CurrentUnitedHealthcarePolicy CSOISNJ.Q

Cardiovascular Disease Risk Tests (for New Jersey Only)

UnitedHealthcare medical policy (New Jersey only) governing coverage and medical necessity determination for various cardiovascular disease (CVD) risk tests, including carotid intima-media thickness (CIMT), arterial compliance/waveform analysis, advanced lipoprotein analyses (including Lp(a), Lp-PLA2), and multi-protein/algorithm-based biomarker tests. Contains descriptions, evidence summaries, and applicable CPT/HCPCS/Laboratory codes listed for reference.

Policy Summary

PayerUnitedHealthcare

PolicyCardiovascular Disease Risk Tests (for New Jersey Only)

Policy CodePolicy CSOISNJ.Q

Change TypeAdded and revised services listed as unproven/not medically necessary

Effective DateOct 1, 2025

Next Review Date

Key ActionDocument clinical rationale linking requests for these tests to management decisions and follow New Jersey state/contractual requirements when requesting coverage.

POLICY UPDATE CHANGES

Added 'cardiovascular disease (HDL reverse cholesterol transport), cholesterol efflux capacity, LC-MS/MS, quantitative measurement of 5 distinct HDL-bound apolipoproteins ...' to list of unproven and not medically necessary services.

Revised list of unproven and not medically necessary services.

11Tests/techniques listed as unproven/not medically necessary

1CPT codes added

multipleBiomarkers reviewed

Document page count referenced

MultipleGuideline sources cited

Coverage Summary

UnitedHealthcare's New Jersey–only medical policy CSOISNJ.Q addresses coverage and medical necessity determinations for a group of cardiovascular disease (CVD) risk tests, including carotid intima-media thickness (CIMT), arterial compliance/waveform analysis, and a range of advanced lipoprotein analyses and biomarkers (for example, Lp(a), Lp-PLA2, and cholesterol efflux capacity), peripheral endothelial function assessments (eg, PAT/RHI, brachial FMD), and multi-protein/algorithmic panels (eg, aptamer-based arrays and other algorithm-scored protein panels).

The policy's overall coverage stance is mixed: several specific tests and multi-protein algorithmic panels are explicitly listed as unproven and not medically necessary for New Jersey members because the evidence does not demonstrate clinical utility. The document lists applicable CPT/HCPCS/laboratory codes for reference and notes an added CPT code (0541U) associated with the cholesterol efflux/advanced HDL assay in the 10/01/2025 revision.

Clinical thresholds referenced

Lp(a)>= 50 mg/dL or >= 125 nmol/L

Triglycerides (risk-enhancing)>= 175 mg/dL

High-sensitivity C-reactive protein (hsCRP)>= 2.0 mg/L

Apolipoprotein B (apoB)>= 130 mg/dL

Not Medically Necessary / Unproven Tests

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

ALL of the following

Carotid intima-media thickness (CIMT) measurement as an effective screening tool for the management of cardiovascular disease
Arterial compliance/waveform analysis: Arterial compliance testing, using waveform analysis as a method to determine risk for cardiovascular disease
Advanced lipoprotein analysis [e.g., lipoprotein(a), subfractions or particle size] as method to determine risk for cardiovascular disease
Lp-PLA2:

Clinical Conclusions and Coverage-relevant Statements

Clinical Conclusions / Coverage-relevant Statements

Summarized conclusions from evidence and guidelines regarding utility of tests:

Insufficient evidence for Lp-PLA2 utility: Insufficient evidence to support clinical utility of Lp-PLA2 alone or combined with other biomarkers to determine CHD risk in healthy or asymptomatic individuals; additional trials needed.

Lp(a) associations but unclear clinical utility: Elevated Lp(a) levels are associated with increased risk of CVD events in many cohort studies and meta-analyses, but clinical utility and incremental value over conventional risk factors and outcome improvement are not established.

Multi-protein panels lack demonstrated clinical utility: Multi-protein blood tests with algorithm and reported as a risk score have insufficient quality evidence to conclude effectiveness for screening or management of CVD; clinical utility not demonstrated.

Unproven and Not Medically Necessary Services (revised 10/01/2025)

Unproven and Not Medically Necessary Services (as revised 10/01/2025)

Policy lists tests/procedures considered unproven or not medically necessary; revision added specific advanced HDL/cholesterol efflux metrics.

