Coverage Policy Manual
Policy #: 2001004
Category: Radiology
Initiated: January 2001
Last Review: October 2018
  Magnetic Resonance Imaging (MRI), Cardiac Applications

Description: Cardiac Magnetic resonance imaging (CMRI) is a non-invasive three-dimensional imaging modality that can provide anatomic and functional information about cardiovascular structures.  

MRI techniques provide high spatial resolution images, do not involve radiation exposure, and can characterize tissue to a greater degree than other modalities.   Disadvantages of these techniques include relatively long imaging times which can result in cardiac and respiratory motion artifacts, as well as for prolonged postprocessing and data analysis; and the scarcity of personnel trained in the newer cardiac MRI techniques.

With rapidly evolving technology and without definitive guidelines it is difficult to develop coverage policy for cardiac MRI that is precise and explicit.  Other studies (e.g., echocardiograms, CT scans, radionuclide scintigraphy) are often adequate for diagnosis of disease or planning for therapeutic interventions, and are more cost-effective in a particular clinical setting.  The following coverage follows the ABCBS member benefit contract “Primary Coverage Criteria” which includes cost-effectiveness requirements.  Conditions/clinical circumstances that are listed as having limited coverage in the following policy are “limited” depending on whether a more cost-effective study would be appropriate in the particular setting.

Policy/
Coverage:
CMRI (including CMR Angiography) has limited coverage for the following conditions/clinical circumstances:
    • Assessment of complex congenital heart disease including anomalies of coronary circulation, great vessels, and cardiac chambers and valves.  Procedures may include LV/RV mass and volumes, MR angiography, quantification of valvular disease, and contrast enhancement.
    • Quantification of LV function or myocardial mass, when accurate assessment is important and when other methods have proven inadequate;
    • Evaluation of native or prosthetic cardiac valves, only if trans-esophageal echo is inadequate or contraindicated, and recognizing the limitations of CMR;
    • Measurement of right & left ventricular mass and volume in situations where precise measurement of these variables is medically necessary;
    • Measurement of regional wall-motion studies;
    • Diagnosis of specific cardiomyopathy/myocarditis (e.g.. amyloid, sarcoid, hemachromatosis);
    • Diagnosis of cardiac masses (including intracardiac thrombi and tumors);
    • Evaluation for aortic dissection;
    • Evaluation of pulmonary veins prior to radiofrequency ablation of atrial fibrillation, when CT angiography is contraindicated;
    • To determine myocardial viability in patients with revascularizable coronary artery disease, if such study will impact a decision to revascularize;
    • Diagnosis of ventricular aneurysms
    • Evaluation of pericardial disease;
    • Evaluation of patients with anginal symptoms or infarction but normal epicardial coronary arteries at angiography and no evidence of coronary artery spasm; and
    • Evaluation for arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVC or ARVD).
 
For those conditions/clinical circumstances listed as covered, CMRI/CMRA is limited to situations in which other evaluations that are known to be of similar benefit and are more cost effective have been performed with indeterminate results are contraindicated.  There will be circumstances where the attending physician will determine that CMRI/CMRA is indicated as the initial study (e.g., evaluation of a particular pericardial disease, evaluation for an intracardiac tumor). The physician requesting and the physician performing the CRMI/CRMA should note in the chart a valid reason(s) for performing the CRMI/CRMA rather than an alternative procedure.  In addition, the record should reflect the expected improvement in health outcome(s) that would result from the CRMI/CRMA.
 
CMRI (including CMRA) for the following conditions/clinical circumstances:
    • Study of valvular heart disease (except in the limited circumstances noted above);
    • Study of patients with diabetes mellitus with suspected or unsuspected coronary artery or microvascular disease as initial evaluation;
    • Comprehensive assessment of diagnosis of coronary artery disease;
    • Detection of coronary artery stenosis;
    • Dobutamine stress testing (except for viability evaluation);
    • Interventional CMRI/CMRA;
    • Screening for coronary artery disease;
    • Use in any investigational protocol examining effects of specific drugs on the myocardium or coronary vessels, or in studying any aspect of a specific cardiac condition
does not meet Primary Coverage Criteria that there be scientific evidence of effectiveness.
 
