urgent treatment decisions would be delayed by sequential testing.
Screening tests only acceptable when recommended by USPSTF (Grade A or B) or other published professional society guidelines.
Repeat testing is only acceptable with documented changes in the individual's condition requiring further evaluation; adherence to minimum retesting intervals is expected.

Panel Composition Rules

Each listed panel must include ALL of the following constituent analytes (codes) to meet the panel definition:

80051 Electrolyte panel must include Carbon dioxide (bicarbonate) (82374), Chloride (82435), Potassium (84132), Sodium (84295).

80053 Comprehensive metabolic panel must include Albumin (82040), Bilirubin, total (82247), Calcium, total (82310), Carbon dioxide (bicarbonate) (82374), Chloride (82435), Creatinine (82565), Glucose (82947), Phosphatase, alkaline (84075), Potassium (84132), Protein, total (84155), Sodium (84295), ALT (84460), AST (84450), Urea nitrogen (BUN) (84520).

80055 Obstetric panel must include CBC (85025 or 85027 and 85004 OR 85027 and 85007 or 85009), Hepatitis B surface antigen (87340), Antibody, rubella (86762), Syphilis non-treponemal qualitative (86592), Antibody screen, RBC (86850), Blood typing ABO (86900) AND Rh (D) (86901).

80069 Renal function panel must include Albumin (82040), Calcium, total (82310), Carbon dioxide (bicarbonate) (82374), Creatinine (82565), Glucose (82947), Phosphorus inorganic (84100), Potassium (84132), Sodium (84295), Urea nitrogen (BUN) (84520).

80074 Acute hepatitis panel must include Hepatitis A IgM (86709), Hepatitis B core IgM (86705), Hepatitis B surface antigen (87340), Hepatitis C antibody (86803).

80076 Hepatic function panel must include Albumin (82040), Bilirubin total (82247), Bilirubin direct (82248), Phosphatase alkaline (84075), Protein total (84155), ALT (84460), AST (84450).

80400 ACTH stimulation panel; for adrenal insufficiency: 80400 ACTH stimulation panel must include Cortisol (82533 x2).

80402 ACTH stimulation panel; for 21 hydroxylase deficiency: 80402 ACTH stimulation panel must include Cortisol (82533 x2) and 17 hydroxyprogesterone (83498 x2).

80406 ACTH stimulation panel; for 3 beta-hydroxydehydrogenase deficiency: 80406 ACTH stimulation panel must include Cortisol (82533 x2) and 17 hydroxypregnenolone (84143 x2).

80408 Aldosterone suppression evaluation panel must include Aldosterone (82088 x2) and Renin (84244 x2).

80410 Calcitonin stimulation panel must include Calcitonin (82308 x3).

80412 CRH stimulation panel must include Cortisol (82533 x6) and ACTH (82024 x6).

80414 Chorionic gonadotropin stimulation panel; testosterone response must include Testosterone (84403 x2 on 3 pooled blood samples).

80415 Chorionic gonadotropin stimulation panel; estradiol response must include Estradiol, total (82670 x2 on 3 pooled blood samples).

80416 Renal vein renin stimulation panel must include Renin (84244 x6).

80417 Peripheral vein renin stimulation panel must include Renin (84244 x2).

80418 Combined rapid anterior pituitary evaluation panel must include ACTH (82024 x4), LH (83002 x4), FSH (83001 x4), Prolactin (84146 x4), HGH (83003 x4), Cortisol (unspecified sampling).

80420 Dexamethasone suppression panel, 48 hour must include Free cortisol, urine (82530 x2), Cortisol (82533 x2), Volume measurement for timed collection (81050 x2).

80422 Glucagon tolerance panel; for insulinoma must include Glucose (82947 x3) and Insulin (83525 x3).

80424 Glucagon tolerance panel; for pheochromocytoma must include Catecholamines, fractionated (82384 x2).

80426 Gonadotropin releasing hormone stimulation panel must include FSH (83001 x4) and LH (83002 x4).

80428 Growth hormone stimulation panel must include HGH (83003 x4).

80430 Growth hormone suppression panel must include Glucose (82947 x3) and HGH (83003 x4).

80432 Insulin-induced C-peptide suppression panel must include Insulin (83525), C-peptide (84681 x5), Glucose (82947 x5).

