Medical Policy


Subject:Coronary Artery Imaging: Contrast-Enhanced Coronary Computed Tomography Angiography (CCTA), Coronary Magnetic Resonance Angiography (MRA), and Cardiac Magnetic Resonance Imaging (MRI)
Policy #:  RAD.00035Current Effective Date:  04/15/2014
Status:ReviewedLast Review Date:  02/13/2014

Description/Scope

This document addresses contrast-enhanced computed tomography angiography (CTA) of the coronary arteries (coronary CTA or CCTA), magnetic resonance angiography (MRA) and magnetic resonance imaging (MRI) of the coronary arteries. 

Note: This document does not address the use of electron beam computed tomography (EBCT) to quantify coronary calcification, which is addressed in RAD.00001 Computed Tomography to Detect Coronary Artery Calcification.

Position Statement

Medically Necessary:

Contrast-enhanced coronary computed tomography angiography (CCTA), coronary magnetic resonance angiography (MRA), or cardiac magnetic resonance imaging (MRI) is considered medically necessary for the evaluation of suspected anomalous coronary arteries:

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:

Cardiac magnetic resonance imaging (MRI) is considered investigational and not medically necessary for the following:

Rationale

Coronary CT Angiography

Coronary CT Angiography (CCTA) to Detect Coronary Artery Disease (CAD)
A number of studies have addressed the diagnostic accuracy of CCTA in the evaluation of CAD. Studies can be broadly subdivided into those that address the use of CCTA to evaluate individuals with symptoms suggestive of CAD, to risk stratify individuals at risk for coronary artery disease, and those that use CCTA after equivocal results of other cardiac imaging procedures, such as myocardial perfusion imaging (MPI) or echocardiography. In part these proposed uses result from the observation that a negative CCTA has high negative predictive value for the presence of CAD (Bluemke, 2008).

Several authors have compared CCTA to invasive coronary angiography ("the gold standard"). One such study (Miller, 2008) enrolled 291 participants in multiple centers with suspected CAD. Participants underwent CCTA prior to a scheduled invasive coronary angiogram. The primary outcome was the accuracy of CCTA in detecting stenoses of 50% or more compared to invasive coronary angiography, based on a per-person analysis (as opposed to a per-lesion analysis). Accuracy was measured as the area under the receiver operating curve (AUC). The authors found an AUC of 0.93 for CCTA which indicates that CCTA using a 64-row detector in symptomatic individuals (high prevalence) had a high degree of correlation to invasive coronary angiography. Miller also found a negative predictive value of 83%, which is lower than other similar studies have reported (Cademartiri, 2007; Hausleiter, 2007; Hussman, 2008; Schlosser, 2007). The lower negative predictive value in this well-controlled multi-center study is important to consider, particularly since a high negative predictive value forms the scientific rationale for the proposed clinical utility of CCTA to deselect individuals for invasive coronary angiography. Miller hypothesized that the higher negative predictive value in other studies may be related to the limitations inherent in single-center designs and the degree of rigor used in controlling for bias in smaller studies. Heterogeneity in study results has also been noted in a 2006 meta-analysis by Hamon and colleagues. Miller and colleagues conclude by stating, "Further studies are needed to define [CCTA's] precise role in the diagnostic algorithm for the evaluation of patients with suspected coronary artery disease."

In addition to concerns about the diagnostic validity of CCTA, studies which compare imaging results as the outcome of interest are assessing an intermediate outcome. The relevant clinical health outcomes for studies of CCTA include such metrics as survival, major adverse cardiac events, and safety. It is also important to realize that studies which address whether physicians will use the CCTA results are assessing the diagnostic, but not clinical utility of the test. That a provider would rely on the test is a key element of clinical utility, but it does not establish clinical utility. One additional limitation regarding CCTA is that, as opposed to myocardial perfusion imaging or echocardiography, CCTA only provides information about the anatomy of a stenosis but does not provide information on the functional significance of any stenosis.

Randomized trials that assess the efficacy of CCTA as the initial study in individuals with suspected CAD must include appropriate control groups (often individuals who do not undergo imaging studies). Efficacy could be measured by a variety of cardiac outcomes assessed over medium and long term follow-up. Diagnostic accuracy is sometimes considered an adequate intermediate surrogate outcome in situations where there are limited other diagnostic techniques, or there are significant limitations in the gold standard. However, this is not the case for the evaluation of CAD where there are multiple other diagnostic techniques.

