Colorado Rocky Mountain Health Plans cardiovascular tests Coverage

Coverage Criteria and Evidence Summaries

Not medically necessary / Unproven tests

Covered when ALL of the following are met

Unproven tests

Arterial compliance testing using waveform analysis (pulse wave velocity/waveform-derived indices).
See systematic reviews showing association with outcomes but no demonstrated clinical utility.
Carotid intima‑media thickness (CIMT) measurement for screening or routine management of cardiovascular disease.
Associations with events exist but incremental value and impact on management are unproven.
Advanced lipoprotein analysis (e.g., particle sizing, NMR, subfractions) as routine risk‑determination tools.
Studies report inconsistent incremental benefit over conventional lipids and lack standardized selection criteria.
Lipoprotein‑associated phospholipase A2 (Lp‑PLA2) testing as a method to determine CVD or ischemic stroke risk.
Evidence quality low and clinical utility to guide management not established.
Endothelial function assessment (eg, peripheral arterial tonometry [PAT], brachial flow‑mediated dilation) for routine risk stratification or community screening.
Cohort studies show inconsistent associations and no evidence that testing changes management or outcomes.
Multiprotein diagnostic biomarker panels reported as risk scores (eg, aptamer‑based microarray algorithms; panels reporting cholesterol efflux capacity or multi‑protein scores).
Proprietary panels show association or high discriminatory performance in derivation/validation cohorts but lack prospective evidence that use changes management or improves patient‑level outcomes.

CIMT — evidence summary and coverage stance

Covered when ALL of the following are met

CIMT general stance: Carotid intima‑media thickness (CIMT) testing has insufficient evidence to demonstrate added benefit beyond traditional risk assessment and is not supported as a routine substitute for established risk tools.

Large cohorts and meta‑analyses show associations with CVD and carotid plaque, but heterogeneity in definitions/measurements and lack of prospective evidence that CIMT measurement changes management or improves outcomes limit clinical utility.

Lp(a) — evidence summary and coverage stance

Covered when ALL of the following are met

Lp(a) general stance: Lp(a) is associated with increased cardiovascular risk and provides independent risk information, but routine measurement without a documented plan for how results will change management is not supported; clinical utility to improve outcomes has not been established.Lp(a) thresholds vary across studies; guideline thresholds (eg, ≥50 mg/dL or ≥125 nmol/L) are referenced by societies.

Individual‑level meta‑analyses and cohort studies demonstrate independent and additive risk with LDL‑C, but heterogeneity in thresholds and populations limits generalizability.

Evidence summaries — Lp(a), Lp-PLA2, multiprotein tests, and CEC

Summaries of clinical evidence and noted gaps

Lp(a) associations: Multiple observational studies, cohort analyses, and systematic reviews show elevated Lp(a) is associated with increased risks of MACEs, myocardial infarction, stroke, revascularization, and CVD events in primary and secondary prevention populations.Study thresholds vary; some analyses use ≥50 mg/dL as abnormal and the ≥90th percentile for highest risk.

Heterogeneity in thresholds, outcome definitions, and populations limits pooled analyses and clinical utility; evidence does not demonstrate that measuring Lp(a) and acting on the result improves outcomes.

Lp‑PLA2 evidence: Meta‑analyses and cohort studies show associations between higher Lp‑PLA2 levels and stroke or plaque instability, but studies use heterogeneous assays and methods and do not establish clinical utility to guide management.

Low‑quality evidence and methodological variation preclude recommendation for routine use.

Multiprotein panels and CEC: Multiprotein biomarker models show promising discriminatory performance (eg, AUC ~0.85) for obstructive CAD in selected cohorts and CEC is inversely associated with CAD in meta‑analyses, but most studies are observational/retrospective and do not show that use of these tests alters clinical management or improves patient outcomes.

Endothelial Function Assessment — Not supported for routine risk stratification

Coverage stance and criteria logic for endothelial function assessment

Endothelial function assessment coverage: Endothelial function testing (eg, PAT, brachial flow‑mediated dilation) is not supported for routine cardiovascular risk stratification because evidence is inconsistent and does not demonstrate clinical utility to predict composite CVD events or to change management.

