CurrentUnitedHealthcarePolicy CS015NE.W

Cardiovascular Disease Risk Tests (for Nebraska Only)

UnitedHealthcare medical policy for Nebraska concerning the coverage and medical necessity of various cardiovascular disease (CVD) risk tests including arterial compliance (pulse wave/pressure/waveform analysis), carotid intima-media thickness (CIMT), advanced lipoprotein analyses (including Lp(a), apoB/apoA1, NMR, HDL proteomics), Lp-PLA2, endothelial function assessments (PAT/brachial ultrasound), and multiprotein/algorithmic biomarker panels. The document lists tests considered unproven and not medically necessary and provides related CPT/HCPCS/PLA codes and supporting evidence summaries.

Policy Summary

PayerUnitedHealthcare

PolicyCardiovascular Disease Risk Tests (for Nebraska Only)

Policy CodePolicy CS015NE.W

Change TypeRevised (Supporting Information updates)

Effective DateMay 1, 2026

Next Review Date

Key ActionThis medical policy applies only to the State of Nebraska; providers must follow Nebraska-specific coverage determinations for these tests.

SourceLink

POLICY UPDATE CHANGES

05/01/2026 Summary of Changes = Supporting Information: Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information.

9Tests Listed as Not Medically Necessary (categories)

16Procedure/PLA/CPT/HCPCS Codes Referenced

multipleEvidence volume

clinical utility not established

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~20%Population with elevated Lp(a)

1Policy Revision on File

Coverage Summary

Scope: UnitedHealthcare medical policy for Nebraska addressing coverage and medical necessity of various cardiovascular disease (CVD) risk tests including arterial compliance (pulse wave/pressure/waveform analysis), carotid intima-media thickness (CIMT), advanced lipoprotein analyses (including Lp(a), apoB/apoA1, NMR, HDL proteomics), Lp-PLA2, endothelial function assessments (PAT/brachial ultrasound), and multiprotein/algorithmic biomarker panels. Effective date: May 1, 2026.

High-level conclusion: Tests reviewed (arterial compliance, CIMT, advanced lipoprotein measures, Lp-PLA2, endothelial function testing, and multiprotein diagnostic biomarker panels) are considered unproven / not medically necessary due to insufficient evidence of clinical utility to change management or improve outcomes for the listed indications in Nebraska.

Key thresholds and quick facts

Lp(a) abnormal threshold≥ 50 mg/dL

Lp(a) risk strataLow <30 mg/dL ( <75 nmol/L); Intermediate 30–50 mg/dL (75–125 nmol/L); High ≥50 mg/dL (≥125 nmol/L); Very high >180 mg/dL (>430 nmol/L)

ApoB optimal goals<90 mg/dL (increased risk); <80 mg/dL (established ASCVD or diabetes+risk factor); <70 mg/dL (extreme risk)

Lp(a) prevalenceApproximately 20% of the population have elevated Lp(a)

Tests listed as Not Medically Necessary (categories)9

Procedure/PLA/CPT/HCPCS Codes Referenced16

Medical-Necessity Criteria

Not Medically Necessary / Unproven Tests

The following are 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 measurement as an effective screening tool for the management of cardiovascular disease
Advanced lipoprotein analysis (e.g., lipoprotein(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

Codes Referenced

Listed relevant PLA/HCPCS/CPT Codes referencedmixed

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 (CAD), analysis of 3 proteins (hs-troponin, adiponectin, KIM-1) with 3 clinical parameters, plasma, algorithm reported as risk score for obstructive CAD.
0309U	Cardiology (CVD), analysis of 4 proteins (NT-proBNP, osteopontin, TIMP-1, KIM-1), plasma, algorithm reported as a risk score for MACE.
0377U	Quantification of advanced serum or plasma lipoprotein profile by NMR spectrometry with report of lipoprotein profile (including 23 variables).
0415U	IL-16, FAS, FASLigand, HGF, CTACK, EOTAXIN, MCP-3 by immunoassay combined with age/sex/family history/diabetes history, algorithm reported as 5-year score for ACS.
0541U	Cholesterol efflux capacity, LC-MS/MS, quantitative measurement of 5 distinct HDL-bound apolipoproteins (Apo A1, C1, C2, C3, C4), algorithm reported as prediction of CAD (pCAD) score.
83695	Lipoprotein (a).
83698
83701	Lipoprotein, blood; high resolution fractionation and quantitation of lipoproteins including lipoprotein subclasses when performed (e.g., electrophoresis, ultracentrifugation).

