CurrentUnitedHealthcarePolicy CSNCT0389.07

Cardiovascular Disease Risk Tests (for North Carolina Only)

UnitedHealthcare medical policy for North Carolina addressing the medical necessity and evidence for noninvasive arterial compliance testing (pulse wave analysis/PWV), carotid intima-media thickness (CIMT), advanced lipoprotein analyses (including Lp(a), Lp-PLA2, NMR and other fractionation), and multi-protein algorithmic biomarker tests for cardiovascular disease risk assessment.

Policy Summary

PayerUnitedHealthcare

PolicyCardiovascular Disease Risk Tests (for North Carolina Only)

Policy CodePolicy CSNCT0389.07

Change TypeCoverage clarification and code updates

Effective DateOct 1, 2025

Next Review Date

Key ActionWhen ordering advanced or proprietary lipoprotein or multi-protein algorithmic tests listed in this policy, document the clinical indication and rationale because these tests are considered unproven/not medically necessary and may be subject to denial or require verification of coverage.

SourceLink

POLICY UPDATE CHANGES

Added 'cardiovascular disease (HDL reverse cholesterol transport), cholesterol efflux capacity, LC-MS/MS, quantitative measurement of 5 distinct HDL-bound apolipoproteins (apolipoproteins A1, C1, C2, C3, and C4), with algorithm and reported as a risk score' to the list of unproven and not medically necessary services.

Added CPT code 0541U to Applicable Codes.

Revised description for CPT code 0308U.

Updated Clinical Evidence and References sections to reflect the most current information.

Archived previous policy version CSNCT0389.06.

1State-specific policy (North Carolina only)

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Not Medically Necessary / Unproven Tests

Not medically necessary / Unproven tests

The following tests are considered unproven and not medically necessary due to insufficient evidence of efficacy:

ALL of the following

Arterial compliance testing using waveform analysis as a method to determine risk for cardiovascular disease
Carotid intima-media thickness (CIMT) measurement as an effective screening tool for the management of cardiovascular disease
Advanced lipoprotein analysis (e.g., Lp(a) subfractions or particle size) as a method to determine risk for cardiovascular disease
Lipoprotein-associated phospholipase A2 (Lp-PLA2) enzyme as a method to determine risk for cardiovascular disease or ischemic stroke
Endothelial function assessment (peripheral arterial tonometry [PAT] or brachial artery pressure ultrasound) as a prognostic indicator to determine risk of cardiovascular disease
Multi-protein diagnostic biomarker tests (examples listed)
- Analysis of protein biomarkers by aptamer-based microarray and algorithm
- Cardiovascular disease (HDL reverse cholesterol transport), cholesterol efflux capacity, LC-MS/MS, quantitative measurement of 5 distinct HDL-bound apolipoproteins (Apo A1, C1, C2, C3, C4) with algorithm reported as a risk score
- 3-protein panel: high-sensitivity troponin, adiponectin, and kidney injury molecule-1 (KIM-1) with algorithm and reported risk score
- 4-protein panel: NT-proBNP, osteopontin, TIMP-1, and KIM-1 with algorithm and reported risk score
- 7-protein panel: IL-16, FAS, FASLigand, HGF, CTACK, EOTAXIN, MCP-3 with algorithm and reported risk score

ALL of the following

(Operational) These services are listed as unproven and not medically necessary for cardiovascular risk assessment and management per this policy.

Clinical utility conclusions from evidence review

Summarized determinations from cited studies regarding clinical utility:

ALL of the following

Lp(a): Observational cohorts and meta-analyses show elevated Lp(a) is associated with increased risk of ischemic stroke, coronary events and CVD, but the cited literature does not demonstrate that measuring Lp(a) improves clinical outcomes or management decisions.
Multiple limitations noted (heterogeneity, lack of standard cutoffs in many studies, lack of intervention/outcome data).
Lp-PLA2: Elevated Lp-PLA2 activity or mass is associated with higher risk of stroke and CHD in some cohorts and meta-analyses, but inconsistency across studies and low-quality evidence prevent conclusions that testing improves outcomes or guides effective management.
Test methods varied across studies; role as adjunctive risk assessment not established.
Multi-protein biomarker panels/algorithm-reported risk scores: Some derivation and validation studies report good discrimination (AUCs up to ~0.85) for obstructive CAD or MACE, but there is insufficient evidence that using these tests changes clinical management or improves patient outcomes.
Limited prospective/utility data; external validation limited.

Guideline recommendations (when testing may be considered)

Selected guideline-based contexts where testing may be considered:

ANY of the following

AACE/ACE (2020): consider measuring Lp(a) in individuals with clinical ASCVD (especially premature/recurrent despite LDL-C lowering); family history of premature ASCVD or increased Lp(a); South Asian or African ancestry with family history; 10-year ASCVD risk ≥ 10% (primary prevention); personal/family history of aortic valve stenosis; refractory LDL-C despite therapy.
ACC/AHA (2019): Lp(a) measurement is a relative indication in the presence of family history of premature ASCVD; Lp(a) ≥ 50 mg/dL or ≥ 125 nmol/L is a risk-enhancing factor.
AACE (2017): Lp(a) testing is not generally recommended but may help assign risk in select cases (e.g., unexplained family history of early ASCVD); CIMT may be considered to refine risk stratification in some patients; Lp-PLA2 has shown greater specificity than hsCRP in some studies for risk stratification.

