ModifiedUnitedHealthcarePolicy CS015LA.Q

Cardiovascular Disease Risk Tests (for Louisiana Only)

Defines UnitedHealthcare Louisiana policy on coverage and medical necessity for several cardiovascular disease (CVD) risk tests (e.g., arterial compliance, carotid intima-media thickness, advanced lipoprotein and multi-protein biomarker panels) for members in Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicyCardiovascular Disease Risk Tests (for Louisiana Only)

Policy CodePolicy CS015LA.Q

Change TypeMaterial additions and coding update

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionVerify benefit-specific prior authorization requirements before ordering listed CIMT, advanced lipoprotein, or multi-protein biomarker tests.

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 the Applicable Codes section.

Updated Clinical Evidence and References sections.

multipleUnproven tests

>10Codes listed

LouisianaGeographic applicability

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recommendedGuideline support (Lp[a])

Coverage Criteria and Clinical Rationale

Not Medically Necessary / Unproven Tests

The following tests and services are designated as Not Medically Necessary / Unproven due to insufficient evidence of clinical utility (i.e., lack of prospective studies demonstrating that use of the test alters management or improves patient outcomes):

ALL of the following

Arterial compliance testing (including pulse wave analysis or pulse wave velocity) using waveform analysis as a method to determine risk for cardiovascular disease
Carotid intima-media thickness (CIMT) measurement as a routine screening tool for cardiovascular disease management
Advanced lipoprotein analyses beyond standard fasting lipid profile (examples include lipoprotein(a) subfractionation, LDL particle number/size, small dense LDL assays) as a method to determine cardiovascular risk or to guide routine management
Lipoprotein-associated phospholipase A2 (Lp-PLA2) enzyme testing as a method to determine risk for cardiovascular disease or ischemic stroke
Endothelial function assessments (including peripheral arterial tonometry [PAT], reactive hyperemia index, and brachial artery flow-mediated dilation [FMD]) for routine cardiovascular risk screening in asymptomatic individuals
Multi-protein diagnostic biomarker panels reported as a risk score, including but not limited to: analysis of protein biomarkers by aptamer-based microarray with algorithm; panels reporting HDL reverse cholesterol transport or cholesterol efflux capacity by LC-MS/MS; quantitative measurement of multiple HDL-bound apolipoproteins (for example apolipoproteins A1, C1, C2, C3, C4) with an algorithmic risk score; and algorithm-reported risk scores derived from small protein sets (eg, hs-troponin/adiponectin/KIM-1; NT-proBNP/osteopontin/TIMP-1/KIM-1; 7-protein panels such as IL-16, FAS, FAS Ligand, HGF, CTACK, EOTAXIN, MCP-3)
Cholesterol efflux capacity assays and HDL apolipoprotein panels reported with an algorithmic risk score
Any other multi-marker or aptamer-based algorithmic biomarker tests not supported by high-quality prospective evidence demonstrating improved clinical decision-making or patient outcomes

Applicable Codes and Key Thresholds

Applicable procedure and lab codesmixed

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.
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.

1–10 of 15

1/2

Applicable CPT Codes (added)CPT

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.

cfPWV cut-off points reported in meta-analysis

cfPWV cut-off rangeMeta-analysis reported closest cut-off points ~10.7–11.5 m/s for carotid-femoral pulse wave velocity (cfPWV)

cfPWV predictive performancePooled diagnostic odds ratios: 11.23 for cardiovascular mortality and 6.52 for all-cause mortality (HSROC AUC 0.75–0.78)

Population and study countNine studies (n = 3,170) of longitudinal design included in the cfPWV meta-analysis

CIMT cutoff and Lp(a) threshold

CIMT diagnostic cutoffMeta-analysis subgroup identified an IMT cutoff of ~1.0 mm as a more accurate diagnostic criterion for CAD

CIMT diagnostic performance

Provider Requirements, Prior Authorization, and Documentation

Note

(reserved)

Billing Rule

Coding and documentation note

Inclusion of a code in the policy code table is for reference only and does not guarantee coverage. Verify member benefits, prior authorization requirements, and applicable federal/state/contractual rules before ordering or billing these tests.