Another consideration is the safety of CCTA. Previously, it was suggested that the use of 64-slice CCTA scanners were associated with a non-negligible lifetime attributable risk of cancer. However, second-generation CCTA scanners may be used which can decrease the amount of radiation exposure. A study by Chen and colleagues (2013) reported on 107 participants who received CCTA with a second-generation 320-detector row machine and compared the radiation exposure to 100 participants who had previous imaging with a first-generation scanner. For the second-generation scanner the median radiation dose was 0.93 mSv and 2.76 mSv with the first-generation scanner. This radiation dose places CT scans at an intermediate (1–10 mSv) level of risk under international guidelines, a risk level for which the corresponding benefit should be "moderate" to "substantial." Einstein and colleagues (2007) reported that a non-negligible LAR (lifetime attributable risk) of cancer" and that the risk is "Considerably greater for women, younger patients and for combined cardiac and aortic scans." CCTA also presents the risk of renal damage (like coronary angiography) if nephrotoxic contrast agents are used and of complications from the use of medicines to slow the heart rate to obtain a usable image. In addition, depending on how CCTA is integrated into cardiac work-up, the individual could be exposed to multiple different imaging tests with cumulative radiation exposure, particularly if CCTA results in an additional layer of imaging.

The need for final health outcomes to define the role of CCTA in the hierarchy of imaging tests is highlighted by an editorial accompanying the Miller study, which noted:     

Some proponents argue that diagnostic cardiac CT angiography should not be held to the same outcome standard as therapeutic procedures, since diagnostic procedures are not directly responsible for improved outcomes. However, the value of diagnostic tests lies in whether, by leading to a more appropriate choice of therapy, they ultimately result in better outcomes … Although [the Miller study] was carefully done and provides more data on diagnostic accuracy, it does not advance our knowledge of the appropriate use and possible benefits of the technology… Because all patients received both cardiac CT angiography and conventional coronary angiography and no data on outcomes are reported, the study does not answer this important question (Redberg, 2008).

The Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography (ACCURACY) Trial evaluated CCTA results from 230 of 245 individuals experiencing typical or atypical chest pain but without known CAD. This prospective study evaluated subjects with chest pain at 16 sites who were clinically referred for invasive coronary angiography. CCTAs were scored by consensus of three independent blinded readers. The invasive coronary angiographies were evaluated for coronary stenosis based on quantitative coronary angiography. A total of 230 subjects underwent both CCTA and invasive coronary angiography (59.1% male; mean age: 57 ± 10 years). The sensitivity, specificity, and positive and negative predictive values to detect greater than or equal to 50% or greater than or equal to 70% stenosis were 95%, 83%, 64%, and 99%, respectively, and 94%, 83%, 48%, 99%, respectively. No differences in sensitivity and specificity were noted for non-obese compared with obese subjects or for heart rates less than or equal to 65 beats/min compared with greater than 65 beats/min, whereas calcium scores greater than 400 reduced specificity significantly. Pretest disease probability, radiation dose, incidental noncardiac finding prevalence and follow-up were not reported (Budoff, 2008b).

In 2010, Hamirani and colleagues compared the accuracy of nuclear stress imaging to CCTA in 122 symptomatic individuals with cardiac catheterization. These individuals underwent MPI and CCTA evaluations within 6 months. The study was not a head-to-head comparison of MPI and CCTA but rather a comparison of diagnostic accuracy of each modality to cardiac catheterization. The comparability of the techniques is in question since CCTA provides anatomic information whereas MPI has additional functional and prognostic value. The prevalence of greater than 50% stenosis on cardiac catheterization was 74.6%, CCTA was 80.3%. The prevalence of greater than 70% stenosis on cardiac catheterization was 63.9%, CCTA was 62.3%. On MPI, 68 individuals were found to have perfusion defects. Sensitivity, specificity and positive and negative predictive values in those with greater than 50% lesions for CCTA were 98.9%, 74.2%, 91.8%, and 95.8%, respectively. For MPI, the values were 56%, 38.7%, 72.9%, and 23% respectively. Sensitivity, specificity and positive and negative predictive values in those with greater than 70% lesions for CCTA were 89.7%, 86.4%, 92.1%, and 82.6% respectively. For MPI, the values were 57.7%, 43.2%, 64.3%, and 36.5%, respectively. The study is limited by its retrospective and observational design. The participants in the study also had a higher prevalence of CAD (53%), which might have affected the specificity and negative predictive value of the study. The authors also noted that CCTA is limited by artifacts caused by high coronary artery calcium scores, coronary motion caused by fast heart rates and by breathing artifacts.

Additional studies and meta-analyses of 64-slice MDCT scanning have examined the diagnostic accuracy of CCTA in comparison to conventional ICA (Meijer, 2008; Mowatt, 2008a; Stein, 2008). In these and other prior studies of CCTA vs. invasive coronary angiography, high disease prevalence has a positive impact on the accuracy of the CCTA test results. The test accuracy of CCTA among populations with lower disease prevalence is of interest in the further assessment of clinical utility for CCTA in comparison to invasive coronary angiography results. In addition, the lack of health outcomes data that go beyond reports of diagnostic accuracy are the basis of the position statement identifying CCTA as an investigational technique to diagnose CAD.