Cholesterol efflux / advanced HDL apolipoprotein measurement (added 10/01/2025): 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

Explicitly added to list of unproven/not medically necessary in 10/01/2025 revision

Advanced lipoprotein analyses (particle sizing, NMR, remnant cholesterol): Advanced lipoprotein analyses (particle sizing, NMR LDL-P, small dense LDL, remnant cholesterol) are considered lacking standardization/evidence and listed as unproven/not medically necessary per policy references

Nonstandard vascular and endothelial biomarkers: Peripheral arterial tonometry, arterial stiffness/pulse wave analysis, CIMT, FMD and other nonstandard vascular biomarkers are considered not routinely recommended and are categorized as unproven/experimental or not medically necessary for routine screening in asymptomatic adults

Codes (reference and policy-relevant)

Referenced CPT/HCPCS/Laboratory codes (reference only)mixed

0052U	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.
0308U	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.
0309U	Cardiology (coronary artery disease [CAD]): analysis of 3 proteins (hs-troponin, adiponectin, KIM-1) with 3 clinical parameters, plasma, algorithm reported as a risk score for obstructive CAD.
0377U	Cardiology (cardiovascular disease), analysis of 4 proteins (NT-proBNP, osteopontin, TIMP-1, KIM-1), plasma, algorithm reported as a risk score for major adverse cardiac event.
0415U	Cardiovascular disease (acute coronary syndrome [ACS]), IL-16, FAS, FASLigand, HGF, CTACK, EOTAXIN, MCP-3 by immunoassay combined with age, sex, family history, and personal history of diabetes, blood, algorithm reported as a 5-year score for ACS.
0541U	Cardiovascular disease (HDL reverse cholesterol transport), cholesterol efflux capacity, LC-MSIMS, quantitative measurement of 5 distinct HDL-bound apolipoproteins, serum, algorithm reported as prediction of coronary artery disease (pCAD) score.
83695
83698	Lipoprotein (a).
83701	Lipoprotein-associated phospholipase A2 (Lp-PLA2).
83704	Lipoprotein, blood; high resolution fractionation and quantitation of lipoproteins including lipoprotein subclasses when performed.

1–10 of 14

1/2

Codes not on NJ Medicaid Fee Schedule (may not be covered by NJ Medicaid)mixed

0308U	Not on State of New Jersey Medicaid Fee Schedule
0309U	Not on State of New Jersey Medicaid Fee Schedule
0377U	Not on State of New Jersey Medicaid Fee Schedule
0415U	Not on State of New Jersey Medicaid Fee Schedule
0541U	Not on State of New Jersey Medicaid Fee Schedule

Applicable CPT codes (policy added)CPT

0541U

Added CPT code referenced in summary of changes (associated with added advanced HDL/cholesterol efflux measurement)

Provider Actions & Billing Impact

Denial Risk

Tests Considered Not Medically Necessary — Denial Risk

The following tests are considered not medically necessary and are subject to denial when billed without meeting the policy's medical necessity criteria. Denials may be issued if documentation does not justify clinical use for management or if federal/state/contractual requirements are not met.

Affected codes: 83695, 83698, 83701, 83704, 93050, 93799, 93895, 93998, 0052U, 0308U, 0309U, 0377U, 0415U, 0541U

Prior Authorization

Testing Should Be Justified by Clinical Context — Prior Authorization & Documentation

Targeted Lp(a) testing should be considered in accordance with current clinical guidelines (e.g., to refine cardiovascular risk assessment in individuals with a family history of premature ASCVD, unexplained early cardiovascular disease, or severe hypercholesterolemia). When ordering Lp(a), document the specific guideline-based indication and how results will influence management (treatment decisions, intensity of risk reduction strategies, or referral).

Background & Evidence Summary

Policy background summarizes the evidence and rationale evaluating tests proposed to measure or monitor atherosclerosis and CVD risk (eg, arterial compliance/waveform analysis, CIMT, advanced lipoprotein testing including Lp(a) and Lp-PLA2, cholesterol efflux capacity, endothelial function measures such as PAT/FMD, and multi-protein algorithmic biomarker panels).

