Does Not Apply to Commercial Genetic Testing Program effective 6/1/2018
Obstructive coronary artery disease (CAD) in individuals with stable chest pain is typically evaluated by stress echocardiography, myocardial perfusion imaging, and computed tomography angiography. Corus CAD™, developed by CardioDX®, Inc., is a genomic test designed for use in an outpatient setting with clinically stable, non-diabetic individuals who present with chest pain or who have a high risk of coronary artery disease but do not have a previously diagnosed myocardial infarction or prior revascularization procedure. Test results are provided as a numeric score that quantifies the likelihood that the individual with stable chest pain has obstructive CAD.
Gene expression testing to evaluate coronary artery disease is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
There is a lack of available evidence to determine the clinical importance of this test over standard, accepted testing methods and for use in predicting clinical events or altering treatment.
American Heart Association. (2012). Genetics and cardiovascular disease. A policy statement from the American Heart Association. Retrieved September 6, 2017 from http://www.heart.org.
American Heart Association. (2017). The expressed genome in cardiovascular diseases and stroke: refinement, diagnosis, and prediction: a scientific statement from the American Heart Association. Retrieved November 10, 2017 from https://professional.heart.org.
BlueCross BlueShield Association. Evidence Positioning System. (4:2019). Gene expression testing in the evaluation of patients with stable ischemic heart disease (2.04.72). Retrieved September 5, 2019 from https://www.evidencepositioningsystem.com/. (29 articles and/or guidelines reviewed)
Daniels, S. E., Beineke, P., Rhees, B., McPherson, J. A., Kraus, W. E., Thomas, G. S., et al. (2014). Biological and analytical stability of a peripheral blood gene expression score for obstructive coronary artery disease in the PREDICT and COMPASS studies. Journal of Cardiovascular Translational Research, 7 (7), 616-622. (Level 2 evidence)
Filsoof, D. M., Safford, R. E., Newby, K. Rosenberg, S., Kontras, D. G., Baker, A., et al. (2015). Impact of exercise stress testing on diagnostic gene expression in patients with obstructive and nonobstructive coronary artery disease. American Journal of Cardiology, 115 (10), 1346-1350. Abstract retrieved November 6, 2015 from PubMed database.
Gul, B., Lansky, A., Budoff, M., Sharp, D., Maniet, B., Herman, L., Kuo, J., et al. (2019). The clinical utility of a precision medicine blood test incorporating age, sex, and gene expression for evaluating women with stable symptoms suggestive of obstructive coronary artery disease: analysis from the PRESET registry. Journal of Women’s Health, 28 (5), 728-735. (Level 2 evidence)
Ladapo, J. A., Herman, L., Weiner, B. H., Rhees, B., Castle, L., Monane, M., et al. (2015). Use of a blood test incorporating age, sex and gene expression influences medical decision-making in the evaluation of women presenting with symptoms suggestive of obstructive coronary artery disease: summary results from two ambulatory care studies in primary care. Menopause: The Journal of the North American Menopause Society, 22 (11), 1-7. (Level 2 evidence)
Ladapo, J. A., Lyons, H., Yau, M., Rich, P., Newton, D., Bruce-Mensah, K., et al. (2014). Enhanced assessment of chest pain and related symptoms in the primary care setting through the use of a novel personalized medicine genomic test. American Journal of Medical Quality, 30 (4), 345-352. (Level 2 evidence)
Ladapo, J.A., Budoff, M.J., Sharp, D., Kuo, J., Huang, L., Maniet, B., et al. (2017). Utility of a precision medicine test in elderly adults with symptoms suggestive of coronary artery disease. Journal of the American Geriatric Society, 66 (2), 309-315. (Level 3 evidence)
Voora, D., Coles, A., Lee, K.L., Hoffmann, U., Wingrove, J.A., Rhees, B., et al. (2017). An age- and sex- specific gene expression score is associated with revascularization and coronary artery disease: insights from the prospective multicenter imaging study for evaluation of chest pain (PROMISE) trial. American Heart Journal, 184, 133-140. Abstract retrieved September 5, 2019 from PubMed database.
ORIGINAL EFFECTIVE DATE: 10/8/2011
MOST RECENT REVIEW DATE: 10/10/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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