ModifiedHumanaPolicy LAB2023028

Laboratory - Cardiovascular Disease Risk Assessment in Adults

This Medicare Advantage payment policy describes Humana's reimbursement stance for laboratory biomarkers and panels used to assess cardiovascular disease (CVD) risk in adults and applies to providers submitting claims for Humana Medicare Advantage products.

Policy Summary

PayerHumana

PolicyLaboratory - Cardiovascular Disease Risk Assessment in Adults

Policy CodePolicy LAB2023028

Change TypeReimbursement criteria clarified and added

Effective Date

Next Review Date

Key ActionSubmit claims for Apo B and Lp(a) only when documented clinical criteria or lifetime/age criteria are met and follow Original Medicare NCDs/LCDs where applicable.

SourceLink

POLICY UPDATE CHANGES

Apolipoprotein B (Apo B) measurement (CPT 82172) is reimbursable for individuals with specified conditions including diabetes, hypertriglyceridemia, obesity/metabolic syndrome, history of circulatory system disorders, disorders of transport metabolism, or presence of coronary angioplasty implant.

Once-per-lifetime measurement of lipoprotein(a) (CPT 83695) is reimbursable for individuals 18 years or older.

Multiple novel lipid and non-lipid biomarkers and proprietary CVD risk panels (specified CPT/HCPCS codes) are not reimbursable.

>=1Apo B reimbursable when criteria met

1 lifetimeLp(a) reimbursable frequency

MultipleNovel biomarkers/panels not reimbursable

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ExceptionSmall dense LDL exception

~20+Bibliographic references cited

LAB2023028Policy identifier

Coverage Criteria

Covered when ALL of the following criteria are met:

ALL of the following

Measurement of apolipoprotein B (Apo B) (CPT code 82172) is reimbursable when the individual has any of the following conditions: diabetes mellitus; disorder of galactose, lipoprotein, or amino acid transport metabolism; history of circulatory system disorders; hypertriglyceridemia; obesity or metabolic syndrome; presence of coronary angioplasty implant.
Operational: follow applicable CPT coding and one test per clinical indication unless otherwise specified by plan rules.
Measurement of lipoprotein(a) [Lp(a)] (CPT code 83695) is reimbursable once per lifetime for individuals 18 years of age or older.
Operational: lifetime rule applies across Humana Medicare Advantage membership; document age and prior Lp(a) testing in medical record.
Measurement of components of a conventional lipid panel (CPT code 80061) may include total cholesterol (82465), HDL (83718), and triglycerides (84478). Measurement of individual lipid panel components listed separately (82465, 83718, 84478) on the same date of service as CPT 80061 is not separately reimbursable.
Billing rule: do not bill component CPTs in addition to 80061 on same DOS.

Referenced Evidence and Guidelines

Referenced evidence and guidelines supporting the coverage positions include the following sources:

ANY of the following

2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease (Ziaeian B., et al.)
Guideline supports targeted use of biomarkers in risk assessment rather than broad panel testing.
American Heart Association scientific statement on Lipoprotein(a) (Reyes-Soffer G., et al., 2022)
Supports clinical relevance of Lp(a) and rationale for one-time measurement in adults.
VA/DoD and Canadian Cardiovascular Society guidance on dyslipidemia management (O'Malley P.G. et al., 2020; Pearson G.J. et al., 2021)
Inform interpretation of Apo B and other lipid-related biomarkers in management decisions.
CDC/AHA statement on markers of inflammation and cardiovascular disease (Pearson T.A. et al., 2003)

References-only Content: Not Medically Necessary / Not Reimbursable

Not medically necessary / not reimbursable — the following tests, panels, and indications are not covered:

ALL of the following

Measurement of homocysteine (CPT 83090) for CVD risk assessment is not reimbursable.
Exception: if homocysteine measurement is clinically required for a documented non-CVD indication, coverage may be considered per standard medical necessity rules.
Measurement of novel lipid and non-lipid biomarkers (CPT 82610, 83700, 83701, 83704, 83719, 83880, 85384, 85415) as part of CVD risk assessment is not reimbursable.
Includes tests performed for exploratory or unproven clinical utility in routine risk assessment.
Direct measurement of small dense LDL (CPT 83722) is not reimbursable except when billed with diagnoses of Cushing's syndrome, chronic kidney disease, obstruction of the bile duct, or pregnancy.
Operational: require diagnosis code consistent with allowed exception on claim to consider reimbursement.

Coding and Test Frequency

Key CPT/HCPCS codes mentionedCPT | HCPCS | mixed

82172	Apolipoprotein, each
83695	Lipoprotein (a)
83090	Homocysteine
86140	C-reactive protein
83722	Lipoprotein, direct measurement; small dense LDL cholesterol
80061	Lipid panel (cholesterol, HDL, triglycerides)
82465	Cholesterol, serum or whole blood, total
83718	Lipoprotein, direct measurement; high density cholesterol (HDL cholesterol)
84478	Triglycerides
0019M	Cardiovascular disease, plasma, analysis of protein biomarkers by aptamer-based microarray (SOMAmer®)