For contracts without Primary Coverage Criteria, CMRI (including CMRA) for the following conditions/clinical circumstances:
    • Study of valvular heart disease (except in the limited circumstances noted above);
    • Study of patients with diabetes mellitus with suspected or unsuspected coronary artery or microvascular disease as initial evaluation;
    • Comprehensive assessment of diagnosis of coronary artery disease;
    • Detection of coronary artery stenosis;
    • Dobutamine stress testing (except for viability evaluation);
    • Interventional CMRI/CMRA;
    • Screening for coronary artery disease;
    • Use in any investigational protocol examining effects of specific drugs on the myocardium or coronary vessels, or in studying any aspect of a specific cardiac condition
is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
 
Note: Screening tests are exclusions in most member benefit certificates of coverage except for coverage based on the Patient Protection and Affordable Care Act (PPACA) screening recommendations for non-grandfathered plans and those contracts with wellness benefits (which like PPACA, covers specific screening procedures). (Effective 8/2011)
 

Rationale:
Cardiac MRI is achieving increased use and validity for a number of cardiac indications.  Its utility for a number of conditions is considered to be as, or more effective, than other imaging modalities.  For instance:
    • the role of CMRI for the morphological evaluation of complex cardiac and/or great vessel anomalies is well accepted;
    • the measurement of right or left ventricular mass and volume is best achieved with CMRI;
    • the evaluation of right and left ventricular systolic and diastolic function may be more precise than measurements by other techniques;
    • the measurement of ventricular “strain” may not be obtained by other procedures; the differentiation of myocarditis vs cardiomyopathy may be determined by CMRI;
    • the presence of intracardiac tumors (including thrombi) or ventricular aneurysms may not be visualized as well by other non-invasive procedures;
    • congenital pericardial defects, tumors, effusions, and constrictive pericarditis are diagnosed precisely with CMRI; and
    • a small number of patients with standard symptoms of coronary artery disease have normal or near normal epicardial coronary arteries on coronary angiography and no evidence of coronary artery spasm, but delayed subendocardial contrast enhancement detected on MRI (with relief of the angina and improvement of the delay in subendocardial blood flow by beta blockers).
 
Many of the proposed and recommended uses of CMRI are based on anecdotal reports and small case series (often retrospective).  An additional problem is that many of the proposed uses are based on intermediate outcomes (i.e., the ability to demonstrate a defect visually), but studies showing improved patient outcome based on the improved imaging have not been demonstrated.  For these reasons, most of the covered conditions/clinical situations for CMRI are only when less cost-effective non-invasive procedures have produced indeterminate results.  
 
