Medical Policy Computed Tomography Angiography (CTA) for Coronary Artery Disease Effective Date: October 2006; Revised [04/09; 3/11]

Subject: Computed Tomography Angiography (CTA) for Coronary Artery Disease Overview: Computed Tomography Angiography (CTA) is intended as an alternative to invasive coronary

angiography. Multislice computed tomography is a noninvasive imaging technique used for visualizing crosssections of coronary vessels. The vessels can be displayed in two-dimensional (2D) (axial, coronal and sagittal) or three-dimensional (3D) formats. MSCT can be used to measure variations in the diameter of coronary vessel lumens, identify locations of excessive narrowing of vessels, consequently identifying the causes of past or potential adverse coronary events.

Policy and Coverage Criteria: NOTE: Reviewed by National Imaging Associates Computed Tomography Angiography (CTA) is covered for the evaluation of coronary artery disease.

Exclusions: N/A Supporting Information: 1. Technology Assessment: Contrast-enhanced cardiac CT angiography involves the use of multislice CT and intravenously administered contrast material to obtain detailed images of the blood vessels of the heart. It has been used as an alternative to conventional invasive coronary angiography for evaluating coronary artery disease and coronary artery anomalies. The performance of cardiac CT angiography has been improved by increasing the number of slices that can be acquired simultaneously by increasing the number of detector rows (AHTA, 2006). As the number of slices that can be acquired simultaneously increases, the scanning time is shortened and the spatial resolution is increased. Initial cardiac CT imaging was conducted with four-slice detector CT. Scanning times were reduced from 40 seconds down to 20 seconds with 16-slice detector CT and with the advent of 64slice detector CT, scanning times have been reduced to a 10 second breath-hold. Cardiac CT angiography using 64-slices has been shown in studies to have a high negative predictive value (93 to 100 percent), using conventional coronary angiography as the reference standard. Given its high negative predictive value, cardiac CT angiography has been shown to be most useful for evaluating persons at low risk of coronary artery disease where invasive coronary angiography may otherwise be indicated. This would include evaluation of low risk persons with a positive exercise stress test, evaluation of asymptomatic low risk persons with an equivocal exercise or pharmacologic stress test, and evaluation of low-risk persons with chest pain who have a contraindication to exercise and pharmacological stress testing. The key difference between regular CT and CTA is that CTA includes reconstruction, post-processing and interpretation. Additional information is provided by CTA, including: vessel wall thickness, relationship to adjacent structures, and enhanced depiction of the venous anatomy. 2. Literature Review: There are an increasing number of studies evaluating the use of CTA for the detection and analysis of CAD. A 2011 meta-analysis by von Ballmoos et al. reviewed studies comparing results from CTA with catheter coronary angiography in symptomatic patients with suspected CAD. The analysis found early evidence suggests low-dose CTA matches the sensitivity of catheter-based angiography, has low radiation exposure, and is a potentially valid alternative to catheter angiography for triaging symptomatic patients with a clinical suspicion of CAD.