1–10 of 15

1/2

FDA device clearances referencedmixed

K032519	Endo PAT 2000 510(k) clearance (intended as diagnostic aid for detection of coronary artery endothelial dysfunction; not intended for general population screening)
K001852	Predicate device PAT 1000 RD (Itamar Medical Ltd.) referenced in 510(k)
K122129	SphygmoCor XCEL System 510(k) clearance (central arterial pressure waveform analysis)
DXN	FDA product code for noninvasive blood pressure measurement system products (informational)
IYO	FDA product code for B-mode ultrasound equipment (CIMT equipment)
DFC	FDA product code for products measuring lipoprotein(a)
NOE/JJX	FDA product codes for Lp-PLA2 measurement products

Provider Actions & Billing Guidance

Denial Risk

Claims for Unproven Tests Risk Denial

Claims for the listed tests are considered unproven/not medically necessary and are subject to denial when billed for Nebraska members.

83695 - Lipoprotein (a)
83698 - (related lipoprotein code)
0019M - Analysis of protein biomarkers by aptamer-based microarray and algorithm
0052U - Lipoprotein, high resolution fractionation and quantitation (vertical auto profile ultracentrifugation)
0308U - Analysis of 3 proteins with algorithm reported as risk score for obstructive CAD
0309U - Analysis of 4 proteins with algorithm reported as risk score for major adverse cardiac event
0377U - Advanced serum or plasma lipoprotein profile by NMR spectrometry
0415U - Immunoassay panel with algorithm reported as a 5-year score for ACS
0541U - Cholesterol efflux capacity and quantitative measurement of 5 HDL-bound apolipoproteins
83701 - Lipoprotein, blood; high resolution fractionation and quantitation
83704 - Lipoprotein particle number quantitation (e.g., by NMR)

Background & Evidence Summary

Background: This policy reviews emerging and nonstandard CVD risk tests proposed to stratify atherosclerotic risk before symptomatic disease, including arterial compliance measures (pulse wave analysis, PWV), carotid intima-media thickness (CIMT), advanced lipoprotein measures (Lp(a), apoB, particle subfractions/NMR, HDL proteomics), Lp-PLA2, endothelial function testing (peripheral arterial tonometry [PAT], brachial ultrasound), and multiprotein algorithmic assays.

Overall conclusion: Although many studies report associations between these biomarkers/tests and cardiovascular risk, the evidence is insufficient to demonstrate clinical utility — i.e., that use of these tests changes management or improves patient outcomes — and thus these emerging/nonstandard tests are considered insufficiently supported to change clinical care for the listed uses.

