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Non-invasive Imaging for Coronary Artery Disease

The pace of innovation in the field of non-invasive imaging diagnostics for Coronary Artery Disease (CAD) is has made it difficult to assess the comparative effectiveness and incremental value of these technologies relative to each other and other diagnostic procedures. This has left payers to devise coverage determinations for these technologies with little evidence of their clinical effectiveness and has left patients and clinicians without a clear understanding of the utility of these diagnostics. In order to address this issue and to develop a shared understanding of what type of evidence is minimally sufficient for decision makers (payers, clinicians, patients, and policy makers), CMTP, in collaboration with experts from all relevant stakeholder groups, will develop an Effectiveness Guidance Document on Non-Invasive Imaging for CAD that outlines what type of evidence is sufficient for decision making, and recommends how this evidence can be generated in a timely fashion to guide decisions about the use of the next new cardiac imaging technology.

Project History

 In 2007, the CMTP Advisory Group developed a protocol for a randomized controlled trial (RCT) comparing clinical outcomes for patients at intermediate risk for CAD initially evaluated with CCTA (64-slice and higher) against outcomes for patients receiving other diagnostic tests. The study endpoints included occurrence of major adverse cardiac events within 24 months, rates of coronary angiography, revascularization, ED visits, hospitalization, number and cost of added imaging tests, and radiation dose.  The decision by the federal Centers for Medicare and Medicaid Services (CMS) in March 2008 not to mandate coverage with evidence development (CED) as a condition for reimbursement rendered the conduct of an RCT unfeasible.  Thus, CCTA is under reconsideration as a CMTP Applied Policy Project.

On October 20, 2008, CMTP hosted a multi-stakeholder Cardiac Imaging Think Tank identify and discuss strategies to improve:  (1) the quality of evidence available to evaluate the incremental clinical benefit of emerging cardiac technologies and (2) the  efficiency of the process to develop that evidence.   The discussion from this think tank, which was co-sponsored by The Institute for Clinical and Economic Review (ICER), the American College of Cardiology (ACC), the Society of Cardiovascular Computed Tomography (SCCT), the America College of Radiology (ACR), and the North American Society for Cardiovascular Imaging (ASCI), will serve as a starting point for an effectiveness guidance document on Non-invasive Imaging for Cardiac Imaging.  

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