At a high level, the policy concludes that although many studies and systematic reviews show statistical associations between these biomarkers or measures and CVD outcomes, the literature generally lacks consistent data that use of these tests in clinical practice alters management or improves patient-centered outcomes. Consequently, many listed tests are designated as unproven and not medically necessary for New Jersey members due to inadequate evidence of clinical utility, with targeted exceptions and guideline-based contexts noted for selective testing (eg, selective Lp(a) measurement per specialty guidance).

Evidence source	Summary
Systematic reviews / meta-analyses
Multiple systematic reviews and meta-analyses report associations between proposed tests and outcomes but conclude limited or inconsistent evidence of clinical utility or incremental value over standard risk factors (examples: emerging risk factors collaboration on lipid markers; Sequi-Dominguez cfPWV meta-analysis; Willeit et al. CIMT progression meta-analysis).
Cohort / observational studies
Large cohort and observational studies show associations of biomarkers/measurements with CVD events (eg, BiomarCaRE, Jackson Heart Study, various population cohorts), but do not establish that testing changes management or improves outcomes.
ACCELERATE trial subgroup analyses
Post-hoc analysis of ACCELERATE found higher Lp(a) tertiles associated with increased cardiovascular events in a high-risk secondary prevention cohort, but did not demonstrate that measuring Lp(a) within clinical care improves outcomes.
BiomarCaRE (Waldeyer et al. 2017)
Analysis of 56,804 participants found Lp(a) ≥90th percentile associated with higher hazard for major coronary events (HR ~1.49) and CVD (HR ~1.44) versus lowest third, suggesting association but not proven clinical utility for management.
Lp-PLA2 meta-analyses
Multiple meta-analyses report modest associations between higher Lp-PLA2 mass/activity and increased risk of stroke and CHD (eg Hu et al. 2019; Li et al. 2017), but heterogeneity and lack of evidence that testing alters outcomes limit clinical utility.
Endothelial function studies
Studies of peripheral arterial tonometry (PAT) and brachial flow-mediated dilation show mixed and often non-significant associations with composite CVD endpoints (eg Framingham, Gutenberg Health Study); overall evidence insufficient to support routine clinical use.
Cholesterol efflux capacity (CEC) meta-analyses
Systematic reviews/meta-analyses (eg Lee et al. 2021; Cheng et al. 2022) show lower CEC is associated with higher CAD risk and that a 0.1 unit increase in CEC is linked to ~5% reduced adverse CV events, but standardized assays, incremental value, and impact on outcomes are not established.
Multi-protein algorithmic tests (various panels/HART, HART CADhs, proteomic panels)
Evidence for multi-protein, algorithm-scored blood tests is limited to observational and diagnostic performance studies (eg Hayes brief on HART, McCarthy et al., Neumann et al., Mohebi et al.); clinical utility for screening or improving outcomes has not been demonstrated.
ACC/AHA guideline statements
ACC/AHA guidance does not recommend routine CIMT, arterial stiffness, or advanced lipoprotein analysis for asymptomatic adults (Class III), and states Lp-PLA2 may be reasonable in intermediate-risk adults but no evidence it changes management.
ESC/EAS and NLA guidance on Lp(a)
ESC/EAS recommends at least once lifetime Lp(a) measurement to identify very high inherited levels (>180 mg/dL); NLA and other societies recommend selective Lp(a) testing in specified clinical contexts but acknowledge limited evidence that lowering Lp(a) improves outcomes.
Biomarkers evidence summaries (Emerging Risk Factors Collaboration)
Large pooled cohort analyses found replacing total cholesterol/HDL-C with various advanced lipid parameters (apoB, Lp(a), Lp-PLA2) did not substantially improve CVD risk prediction.
Pulse wave velocity (cfPWV) prognostic studies/meta-analysis
Systematic review/meta-analysis of cfPWV found it predicts cardiovascular and all-cause mortality (pooled DOR/AUC reported) but incremental value and clinical utility for management were not reported.

Definitions / glossary:

Lp(a): Lipoprotein(a), an LDL-like particle with apo(a) attached; elevated levels are associated with increased CVD risk in observational studies.

Lp-PLA2: Lipoprotein-associated phospholipase A2, an enzyme associated with inflammation and atherosclerosis; measurable as mass or activity.

CEC (Cholesterol efflux capacity): A functional measure of HDL ability to remove cholesterol from macrophages (HDL reverse cholesterol transport).