Despite the absence of assessment of CMRI by independent reviewers, recent reviews by proponents of CMRI, published in first line peer-reviewed journals, have provided the following comments on specific uses of CMRI/CMRA:
    • “Echocardiography and catheterization remain the mainstay of assessment for valvular heart disease…Since CMRI can reproducibly determine ventricular function and myocardial mass, it enables accurate assessment of ventricular remodeling.  CMRI can be used to follow up patients with valvular disease who might need surgical intervention in the future.  Its potential in clinical use in valvular disease needs further study”
    • "Clear visualization and assessment of right ventricle and pulmonary artery morphology and function are important in assessment of many congenial heart diseases.  Assessment of right ventricular structure and function by echocardiography is difficult because of its proximity to the chest wall and complex shape…CMRI can assess structure and function accurately and reproducibly in such situations.  This method has been extensively evaluated in the assessment of pulmonary valve, pulmonary arterial tree, and related hemodynamics in congenital heart disease and is the preferred non-invasive modality”
    • “If the etiology of a cardiomyopathy is uncertain, contrast-enhanced MRI can be of utility to determine if it represents a focal or global cardiomyopathy and if active inflammation is present”
    • “Although there is some evidence to support that in certain cardiomyopathies such as those caused by hemochromatosis and patients with elevated troponins, cardiac MRI may provide useful information about cardiac physiology.  However, cardiac MRI at this time cannot be used for the evaluation of undefined cardiomyopathy in all patients.  There is no scientific evidence to support the contention that cardiac MRI should be performed in all patients with undefined cardiac myopathy”
    • “CMRI is an important method to study pathogenesis of hypertrophic cardiomyopathy…Myocardial perfusion abnormalities and fibrosis have been shown in both symptomatic patients with hypertrophic cardiomyopathy by contrast-enhanced techniques.  The precise importance of the distribution of contractile abnormalities, perfusion defects, and fibrosis remains to be determined”  
    • “Restrictive cardiomyopathy and constrictive pericarditis have many similar clinical and pathophysiological characteristics…Sensitivity, specificity, and accuracy for diagnosis of constriction with CMRI are high (88%, 100%, and 93% respectively), with pericardial thickening seen in 88%”
    • “MR has an increasing part to play in management of cardiac neoplasms.  Apart from atrial myxomas and primary valvular tumors, for which echocardiography is adequate for diagnosis and planning of treatment, CMRI provides additional anatomical information within the heart and evidence of extension into extracardiac structures”
    • “In a multicenter study, use of three-dimensional CMRA was compared with elective X-ray coronary angiography in 109 patients.  Results showed that 636 of 759 proximal and middle segments of coronary arteries could be interpreted on magnetic resonance angiography.  In these segments, 83% of clinically important lesions (>= 50% luminal stenosis) were detected by CMRA.  Accuracy of this technique in diagnosis of coronary artery disease was 75% (95% CI 63-81).  Sensitivity, specificity, and accuracy of detection of patients with disease of the left main stem or three-vessel disease were 100%, 85%, and 87%, respectively…Studies comparing CMRA with conventional angiography need to account for rapid technological advances in this area, and many patients must be recruited to have any effect on day to day clinical practice.  Available data suggest that CMR might be a non-invasive method for assessment of the proximal few centimeters of coronary arteries in ischemic heart disease”
    • “MRI has some utility in imaging in demonstrating abnormalities of wall motion and in demonstrating pericardial effusions.  MRI has little utility for routine use in imaging of patients with suspected myocardial ischemia…MRA & MRI plaque characterization are still primarily investigational and are not yet in wide clinical use”
    • “There is no evidence to support the use of functional cardiac MRI as the initial testing for asymptomatic diabetic patients”
    • “Functional CMRI, which applies the same principles as stress echocardiography, can also be used tin assessment of viability.  Diastolic wall thickness, endocardial motion, and systolic wall thickening are used to evaluate response to dobutamine stress.  Diastolic wall thickness of 5.5 mm or more and systolic wall thickening of 2 mm or more have been shown to predict reversibility of contractile function after revascularization. Stress-induced systolic wall thickening and diastolic wall thickness had sensitivity and specificity of 89% and 94% and 92% and 56%, respectively”
    • “Comprehensive assessment of sequelae of coronary artery disease includes outlining of remodeled anatomy and function of the ventricles, assessment of myocardial perfusion at rest and after stress, detection of myocardial viability, and definition of the coronary anatomy and valvular pathology.  This plethora of information allows informed decision making in patient’s management.  CMRI has been proposed as a non-invasive modality that could provide a one-stop evaluation of coronary artery disease.  Few integrated protocols have ben proposed for comprehensive assessment of coronary artery disease…A similar integrated CMRI protocol has been tried in risk assessment of patients presenting with chest pain at the emergency department with acute coronary syndrome, with sensitivity and specificity of 85%.  If comprehensive assessment of coronary artery disease by CMRI becomes a clinical reality, this modality will be one of the most important investigations in ischemic heart disease”
    • “The reviewed studies provide some evidence that MRI can be used to evaluate cardiac wall motion, wall thickening, or contrast agent uptake as indicators of myocardial viability in patients with ischemic heart disease.  Certain MRI-based methods appear to have moderate to high sensitivity and specificity that may be comparable with the sensitivity and specificity of TEE and PET for the detection of viable, hibernating myocardium.  However, interpretation of data from the available studies was hampered by limitations such as small sample size, variations in study populations, and lack of standardization of protocols for MRI.  Moreover, none of the studies provided evidence regarding the impact of MRI assessment of myocardial viability on clinical management or health outcomes for patients who would be candidates for revascularization, and therefore, it is difficult to draw conclusions regarding the appropriate clinical role for MRI for myocardial viability assessment”
 
2008 Update
MR of the heart and blood vessels is now often referred to as cardiovascular magnetic resonance (CMR).  Traditionally, the presence of a pacemaker or certain other metal devices has precluded magnetic resonance studies, but pacemakers are being developed which are compatible with CMR.  
 
Major clinical applications include:
Complex Congenital Heart Disease:  Three-dimensional structure as well as pulmonary and systemic blood flows (Beerbaum, 1996) can be measured. Myocardial fibrosis in post-op tetralogy of Fallot patients is a marker of adverse outcomes and can be detected by CMR (Babu-Narayan, 2006)
 
Aortic Disease—CMR can precisely define the dimensions and extent of complex aortic aneurysms and associated complications (Summers, 1998).  Some CMR systems can image the thoracic aorta within 25 seconds.
 