Large community cohorts and systematic reviews report conflicting findings and fail to show clinically relevant associations with incident CVD or mortality.

Multiprotein biomarkers and risk scores — investigational/insufficient evidence for improved outcomes

Coverage stance and criteria logic for multiprotein/biomarker panels and CEC

CEC association evidence: Cholesterol efflux capacity (CEC) is inversely associated with CAD and adverse cardiovascular events in observational meta‑analyses, but associations with cardiovascular mortality are inconsistent and lack standardized assays and cutoffs.

Incremental clinical utility and impact on outcomes have not been established.

Multiprotein risk scores: Multiprotein biomarker‑based risk scores demonstrate good discriminatory performance in derivation and some validation cohorts but evidence is observational or retrospective and does not show that using these scores changes management or improves outcomes; therefore they are investigational for routine clinical use.

Documentation should include the specific biomarkers, algorithm, and validation context when such tests are considered.

Advanced lipoprotein testing — conditional coverage per guideline indications

Guideline-based use of advanced lipoprotein testing

Advanced lipid markers (Lp(a), apoB, Lp‑PLA2): Advanced lipid markers may be used selectively following specialty society recommendations as risk‑enhancing factors (eg, Lp(a) for family history of premature ASCVD; apoB when triglycerides ≥200 mg/dL) rather than for routine population screening.

Guidelines (ACC/AHA, ESC/EAS, AACE, NLA) support targeted measurement in specific clinical contexts; ASCP recommends against routine expanded lipid panels.

Lp(a) testing indications

Specialty society recommendations and contexts where testing is considered reasonable

Indications for Lp(a) measurement: Consider measuring Lp(a) at least once in adulthood and in clinical contexts such as family history of premature ASCVD, premature personal ASCVD (<55 years in men, <65 years in women), recurrent or progressive ASCVD despite optimal therapy, borderline‑to‑moderate risk reclassification, and calcific aortic valve disease.Consider thresholds: <30 mg/dL low; 30–50 mg/dL intermediate; ≥50 mg/dL (≥125 nmol/L) high; >180 mg/dL very high.

ESC/EAS and NLA recommend one‑time measurement for lifetime risk assessment and cascade screening where appropriate.

ApoB and advanced lipoprotein testing

Use of apoB and advanced lipoprotein testing

ApoB and advanced testing contexts: Consider ApoB measurement for risk assessment in individuals with high triglycerides, diabetes, obesity/metabolic syndrome, very low LDL‑C, or when LDL‑C is discordant with clinical risk; advanced lipoprotein tests may be used selectively following initial lipid evaluation and guideline indications.ApoB risk‑enhancing threshold ~≥130 mg/dL referenced by ACC/AHA; guideline‑specific optimal goals cited by AACE for select populations.

Advanced tests lack standardization and broad routine endorsement; use should align with specialty guidance and documented intent to change management.

Routine testing discouraged

Tests/screening not routinely recommended

Routine screening discouraged: Do not routinely order expanded lipid panels (particle sizing or NMR) or additional risk markers (eg, hsCRP, ABI, CAC) for cardiovascular risk assessment in asymptomatic adults without specific indications.

ASCP and VA/DoD recommend against routine expanded panels and routine additional marker screening; testing should be limited to scenarios supported by guideline indications.

This policy lists multiple cardiovascular risk tests that are considered unproven or not medically necessary for routine risk assessment or screening when evidence does not demonstrate they change management or improve outcomes. Examples include arterial compliance testing (waveform/pulse wave analysis), carotid intima-media thickness (CIMT), advanced lipoprotein analyses (including particle subfractions and NMR/particle sizing), Lp-PLA2, endothelial function assessment (e.g., peripheral arterial tonometry or brachial flow-mediated dilation), and specified multiprotein diagnostic biomarker panels. Routine ordering of expanded lipid panels is also discouraged by specialty guidance cited in the evidence base.