Other organizations consider diagnostic accuracy an outcome adequate to support the routine use of CCTA in the evaluation of CAD. As noted above, in 2008 the American Heart Association Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention published a scientific statement on CCTA to evaluate CAD (Bluemke, 2008). Based on their literature review, the statement offered recommendations categorized according to the following criteria, based on class or recommendation and level of evidence. As noted, Class II recommendations include both the weight of evidence and opinion. 

Class I:    Conditions for which there is evidence and/or general agreement that a given procedure or treatment is beneficial, useful, and effective.
Class II:  Conditions for which there is conflicting evidence and/or divergence of opinion about the usefulness/efficacy of a procedure or treatment. 

Class III: Conditions for which there is evidence and/or general agreement that a procedure/treatment is not useful/effective and in some cases may be harmful (Budoff, 2006).

Level of Evidence A:   Data derived from multiple randomized clinical trials or meta-analyses.
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.

The specific recommendation regarding CCTA for diagnosis of CAD is as follows:

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 tests (Class IIa, level of evidence B).

In 2010, the American College of Cardiology Foundation (ACCF) Appropriate Use Criteria Task Force published appropriate use criteria for cardiac computed tomography (Taylor, 2010). The task force used a process which combines evidence-based medicine and practice experience by engaging a technical panel in a modified Delphi exercise. It should be noted that the technical requirements of a Rand Modified Delphi approach (Gordon, 2009) were not strictly adhered to in this report and resulted in obtaining a consensus of individuals on the panel rather than an evidence-based approach. In addition, this ACCF publication did not address concerns regarding the limited data about the harms of radiation from CCTA or the consequences of falsely positive CCTA prompting additional unnecessary interventions.

A 2011 study by Chow and colleagues studied the accuracy of CCTA for CAD across multiple centers. There was variability across the multiple centers with a sensitivity, specificity, positive predictive value, and negative predictive value ranging from 50.0% to 93.2%, 92.0% to 100%, 84.6% to 100%, and 42.9% to 94.7%, respectively. The authors concluded there needs to be an understanding of what is causing the variability amongst the facilities before there can be a universal adoption of this diagnostic test.

McEvoy and colleagues (2011) reported on 1000 asymptomatic individuals who had already had CCTA previously and followed them for 18 months. Individuals were assessed at 90 days and then again at 18 months for medication use, secondary test referrals, revascularizations and cardiovascular events. Comparing the CCTA group to a matched control group (who had not had a previous CCTA), the authors reported that 785 individuals had a reported normal CCTA with 215 individuals with "positive CCTA" results. There was no difference in the use of statins between the CCTA group and the control group at baseline however statins were prescribed more often to those with a positive CCTA result compared with the control group. Similar findings were noted with the use of aspirin. Those individuals who had positive CCTA results were more likely to be referred for secondary tests when compared with the control group. Revascularization was more prevalent in the CCTA group as opposed to the control group. At 90 days, 12 individuals had percutaneous coronary intervention, 1 individual had coronary artery bypass graft surgery in the CCTA group whereas 1 individual in the control group had percutaneous coronary intervention. There were no differences in revascularizations at 18 months. In the first 90 days there were no cardiac events for either group (CCTA and control). At 18 months there was 1 admission for unstable angina in the CCTA group and 1 unspecified cardiac death in the control group. At 18 months, screening CCTA was associated with increased invasive testing, but no difference in events and should not be considered a justifiable test at this time.

A 2012 study by Hoffman and colleagues compared the effectiveness of CCTA with that of standard evaluation in individuals suggestive of acute coronary syndrome in the emergency room. Individuals were excluded if they had known CAD. The primary end point was length of hospital stay. The secondary endpoint was time to diagnosis. A total of 501 individuals had CCTA, 499 individuals had a standard evaluation in the emergency room. And while the length of hospital stay was decreased in the group that had CCTA and more individuals who had CCTA were discharged from the emergency room, there was more downstream testing and higher radiation exposure to this group. Another study by Litt (2012) also compared individuals at low-to-intermediate risk with possible acute coronary syndromes who presented to the emergency room. Individuals were randomly assigned in a 2:1 ratio to undergo CCTA or receive traditional care. The primary outcome was safety (measured by the rate of cardiac events within 30 days). None of the participants with a negative CCTA had myocardial infarction or died within 30 days. There were no cardiac deaths in the traditional group. And while the CCTA group had a higher rate of discharge from the emergency room and decreased overall length of stay, there were no differences between the groups in the use of invasive angiography or rate of revascularization. Schlett et al (2011) reported on the 2-year prognostic value of CCTA for predicting major adverse cardiac events. Major adverse cardiac events were defined as cardiac death, ST-segment elevation myocardial infarction, non-ST segment elevation myocardial infarction, or coronary revascularization. They followed 368 individuals who presented to the emergency room with acute chest pain and had CCTA. A telephone call follow-up was done at 6 months and 2 years. At 23 months, 333 individuals were available for follow up. A total of 25 individuals experienced major adverse cardiac events (12 had myocardial infarction, 23 had revascularizations). Of the 25 individuals who had major adverse cardiac events, 20 events occurred during the first 30 days with recurrence of 10% at 2 years. This was an observational study at a single institution and CCTA was not used to direct or manage care. Larger studies are needed to determine whether CCTA is more appropriate than the existing standard of care.

