CMS Questions CTA’s Adoption for CAD

By: 
Cristen C. Bolan

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July 16, 2007
Guest Editor for Diagnostic & Invasive Cardiology

In the new order of the day, many experts believe that CT angiography (CTA) will replace invasive cardiac catheterization as the primary diagnostic tool for detecting coronary artery disease (CAD) and disorders. This notion has been backed by heavy investments from vendors in clinical trials that may shore up supporting data.

Recently, Toshiba launched one of the largest clinical trials to date, the Toshiba CorE 64 trial, to evaluate the use of 64-slice CT technology. One of the trial’s objectives is to determine if CT could be a diagnostic alternative to cardiac catheterization. If the results prove to be in CT’s favor, trials like this may be justification enough for cardiac CTA to become the gold standard for diagnosing CAD.

But before you write off cardiac catheterization, the Centers for Medicare and Medicaid Services (CMS) is not yet convinced. CMS considers substituting cardiac cath with CTA potentially risky due to the lack of clinical data supporting positive patient outcomes, and, on June 13 of this year, it initiated a National Coverage Analysis (NCA) regarding CTA. CMS states on its Web site (http://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=206) that while “[p]roponents have claimed that the use of cardiac CTA will lead to better health outcomes and a reduction in cardiac catheterization, the current standard for diagnosis of coronary artery disease…CMS is concerned that despite the lack of clinical evidence to demonstrate improved patient health outcomes with CTA, the procedure has been rapidly adopted by the clinical community.”

CMS indicates that the NCA will evaluate the available evidence for CTA when used to diagnose CAD to determine if a national coverage determination (NCD) is warranted. Plus, the organization has called out for public comments and clinical studies that evaluate CTA technology.

CMS has given the public and the industry 30 days to respond before deciding on whether the situation merits the proposed NCD. So before you substitute cardiac cath with CTA, you might want to wait a few days.


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