Applicable codes listed in this policy may be subject to benefit-specific prior authorization or other billing rules.

Prior Authorization

Prior Authorization Required — verify benefits

Background and Scope

Cardiovascular disease (including coronary artery disease, stroke, and hypertension) remains a leading cause of morbidity and mortality. This policy defines UnitedHealthcare Louisiana’s position on a range of CVD risk tests — including arterial compliance/waveform analysis, carotid intima‑media thickness (CIMT), endothelial function testing (PAT/FMD), advanced lipoprotein panels (Lp[a], ApoB, particle analyses), Lp‑PLA2, and proprietary multi‑protein biomarker panels — and clarifies which services are considered unproven or not medically necessary for members in Louisiana.

Key Definitions and Test Descriptions

Arterial compliance / pulse wave analysis

DefinitionArterial compliance (arterial elasticity/stiffness) is the noninvasive assessment of arterial elasticity using waveform analysis including pulse wave velocity and augmentation index

Test descriptionNoninvasive methods include pulse wave velocity (e.g., carotid-femoral PWV) and arterial pressure waveform analysis that digitizes waveforms to estimate central arterial pressures and augmentation index

Clinical contextThese indices are proposed as early indicators of cardiovascular disease but incremental clinical utility for management is not established

Carotid intima-media thickness (CIMT)

DefinitionCarotid intima-media thickness (CIMT) is an ultrasound measurement of carotid artery wall thickness used as a marker of carotid atherosclerosis and subclinical atherosclerosis

Description

Policy Summary

PayerUnitedHealthcare

PolicyCardiovascular Disease Risk Tests (for Louisiana Only)

Policy CodePolicy CS015LA.Q

Change TypeMaterial additions and coding update

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionVerify benefit-specific prior authorization requirements before ordering listed CIMT, advanced lipoprotein, or multi-protein biomarker tests.

SourceLink

On This Page

Pooled sensitivity 0.68 and specificity 0.70 (AUC 0.74); subgroup with 1 mm cutoff showed sensitivity 0.66, specificity 0.79 (AUC 0.80)

Lp(a) threshold exampleATTICA cohort used a threshold of 50 mg/dL to define abnormal Lp(a); Lp(a) ≥50 mg/dL associated with higher 10-year CVD event rate

Lp(a) risk thresholds and nmol conversions

Low Lp(a)< 30 mg/dL (≈75 nmol/L)

Intermediate Lp(a)30–50 mg/dL (≈75–125 nmol/L)

High Lp(a)≥ 50 mg/dL (≈125 nmol/L)

Very high Lp(a)> 180 mg/dL (> 430 nmol/L)

Ankle-brachial index (ABI)

ABI threshold for PADAnkle-brachial index (ABI) < 0.9 indicates peripheral arterial disease

ACC/AHA guidance noteABI < 0.9 listed as a risk-enhancing factor in ACC/AHA primary prevention guidance

Screening evidenceUSPSTF 2018 statement indicates insufficient evidence to screen asymptomatic adults routinely with ABI

Triglyceride threshold related to ApoB

Triglyceride thresholdTriglycerides ≥ 200 mg/dL cited as a relative indication to measure apolipoprotein B (ApoB)

ApoB clinical roleApoB used as an adjunct to standard lipid testing for risk assessment in selected patients

Corresponding ACC/AHA noteACC/AHA indicates ApoB ≥ 130 mg/dL is a risk-enhancing factor and measurement may be considered when triglycerides ≥ 200 mg/dL

CLIA quality standard and related regulatory notes

CLIA quality standard requirementAdvanced lipoprotein analysis must be performed in accordance with the quality standard established by the Clinical Laboratory Improvement Amendments (CLIA) of 1988

FDA product codesProducts used to measure Lp(a) and Lp-PLA2 have specific FDA product codes (DER, MSJ for Lp(a); NOE and JJX for Lp-PLA2)

CIMT and device regulationB-mode ultrasound equipment used to measure CIMT is regulated by FDA (product code IYO)

Prior authorization may be required for select advanced lipid and specialty cardiovascular tests depending on the member's benefit plan. Confirm PA requirements prior to ordering.

