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«PacifiCare’s medical management guidelines represent the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. They are ...»

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CPT Code Section 0144T Computed tomography, heart, without contrast material, including image post processing and quantitative evaluation of coronary calcium 0145T Computed tomography, heart, with contrast material(s), including noncontrast images, if performed, cardiac gating and 3D image postprocessing; cardiac structure and morphology 0146T Computed tomography, heart, with contrast material(s), including noncontrast images, if performed, cardiac gating and 3D image postprocessing; computed tomographic angiography of coronary arteries (including native and anomalous coronary arteries, coronary bypass grafts), without quantitative evaluation of coronary calcium 0147T Computed tomography, heart, with contrast material(s), including noncontrast images, if performed, cardiac gating and 3D image postprocessing; computed tomographic angiography of coronary arteries (including native and anomalous coronary arteries, coronary bypass grafts), with quantitative evaluation of coronary calcium 0148T Computed tomography, heart, with contrast material(s), including noncontrast images, if performed, cardiac gating and 3D image postprocessing; cardiac structure and morphology and computed tomographic angiography of coronary arteries (including native and anomalous coronary arteries, coronary bypass grafts), without quantitative evaluation of coronary calcium 0149T Computed tomography, heart, with contrast material(s), including noncontrast images, if performed, cardiac gating and 3D image postprocessing; cardiac structure and morphology and computed tomographic angiography of coronary arteries (including native and anomalous coronary arteries, coronary bypass grafts), with quantitative evaluation of coronary calcium 0150T Computed tomography, heart, with contrast material(s), including noncontrast images, if performed, cardiac gating and 3D image postprocessing; cardiac structure and morphology in congenital heart disease 0151T Computed tomography, heart, with contrast material(s), including noncontrast images, if performed, cardiac gating and 3D image postprocessing, function evaluation (left and right ventricular function, ejection-fraction and segmental wall motion) (List separately in addition to code for primary procedure) HCPCS Code Section S8092 Electron beam computed tomography (also known as ultrafast ct, cine ct) Cardiac Computed Tomography (CT), Coronary Artery Calcium Scoring and Cardiac CT Angiography - Commercial Medical Management Guideline

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This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation.

Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

Confidential and Proprietary, © UnitedHealthcare, Inc. 2009 Cardiac Computed Tomography (CT), Coronary Artery Calcium Scoring and Cardiac CT Angiography - Commercial Medical Management Guideline TITLE: Cardiovascular Disease Risk Tests Authorized By: Medical Management Guideline Committee

Adoption Date: 09/16/09 Revision Date:

Disclaimer This medical management guideline represents the recommendation of the PacifiCare Medical Management Guideline (MMG) committee. It is based on the MMG committee's review of the available evidence as of the date of this medical management guideline.

This medical management guideline contains clinical practice and utilization criteria to assist professionals in PacifiCare’s medical management practice when making medical necessity determinations prior to, subsequent to, or concurrent with the provisions of health care services. This medical management guideline is intended to support consistent, appropriate medical necessity determinations, but it does not replace an individualized case-by-case review and medical necessity determination for each PacifiCare member.

Member benefit coverage and limitations may vary based on the member’s benefit plan.

This information is being distributed to you for personal reference. The information belongs to UnitedHealthcare and unauthorized copying, use and distribution are prohibited. This information is intended to serve only as a general reference resource regarding our Medical Policies and is not intended to address every aspect of a clinical situation. Physicians and patients should not rely on these Medical Policies in making health care decisions. Physicians and patients must exercise their independent clinical discretion and judgment in determining care. The enrollee's specific benefit documents supercede these policies and are used to make coverage determinations. These Medical Policies are believed to be current as of the date noted.

–  –  –

Description After evaluating relevant benefit document language (exclusions or limitations), refer to Coverage sections of this document to determine coverage.





This policy describes the use of noninvasive arterial waveform analysis, carotid intima-media thickness measurement and advanced lipoprotein analysis to assess risk for cardiovascular disease.

Cardiovascular Disease Risk Tests - Commercial Medical Management Guideline

Coverage All reviewers must first identify member eligibility, any federal or state regulatory requirements and the plan benefit coverage prior to use of this policy.

Coverage Rationale Arterial compliance testing, using waveform analysis, is unproven as a method to determine risk for cardiovascular disease.

There is insufficient evidence to conclude that noninvasive arterial compliance testing is effective as a screening tool for the early detection of cardiovascular disease (CVD). There is inadequate clinical evidence from prospective studies that the use of this technology alters patient management and improves clinical outcomes. Additional research involving larger, better-designed studies is needed to establish the role of arterial compliance in the early identification, prevention and management of CVD.

Carotid intima-media thickness (CIMT) measurement is unproven as an effective screening tool for the management of cardiovascular disease.

There is inadequate clinical evidence from prospective studies that the use of this technology alters patient management and improves clinical outcomes.

Advanced lipoprotein analysis (i.e. apolipoprotein, lipoprotein (a) or lipoprotein-associated phospholipase A2) is unproven as a method to determine risk of cardiovascular disease or ischemic stroke.

While advanced lipoprotein analysis detects elevated or reduced levels of lipoproteins, there is lack of agreement on how this information would be used in clinical decision-making. In addition, while the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III identifies lipoprotein (a) and apolipoprotein analysis as emerging technologies, it does not recommend their routine use in identifying persons at risk for cardiovascular disease or ischemic stroke. At the present time, measurements of lipoprotein-associated phospholipase A2 are not a component of the NCEP guidelines.