Summary
A variety of studies and meta-analyses have reported that CCTA has a high negative predictive value for CAD, and that CCTA is a potentially useful technique to deselect individuals for invasive coronary artery angiogram, particularly those individuals considered to be at intermediate risk of CAD. These studies, and resultant clinical recommendations and appropriate use criteria, have focused on the diagnostic accuracy of CCTA. In contrast, there are inadequate data to support the clinical utility of CCTA, specifically how CCTA will be integrated into the management of individuals with suspected CAD, and how CCTA will ultimately improve outcomes. These final health outcomes are considered important, due to multiple other imaging and evaluation options. In addition, CCTA is associated with significant radiation exposure, which is a concern given that some individuals may undergo multiple imaging tests. Therefore, the lack of health outcomes data that go beyond reports of diagnostic accuracy are the basis of the position statement identifying CCTA as an investigational technique to diagnose CAD.

Coronary CT Angiography to Evaluate Anomalous Coronary Arteries
Anomalous coronary arteries are uncommon findings. However, these congenital anomalies can be very important clinically depending on the course of the anomalous arteries. Projection x-ray angiography has traditionally been the preferred imaging technique for the diagnosis and characterization of anomalous arteries. However, conventional angiography is considered a flawed gold standard; sometimes the anomalous artery is not well visualized, and the declining use of pulmonary artery catheters during conventional angiography makes it more difficult to discern the anterior versus posterior trajectory of the anomalous artery.

Given the low incidence of this condition, it is not surprising that there is relatively limited literature. Existing studies consist of case series comparing CCTA with conventional angiography. As noted in the review of the literature by Bluemke and colleagues, seven case series enrolling a total of 161 participants have been reported. In all but one study, the CCTA correctly identified the anomalous artery, with one exception where 29 of 30 of the arteries were correctly identified. However, none of the studies discussed the impact on therapeutic decisions. Even though the literature focuses on diagnostic accuracy as opposed to final health outcome, in this specific situation the limited outcome of diagnostic accuracy is considered adequate to validate the medical necessity of CCTA to evaluate anomalous coronary arteries when conventional angiography is non-diagnostic and when the result will impact treatment. Unlike CCTA as a technique to diagnose CAD, in this situation conventional angiography is considered a flawed gold standard and CCTA can provide valuable anatomic information when the angiography is considered equivocal.

A writing group deployed by the Working Group Nuclear Cardiology and Cardiac CT of the European Society of Cardiology and the European Council of Nuclear Cardiology published a report on Cardiac Computed Tomography in which the following is noted:

The robust visualization and classification of anomalous coronary arteries make CTA a first-choice imaging modality for the investigation of known or suspected coronary artery anomalies. Radiation dose must be considered often in the young patients, and measures to keep dose as low as possible must be employed (Schroeder, 2008).

A review by Shinbane and colleagues (2013) highlights that anomalies of the coronary arteries can lead to ischemia, infarction, ventricular dysfunction, ventricular arrhythmias or cardiac death. Since the anomalies are congenital, the symptoms often occur in childhood, especially during exercise. Surgery may be necessary. The CCTA can provide visualization of the coronary arteries noninvasively which can assist in determination of the optimal surgical approach (for example, a minimally invasive approach versus an open approach).

Coronary CT Angiography (CCTA) for New Onset Heart Failure
Echocardiography has been the preferred imaging modality due to its widespread use and lack of radiation. MRI can also provide high anatomical resolution of all aspects of the heart and surrounding structure. While CCTA can also provide assessment of cardiac structure and function, reports are limited and CCTA loses accuracy with high heart rates. A 2013 ACCF/AHA Guideline for the Management of Heart Failure (Yancy) does not give a specific recommendation for the use of CCTA in diagnosing new-onset heart failure.

Coronary CT Angiography (CCTA) for Pre-operative Noncoronary Cardiac Surgery
CCTA can be used as part of a pre-operative evaluation for those undergoing noncoronary cardiac surgery. However, in 2010 the ACCF Appropriate use criteria for cardiac computed tomography (Taylor) indicated CCTA as inappropriate or uncertain as a preoperative evaluation of noncardiac surgery without active cardiac conditions. Conversely, for noncoronary cardiac surgery, the appropriate use criteria stated CCTA may be appropriate for coronary evaluation for those individuals with an intermediate pretest probability of CAD. Randomized control trials comparing CCTA to other modalities in the preoperative setting is necessary.