Advanced lipid testing (e.g., NMR, Lp(a), advanced lipoprotein subfraction testing)
CIMT and other vascular imaging when used for CVD risk assessment

Documentation Required

Required documentation for medical necessity

Advanced lipid tests and related specialty assays have limited supporting evidence for routine use. Documentation submitted for medical necessity should include the clinical indication, baseline risk assessment (traditional risk factors and risk score), and rationale for choosing the advanced test and how results will change management.

Provide personal/family history, prior lipid testing, and treatment attempts.
Indicate guideline-based indication if present (see policy guidance).

Step Therapy

Step therapy sequencing

Stepwise risk assessment and optimization of standard therapies should be completed before ordering advanced or proprietary tests. Consider standard lipid panel, ASCVD risk estimation, and appropriate therapeutic trials prior to specialty testing.

Ensure conventional risk stratification and treatment optimization have been attempted and documented.

Denial Risk

Denial risk for unproven or routine use

Carotid intima-media thickness (CIMT), endothelial function testing, routine ABI screening in asymptomatic adults, advanced lipoprotein panels, Lp-PLA2, and proprietary multi-protein panels are considered unproven for routine CVD risk screening or management. Claims for these services when ordered routinely or without clear impact on management are at risk for denial.

Arterial compliance/waveform analysis
CIMT for routine screening
Endothelial function assessment (e.g., PAT, brachial artery ultrasound)
Advanced lipoprotein analyses and Lp-PLA2
Proprietary multi-protein algorithmic panels (see documentation requirements)
ABI screening in asymptomatic adults

Denial Risk

Endothelial function assessment — insufficient evidence

Endothelial function assessment (including peripheral arterial tonometry and brachial artery ultrasound) is not supported by sufficient evidence to demonstrate clinical utility for predicting cardiovascular events or changing management. Use is likely to be denied when used for routine risk stratification.

Documented statistical associations do not equate to demonstrated clinical utility or improved outcomes.

Denial Risk

ABI screening evidence insufficiency

Ankle-brachial index (ABI) screening in asymptomatic adults lacks sufficient evidence to assess the balance of benefits and harms. Routine ABI screening for CVD risk assessment in asymptomatic individuals is likely to be denied.

Refer to USPSTF statement indicating insufficient evidence for ABI screening in asymptomatic adults.

Documentation Required

Proprietary multi-protein risk score — evidence submission requirement

Proprietary multi-protein risk scores and algorithm-based biomarker panels require submission of clinical utility evidence from the performing laboratory or manufacturer. Labs must provide peer-reviewed clinical outcome data demonstrating that the test meaningfully changes management and improves patient outcomes for the intended use.

When submitting for coverage consideration, include component biomarkers, algorithm description, analytic validation, clinical validity, and clinical utility evidence.
Examples of listed proprietary codes: 0019M, 0308U, 0309U, 0415U, 0541U.

Denial Risk

Denial risk for added unproven tests

Newly added or evolving tests (for example, HDL reverse cholesterol transport/cholesterol efflux capacity assays and other novel biomarker panels) are included among services likely to be denied until high-quality evidence demonstrates clinical utility and impact on patient management.

Providers should expect denial risk for recently introduced or unproven assays unless robust clinical utility data are provided.

Billing Rule

Prior authorization and state-fee-schedule note

UnitedHealthcare may utilize third-party utilization management tools (e.g., InterQual) and federal/state/contractual provisions may supersede this policy. Confirm applicable external utilization criteria and local fee schedule coverage (e.g., some codes may not be covered under certain state Medicaid programs).

