An intersocietal task force representing radiologists and cardiologists has asked the Centers for Medicare and Medicaid Services to withdraw its controversial national coverage determination for cardiac CT because of omissions in the scientific inquiry that guided development of the reimbursement rules. Led by Dr. Michael Poon, president of the Society of Cardiac Computed Tomography, the group identified 25 relevant peer-reviewed studies -- all published since mid-2006 -- that CMS purportedly did not consider when designing the proposed national coverage determination (NCD). The gap in the agency's literature review included consideration of most published peer-reviewed studies of 64-slice CT angiography and yet-to-be-published results from CORE64, the first prospective multicenter clinical trial of the technology. "We found that more evidence was excluded than was included," Poon said in an interview with Diagnostic Imaging. The intersocietal task force focused on scientific arguments in official comments submitted to CMS Jan. 11 expressing its opposition to the pending NCD. The group represented the American College of Cardiology, American College of Radiology, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and SCCT.

The rule proposes to eliminate Medicare payment for two applications of coronary CTA, unless they are performed as part of a CMS-sanctioned clinical trial approved:

• symptomatic patients with chronic stable angina at intermediate risk of coronary artery disease
• symptomatic patients with unstable angina at a low risk of short-term death and intermediate risk of CAD

Reimbursement policy for other cardiac CT applications would be left up to Medicare's regional carriers.

The proposed NCD was announced Dec. 13, 2007. The public comment period ended Jan. 12. A final NCD is due to be released in March.

CMS's handling of the rules-making process was frustrating for Poon, an associate clinical professor of cardiology at Mount Sinai Medical Center in New York City, because it demanded more data about the efficacy of coronary CTA from the required clinical trials while its planners allegedly did not fully considered data published in existing studies. "We say look at the existing evidence before you ask for more," he said. The coverage determination was made on based on published scientific evidence available to the 11-member Medicare Evidence Development and Coverage Advisory Committee as of its May 2006 meeting, Poon said. CMS officials, including Dr. Steve E. Phurrough, director of the coverage and analysis group, refused to accept an updated summary of clinical trials prepared by cardiologist Dr. James K. Min, said Dr. Pamela Woodard, president of the North American Society for Cardiac Imaging. Min made the offer during a conference call in November involving the ACC, ACR, and several high-level CMS officials.

"They seemed to imply that they had enough information and did not need further assistance," Woodard said. In a written statement, Dr. Barry Straub, chief medical officer of CMS, said the charge that evidence published in the last 18 months was missing is incorrect. Nineteen studies published in 2006 and 2007 were included in its analysis. CMS staff review included a 2006 technology assessment from the Agency for Healthcare Research and Quality and a Blue Cross-Blue Shield Technology Center evaluation of CTA that were published in 2005 and updated in 2006, according to Straub. Neither organization felt that the available evidence supported the conclusion that CTA for diagnosing coronary artery disease met the necessary evidence-based criteria for routine use, he said. If adopted, the NCD would replace local coverage determinations that sanction Medicare Part B billing for cardiac CT in all 50 states. The mandatory trial requirement would deny access to cardiac CTA to most patients, Woodard said. "You will have a large swath of the population who would benefit from cardiac CTA but will not be able to get it," she said. "If just research trials are reimbursed, the only patients who will receive the procedures will be those who have access to centers of excellence." For more information from the Diagnostic Imaging archives: National coverage policy could restrict Medicare payment for coronary CTA NOPR paperwork bedevils payment for PET applications Medical imaging costs skyrocket, as cardiologist involvement rises