Coronary MRA to Detect Coronary Artery Disease (CAD)
Compared to CCTA, there is more limited literature regarding coronary MRA as a diagnostic technique for CAD. However, the same limitations apply, i.e., the majority of studies are single institution studies reporting diagnostic performance on a per-segment or per-artery basis, as opposed to the more clinically relevant per-person basis. As reviewed by Bluemke, the negative predictive value in the 17 reviewed studies ranged from 71-96%, which is generally lower than the values reported for CCTA. The Bluemke review notes that the diagnostic accuracy of CCTA favors coronary MRA. However, the main limitation in this literature is the lack of final outcome studies, similar to CCTA. 

Yoon and colleagues (2012) reported a retrospective review of 226 individuals with suspected CAD, but without previously known CAD, who underwent coronary MRA. Nineteen individuals were lost to follow-up and were excluded from the final analysis. The most common reason for coronary MRA was chest pain, followed by palpitations, dyspnea, and syncope. Sixty-eight individuals were asymptomatic but had multiple risk factors. Coronary MRA showed at least 1 significant coronary artery stenosis in 84 of 207 individuals. Median follow-up period was 25 months. During follow-up, cardiac events of those individuals with significant stenosis included cardiac death (n=1) and unstable angina (n=4). For the individuals without significant stenosis, there were no severe cardiac events. Within 90 days following cardiac MRA, 25 individuals with significant stenosis had a revascularization procedure. For the individuals without significant stenosis, none of them underwent revascularization within 90 days after cardiac MRA. This study is limited by its retrospective design and the fact that "the diagnostic and therapeutic procedures were not guided by\specific study protocol and might be influenced by a result of CMRA."

Coronary MRA to Diagnose Anomalous Coronary Arteries
A total of six studies including 109 participants undergoing MRA to diagnose anomalous coronary arteries were identified in the review by Bluemke. In these studies, coronary MRA correctly identified the anomalous anatomy in 93-100% of cases. Consideration of the medical necessity of coronary MRA for this indication is similar to CCTA for the same indication. Therefore, coronary MRA is considered medically necessary when conventional angiography is either unsuccessful or equivocal.

Cardiac MRI
The 2006 American College of Cardiology Appropriateness Criteria (Hendel, 2006) rates cardiac MRI as an appropriate indication for the evaluation of suspected coronary anomalies.

Background/Overview

CCTA is a non-invasive imaging test that may or may not use intravenously administered contrast material and a high-resolution, high-speed CT machine (multi-detector row scanner) to obtain detailed volumetric images of blood vessels. CCTA has been proposed as a non-invasive alternative to invasive coronary angiography, particularly in individuals with an intermediate risk of significant coronary artery disease (CAD). 

MRA of the coronaries may be done by 3D navigator based T2 prepared fat sat whole heart steady state free precession imaging (most common) and 3D navigator based fat sat whole heart gradient echo imaging (much less common) or it may be done with gadolinium contrast. This technique does not involve radiation exposure. 

MRI is a non-invasive imaging modality that uses magnetic and radiofrequency fields to image body tissue producing very detailed, cross-sectional pictures of the body.

Definitions

Coronary contrast-enhanced computed tomography angiography (CCTA): A non-invasive radiological imaging technique that utilizes iodinated contrast agents followed by rapid imaging with a multi-detector row scanner, in order to acquire images of coronary arteries.

Magnetic resonance angiography (MRA): A non-invasive radiological imaging technique that utilizes traditional MRI technology to provide detailed images of blood vessels.

Magnetic resonance imaging (MRI): A non-invasive diagnostic technique that produces computerized images of internal body structures and tissues.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage or these services as it applies to an individual member.

CCTA/Coronary MRA
When services may be Medically Necessary when criteria are met:

CPT 
75574Computed tomographic angiography, heart, coronary arteries and bypass grafts (when present), with contrast material, including 3D image postprocessing (including evaluation of cardiac structure and morphology, assessment of cardiac function, and evaluation of venous structures, if performed)
76498Unlisted magnetic resonance procedure (eg, diagnostic, interventional) [when specified as coronary magnetic resonance angiography]
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
746.85Coronary artery anomaly
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
Q24.5Malformation of coronary vessels

When services are Investigational and Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses not listed, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Cardiac MRI
When services may also be Medically Necessary when criteria are met:

CPT 
75557Cardiac magnetic resonance imaging for morphology and function without contrast material;
75559Cardiac magnetic resonance imaging for morphology and function without contrast material; with stress imaging
75561Cardiac magnetic resonance imaging for morphology and function without contrast material(s), followed by contrast material(s) and further sequences;
75563Cardiac magnetic resonance imaging for morphology and function without contrast material(s), followed by contrast material(s) and further sequences; with stress imaging
  
ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
746.85Coronary artery anomaly
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
Q24.5Malformation of coronary vessels

When services are Investigational and Not Medically Necessary:
For the MRI procedure codes listed above when criteria are not met or for the following diagnoses, or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

ICD-9 Diagnosis[For dates of service prior to 10/01/2014]
414.00-414.07Coronary atherosclerosis
414.2Chronic total occlusion of coronary artery
414.3Coronary atherosclerosis due to lipid rich plaque
414.4Coronary atherosclerosis due to calcified coronary lesion
414.8Other specified forms of chronic ischemic heart disease
414.9Chronic ischemic heart disease, unspecified
V81.0Special screening for ischemic heart disease
  
ICD-10 Diagnosis[For dates of service on or after 10/01/2014]
I25.10-I25.119Atherosclerotic heart disease of native coronary artery
I25.700-I25.799Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
I25.810-I25.89Other forms of chronic ischemic heart disease
I25.9Chronic ischemic heart disease, unspecified
Z13.6Encounter for screening for cardiovascular disorders
  
References

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  31. Litt HI, Gatsonis C, Snyder B, et al. CT angiography for safe discharge of patients with possible acute coronary syndromes.N Engl J Med. 2012; 366(15):1393-1403.
  32. Marano R, De CF, Floriani I, et al. Italian multicenter, prospective study to evaluate the negative predictive value of 16- and 64-slice MDCT imaging in patients scheduled for coronary angiography (NIMISCAD-Non Invasive Multicenter Italian Study for Coronary Artery Disease). Eur Radiol. 2009; 19(5):1114-1123.
  33. McEvoy JW, Blaha MJ, Nasir K, et al. Impact of coronary computed tomographic angiography results on patient and physician behavior in a low-risk population. Arch Intern Med. 2011; 171(14):1260-1268.
  34. Meijboom WB, Meijs MF, Schuijf JD, et al. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008; 52(25):2135-2144.
  35. Meijboom WB, Mollet NR, Van Mieghem AG, et al. Preoperative computed tomography coronary angiography to detect significant coronary artery disease in patients referred for cardiac valve surgery. JACC. 2006; 48(8):1658-1665.
  36. Meijboom WB, Mollet NR, Van Mieghem CA, et al. 64-slice computed tomography coronary angiography in patients with non-ST elevation acute coronary syndrome. Heart. 2007; 93(11):1386-1392.
  37. Meijboom WB, van Mieghem CA, Mollet NR, 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):1469-1475.
  38. Meijer AB, O YL, Geleijns J, et al. Meta-analysis of 40- and 64-MDCT angiography for assessing coronary artery stenosis. AJR Am J Roentgenol. 2008; 191(6):1667-1675.
  39. Miller JM, Rochitte CE, Dewey M, et at. Diagnostic performance of coronary angiography by 64-row CT. N Eng J Med. 2008; 359(22):2324-2336.
  40. Mollet NR, Cademartiri1 F, Mieghem CV, et al. Adjunctive value of CT coronary angiography in the diagnostic work-up of patients with typical angina pectoris. European Heart Journal. 2007; 28(15):1872–1878.
  41. Mowatt G, Cook JA, Hillis GS, et al. 64-slice computed tomography angiography in the diagnosis and assessment of coronary artery disease: systematic review and meta-analysis. Heart. 2008a; 94(11):1386-1393.
  42. Ostrom MP, Gopal A, Ahmadi N, et al. Mortality incidence and the severity of coronary atherosclerosis assessed by computed tomography angiography. J Am Coll Cardiol. 2008; 52(16):1335-1343.
  43. Pahwa AK, Arbab-Zadeh A, J Brotman D, S Feldman L. Potential role of coronary computed tomography-angiography for guiding perioperative cardiac management for non-cardiac surgery. Heart Int. 2013; 8(1):e1.
  44. Ravipati G, Aronow WS, Lai H, et al. Comparison of sensitivity, specificity, positive predictive value, and negative predictive value of stress testing versus 64-multislice coronary computed tomography angiography in predicting obstructive coronary artery disease diagnosed by coronary angiography. Am J Cardiol. 2008; 101(6):774-775.
  45. Redberg RF, Walsh J. Pay now, benefits may follow – The case of cardiac computed tomographic angiography. N Eng J Med. 2008; 359(22):2309-2310.
  46. Rubinshtein R, Halon DA, Gaspar T, et al. Impact of 64-slice cardiac computed tomographic angiography on clinical decision-making in emergency department patients with chest pain of possible myocardial ischemic origin. Am J Cardiol. 2007c; 100(10):1522-1526.
  47. Rubinshtein R, Halon DA, Gaspar T, et al. Usefulness of 64-slice cardiac computed tomographic angiography for diagnosing acute coronary syndromes and predicting clinical outcome in emergency department patients with chest pain of uncertain origin. Circulation. 2007a; 115(13):1762-1768.
  48. Rubinshtein R, Halon DA, Gaspar T, et al. Usefulness of 64-slice multidetector computed tomography in diagnostic triage of patients with chest pain and negative or nondiagnostic exercise treadmill test result. Am J Cardiol. 2007b; 99(7):925-929.
  49. Schlett CL, Banerji D, Siegel E, et al. Prognostic value of CT angiography for major adverse cardiac events in patients with acute chest pain from the emergency department: 2-year outcomes of the ROMICAT trial. JACC Cardiovasc Imaging. 2011; 4(5):481-491.
  50. Schlosser T, Mohrs OK, Magedanz A, et al. Noninvasive coronary angiography using 64-detector-row computed tomography in patients with a low to moderate pretest probability of significant coronary artery disease. Acta Radiol. 2007; 48(3):300-307.
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  52. Shinbane JS, Shriki J, Fleischman F, et al. Anomalous coronary arteries: cardiovascular computed tomographic angiography for surgical decisions and planning. World J Pediatr Congenit Heart Surg. 2013; 4(2):142-154.
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  54. Sun Z, Davidson R, Lin CH. Multi-detector row CT angiography in the assessment of coronary in-stent restenosis: a systematic review. Eur J Radiol. 2009; 69(3):489-495.
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Government Agency, Medical Society, and Other Authoritative Publications:

  1. Abbara S, Arbab-Zadeh B, Callister TQ, et al. SCCT guidelines for performance of coronary computed tomographic angiography: A report of the Society of Cardiovascular Computed Tomography Guidelines Committee. J Cardiovas Comput Tomog. 2009; 3(3):190-204.
  2. Agency for Healthcare Research and Quality. Non-invasive imaging for coronary artery disease. Health Technology Assessment report. 2006 Oct. No. 290-02-0025. Available at: http://www.cms.hhs.gov/determinationprocess/downloads/id34TA.pdf. Accessed on January 16, 2014.
  3. American College of Radiology. ACR Appropriateness Criteria®. Available at: http://www.acr.org/Quality-Safety/Appropriateness-Criteria. Accessed on January 16, 2014.
    • Chest pain suggestive of acute coronary syndrome (2010)
    • Chronic chest pain - high probability of coronary artery disease (2010)
    • Chronic chest pain - low to intermediate probability of coronary artery disease (2012)
  4. Blue Cross Blue Shield Association. Coronary computed tomographic angiography in the evaluation of patients with acute chest pain. TEC Assessment, 2011; 26(9).
  5. Bluemke DA, Achenbach S, Budoff M, et al. Noninvasive coronary artery imaging. magnetic resonance angiography and multidetector 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.
  6. Budoff MJ, Achenbach S, Blumenthal RS, et al. Assessment of coronary artery disease by cardiac computed tomography: a scientific statement from the American Heart Association Committee on Cardiovascular Imaging and Intervention, Council on Cardiovascular Radiology and Intervention, and Committee on Cardiac Imaging, Council on Clinical Cardiology. Circulation. 2006; 114(16):1761-1791.
  7. Gerber TC, Carr JJ, Arai AE, et al. Ionizing radiation in cardiac imaging: a science advisory from the American Heart Association Committee on Cardiac Imaging of the Council on Clinical Cardiology and Committee on Cardiovascular Imaging and Intervention of the Council on Cardiovascular Radiology and Intervention. Circulation. 2009; 119(7):1056-1065.
  8. Gordon, TJ. Chapter 4: The Delphi Method. In: Glenn JC, Gordon TJ, Editors. Futures Research Methodology V3.0. The Millennium Project. 2009. Available at: www.millennium-project.org/FRMv3_0/04-Delphi.pdf. Accessed on January 16, 2014.
  9. Hendel RC, Berman DS, Di Carli MF, et al. ACCF/ASNC/ACR/AHA/ASE/SCCT/SCMR/SNM 2009 appropriate use criteria for cardiac radionuclide imaging: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the American Society of Nuclear Cardiology, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, and the Society of Nuclear Medicine. J Am Coll Cardiol. 2009; 53(23):2201-2229.
  10. Hendel RC, Patel MR, Kramer CM, et al. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006; 48(7):1475-1497.
  11. Institute for Clinical and Economic Review (ICER). Coronary computed tomographic angiography for detection of coronary artery disease. Final appraisal document. January 9, 2009. Available at: http://www.icer-review.org/appraisals/completed-appraisal/. Accessed on January 16, 2014.
  12. Institute for Clinical Systems Improvement. Health Care Guideline: Diagnosis and treatment of chest pain and acute coronary syndrome (ACS). Eighth Edition, November 2012. Available at: https://www.icsi.org/_asset/ydv4b3/ACS-Interactive1112b.pdf. Accessed on January 16, 2014.
  13. Schroeder S, Achenbach S, Bengel F, Burgstahler C, Working Group Nuclear Cardiology and Cardiac CT, European Society of Cardiology, European Council of Nuclear Cardiology, et al. Cardiac computed tomography: indications, applications, limitations, and training requirements: report of a Writing Group deployed by the Working Group Nuclear Cardiology and Cardiac CT of the European Society of Cardiology and the European Council of Nuclear Cardiology. Eur Heart J. 2008; 29(4):531-556.
  14. Taylor AJ, Cerqueira M, Hodgson JM, et al. ACCF/SCCT/ACR/AHA/ASE/ASNC/SCAI/SCMR 2010 Appropriate use criteria for cardiac computed tomography. A Report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, the Society of Cardiovascular Computed Tomography, the American College of Radiology, the American Heart Association, the American Society of Echocardiography, the American Society of Nuclear Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society for Cardiovascular Magnetic Resonance. Circulation. 2010; 122(21):e525-555. Available at: http://circ.ahajournals.org/content/122/21/e525.full.pdf. Accessed on January 16, 2014.
  15. Walsh J. California Technology Assessment Forum. Computed tomographic angiography in the diagnosis of coronary artery stenosis and for the evaluation of acute chest pain. A Technology Assessment. 2007. Available at: http://www.ctaf.org/sites/default/files/assessments/768_file_CTA_Wv2.pdf. Accessed on January 16, 2014.
  16. Yancy CW, Jessup M, Bozkurt B, et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013; 62(16):e147-239.
Web Sites for Additional Information
  1. National Institutes of Health (NIH). National Heart, Lung, and Blood Institute. Available at: http://www.nhlbi.nih.gov/. Accessed on January 16, 2014.
Index