CPT 0541U added to applicable codes; note: may not be on State of Louisiana Medicaid Fee Schedule.

CIMT uses B-mode ultrasound to capture carotid images and software to analyze IMT; various IMT definitions exist (single-segment vs combined IMT) with Combined-IMT more strongly associated with CVD events

LimitationsClinical evidence is insufficient that CIMT testing adds benefit beyond traditional risk assessment or alters management to improve outcomes

Advanced lipoprotein analysis and Lp-PLA2

DefinitionAdvanced lipoprotein analysis includes laboratory assays assessing lipoprotein subclasses/particles (e.g., NMR, ultracentrifugation), lipoprotein(a), apolipoproteins, and Lp-PLA2

Assay typesExamples include NMR spectrometry, vertical auto profile ultracentrifugation, and LC-MS/MS for specific HDL apolipoproteins

Clinical utility noteStudies report inconsistent incremental benefit over conventional risk factors and assay standardization is lacking; clinical utility remains unestablished

Multi-protein diagnostic biomarker panels

DefinitionMulti-protein diagnostic biomarker panels are algorithmically scored blood tests measuring multiple proteins (examples include 3-, 4-, or 7-protein panels and aptamer-based proteomic assays)

ExamplesTest examples described include 3-protein (hs-troponin, adiponectin, KIM-1), 4-protein (NT-proBNP, osteopontin, TIMP-1, KIM-1), and aptamer-based 4-protein panels reported with an algorithmic risk score

Evidence and limitationSystematic reviews and meta-analyses report associations or model performance but do not demonstrate improved patient outcomes or established clinical utility

CIMT — short definition

CIMT (short definition)Carotid intima-media thickness (CIMT) is an ultrasound measure of carotid artery wall thickness used as a subclinical atherosclerosis marker

Use noteUsed in research and some risk stratification contexts; routine clinical utility and impact on management remain unproven

Lipoprotein (a) — definition and assay variability

Lp(a) definitionLipoprotein(a) is an LDL-like particle containing apolipoprotein(a) and is associated with increased cardiovascular risk; thresholds vary across studies

Assay variability noteLp(a) assays and reporting units vary; guideline-recommended thresholds use mg/dL and nmol/L conversions and differ across societies

Epidemiologic associationCohort and pooled analyses show higher risk at elevated percentiles (e.g., ≥90th percentile) and thresholds such as 50 mg/dL used in some studies

Lp-PLA2 — definition and clinical utility notes

Lp-PLA2 definitionLipoprotein-associated phospholipase A2 (Lp-PLA2) is a vascular inflammatory enzyme measured as mass or activity and evaluated as a biomarker for CHD and stroke risk

Clinical utility noteMeta-analyses report modest associations with stroke and CHD (e.g., one-SD increases RR ≈1.07–1.11; highest vs lowest categories RR up to ~1.56–1.68) but assay heterogeneity and low-quality evidence limit conclusions

RecommendationAdditional well-designed trials are needed to establish clinical utility before routine use

Lp(a) — association with major coronary events at high percentiles

Lp(a) and major coronary eventsBiomarCaRE pooled analysis found Lp(a) levels ≥90th percentile associated with increased risk for major coronary events and CVD

Subgroup noteHighest Lp(a)-associated risk was observed in participants with diabetes in the pooled cohorts

Follow-up and eventsAnalysis included 56,804 participants with median follow-up around 8–9 years showing increased MCE and CVD event rates at high Lp(a) percentiles

Lp-PLA2 — mass versus activity and related notes

Lp-PLA2 mass vs activityLp-PLA2 can be measured either as mass or as enzymatic activity; studies report associations for both measures

Meta-analysis findingsMeta-analyses show one-SD higher Lp-PLA2 associated with modestly increased stroke risk and highest vs lowest categories with larger RRs