Study / Source	Key finding
Li et al. (2025) meta-analysis	ePWV associated with increased cardiovascular events and mortality; no established cutoff; clinical utility not assessed.
Sequí-Domínguez et al. (2020) meta-analysis	cfPWV predictive for cardiovascular and all-cause mortality (pooled DORs/AUC reported); incremental value and clinical utility not reported.
Multiple systematic reviews/meta-analyses (2017-2025) on CIMT	CIMT associated with future CVD and carotid plaque but provides modest incremental reclassification beyond traditional risk factors; clinical utility unclear.
Emerging Risk Factors Collaboration (Di Angelantonio et al., 2012)	Adding emerging lipid markers (apoB, Lp(a), Lp-PLA2) to total cholesterol and HDL-C did not significantly improve CVD risk prediction.
Lp(a) and stroke recurrence (Palaiodimou et al. 2025)	Elevated Lp(a) associated with stroke recurrence (OR 1.69, 95% CI 1.09–2.63) and poor functional outcome (OR 2.09, 95% CI 1.40–3.11).
Lp(a) and long-term MACE (Berman et al. 2024)	In cohort of 16,419, 71st–90th percentile Lp(a) adjusted HR 1.21 and 91st–100th percentile HR 1.26 for MACEs; measurement clinical utility not established.
Women's Health Study (Ridker et al. 2024)	Top vs bottom quintile HR for first MACE: Lp(a) 1.33 (95% CI, 1.21–1.47); authors note Lp(a) is genetically determined and measurement recommended once.
Lp-PLA2 meta-analyses (Hu et al. 2019; Tian et al. 2017; Li 2017a)	Elevated Lp-PLA2 associated with small increased relative risks for stroke and ischemic stroke (RRs/HRs vary by mass vs activity); overall clinical utility not established.
Multiprotein panels (systematic reviews, Neumann 2024, Hayes 2023)	Biomarkers/panels show associations with events and some high AUCs in select cohorts, but generally add minimal improvement to established risk models and clinical utility is unproven.
Endothelial function (PAT/flow-mediated dilation) evidence (Cooper 2021; Schnabel 2021; Venuraju 2019; Hamburg 2008)	Studies report conflicting or null associations with composite CVD events; PAT measures not predictive for composite CVD in large cohorts though lower PAT ratio linked to higher incident stroke in some analyses; overall insufficient evidence of clinical utility for risk prediction.
PAT association with CVD/stroke (Cooper et al.; sensitivity analyses)	In Framingham analyses PAT ratio not associated with composite CVD events but higher PAT ratio associated with lower incident stroke risk (sensitivity analyses); results inconsistent and clinical utility not established.
Schnabel et al. (2021)	Peripheral vascular function measures (flow-mediated dilation, PAT) did not show clinically relevant associations with incident CVD or mortality in a large community cohort; routine measurement not supported.
Endo PAT 2000 FDA clearance (K032519)	Cleared as a diagnostic aid for detection of coronary artery endothelial dysfunction in patients with ischemic signs/symptoms undergoing angiography evaluation; not intended for general population screening.
Guideline statements (ESC/EAS 2025; NLA 2024; ACC/AHA; AACE; ASCP; USPSTF)	Guidelines recommend measuring Lp(a) at least once (ESC/EAS, NLA); generally discourage routine use of CIMT, arterial stiffness, PAT, and expanded lipid panels for population screening; apoB considered in selected contexts.

Definitions

Definitions:

CIMT: Carotid intima-media thickness measured by ultrasound as a marker of carotid atherosclerosis; an ultrasound measurement of carotid artery wall thickness used for risk stratification.

ePWV / cfPWV: Estimated pulse wave velocity / carotid-femoral pulse wave velocity — noninvasive measures of arterial stiffness (arterial compliance) derived from pulse wave analysis.

Lp-PLA2: Lipoprotein-associated phospholipase A2, a vascular inflammatory enzyme biomarker measured as mass or activity and studied as a surrogate biomarker for coronary heart disease and ischemic stroke.

Multiprotein diagnostic biomarker: Assays measuring panels of proteins combined with algorithms to produce risk scores (examples include HART CADhs, HART CVE, and other proteomic panels reported with algorithmic risk scores).

Lp(a): Lipoprotein(a), an LDL-like particle with apolipoprotein(a), a genetically determined biomarker associated with increased ASCVD and aortic valve stenosis risk; measurement often considered once for risk stratification.

CEC: Cholesterol efflux capacity — a functional measure of HDL-mediated cholesterol efflux from macrophages, assessed by LC-MS/MS or other assays.

PAT: Peripheral arterial tonometry — noninvasive measurement of endothelial function via fingertip pulse amplitude/reactive hyperemia index (RHI, PAT ratio) to assess microvascular endothelial function.

apoB: Apolipoprotein B — a measure of atherogenic particle number that may better reflect ASCVD risk than LDL-C in certain contexts.