Carotid intima-media thickness (CIMT) has been shown in cohort studies and meta-analyses to associate with cardiovascular outcomes, but current evidence is insufficient to demonstrate that routine CIMT measurement provides added clinical benefit beyond standard risk assessment or that integrating CIMT into care alters management to improve outcomes. Large randomized trial meta-analyses and cohort analyses highlight heterogeneity in measurement and interpretation and do not establish that routine CIMT replaces guideline-based risk stratification.

While Lipoprotein(a) (Lp[a]) is independently associated with increased cardiovascular risk in multiple observational studies, routine measurement without a documented plan for how results will change management is not supported because the clinical utility to improve decision-making or outcomes has not been established. Specialty societies recommend selective measurement in specific scenarios (see guidance), but routine, unconditional Lp(a) testing is not endorsed by the evidence reviewed.

Multiprotein blood tests that generate a composite risk score from proprietary panels (for example, aptamer-based assays or multi-analyte algorithms reported as a single risk score) currently lack sufficient high-quality clinical evidence demonstrating they improve patient management or outcomes. Published evaluations show associations with risk but do not provide convincing clinical utility data, and for some named tests there is inadequate peer-reviewed literature to support routine use.

Measurement of endothelial function using peripheral arterial tonometry (PAT) or brachial flow-mediated dilation has inconsistent associations with incident cardiovascular events in cohort studies. The literature does not demonstrate reliable clinical utility for routine community screening or risk stratification, and routine measurement for this purpose is not supported by the current evidence base.

Regulatory status is informational: FDA clearance or approval alone does not constitute coverage. Measurement of carotid intima-media thickness is a procedural use of ultrasound equipment (not an FDA-regulated test product), and laboratories performing advanced lipoprotein analyses must meet CLIA quality standards. Coverage decisions require evaluation against the policy criteria and member benefits rather than being based solely on device clearances.

Use of the tests listed above for determining cardiovascular disease risk, screening, or routine management is considered not medically necessary when policy criteria are not met. Specifically, tests proposed to refine risk but lacking evidence of impact on treatment decisions or outcomes (including arterial compliance measures, CIMT, advanced lipoprotein analyses, Lp-PLA2, endothelial function testing, and multiprotein panels) are subject to denial as not medically necessary in those contexts.

The use of CIMT or advanced lipoprotein testing (including Lp[a] assays and particle-sizing methods) for routine cardiovascular risk assessment is considered not medically necessary when the results are unlikely to change clinical management. Prior authorization should require documentation that testing is expected to influence treatment decisions; absent that rationale, routine use is unsupported by the evidence.

The clinical utility of Lp-PLA2, whether measured alone or combined with other biomarkers, has not been established to guide therapy or improve outcomes. Similarly, multiprotein panel tests show prognostic associations but lack evidence that their use changes management or patient-centered outcomes; therefore they are considered investigational for routine clinical decision-making.

Endothelial function assessment (e.g., PAT, brachial flow-mediated dilation) is considered not medically necessary for routine screening or cardiovascular risk assessment because cohort studies and analyses show inconsistent predictive value and no demonstrated effect on clinical decision-making or outcomes.

Routine ordering of expanded lipid panels (particle sizing or NMR) and indiscriminate use of additional risk markers (such as hsCRP, ABI, or CAC) for asymptomatic patients is not routinely recommended. Specialty guidance cited in the evidence (including ASCP and VA/DoD statements) advises against routine use of these expanded tests for general cardiovascular risk screening.

Applicable Codes and Thresholds

Proprietary/multiplex test PLA/CPT Category I/III 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.
0541U	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 applicable CPT/HCPCS codes referencedmixed

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.

Regulatory product codes referencedmixed

DXN	FDA product code for noninvasive blood pressure measurement systems (search code)
IYO	FDA product code for B-mode ultrasound equipment
DFC	FDA product code for Lp(a) measurement devices
NOE	FDA product code for measurement of lipoprotein-associated phospholipase A2
JJX	FDA product code for measurement of lipoprotein-associated phospholipase A2

