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The Centers for Medicare and Medicaid Services has initiated a national coverage analysis to evaluate the available evidence for coronary CT angiography. As part of the effort, the agency on June 13 asked practitioners to submit comments. If the remarks so far are any indication -- and if CMS listens -- coronary CTA will have no problem securing Medicare reimbursement.
The Centers for Medicare and Medicaid Services has initiated a national coverage analysis to evaluate the available evidence for coronary CT angiography. As part of the effort, the agency on June 13 asked practitioners to submit comments. If the remarks so far are any indication -- and if CMS listens -- coronary CTA will have no problem securing Medicare reimbursement.Two-thirds of the way into the 30-day comment period, the tally was 25 in favor of reimbursement, three seeking more evidence, two lamenting the fall from grace of electron-beam CT angiography, and one calling for CMS to set professionally accepted credentialing guidelines. The gist of the favorable remarks is that, with judicious patient selection, CCTA saves money and time and improves patient care. Practitioners best utilize coronary CTA in low to intermediate risk patients for its negative predictive value. Jeffrey Fine, Ph.D., vice president of CVI3, oversees a CCTA data registry with more then 20,000 cases. He commented that evidence to date indicates that the use of CCTA saves money by replacing SPECT and catheter angiography. His data also show that practitioners are using the new technology appropriately. Henry Trepp, supervisor of nuclear medicine radiology at Covenant Medical Center, and Dr. Jeffrey Christie, a cardiologist with Indiana Heart Physicians in Indianapolis, expressed concern that industry's push to adopt 64-slice CT is forging ahead of the available clinical evidence. It may be the next great thing, Christie said, but it is not there now. "Development must continue, and the technology must be financially viable. In the meantime, it is incumbent on CMS to serve as a counter to the CT manufacturing marketing that is pushing this technology into use before it is ready," Christie said. Trepp cited the shortage of radiologists coupled with the lack of training for both radiologists and cardiologists as reasons to slow down the adoption of the technology. He also mentioned that CCTA could be another avenue for cardiologists to self-refer and wondered if enough attention has been paid to that issue. The comments of Trepp and Christie reflect the position within CMS. The agency stated in its national coverage analysis that CCTA has been rapidly adopted by the clinical community despite the lack of clinical evidence to demonstrate improved patient health outcomes with the procedure. Dr. Arthur Stillman, director of cardiothoracic imaging at Emory University Hospital, pointed out that the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) study showed no meaningful difference in survival or reduced risk of heart attack with the use of interventional device procedures (angioplasty, stents) plus optimal medical therapy compared with optimal medical therapy alone for patients with chronic angina. "One may then argue that these patients did not need angiography at all except to establish that they, in fact, had coronary artery disease," he said. "CTA could be effectively used to identify patients with coronary disease without the need of invasive angiography, so that these patients may be treated by optimal medical therapy ... a much more cost-effective approach."
While not every commenter identified his or her specialty, it seemed that most remarks came from cardiologists, then radiologists, and then managers or directors of imaging centers. Even a cardiothoracic surgeon chimed in. Dr. Keith Horvath, with the National Institutes of Health Heart Center at Suburban Hospital, said that CTA has become an invaluable tool for preoperative screening of two types of patients:
Commenters on both sides of the debate expressed concern with radiation exposure and stressed the need for judicious patient selection, proper training and/or credentialing, and continued technological efforts to rein in dose.
This national coverage analysis will evaluate the available evidence for CTA when used to diagnose coronary artery disease and decide if a national coverage determination is warranted. CMS stated that it is particularly interested in recommendations as to the types of studies needed if the evidence for coverage is determined to be premature.CMS will also consider "coverage with evidence development" as an appropriate national coverage determination decision. Coverage with evidence development is a circumstance under which CMS would grant reimbursement but require, as a condition of coverage, collection of additional patient data to supplement standard claims data. Interested stakeholders have until July 13 to
submit a comment
. CMS will publish a proposed decision memo based on the new feedback on Dec. 13, 2007. The completion date for the national coverage analysis is scheduled for March 12, 2008. Even a simple plea such as that of Dr. Christopher LaVergne of the Woodlands-North Houston Heart Center could help sway the balance in favor of reimbursement. "Please continue paying for this very important test," LaVergne said.For more from the Diagnostic Imaging archives:
Coronary artery CT assesses sudden death risk from all cardiovascular causes
Low-dose technique makes 64-slice heart scans more palatable
Researchers maximize performance with 64-slice cardiac CT
Chest radiologists take closer look at heart