PAT / RHI: Peripheral arterial tonometry / reactive hyperemia index, noninvasive fingertip pulse-amplitude measures of endothelial function.

CIMT: Carotid intima-media thickness, an ultrasound-based measure of carotid artery wall thickness used as a surrogate marker of atherosclerosis.

Revision History

10/01/2025addedLatest

Material change — Added CPT code 0541U and explicitly added 'cardiovascular disease (HDL reverse cholesterol transport), cholesterol efflux capacity, LC‑MS/MS, quantitative measurement of 5 distinct HDL‑bound apolipoproteins (A1, C1, C2, C3, C4), with algorithm and reported as a risk score' to the list of unproven and not medically necessary services.

10/01/2025revised

Material change — Revised list of unproven and not medically necessary services; Supporting Information, Clinical Evidence, and References sections updated; previous policy version archived.

Policy Summary

PayerUnitedHealthcare

PolicyCardiovascular Disease Risk Tests (for New Jersey Only)

Policy CodePolicy CSOISNJ.Q

Change TypeAdded and revised services listed as unproven/not medically necessary

Effective DateOct 1, 2025

Next Review Date

Key ActionDocument clinical rationale linking requests for these tests to management decisions and follow New Jersey state/contractual requirements when requesting coverage.

On This Page

Lipoprotein-associated phospholipase A2 (Lp-PLA2) enzyme as a method to determine risk for cardiovascular disease or ischemic stroke

Multi-protein diagnostic biomarker panels: Multi-protein diagnostic biomarker (listed variants) as method to determine risk for cardiovascular disease

Endothelial function assessment tools such as peripheral arterial tonometry (PAT) or brachial artery pressure ultrasound as a prognostic indicator to determine risk of cardiovascular disease

Aptamer-based proteomic analysis: Analysis of protein biomarkers by aptamer-based microarray and algorithm

3-protein algorithm score (hs-troponin, adiponectin, KIM-1): 3 proteins (hs-troponin, adiponectin, kidney injury molecule-1 [KIM-1]) with algorithm and reported as a risk score

Cholesterol efflux / advanced HDL apolipoprotein panel (0541U): Cardiovascular disease (HDL reverse cholesterol transport), cholesterol efflux capacity, LC-MSIMS, quantitative measurement of 5 distinct HDL-bound apolipoproteins (apolipoproteins A1, C1, C2, C3, and C4), with algorithm and reported as a risk score

4-protein algorithm score (NT-proBNP, osteopontin, TIMP-1, KIM-1): Proteins (NT-proBNP, osteopontin, TIMP-1, and KIM-1) with algorithm and reported as a risk score

7-protein ACS algorithm: 7 proteins (IL-16, FAS, FASLigand, HGF, CTACK, EOTAXIN, and MCP-3) with algorithm and reported as a risk score

Endothelial function assessments insufficient: Endothelial function assessment (eg, PAT, brachial FMD) has insufficient evidence to support effectiveness and clinical utility for establishing CVD risk; studies conflicting and do not show clear impact on management or outcomes.

Cholesterol efflux capacity (CEC) — association only: Cholesterol efflux capacity (CEC) is associated inversely with CAD risk in observational studies, but incremental value, standardized assays, and clinical utility to improve outcomes are not established.

Guideline-based Recommendations (selected)

Conditions where professional societies recommend consideration or not recommending testing:

AACE/ACE Lp(a) measurement contexts (2020): AACE/ACE (2020): Consider measurement of Lp(a) in: all individuals with clinical ASCVD (especially premature or recurrent despite LDL-C lowering); individuals of South Asian or African ancestry with family history of ASCVD or increased Lp(a); family history of premature ASCVD or increased Lp(a); individuals with 10-year ASCVD risk >= 10% (primary prevention) to stratify risk; patients with refractory LDL-C elevations despite aggressive therapy; personal or family history of aortic valve stenosis.

AACE (2017) CIMT and lipid testing guidance: AACE (2017): CIMT may be considered to refine risk stratification (intermediate evidence); apoB goals stated for risk categories; Lp-PLA2 measurement sometimes more specific than hsCRP when further stratification needed; Lp(a) testing not generally recommended except select cases (Caucasians with ASCVD, unexplained family history of early ASCVD, or unknown family history).