Pericardial Disease --  Pericardial thickening is easily detected, and pericardial fluid can be distinguished from pericardium. CMR is the most accurate test for evaluation of complex pericardial abnormalities (Breen, 2001).  The effects of respiration on ventricular filling can be observed (Francone, 2005).  Hemorrhagic and nonhemorrhagic pericardial effusions can be differentiated. (Smith, 2001).
 
Chronic Ischemic Heart Disease -- In one study with 208 patients, dobutamine stress echo had a greater sensitivity (86 vs 74%) and specificity (86 vs 70%) compared to dobutamine stress echo in detecting significant coronary lesions; coronary angiography was the gold standard (Nagel, 1999). Coronary MR angiography is under intense study, and at this time it is useful for evaluation of anomalous coronary arteries and for monitoring coronary artery aneurysms.  However, currently CMR is not accurate or cost-effective enough for routine use in evaluating coronary artery disease.
 
After Myocardial Infarction:  While not needed routinely, CMR can accurately assess complications of infarction, including mitral regurgitation, ventricular septal defect, left ventricular thrombus, and pseudoaneurysm.  Late gadolinium enhancement (LGE, meaning persistence of gadolinium enhancement > 10 minutes after injection) reflects permanently damaged muscle, including old and new infarction.  Infarct sizing is precise and reproducible, and thus this may be the best technique for infarct size measurement in research studies (Kim, 2008).  In clinical practice, precise measurement of infarct size is not necessary.
 
Myocardial Viability:  LGE CMR can predict recovery of left ventricular function after revascularization (Kim, 2000; Selvanayagam, 2004).  When combined with low dose dobutamine, it can quantify the amount of myocardial viability after an acute MI (Geskin, 1998; Gunning, 1998).  However, a Hayes Technology assessment, while finding some evidence that CMR can be used for assessment of  myocardial viability in patients with ischemic heart disease, concluded that interpretation of the data was hampered by small sample size, variations in study populations, and lack of standard CMR protocols.  None of the studies provided evidence regarding the impact of CMR myocardial viability assessment on health outcomes or clinical management.  Therefore, a HAYES Rating™ of C is assigned to CMR for prediction of response of patients with left ventricular dysfunction and ischemic heart disease to revascularization procedures. Hayes, 2004)
 
Troponin-positive chest pain with normal coronaries:  Patients often present with chest pain (typical or atypical), with positive troponin and have a normal coronary angiogram.  It is often unclear whether the patient truly suffered myocardial necrosis and what the etiology might be (eg coronary vasospasm, thrombus).  In one study, 60 such patients (40% with initial ST elevation) were studied by CMR within 3 months of the event (Assomull, 2007).  Based on the LGE pattern, a cause for the troponin elevation was identified in 65% of the patients: myocarditis in 50%, MI in 12%, and cardiomyopathy in 3%.
 
Cardiac Masses: CMR appears to have a higher sensitivity and similar specificity as compared to echo.  In the largest study (160 patients studied by CMR with LGE, TEE, and transthoracic echo; and with surgical or pathological confirmation of thrombus), CMR was equally specific (99 v 96 v 96%) but CMR was more sensitive (88 v 40 v 23%) (Assomull, 2007).  
 
Cardiomyopathy:  LGE can help differentiate ischemic vs nonischemic cardiomyopathy. LGE is present in 81 to 100% of patients with ischemic cardiomyopathy, as opposed to 12 to 41% of patients without significant obstructive coronary disease (Soriano, 2005; McCrohon, 2003). While there is overlap, the patterns of LGE tend to be different (subendocardial/transmural LGE in ischemic cardiomyopathy versus isolated mid-wall or epicardial hyperenhancement in non-ischemic cardiomyopathy (Bello, 2003; Vogel-Claussen, 2006). The Claussen article points out that delayed myocardial enhancement is not specific for myocardial infarction and can occur in a variety of other disorders, such as inflammatory or infectious diseases of the myocardium, cardiomyopathy, cardiac neoplasms, and congenital or genetic cardiac conditions, as well as after cardiac interventions, and the patient's clinical history is critical in the evaluation of delayed myocardial enhancement MR images.
 