Mowatt et al. (2008a) reported on a systematic review and meta-analysis assessing the accuracy of 64-slice CTA compared with conventional coronary angiography in the diagnosis and assessment of CAD. Based on the 28 studies they reviewed, the authors concluded that given the high sensitivity and negative predictive value, the main role of CTA may be to rule out significant CAD, and reduce the need for invasive angiography. Mowatt et al. found that CTA may have an increasing role in patients that fall into an intermediate category with an uncertain CAD diagnosis after clinical assessment and other non-invasive tests. In a separate study, Mowatt et al. (2008b) reported on the results a review of the clinical effectiveness and cost-effectiveness of CTA as an alternative to coronary angiography for the investigation of CAD. They found the main value of 64-slice CTA to be ruling out significant CAD. However, it is unlikely to replace coronary angiography in assessment for revascularization. A 2007 study by Meijboom et al. evaluated the diagnostic performance and clinical usefulness of 64-slice CTA in 254 symptomatic patients with suspected CAD. The researchers divided the patients into three groups based on their estimated probability of having significant CAD: low (1-30%), intermediate (31-70%), or high (71-99%). Compariston between CTA and coronary angiography was performed on the groups at three levels: patient-bypatient, vessel-by-vessel, and segment-by-segment analysis. Based on their results, Meijboom et al. found that the pretest probability of CAD impacts the diagnostic performance of CTA. The 64-slice CTA was found to be useful in symptomatic patients with a low or intermediate estimated probability of having significant CAD, and a negative CTA can reliably rule out the presence of significant CAD. A different study by Husmann et al. (2007) evaluated 88 consecutive patients with suspected CAD to compare the diagnostic accuracy of 64-slice CTA in groups of patients with low, intermediate, and high risk of CAD events. Per patient accuracy for low, intermediate and high risk were 82.4%, 89.7%, and 92.0%, respectively. Per vessel accuracy for low, intermediate and high risk were 93.4%, 93.0% and 90.0%. Per segment accuracy were 95.9%, 95.3%, and 92.3% for low, intermediate, and high risk. Based on their results Husmann et al. concluded that CTA can be used safely to rule out CAD in patients with low or intermediate risk as well as those with high risk for CAD events. They stated, “Our data suggest that in a clinical setting, CTA would have avoided unnecessary invasive angiography in 56%, 41%, and 24% of patients win the groups with low, intermediate, and high risk for CAD events.” The researchers also noted, “this would not be achieved at the cost of falsely sending many patients to invasive angiography, as the high number of avoided invasive angiography by far outweighs the few false-positive values.” Hausleiter et al. conducted a prospective, blinded study to assess the clinical usefulness of 16 or 64-slice CTA for the detection of significant CAD in patients testing with intermediate risk for having CAD. Invasive angiography was used as a reference. 243 patients were evaluated with the primary endpoint being the accuracy in the detection of patients with significant CAD. 102 of the 243 patients were found to have CAD upon invasive angiography. 101 of these were correctly identified using multi-slice CT angiography. Based on the high negative predictive value observed (99% by patient, artery, and segment-based analysis) Hausleiter et al. suggest that CTA with high resolution scanners could be a suitable means for the management of patients with an intermediate pre-test likelihood of significant CAD. 3. Benchmarks BCBS MA: We cover multislice or multidetector contrast enhanced computed tomographic angiography (CCTA) for coronary artery evaluation for commercial products for the evaluation of anomalous (native) coronary arteries in symptomatic patients when conventional angiography is unsuccessful or equivocal and when the results will impact treatment (ICD-9-CM diagnosis 746.85). We do not cover High Speed CT Technology, which may be referenced as the following, for other than the indications stated above: • Multislice or Multidetector contrast enhanced computed tomographic angiography (MDCT): • Angiography (CTA) for Coronary Artery Evaluation; • Electron Beam (EBCT): ultrafast CT or Cine CT We do not cover Computed tomography (CT) scanning, using either spiral (helical) or electron beam (ultrafast) CT, with or without computer-assisted detection or diagnosis, as a screening technique for lung cancer since it is considered investigational and does not meet the BCBSMA medical Technology Assessment Guidelines.

We do not cover chest radiographs (x-rays) with or without computer-assisted detection or diagnosis as a screening technique for lung cancer since it is considered investigational and does not meet the BCBSMA medical Technology Assessment Guidelines. We do not cover Computed tomography to detect coronary artery calcification since it is considered investigational and does not meet the BCBSMA Medical Technology Assessment Guidelines. Note: The high speed technology used in this exam is either the Electron beam (EBCT)/Ultra fast CT or Multidetector Computed Tomographic Angiography (MDCT) http://www.bluecrossma.com/common/en_US/medical_policies/355%20Highspeed%20CT%20for%20Heart%20Disease%20and%20Screening%20for%20Lung%20Cancer%20prn.pdf#page =1 Tufts Health Plan: Covered service when medically necessary http://www.tuftshealthplan.com/providers/pdf/payment_policies/Imaging_Services_Professional.pdf Anthem BCBS NH: Contrast-enhanced coronary computed tomography angiography (CCTA) or coronary magnetic resonance angiography (MRA) is considered medically necessary for the evaluation of suspected anomalous coronary arteries when conventional angiography has been unsuccessful or has provided equivocal results and the results could impact treatment. Investigational and Not Medically Necessary: Coronary computed tomography angiography (CCTA) or coronary magnetic resonance angiography (MRA) is considered investigational and not medically necessary for all other indications, including, but not limited to, the following: • Screening for coronary artery disease (CAD), either in asymptomatic individuals or as part of a preoperative evaluation; • Diagnosis of CAD, in individuals with acute or non-acute symptoms, or after a coronary intervention; • As a technique to evaluate cardiac function. http://www.anthem.com/medicalpolicies/policies/mp_pw_a050551.htm CIGNA: Covered when criteria is met http://www.cigna.com/customer_care/healthcare_professional/coverage_positions/medical/mm_0399_coveragep ositioncriteria_computed_tomography_angiography.pdf 4. Governmental/Regulatory Agencies: CMS: Upon review of the available evidence, the Centers for Medicare and Medicaid Services has determined that the use of cardiac CTA to diagnosis coronary artery disease (CAD), shall remain at local contractor discretion, and no national coverage determination (NCD) is appropriate at this time. (June, 2008) http://www.cms.hhs.gov/Transmittals/Downloads/R85NCD.pdf American Heart Association: Classification of recommendations and levels of evidence re expressed in the American College of Cardiology/American eart Association (ACC/AHA) format as follows: Class I: Conditions for which there is evidence for and/or eneral agreement that the procedure or treatment is beneficial, useful, and effective. Class II: Conditions for which there is conflicting evidence and/or a divergence of opinion about the usefulness/ efficacy of a procedure or treatment. Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy. Class IIb: Usefulness/efficacy is less well established by evidence/opinion. Class III: Conditions for which there is evidence and/or general agreement that the procedure/treatment is not useful/effective and in some cases may be harmful. Level of Evidence A: Data derived from multiple randomized clinical trials. Level of Evidence B: Data derived from a single randomized trial or nonrandomized studies. Level of Evidence C: Only consensus opinion of experts, case studies, or standard of care.