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Guideline-aligned statements and recommendations (informational)

This section summarizes guideline positions referenced in the policy — these are informational and indicate where tests are recommended, reasonable, not recommended, or of uncertain utility:

ANY of the following

ACC/AHA 2019: identifies risk-enhancing factors including elevated Lp(a) (≥ 50 mg/dL or ≥ 125 nmol/L), elevated hsCRP (≥ 2.0 mg/L), apoB (≥130 mg/dL), persistent triglycerides ≥175 mg/dL (nonfasting), and ABI <0.9; CIMT not recommended for routine measurement (2013 guidance).
ACC/AHA (2010/various): measures of arterial stiffness outside research settings are not recommended; CIMT may be reasonable in selected asymptomatic adults at intermediate risk (Class IIa); advanced lipoprotein testing beyond standard profile is not recommended for routine assessment (Class III); Lp-PLA2 might be reasonable in intermediate-risk asymptomatic adults but usefulness is less established (Class IIb).
AHA 2022: Lp(a) is causal for ASCVD and may inform decision-making but further studies are needed.
USPSTF 2018: evidence insufficient to recommend ABI screening for PAD and CVD risk in asymptomatic adults.

UnitedHealthcare policy decisions reflected in this part (summary of changed items)

Operational coverage changes and not medically necessary additions noted in Policy History:

ALL of the following

A specific HDL reverse cholesterol transport cholesterol efflux capacity LC-MS/MS panel (quantitative measurement of 5 HDL-bound apolipoproteins A1, C1, C2, C3, C4 with algorithm and reported risk score) was added to the list of unproven and not medically necessary services.
CPT code 0541U was added to Applicable Codes; note that 0541U is not on the North Carolina Medicaid Fee Schedule and therefore may not be covered by the North Carolina Medicaid Program.
CPT code 0308U description was revised in the Applicable Codes section.

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title': 'UnitedHealthcare policy decisions reflected in this part (summary of changed items)

Relevant CPT/PLA/HCPCS Codes (for reference)

Proprietary / algorithmic PLA / multi-protein test CPT/PLA codes (listed for reference)CPT|PLA|HCPCS

0019M	Cardiovascular disease, plasma, analysis of protein biomarkers by aptamer-based microarray and algorithm reported as 4-year likelihood of coronary event in high-risk populations.
0052U	Lipoprotein, blood, high resolution fractionation and quantitation of lipoproteins, including all five major lipoprotein classes and subclasses of HDL, LDL, and VLDL by vertical auto profile ultracentrifugation.
0308U	Cardiology (coronary artery disease [CAD]), analysis of 3 proteins (high sensitivity [hs] troponin, adiponectin, and kidney injury molecule-1 [KIM-1]) with 3 clinical parameters (age, sex, history of cardiac intervention), plasma, algorithm reported as a risk score for obstructive CAD.
0309U	Cardiology (cardiovascular disease), analysis of 4 proteins [NT-proBNP, osteopontin, tissue inhibitor of metalloproteinase-1 (TIMP-1), and kidney injury molecule-1 (KIM-1)], plasma, algorithm reported as a risk score for major adverse cardiac event.
0377U	Cardiovascular disease, quantification of advanced serum or plasma lipoprotein profile, by nuclear magnetic resonance (NMR) spectrometry with report of a lipoprotein profile (including 23 variables).
0415U	Cardiovascular disease [acute coronary syndrome (ACS)], IL-16, FAS, FASLigand, HGF, CTACK, EOTAXIN, and MCP-3 by immunoassay combined with age, sex, family history, and personal history of diabetes, blood, algorithm reported as a 5-year (deleted risk) score for ACS.
0541U	Cardiovascular disease (HDL reverse cholesterol transport), cholesterol efflux capacity, LC-MS/MS, quantitative measurement of 5 distinct HDL-bound apolipoproteins (apolipoproteins A1, C1, C2, C3, and C4), serum, algorithm reported as prediction of coronary artery disease (pCAD) score.

Other relevant CPT/HCPCS codes referencedCPT|HCPCS

83695	Lipoprotein (a).
83698	Lipoprotein-associated phospholipase A2 (Lp-PLA2).
83701	Lipoprotein, blood; high resolution fractionation and quantitation of lipoproteins including lipoprotein subclasses when performed (e.g., electrophoresis, ultracentrifugation).
83704	Lipoprotein, blood; quantitation of lipoprotein particle number(s) (e.g., by nuclear magnetic resonance spectroscopy), includes lipoprotein particle subclass(es), when performed.
93050	Arterial pressure waveform analysis for assessment of central arterial pressures, includes obtaining waveform(s), digitization and application of nonlinear mathematical transformations to determine central arterial pressures and augmentation index, with interpretation and report, upper extremity artery, non-invasive.
93799	Unlisted cardiovascular service or procedure.
93895	Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral.
93998	Unlisted noninvasive vascular diagnostic study.