CAD
Computed Tomography Angiography
Coronary Artery Disease
CTA
Magnetic Resonance Angiography
Magnetic Resonance Imaging
MRA
MRI
Virtual Angiography

Document History
StatusDateAction
Reviewed02/13/2014Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Rationale, Background/Overview, and References.
Revised08/08/2013MPTAC review. Updated Medically Necessary Position Statement regarding anomalous coronary arteries to include those under age 18 years. Updated Rationale and References.
Reviewed05/09/2013MPTAC review. Updated Rationale and References.
Reviewed11/08/2012MPTAC review. Updated Rationale and References.
Revised11/17/2011MPTAC review. Title change to include cardiac MRI. Addition of cardiac MRI to medically necessary Position Statement. Addition of cardiac MRI to investigational and not medically necessary statement. Updated Description/Scope, Rationale, Background/Overview, Definitions, Coding, References and Index.
Reviewed02/17/2011MPTAC review. Updated Rationale and References.
Reviewed02/25/2010MPTAC review. No change to stance. The Rationale and References were updated.
 01/01/2010Updated Coding section with 01/01/2010 CPT changes; removed CPT 0146T, 0147T, 0148T, 0149T, 0151T deleted 12/31/2009.
Revised02/26/2009

MPTAC review. The position statement has been revised to now consider coronary MRA as 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. The title was changed to: Coronary Artery Imaging: Contrast-Enhanced Coronary Computed Tomography Angiography (CCTA) and Coronary Magnetic Resonance Angiography (MRA).

The Rationale, Background and Coding sections and References have been updated.

Revised02/21/2008MPTAC review. No change to stance. The title was changed from Contrast-Enhanced Cardiac Computed Tomography Angiography (CTA) and Cardiac Magnetic Resonance Angiography (MRA) to: Coronary Artery Imaging: Contrast-Enhanced Computed Tomography Angiography (CTA) and Cardiac Magnetic Resonance Angiography (MRA). The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting. References, Coding, and Background sections were updated.
Reviewed03/08/2007MPTAC review. No change to stance/criteria. Information in the Rationale section was updated to include comments from the 2006 AHA Scientific Statement (Budoff, 2006). References and Coding sections were also updated.
Revised12/07/2006MPTAC review. Position stance was revised to consider CTA medically necessary for the evaluation of suspected anomalous coronary arteries, subject to criteria being met. Also added a statement regarding MRA for evaluation of coronary arteries as investigational/not medically necessary. Rationale, Coding, and Reference sections were also updated.
Reviewed03/23/2006MPTAC review. No changes to criteria. References were updated.
 01/01/2006Updated Coding section with 01/01/2006 CPT/HCPCS changes.
 11/17/2005Added reference for Centers for Medicare and Medicaid Services (CMS) – National Coverage Determination (NCD).
New04/28/2005MPTAC initial document development.