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Magnetic Resonance Imaging (MRI), Cardiac Applications | |
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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. |
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Policy/ Coverage: |
Effective March 2025
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
Cardiac Magnetic resonance imaging (CMRI) (including CMR Angiography) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and has limited coverage for the following conditions/clinical circumstances:
For those conditions/clinical circumstances listed above 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.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
CMRI (including CMRA) for the following conditions/clinical circumstances does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes and is not covered:
For members with contracts without primary coverage criteria, CMRI (including CMRA) for the following conditions/clinical circumstances is considered
investigational. Investigational services are specific contract exclusion in most member benefit certificates 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)
Effective Prior to March 2025
CMRI (including CMR Angiography) has limited coverage for the following conditions/clinical circumstances:
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:
For contracts without Primary Coverage Criteria, CMRI (including CMRA) for the following conditions/clinical circumstances:
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)
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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:
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:
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.
2019 Update
A literature search was conducted through September 2019. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2024. No new literature was identified that would prompt a change in the coverage statement.
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References: |
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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. | |
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