FDA 510(k) clearances citedmixed

K032519	Endo PAT 2000 510(k) clearance
K001852	PAT 1000 RD predicate device 510(k)
K122129	SphygmoCor XCEL System 510(k) clearance
K070795	SphygmoCor CVMS predicate 510(k)

inv-26: cfPWV cutoff

cfPWV cutoff (cardiovascular mortality)10.7 m/s (closest cutoff point in cfPWV meta-analysis)

cfPWV cutoff (all-cause mortality)11.5 m/s (closest cutoff point in cfPWV meta-analysis)

cfPWV performance summaryPooled diagnostic OR 11.23 for cardiovascular mortality; AUC ~0.75–0.78 in meta-analysis

inv-27: CIMT cutoff for CAD diagnostic accuracy

CIMT diagnostic cutoff for CAD1.0 mm (meta-analysis found improved sensitivity/specificity and AUC ~0.80 at 1 mm)

CIMT pooled sensitivity/specificity

Prior Authorization, Documentation, and Billing Guidance

Note

Verify Member-Specific Coverage and Prior Authorization

No explicit prior authorization or coverage action is specified in this policy. Providers must verify coverage and any authorization requirements with the member-specific benefit plan prior to ordering tests listed in this policy.

Check the member-specific benefit plan document for coverage and prior authorization rules before ordering tests
In the event of conflict, the member-specific plan governs

Denial Risk

Endothelial Function Assessment — Insufficient Evidence

Endothelial function assessment (eg, peripheral arterial tonometry, brachial artery flow-mediated dilation) has insufficient evidence to demonstrate clinical utility for risk stratification or to change management. Claims for routine endothelial function testing may be denied if submitted for screening without a documented, plan-approved management change.

Tests include peripheral arterial tonometry (PAT) and brachial artery flow-mediated dilation

Definitions and Test Descriptions

Cardiovascular diseases—coronary artery disease, stroke, and related conditions—are leading causes of morbidity and mortality. A variety of emerging tests have been proposed to improve risk stratification, including arterial compliance measures, CIMT, advanced lipoprotein profiling (including Lp(a) and apoB), Lp-PLA2, endothelial function testing, cholesterol efflux capacity (CEC), and proprietary multiprotein biomarker panels. Existing evidence demonstrates associations between some markers and outcomes but generally lacks consistent, prospective data showing that routine measurement changes clinical management or improves patient-centered outcomes; therefore, the policy limits routine coverage for these tests and emphasizes selective, guideline-directed use where specialty recommendations support it.

inv-58: Carotid intima-media thickness (CIMT)

DefinitionCarotid intima-media thickness (CIMT) is a noninvasive ultrasound measurement of carotid artery wall thickness proposed to correlate with coronary atherosclerosis and used for screening or risk stratification.

PurposeStudied as a marker of subclinical atherosclerosis and potential surrogate for cardiovascular risk, but evidence of added clinical utility is insufficient.

Measurement contextCIMT uses ultrasound images and software to analyze carotid artery wall thickness; cutoff values (e.g., 1 mm) have been evaluated for diagnostic accuracy.

Background, Evidence Reviewed, and Key Findings

Evidence summaries across tests show consistent themes: observational and cohort studies often find associations between biomarkers (for example, Lp(a) and CEC) and cardiovascular events, and some multiprotein models have high discriminatory performance in derivation cohorts. However, study heterogeneity, variable assay methods and thresholds, lack of standardized cutoffs, and absence of prospective trials demonstrating improved outcomes with test-guided management limit clinical utility. For Lp(a), meta-analyses and large cohort projects report increased risk at higher levels (commonly referenced thresholds such as ≥ 50 mg/dL or ≥ 90th percentile), but the evidence does not consistently demonstrate that routine testing alone improves care without a clear management plan. Multiprotein panels and CEC show promising associations but remain investigational pending trials that demonstrate impact on treatment decisions and patient outcomes.

Policy Revisions

2026-04-01policy_revisionLatest

Policy 2026T0389EE issued effective 2026-04-01; updated Clinical Evidence and References sections and archived prior version 2026T0389DD.

OpenPayer

Cardiovascular Disease Risk Tests

Coverage Criteria and Evidence Summaries

Applicable Codes and Thresholds

Prior Authorization, Documentation, and Billing Guidance

Definitions and Test Descriptions

Background, Evidence Reviewed, and Key Findings

Policy Revisions