Benefit Considerations State mandates should be reviewed when determining benefit coverage for early detection of cardiovascular disease. In certain limited circumstances, the state of Texas may mandate coverage for computed tomography (CT) scanning or ultrasonography when performed as a screening test for atherosclerosis and abnormal artery structure and function.

Regulatory Requirements

U.S. Food and Drug Administration (FDA):

The CVProfilor® System received 510(k) approval (K001948) from the FDA on November 1, 2000 as a Class II device for the noninvasive measurement of blood pressure and pulse rate. It is classified as a noninvasive blood pressure measurement system providing a signal from which systolic, diastolic, mean, or any combination of the three pressures

can be derived through the use of transducers placed on the surface of the body. Available at:

http://www.accessdata.fda.gov/cdrh_docs/pdf/K001948.pdf. Accessed July 28, 2009.

Measurement of CIMT is a procedure, and not subject to FDA regulation. B-mode ultrasound equipment used to measure CIMT is regulated by the FDA, but products are too numerous to list. See the following web site for more information (use product code IYO). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed July 28, 2009.

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

Products used to measure lipoprotein (a) are too numerous to list. See the following web site for more information (use product code DFC). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed July 28, Cardiovascular Disease Risk Tests - Commercial Medical Management Guideline 2009.

Products used to measure apoliproteins are too numerous to list. See the following web site for more information (use product code DER or MSJ). Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed July 28, 2009.

The diaDexus PLAC® Test for Lp-PLA2 received initial 510(k) approval (K030477) from the FDA on July 18, 2003. It was approved at that time as an enzyme immunoassay for the quantitative determination of Lp-PLA2 in human plasma, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=10908. Accessed July 28, 2009.

On June 15, 2005, a second 510(k) approval (K050523) was issued for the PLAC Test for the same indications but also

incorporating approval for prediction of risk of ischemic stroke associated with atherosclerosis. Available at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=17691. Accessed July 28, 2009.

Research Evidence Background Cardiovascular diseases (CVD), including coronary artery disease, stroke and hypertension, are the leading causes of morbidity and mortality in the United States. Vascular disease is the major contributor to cardiovascular morbid events and ideally is identified early, before symptoms are detected or irreversible damage has occurred. Arterial compliance (elasticity), carotid intima-media thickness (CIMT) and advanced lipoprotein analysis are tests used to measure and monitor atherosclerosis.

Arterial endothelial dysfunction and endothelial damage, which play an important role in the atherosclerotic process, may result in reduced arterial compliance (elasticity) or increased arterial stiffness, especially in the smaller arteries. Arterial compliance can be measured by several techniques, many of which are invasive or clinically inappropriate. Direct methods include magnetic resonance imaging and ultrasound. Indirect methods include pulse wave velocity and augmentation index. At this time, there is no gold standard for its measurement. Cardiovascular profiling using blood pressure waveform analysis (the rate at which pressure rises and falls during the cardiac cycle), provides a noninvasive assessment of arterial compliance. It is used for both large and small arteries by calculating pulse pressure, body surface area (BSA) and body mass index (BMI) to determine arterial compliance indices. These indices may be used as an early indication of CVD.

Carotid intima-media thickness (CIMT) is based on the theory that the extent of carotid atherosclerosis correlates positively with the severity of coronary atherosclerosis. CIMT is a noninvasive test using ultrasound to capture images of the carotid artery and computer software to analyze the measurements.

Cholesterol is a fat-like substance (lipid) that is present in cell membranes, and travels in the blood in distinct particles containing both lipid and proteins (lipoproteins). Three major classes of lipoproteins are found in the serum of a fasting individual: low density lipoproteins (LDL), high density lipoproteins (HDL), and very low density lipoproteins (VLDL).

LDL cholesterol typically makes up 60 - 70 percent of the total serum cholesterol and contains a single apolipoprotein, namely apo B-100 (apo B). HDL cholesterol normally makes up 20 - 30 percent of the total serum cholesterol. The major apolipoproteins of HDL are apo A-I and apo A-II. The VLDL are triglyceride-rich lipoproteins, but contain 10 - 15 percent of the total serum cholesterol. Apolipoprotein, lipoprotein (a) and lipoprotein-associated phospholipase A2 are emerging risk factors being evaluated for their ability to predict cardiovascular disease or ischemic stroke (NHLBI, 2002).

Clinical Evidence Arterial compliance Cardiovascular Disease Risk Tests - Commercial Medical Management Guideline According to a Hayes brief, insufficient evidence exists to conclude that the CVProfilor CardioVascular Profiling System is effective as a screening method for the early detection of CVD. While there is some promising evidence to support the use of the CVProfilor to assess arterial elasticity and detect the presence of vascular disease, there is inadequate clinical evidence from prospective studies that the use of this technology alters patient management and improves clinical outcomes (Hayes, 2005).

In a small, randomized, controlled trial (n=30), Woodman et al. (2005) compared large and small artery compliance (C1 and C2, respectively), stroke volume/pulse pressure (SV/PP), augmentation index (AIx), central pulse pressure (CPR), stiffness index (SI), systemic arterial compliance (SAC) and brachial pulse pressure to central pulse wave velocity (PWV). The authors concluded that C1, C2, SV/PP, and SAC showed poor agreement with central PWV, an established measure of central arterial stiffness. In comparison, SI, AIx, and CPP are more closely related to central arterial stiffness.



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