80434 Insulin tolerance panel; for ACTH insufficiency must include Cortisol (82533 x5) and Glucose (82947 x5).

80435 Insulin tolerance panel; for growth hormone deficiency must include Glucose (82947 x5) and HGH (83003 x5).

80436 Metyrapone panel must include Cortisol (82533 x2) and 11-deoxycortisol (82634 x2).

80438 TRH stimulation panel; 1 hour must include TSH (84443 x3).

80439 TRH stimulation panel; 2 hour must include TSH (84443 x4).

Promarker ® D (CPT ® 0385U)

NanoDetect-TB (CPT ® 0574U)

Experimental, Investigational, or Unproven Laboratory Testing (Not Covered)

Tests are considered experimental/unproven when ANY of the following apply:

ANY of the following

Lack of sufficient evidence in peer-reviewed literature to demonstrate safety and effectiveness for diagnosis or treatment.
Insufficient evidence that test results improve health outcomes.
Laboratory Developed Tests (LDTs) without adequate evidence or regulatory clearance may be considered unproven if evidence of clinical utility is lacking.

Billing Rule

Use appropriate codes and components

Use appropriate CPT and HCPCS procedure codes for each test performed. Report each analyte or component using the most specific, currently effective code(s) available. Do not report bundled or generic codes when distinct analyte-specific CPT/HCPCS codes exist. Ensure modifiers and units reflect actual specimens, number of isolates, and number of timed samples per the CPT/HCPCS definitions.

Report the most specific CPT/HCPCS code(s) available for each analyte or procedure.
Do not substitute panel codes for individually billable constituent analytes unless the panel code accurately represents the services performed.
Append modifiers and report units consistent with CPT/HCPCS guidance (e.g., number of timed collections, number of isolates).

Billing Rule

Panel billing requires constituent analytes

When billing for panels, identify and report constituent analytes when required by the panel's coding guidance. If constituent analytes are billed instead of a panel code, the constituent analytes billed must match the panel's specified components.

Affected panel CPT codes include, but may not be limited to: 80047, 80048, 80050, 80051, 80053, 80061.

Billing Rule

Multiple timed samples quantity reporting

For tests that require multiple timed samples (e.g., glucose tolerance testing, serial hormone levels), report quantity/units that reflect the number of separately collected timed specimens. When multiple timed samples are part of a single test code, follow CPT guidance for reporting additional units or add-on codes as applicable.

Examples of CPT codes often involving multiple timed samples: 82533 (blood glucose tolerance test), 82308 (vitamin D, 25 hydroxy), 84443 (thyroid stimulating hormone).
Report units to correspond to the number of timed draws when CPT describes per specimen/unit reporting.

Documentation Required

Panel constituent specification is authoritative

When determining coverage and allowable billing, the panel's published constituent specification is authoritative. If a laboratory bills using panel constituent codes, those constituents must match the panel definition; deviations may be subject to denial or adjustment.

Billing Rule

Unlisted procedure codes and reporting additional isolates/units separately

If no specific CPT/HCPCS code exists for a performed procedure, report the appropriate unlisted procedure code and separately report additional isolates, organisms, or units using specific codes when available. Follow CPT instructions for use of unlisted codes and provide full documentation.

Unlisted procedure examples: 85999, 86849, 86999.
When reporting additional isolates or organism-specific testing in conjunction with an unlisted code, also report organism-specific or isolate-specific codes when available (examples: 87503, 87154, 87150).
Provide supporting documentation (test method, analytes, specimen type, units, clinical indication) when using unlisted codes.

Documentation Required

Clinical justification required

Clinical justification is required when the test is not routine, when there is potential for noncoverage, or when requested by Cigna for review. Documentation should demonstrate how results will change clinical management for the member.

Prior Authorization

Prior authorization may be required for certain tests

Prior authorization may be required for certain laboratory tests or panels per plan or medical management program requirements. Check plan-specific prior authorization rules before performing testing that may be subject to review.

Denial Risk

Claims for tests designated experimental or not covered

Claims for tests designated experimental, investigational, unproven, or otherwise not covered will be denied. Do not bill or expect reimbursement for these tests. The following codes are examples of not-covered tests; this list is not exhaustive.

Not covered U-codes and multi-gene panels listed elsewhere in this policy (examples include 0247U, 0261U, 0384U, 0458U, 0558U, 0559U, 0574U, 0616U–0628U).
Epigenetic/DNA methylation test examples listed as not covered: 0616U, 0617U, 0618U, 0619U, 0620U, 0621U, 0622U, 0623U, 0624U, 0625U, 0626U, 0627U.
Any additional codes explicitly listed in the 'Each of the following laboratory tests' or 'Not Covered or Reimbursable' sections of this policy.

03/15/2026Annual review

Annual Review dated 3/15/2026 notes no clinical policy statement changes.

05/15/2026Focused review (material)Latest

Focused Review dated 5/15/2026 indicates addition of not covered tests and codes; added policy statement for not covered or reimbursable tests and specific codes added.