1–10 of 17

1/2

No CPT/HCPCS/ICD-10 codes listed in these chunksmixed

No codes listed

Cited laboratory analytes and biomarkersmixed

Lp(a)	Lipoprotein(a) - discussed as a genetically determined risk factor for atherosclerotic cardiovascular disease
Apo B	Apolipoprotein B
CRP	C-reactive protein
Homocysteine	Homocysteine
Natriuretic peptides	Natriuretic peptides (eg, NT-proBNP)
High-sensitivity troponin	High-sensitivity cardiac troponin
Lp-PLA2	Lipoprotein-associated phospholipase A2

inv-07: Lp(a) frequency

FrequencyOnce-per-lifetime measurement

Applies toIndividuals 18 years of age or older

Relevant CPT code83695

inv-08: No numerical thresholds

Numeric thresholds presentNone — no numerical threshold values specified in these referenced guideline chunks

ScopeApplies to referenced evidence and guideline sections, not coverage criteria

Action

Provider Actions and Billing Guidance

Prior Authorization

Claims and Preauthorization Considerations

As a Medicare Advantage plan, claims payments are subject to other plan requirements for processing and payment, including medical necessity, reasonableness, and any applicable referral or authorization requirements. Where Original Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) exist, those rules apply as outlined in the policy.

Claims are subject to medical necessity and reasonableness determinations.
Claims remain subject to applicable referral and authorization requirements under the member’s plan.
Original Medicare NCDs and LCDs govern when established for the procedure.

Note

References and Guideline Citations (Informational)

References and guideline citations relevant to cardiovascular disease risk assessment and laboratory testing are provided for informational purposes. These include clinical practice guidelines and review articles; they do not by themselves establish prior authorization or billing rules within this policy.

Definitions and Examples

inv-13: Medicare Advantage Payment Policy

DefinitionMedicare Advantage Payment Policy: payment policy developed to explain coverage for Medicare Advantage plans; applies except when Original Medicare NCDs/LCDs establish criteria

Applies toHumana Medicare Advantage products and providers submitting claims for those products

Relation to Original MedicareOriginal Medicare NCDs/LCDs apply where established alongside this policy

inv-14: Lipid panel (80061)

Lipid panel requirementLipid panel (CPT 80061) must include total cholesterol (82465), HDL direct (83718), and triglycerides (84478)

CPT panel code80061

Policy Summary

PayerHumana

PolicyLaboratory - Cardiovascular Disease Risk Assessment in Adults

Policy CodePolicy LAB2023028

Change TypeReimbursement criteria clarified and added

Effective Date

Next Review Date

Key ActionSubmit claims for Apo B and Lp(a) only when documented clinical criteria or lifetime/age criteria are met and follow Original Medicare NCDs/LCDs where applicable.

SourceLink

On This Page

Supports non-reimbursability of routine CRP measurement for general CVD risk assessment when not guideline-supported.

Proprietary multi-biomarker CVD risk panels and advanced algorithmic tests (e.g., CPT 0019M, 0052U, 0308U, 0309U, 0377U, 0415U, 0541U) are not reimbursable.

Includes NGS/aptamer/algorithm-based panels, NMR lipoprotein profiles, and other multi-marker risk scores when submitted as these CPT/PLA codes.

Measurement of lipoprotein-associated phospholipase A2 (Lp-PLA2) (CPT 83698) is not reimbursable.

Routine measurement not supported for general CVD risk assessment.

No laboratory numeric cutpoints or threshold values are provided in these chunks

inv-09: Not stated

Inventory entryNot stated

ContextUsed where the brief/source explicitly lists ‘Not stated’ for a data element

Source exampleBibliographic/reference sections where specific coverage criteria are not provided

Lists clinical guideline citations related to lipid management, primary prevention, and natriuretic peptide measurement.

No explicit prior authorization, step therapy, or quantity limit rules are specified in these references.

Note

No Prior Authorization or Explicit Provider Billing Actions

There is no prior authorization requirement or explicit provider billing action specified within the bibliographic content of this section. The content is informational and bibliographic only; providers should follow standard claims submission procedures and any separate prior authorization processes specified elsewhere by Humana or the applicable Medicare guidance.

No prior authorization, step therapy, or explicit provider billing instructions are present in the cited chunks.
Providers must follow applicable plan-specific prior authorization processes if those are documented elsewhere.

inv-15: Cardiovascular biomarkers (examples)

Examples of biomarkersLDL-C, apolipoprotein B (ApoB), lipoprotein(a) (Lp(a)), natriuretic peptides, high-sensitivity troponin, CRP, Lp-PLA2

Guideline/statement references2016 ESC/EAS Guidelines; 2019 ACC/AHA Guideline on Primary Prevention; CDC biomarker standardization resources

Use in policyThese biomarkers and guideline sources inform the clinical context for CVD risk assessment

inv-16: Lipoprotein(a)

DescriptionLipoprotein(a) (Lp(a)) is described as a genetically determined, causal, and prevalent risk factor for atherosclerotic cardiovascular disease per AHA scientific statement

Policy relevanceLp(a) measurement (CPT 83695) is specifically addressed in coverage frequency (once per lifetime for adults >=18)

Supporting citationAHA scientific statement cited in the policy bibliography (Reyes-Soffer et al., 2022)

inv-17: High-sensitivity cardiac troponin

Use caseHigh-sensitivity cardiac troponin (hs-cTn) is referenced for risk stratification in community and older adult populations

Supporting studiesHigh-Sensitivity Troponin-T and outcomes in community; High-Sensitivity Cardiac Troponin I for risk stratification in older adults (cited)

ContextReferenced in bibliography informing clinical utility rather than specific reimbursement rules in these chunks