1. Neither coronary CTA nor MRA should be used to screen for coronary artery disease in patients who have no signs or symptoms suggestive of coronary artery disease. (Class III, level of evidence C) 2. No multivendor trial data are available for coronary MDCT CTA or for present whole-heart coronary MRA. Thus, the applicability of these methods beyond the reporting research centers is unknown. Ideally, both multivendor and additional multicenter validation of these methods should be performed. (Class I, level of evidence C) 3. The potential benefit of noninvasive coronary angiography is likely to be greatest and is reasonable for symptomatic patients who are at intermediate risk for coronary artery disease after initial risk stratification, including patients with equivocal stress-test results. (Class IIa, level of evidence B) Diagnostic accuracy favors coronary CTA over MRA for these patients. (Class I, level of evidence B) Concerns regarding radiation dose limit the use of coronary CTA in high-risk patients who have a very low pretest likelihood of coronary stenoses; patients with a high pretest likelihood of coronary stenoses are likely to require intervention and invasive catheter angiography for definitive evaluation; thus, CTA is not recommended for those individuals. (Class III, level of evidence C) Pronounced coronary calcification may negatively impact interpretability and accuracy of coronary CTA and thus, the usefulness of CTA is uncertain in these individuals. (Class IIb, level of evidence B) 4. Anomalous coronary artery evaluation can be performed by either CTA or MRA; radiation-protection concerns indicate that MRA is preferred when it is available. (Class IIa, level of evidence B) 5. Reporting of coronary CTA and MRA results should describe any limitations to the technical quality of the examination and the size of the vessels, descriptions of coronary anomalies, coronary stenosis, and significant noncardiac findings within the field of view. (Class I, level of evidence A) 6. Continued research in cardiac CT and MR imaging is encouraged to determine the potential of these noncatheter- based modalities to detect, characterize, and measure atherosclerotic plaque burden, as well as its change over time or as the result of therapy. (Class I, level of evidence C)

Codes:

HCPCS Codes S8093: Computed tomographic angiography, coronary arteries, with contrast material(s) CPT Codes 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

References:

1. Hayes, Inc. Medical Technology Directory. Multi-slice Computed Tomography for Detection of Coronary Artery Disease. Lansdale, PA: Hayes, Inc. July 19, 2007. 2. von Ballmoos, MW., Haring, B., Juillerat, P., Alkadhi, H. Meta-analysis: Diagnostic performance of lowradiation-dose coronary computed tomography angiography. Ann Intern Med. 2011; 154(6): 413-20. 3. Mowatt, G., Cook, JA., Hillis, GS., Walker, S., Fraser, C., Jia, X., Waugh, N. 64-slice computed tomography angiography in the diagnosis and assessment of coronary artery disease: systemactic review and metaanalysis. Heart. 2008a; 94(11): 1386-93.

4. Mowatt, G., Cummins, E., Waugh, N., Walker, S., Cook, J., Jia, X., Hillis, GS., Fraser, C. Systematic review of the clinical effectiveness and cost-effectiveness of 64-slice or higher computed tomography angiography as an alternative to invasive coronary angiography in the investigation of coronary artery disease. Health Technol Assess. 2008b; 12(17): iii-iv, ix-143. 5. Meijboom, WB., van Mieghem, CA., Mollet, NR., Pugliese, F., Weustink, AC., va Pelt, N., et al. 64-slice computed tomography coronary angiography in patients with high, intermediate, or low pretest probability of significant coronary artery disease. J Am Coll Cardiol. 2007; 50(15); 1469-75. 6. Husmann, L., Schepis, T., Scheffel, H., Gaemperil, O., Leschka, S., Valenta, I., et al. Comparison of diagnostic accuracy of 64-slice computed tomography coroncary angiography in patients with low, intermediate, and high cardiovascular risk. Acad Radiol. 2008; 15(4): 452-61. 7. Hausleiter, J., Meyer, T., Hadamitzky, M., Zankl, M., Gerein, P., Dorrler, K., et al. Non-invasive coronary computed tomographic angiography for patients with suspected coronary artery disease: the Coronary Angiography by Computed Tomography with the Use of a Submilimeter resolution (CACTUS) trial. Eur Heart J. 2007; 28(24): 3034-41. 8. Bluemke, DA., Achenbach, S., Budoff, M., Gerber, TC., Gersh, B., Hillis, LD., Hundley, WG., Manning, WJ., Printz, BF., Stuber, M., Woodard, PK. Noninvasive coronary artery imaging: magnetic resonance angiography and multi-detector computed tomography angiography: a scientific statement from the American heart association committee on cardiovascular imaging and intervention of the council on cardiovascular radiology and intervention, and the councils on clinical cardiology and cardiovascular disease in the young. Circulation. 2008; 118(5): 586-606.