Assay heterogeneityDifferent test methods across studies introduce potential bias and limit comparability

Cholesterol efflux capacity (CEC)

CEC definitionCholesterol efflux capacity (CEC) is a functional HDL assay measuring HDL's ability to remove cholesterol from macrophages (reverse cholesterol transport)

Association evidenceSystematic reviews/meta-analyses report lower CEC in CAD patients and that higher CEC is associated with reduced adverse cardiovascular events, but incremental clinical utility is unproven

Assay standardizationNo gold-standard CEC assay established; cutoff values vary across studies limiting clinical application

Reactive Hyperemia Index (RHI)

RHI definitionReactive Hyperemia Index (RHI) is a peripheral arterial tonometry-derived measure reflecting digital pulse amplitude change after induced reactive hyperemia

Test deviceRHI is obtained using fingertip peripheral arterial tonometry (PAT) devices such as EndoPAT

Clinical findingsLarge community cohort analyses did not find clinically relevant associations between PAT-derived measures and incident CVD or mortality

Lipoprotein (a) [Lp(a)] — genetics and risk-enhancing factor

Lp(a) genetics and roleLipoprotein (a) is an LDL-like particle largely determined by genetics and is considered a risk-enhancing factor for atherosclerotic cardiovascular disease

Clinical measurement rationaleGuidelines recommend measuring Lp(a) in select populations (e.g., family history of premature ASCVD, unexplained recurrent ASCVD) and at least once per lifetime per ESC/EAS

Assay/threshold variabilityReported thresholds and units vary across studies and guidelines (mg/dL vs nmol/L); conversion and interpretation should follow guideline context

Apolipoprotein B (ApoB)

ApoB definitionApolipoprotein B (ApoB) is a measure of the number of atherogenic lipoprotein particles and is used as an adjunct to standard lipid testing in selected patients

Guideline targetsAACE guidance provides ApoB treatment goals (e.g., <90 mg/dL for increased risk; <80 mg/dL for established ASCVD/diabetes with risk factors; <70 mg/dL for extreme risk)

Indication noteACC/AHA notes ApoB ≥130 mg/dL is a risk-enhancing factor and measurement is relatively indicated when triglycerides ≥200 mg/dL

Endothelial function testing (EndoPAT) and FDA note

EndoPAT device and clearanceEndoPAT 2000 is a noninvasive PAT device cleared by FDA (510[k] K032519) as a diagnostic aid to detect coronary artery endothelial dysfunction in selected patients

Intended useEndoPAT clearance indicates intended use in patients with signs/symptoms of ischemic heart disease indicated for coronary angiography but lacking obstructive CAD; not intended for general population screening

Clinical evidence limitationCommunity cohort analyses do not support routine use of PAT/EndoPAT for screening asymptomatic populations

Carotid intima-media thickness (CIMT) — device regulation and surrogate marker

CIMT device regulationCIMT measurement is performed using B-mode ultrasound equipment regulated by the FDA (device product code IYO); CIMT itself is a procedure rather than an FDA-regulated test

Surrogate marker noteCIMT is used as a surrogate marker of atherosclerosis in some contexts, but evidence of clinical utility for routine risk stratification is insufficient

Heterogeneity in definitionsMultiple CIMT definitions exist across studies (single-segment vs combined IMT) which may affect associations and limit standardization

Advanced lipoprotein analysis / Lp(a) / Lp-PLA2 — lab assay group

Lab assay groupAdvanced lipoprotein analysis, Lp(a), and Lp-PLA2 comprise laboratory assays measuring lipoprotein subclasses, specific apolipoproteins, and vascular inflammatory enzymes

Assay examplesIncludes NMR spectrometry (0377U), vertical auto profile ultracentrifugation (0052U), and LC-MS/MS panels (0541U) as described in applicable codes

Quality and standardization noteAdvanced lipoprotein analyses must conform to CLIA quality standards; lack of assay standardization limits comparability and clinical utility