Thresholds & Clinical Cutoffs

Clinical cutoffs and thresholds

Lp(a) abnormal threshold (study/guideline)≥ 50 mg/dL

Lp(a) risk strata (NLA/ESC-EAS)Low <30 mg/dL; Intermediate 30–50 mg/dL; High ≥50 mg/dL; Very high >180 mg/dL

ApoB goals (AACE 2017)<90 mg/dL (increased risk); <80 mg/dL (established ASCVD/diabetes+1 RF); <70 mg/dL (extreme risk)

Primary hypertriglyceridemia (risk-enhancing)≥ 175 mg/dL (nonfasting)

High-sensitivity CRP≥ 2.0 mg/L

ABI abnormal< 0.9

BNP / NT‑proBNP abnormal (ADA 2024)BNP ≥ 50 pg/mL; NT-proBNP ≥ 125 pg/mL

Revision History

05/01/2026archivedLatest

Archived previous policy version CS015NE.V

05/01/2026revisedLatest

Summary of Changes = Supporting Information: Updated Description of Services, Clinical Evidence, and References sections to reflect the most current information.

Policy Summary

PayerUnitedHealthcare

PolicyCardiovascular Disease Risk Tests (for Nebraska Only)

Policy CodePolicy CS015NE.W

Change TypeRevised (Supporting Information updates)

Effective DateMay 1, 2026

Next Review Date

Key ActionThis medical policy applies only to the State of Nebraska; providers must follow Nebraska-specific coverage determinations for these tests.

SourceLink

On This Page

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

Multiprotein diagnostic biomarker tests (examples)

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 five distinct HDL-bound apolipoproteins (Apo A1, C1, C2, C3, C4), with algorithm and reported as a risk score
Three proteins: high-sensitivity troponin, adiponectin, and kidney injury molecule-1 (KIM-1), with algorithm and reported as a risk score
Four proteins: NT-proBNP, osteopontin, TIMP-1, and KIM-1, with algorithm and reported as a risk score
Seven proteins: IL-16, FAS, FASLigand, HGF, CTACK, EOTAXIN, and MCP-3, with algorithm and reported as a risk score

Clinical utility and recommendations from guidelines

Coverage and use should follow guideline-recommended indications and evidence of clinical utility:

ALL of the following

Guideline-consistent recommendations for Lp(a)/apoB
- Measure Lp(a) at least once in all adults to help risk stratification (ESC/EAS 2025; NLA 2024)
- Consider Lp(a) measurement in individuals with personal or family history of premature ASCVD, unexplained/recurrent ASCVD, or calcific aortic valve disease (AACE 2020; NLA 2019/2024; ESC/EAS 2019)
- Consider apoB measurement for risk assessment in people with high triglycerides, diabetes, obesity/metabolic syndrome, very low LDL-C, or when discordance between LDL-C and apoB/non-HDL-C exists (NLA 2024; ESC/EAS 2019)
- ApoB optimal goals defined for varying risk levels (AACE 2017): <90 mg/dL for increased risk; <80 mg/dL for established ASCVD/diabetes+one risk factor; <70 mg/dL for extreme risk
Guideline recommendations discouraging routine use / screening
- Routine measurement of flow-mediated dilation or PAT for screening for CVD or mortality in general community cohorts is not supported (Schnabel et al. 2021; ACC/AHA 2010/2013)
- CIMT is not recommended for routine measurement in clinical practice for initial CVD event risk assessment (ACC/AHA 2013)
- Arterial stiffness measures outside research settings are not recommended for routine risk assessment (ACC/AHA 2010)
- USPSTF 2018: insufficient evidence to assess benefit/harm of ABI screening for peripheral artery disease/CVD risk in asymptomatic adults
- ASCP recommends against routinely ordering expanded lipid panels (particle sizing/NMR) as screening tests for CVD (ASCP 2020)

93050 - Arterial pressure waveform analysis (central arterial pressures, augmentation index)

93895 - Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral

93998 - Unlisted noninvasive vascular diagnostic study

93799 - Unlisted cardiovascular service or procedure

0415U, 0019M, 0308U, 0309U, 0377U, 0541U noted as proprietary/algorithmic multiprotein or advanced lipoprotein tests

Documentation Required

Apply Medical Policy to Nebraska Members

This policy and its coverage determinations apply only to UnitedHealthcare members residing in Nebraska; state-specific rules supersede general policy language.