Applicable CPT Category III codes (not exhaustive in this part — additions noted)CPT

0541U	Newly added CPT code (detailed descriptor present in Applicable Codes section of policy); noted as not on NC Medicaid Fee Schedule
0308U	CPT code with revised description (as noted in revision history)

Actions, Documentation & Billing Implications

Documentation Required

Reference codes and clinical rationale when ordering advanced tests

When ordering any of these proprietary or advanced lipoprotein/biomarker tests, document the clinical indication and rationale in the medical record; the policy lists these tests as unproven/not medically necessary and plan reviewers may require clinical justification.

0019M
0052U
0308U
0309U
0377U
0415U
0541U
83695
83698
83701
83704
93050
93895

Clinical Thresholds and Cutpoints Referenced

Risk thresholds and cutpoints

cfPWV mortality-related cutpointapproximately 10.7 - 11.5 m/s — meta-analysis reported closest cut-off points near 10.7 and 11.5 m/s for cardiovascular and all-cause mortality prediction; clinical utility not established.

CIMT diagnostic cutoff referenced in literature≈ 1.0 mm — meta-analysis subgroup identified a 1 mm cutoff with higher specificity for CAD diagnosis; overall clinical utility not established.

Lp(a) elevated threshold (ACC/AHA risk-enhancing factor)≥ 50 mg/dL or ≥ 125 nmol/L — designated a risk-enhancing factor in ACC/AHA guidance.

Persistent hypertriglyceridemia (ACC/AHA risk enhancer)≥ 175 mg/dL (nonfasting)

Apolipoprotein B elevated (ACC/AHA risk enhancer)≥ 130 mg/dL — relative indication when triglycerides ≥ 200 mg/dL.

Ankle-brachial index (ACC/AHA risk enhancer)

Clinical and Policy Background

This policy summarizes the evidence for several noninvasive tests proposed to refine cardiovascular disease (CVD) risk assessment beyond standard risk factors and conventional lipid panels. Tests reviewed include measures of arterial compliance (such as pulse wave analysis and carotid-femoral pulse wave velocity), carotid intima-media thickness (CIMT), advanced lipoprotein testing (including measurement of Lp(a), NMR-based particle counts/fractionation, and Lp-PLA2), and multi-protein algorithmic biomarker panels (proprietary proteomic/algorithm tests and cholesterol efflux capacity/HDL functional assays).

The evidence review finds that many of these tests show statistical associations with atherosclerotic disease or future events in observational studies and meta-analyses (for example, cfPWV has been associated with cardiovascular and all-cause mortality and certain multi-protein panels and cholesterol efflux capacity correlate with CAD), but limitations are consistent across the literature: heterogeneous methods, variable thresholds, limited prospective utility studies, and scarce data showing that test use changes clinical management or improves patient outcomes.

Accordingly, UnitedHealthcare concludes that while some measures demonstrate epidemiologic associations with CVD outcomes, the incremental clinical utility—meaning consistent, prospectively demonstrated improvements in management decisions or patient-important outcomes—from routine use of these arterial compliance tests, CIMT, advanced lipoprotein analyses, Lp-PLA2, endothelial function testing, and multi-protein algorithmic biomarker panels has not been established; these tests are therefore listed as unproven and not medically necessary in this policy.

Defined Terms

Definitions

CIMTCarotid intima-media thickness — ultrasound measurement of carotid artery wall thickness proposed as a marker of atherosclerosis.

cfPWVCarotid-femoral pulse wave velocity — measure of arterial stiffness; higher values associated with increased mortality in observational studies.

Lp(a)Lipoprotein(a) — an LDL-like particle associated with increased cardiovascular risk; clinical utility of routine measurement is not established in this policy.

Lp-PLA2Lipoprotein-associated phospholipase A2 — a vascular inflammatory enzyme measured as a potential risk marker for coronary heart disease and stroke; considered unproven in this policy.

PATPeripheral arterial tonometry — a noninvasive test of microvascular endothelial function, often reported as reactive hyperemia index (RHI) or PAT ratio.

CEC

Policy Updates and Material Changes

10/01/2025coverage_revisionLatest

Revised list of unproven and not medically necessary services; added specific HDL reverse cholesterol transport cholesterol efflux capacity LC‑MS/MS panel (quantitative measurement of 5 HDL‑bound apolipoproteins A1, C1, C2, C3, C4) with algorithm and reported risk score.

10/01/2025code_addition

Added CPT code 0541U to Applicable Codes and noted it is not on the North Carolina Medicaid Fee Schedule and therefore may not be covered by NC Medicaid.

10/01/2025code_revision

Policy Summary

PayerUnitedHealthcare

PolicyCardiovascular Disease Risk Tests (for North Carolina Only)

Policy CodePolicy CSNCT0389.07

Change TypeCoverage clarification and code updates

Effective DateOct 1, 2025

Next Review Date

SourceLink

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