Dan Anderson

In a flurry of last-minute activity, the Centers for Medicare and Medicaid Services in late December proposed restrictions on coverage of cardiac computed tomographic angiography (CCTA). If adopted in its current form, the CMS will establish in mid-March a national coverage determination (NCD) that requires patients be enrolled in a clinical research trial in order to receive the standard of care for diagnosing coronary artery disease (CAD).

If you missed it during the holiday rush—and one wonders if that was the intent—the government wants to limit reimbursement to clinical research participants despite the fact that CCTA has been sanctioned through local coverage decisions for 2 years and has provided more than two dozen studies indicating favorable results.

Why the concern, and why now? Kerry Weems, acting administrator of the CMS, said in a news release that additional research is necessary "to develop evidence on patient outcomes." While the decision committee, led by Steve E. Phurrough, MD, recognizes many in the industry support the use of cardiac CTA, "Critics have pointed out the lack of evidence on outcomes and the limitations to the technology including uninterpretable/unassessable segments and the health risks from the considerable radiation exposure."

I tried for more than a week to get the CMS to offer up one of those critics and they couldn't provide one.

Michael Poon, MD, president of the Society of Cardiovascular Computed Tomography, can't figure out who the critics are, either. "Right now, CCTA is being used in outpatient imaging centers, hospital inpatient, and we have very specific guidelines endorsed by all the key cardiovascular and imaging societies. There are clear local coverage guidelines that support such use."

Pamela Woodard, MD, president of the North American Society for Cardiovascular Imaging, told me that opposing research is "kind of like saying you're against motherhood and apple pie. On the other hand, you can do research for all eternity. There comes a point when you have to say there is enough evidence for certain indications, enough for CMS not to restrict coverage to evidence development."

The fact is, there is ample research supporting the use of cardiac CTA. The CMS reviewed fewer than 10 studies, Dr Poon estimates, but ignored another 20 to 24 studies, including those performed at academic facilities.

Weems said in his statement that the proposed rule provides "consistent coverage and uniform access" to CCTA, but if the policy is set in place, patients would have to wait upwards of a year to be enrolled in a clinical study, and even then many patients who could benefit from CCTA would be excluded. The CMS wants to restrict reimbursements to those patients with chronic stable angina at intermediate risk of coronary artery disease or patients with unstable angina at a low risk of short-term death and intermediate risk of CAD. Poon notes the CMS is mixing risk factor determination with the probability of having coronary artery disease.

What's the alternative for those patients who don't meet the narrow criteria for the clinical study? Cardiac catheterization—a procedure that is more invasive, requires more staffing, presents greater risks of morbidity to the patient, and often requires as much or more radiation exposure than a CT procedure. One other thing: It's more expensive than CCTA. Compare a cardiac image at $1,000, which would be a high estimate, with catheterization, which averages some $15,000.

Study something that is widely known, restrict patient access, and send others to a riskier, more expensive procedure? That kind of thinking makes the heart faint.

Dan Anderson
Editorial Director