Other: CMR may help differentiate the variants of hypertrophic cardiomyopathy (Arrive, 1994).  Sarcoidosis has a specific pattern of patchy LGE (Mahrholdt, 2005).  In hemachromatosis, the T2* signal is reduced.  Restrictive and constrictive disease can be evaluated using CMR (Anderson, 2004).  Amyloid produces homogeneous thickening of the atrial and ventricular walls and septum (Celletti, 1999). Myocardial fibrosis was noted and quantitated in patients with Chagas’ disease using CMR (Rochitte, 2005).  In myocarditis, edema and myocyte damage can be seen (Friedrich, 1998). Cine CMR may have applications in evaluating regurgitant valvular lesions, but quantitative measurements are fraught with technical challenges; at this time CMR would be appropriate only when other methods have proven inadequate, and even then the limitations of CMR must be recognized..  Echocardiography is currently the preferred method for evaluation of valvular and diastolic function (Ravi, 2007).  Stenotic valvular lesions can be assessed by planimetry of the orifice area.  Finally, there is some potential for detection of positive remodeling of coronary arteries (increasing arterial wall thickness with preserved lumen diameter), an early preclinical stage of coronary disease, using black-blood CMR (Kim, 2002). Ultimately, this could be the technique best suited for detecting some of the very earliest changes of atherosclerosis.
 
2012 Update
A literature search was conducted through September 2012.  There was no new randomized trials, practice guidelines, position statements or other publications identified that would prompt a change in the coverage statement.
 
2013 Update
A search of the MEDLINE database through September 2013 was conducted. There was no new published literature or clinical guidelines identified that would prompt a change in the coverage statement. In 2011, The American College of Radiology (ACR) published appropriateness criteria for cardiac imaging in patients with nonspecific chest pain with low probability of coronary artery disease (Hoffman, 2011).  This document supports the current coverage statement.
 
The authors established a rating scale where 1, 2, or 3 is defined as "usually not appropriate"; 4, 5, or 6 is defined as "may be appropriate"; and 7, 8, or 9 is defined as "usually appropriate." MRI of the heart is given a rating of 2 which corresponds to “usually not appropriate”. The authors summarized, “ invasive imaging tests such as transesophageal echocardiography or coronary angiography as well as advanced specific cardiac MRI examinations are rarely indicated in diagnosing low risk nonspecific chest pain” (Hoffman, 2011).
 
2014 Update
A literature search conducted using the MEDLINE database through September 2014 did not reveal any new information that would prompt a change in the coverage statement.   
 
2015 Update
A literature search conducted through September 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Zamani and colleagues published a study of 4145 participants enrolled in the Multi-Ethnic Study of Atherosclerosis, who underwent cardiac MRI and radial arterial tonometry (Zamani, 2015). It computed systemic vascular resistance (SVR=mean arterial pressure/cardiac output) and indices of pulsatile load including total arterial compliance (TAC, approximated as stroke volume/central pulse pressure), forward wave amplitude (Pf), and reflected wave amplitude (Pb). TAC and SVR were adjusted for body surface area to allow for appropriate sex comparisons. Performed allometric adjustment of LV mass for body size and sex and computed standardized regression coefficients (β) for each measure of arterial load. In multivariable regression models that adjusted for multiple confounders, SVR (β=0.08; P<0.001), TAC (β=0.44; P<0.001), Pb (β=0.73; P<0.001), and Pf (β=-0.23; P=0.001) were significant independent predictors of LV mass. Conversely, TAC (β=-0.43; P<0.001), SVR (β=0.22; P<0.001), and Pf (β=-0.18; P=0.004) were independently associated with the LV wall/LV cavity volume ratio. Women demonstrated greater pulsatile load than men, as evidenced by a lower indexed TAC (0.89 versus 1.04 mL/mm Hg per square meter; P<0.0001), whereas men demonstrated a higher indexed SVR (34.0 versus 32.8 Wood Units×m2; P<0.0001). In conclusion, various components of arterial load differentially associate with LV hypertrophy and concentric remodeling. Women demonstrated greater pulsatile load than men. For both LV mass and the LV wall/LV cavity volume ratio, the loading sequence (ie, early load versus late load) is an important determinant of LV response to arterial load.
 
2017 Update
A literature search conducted through September 2017 did not reveal any new information that would prompt a change in the coverage statement.  
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.  

CPT/HCPCS:
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
75565Cardiac magnetic resonance imaging for velocity flow mapping (List separately in addition to code for primary procedure)

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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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