Documentation Required

Codes Provided for Reference Only

The listed CPT/HCPCS/PLA codes and U.S. proprietary test codes are provided for reference only; inclusion does not imply coverage or payment and providers should verify benefit eligibility and coverage prior to ordering.

Examples: 83695, 83698, 83701, 83704, 93050, 93895, 93799, 93998, 0019M, 0052U, 0308U, 0309U, 0377U, 0415U, 0541U

Documentation Required

Measurement Frequency for Lp(a)

Repeat measurement of lipoprotein(a) (Lp[a]) should generally be limited; routine frequent remeasurement in the absence of clinical change or new guideline-directed indication is not supported.

Do not perform routine serial Lp(a) testing more frequently than guideline recommendations or without change in clinical status or management implications.

Documentation Required

Evidence Limitation Notices

Evidence for clinical benefit is limited or inconsistent for advanced lipoprotein testing, multiprotein algorithms, arterial compliance, PAT, and CIMT; these limitations underpin the policy determination of not medically necessary for routine screening or management.

Advanced lipoprotein analysis (including particle subfractions, particle size, NMR profiles)
Multiprotein biomarker algorithms (e.g., aptamer-based panels, proprietary risk scores)
Arterial compliance/waveform analysis and augmentation index
Peripheral arterial tonometry (PAT) / endothelial function testing
Carotid intima-media thickness (CIMT)

Documentation Required

Order Lp(a)/apoB per Guideline Indications

Order Lp(a) or apolipoprotein B (apoB) testing only when indicated by current clinical guidelines — for example, once for lifetime risk assessment or when results would change management per guideline-directed care.

Follow guideline indications for Lp(a)/apoB testing (e.g., family history of premature ASCVD, unexplained premature ASCVD, or when results would influence treatment decisions).
Avoid routine screening of asymptomatic, low-risk individuals without guideline-based indications.

Documentation Required

Do Not Routinely Use PAT/Flow-Mediated Dilation/CIMT for General Screening

Do not routinely use PAT, flow-mediated dilation, or CIMT for general population screening or routine cardiovascular risk management; these tests lack evidence of improving clinical outcomes versus standard risk assessment.

Peripheral arterial tonometry (PAT) / fingertip pulse amplitude tonometry
Brachial artery flow-mediated dilation
Carotid intima-media thickness (CIMT)

Documentation Required

Interpret Natriuretic Peptides for Patients with Diabetes

Interpretation of natriuretic peptides (e.g., BNP, NT-proBNP) in patients with diabetes requires clinical context; diabetes may affect baseline risk and peptide levels and results should be integrated with guideline-directed assessment.

Use natriuretic peptide results alongside clinical evaluation and guideline recommendations when assessing cardiovascular risk in patients with diabetes.
Avoid over-reliance on natriuretic peptide testing alone for risk stratification in diabetes.

Billing Rule

Laboratory Quality/CLIA Requirement

Advanced lipoprotein analysis performed for clinical decision making must be performed in a laboratory that meets Clinical Laboratory Improvement Amendments (CLIA) quality standards.

Ensure testing laboratory CLIA certification and compliance with applicable quality/control requirements prior to ordering advanced lipoprotein or specialized biomarker assays.

Documentation Required

Use of Third-Party Tools

Third-party clinical decision support tools (e.g., InterQual) or other utilization management tools may be applied to support coverage determinations; use of such tools does not override statutory or contractual requirements.

InterQual or similar appropriateness/criteria tools may be used to evaluate the medical necessity of ordered cardiovascular risk tests.