ACC/AHA (2019) Lp(a) thresholds as risk-enhancing: ACC/AHA (2019): Elevated Lp(a) if measured (>=50 mg/dL or >=125 nmol/L) is a risk-enhancing factor, relative indication for measurement is family history of premature ASCVD; other listed risk-enhancing factors (eg triglycerides >=175 mg/dL, hsCRP >=2.0 mg/L, apolipoprotein B >=130 mg/dL).>= 50 mg/dL or >= 125 nmol/L

ACC/AHA (2013/2010) not recommended uses: ACC/AHA (2013/2010): CIMT not recommended for routine measurement for initial CVD risk assessment; arterial stiffness measures not recommended outside research; advanced lipoprotein analysis not recommended routinely; peripheral FMD not recommended for risk assessment in asymptomatic adults.

ACC/AHA (asymptomatic adults) Lp-PLA2 Class IIb: ACC/AHA (asymptomatic adults): Lp-PLA2 might be reasonable for cardiovascular risk assessment in intermediate-risk asymptomatic adults but no evidence it changes management or outcomes (Class IIb, Level B).

Policy Rationale / Coverage Determinations (excerpted guideline-aligned statements)

Guideline and evidence-based statements summarized in policy to inform coverage decisions; specific policy additions noted in revision history.

General policy rationale: Policy rationale summarizes guideline-aligned statements about lack of demonstrated clinical utility for many tests and informs coverage determinations.

FDA clearances noted are informational and not a basis for coverage; see note below.

Not recommended measures (Class III): Measures of arterial stiffness (arterial compliance) are not recommended outside of research settings per ACC/AHA; Class III, Level C (no benefit)

Advanced lipoprotein analysis guidance (Class III): Measurement of advanced lipoprotein parameters (lipoproteins and apolipoproteins beyond standard fasting lipid profile) is not recommended for cardiovascular risk assessment in asymptomatic adults per ACC/AHA; Class III, Level C (no benefit)

Peripheral FMD (Class III): Peripheral arterial flow-mediated dilation (FMD) studies are not recommended for cardiovascular risk assessment in asymptomatic adults per ACC/AHA; Class III, Level B (no benefit)

Guideline-conditional branch

Lp-PLA2 Class IIb remark: Lp-PLA2 might be reasonable for cardiovascular risk assessment in intermediate-risk asymptomatic adults per ACC/AHA; Class IIb, Level B (conflicting evidence; usefulness less established)
Lp(a) society statements: Lp(a) measurement: several societies (AHA/ESC/NLA) note roles — ESC/EAS recommend measuring Lp(a) at least once in each adult lifetime to identify very high inherited levels; NLA recommends measurement in adults with recurrent/progressive ASCVD despite optimal therapy, certain other contexts; evidence on Lp(a)-lowering clinical outcomes is limited
ASCP against routine expanded lipid panels: ASCP recommends against routine expanded lipid panels (particle sizing, NMR) as screening tests for CVD

FDA clearances informational: FDA clearances noted for specific devices (EndoPAT 2000, SphygmoCor systems) but FDA approval alone is informational and not a basis for coverage

Documentation Required

State-Specific Policy — New Jersey Only

This policy applies only to services provided in New Jersey. Providers must follow applicable federal, state, and contractual requirements; state-mandated coverage or mandates in the member's contract take precedence. Ensure coding and billing align with New Jersey Medicaid and other applicable plan rules.

Prior Authorization

Prior Authorization Guidance & Plan-Governing Note

Prior authorization may be required for certain advanced cardiovascular risk tests. Submit clinical documentation that links the requested test to a management decision (e.g., change in therapy, referral, or additional diagnostic workup). Include relevant clinical history, prior risk assessment results, and any prior testing. Follow the payer's PA process and timelines; services not meeting PA requirements or lacking documentation may be denied.

Follow federal/state/contractual plan requirements prior to authorization
Provide: clinical indication, prior test results, planned management change based on results

Billing Rule

FDA Approval Informational Only — Billing Rule

FDA clearance or approval of a test is informational only and does not, by itself, establish coverage. Coverage decisions require demonstration of medical necessity and alignment with policy criteria and applicable federal/state/contractual rules.

CIMT (procedure note): Carotid intima-media thickness measured by B-mode ultrasound; the policy notes the measurement is a procedure (device regulated) rather than an FDA-regulated in vitro test.