Short-sighted coverage rules pose serious threat to coronary CT angio

February 6, 2008

If ever suspicion arose that the way the government regulates medicine is on a dangerous track, the Centers for Medicare and Medicaid Services is on the verge of erasing any doubt with a decision that could severely curb or halt the development of coronary CT angiography.

If ever suspicion arose that the way the government regulates medicine is on a dangerous track, the Centers for Medicare and Medicaid Services is on the verge of erasing any doubt with a decision that could severely curb or halt the development of coronary CT angiography.

As we've documented in news articles at DiagnosticImaging.com, CMS appears to be ready to issue a national coverage decision that would most likely limit the performance of coronary CTA to large academic institutions-and then only under highly restrictive circumstances. In addition, CMS wants all patients given the procedure to take part in a five-year or longer study to document what impact coronary CTA has on patient outcomes.

This move comes at a time when Medicare carriers covering 50 states and the District of Columbia have issued rules permitting reimbursement for coronary CTA and a growing body of clinical evidence suggests the procedure plays an invaluable role in accurately triaging patients with chest pain or coronary artery disease risk fators to appropriate care.

A detailed criticism of the proposal filed, Jan. 11 with CMS on behalf of an intersociety task force representing radiologists and cardiologists, laid bare the many flaws in the CMS approach. Among the problems the task force found, CMS did not consider relevant evidence, ignoring, for example, three-fourths of the available studies on 64-slice CT scanners. Clinically valid indications for coronary CTA that are well supported by evidence are not covered, and the proposed long-term study inaccurately defines patient populations and asks questions unlikely to yield useful information.

How did CMS get so seriously off track? Dark suggestions are circulating that it came under the sway of government accountants and private insurers who fear the impact that coronary CTA could have on their budgets and profits. Another theory is that CMS settled on a course long ago and that a holiday comment period for the proposed national coverage decision-it was announced Dec. 13 and given a Jan. 12 deadlinefor comments-was merely a formality. There is some evidence for this.

CMS officials met in a conference call in November with officials from the American College of Radiology and the American College of Cardiology, and they were offered at that time additional evidence of the value of coronary CTA. CMS indicated that it had enough information and would not need further assistance.

Whatever the reason, it's hard to read through CMS’ plans and approach without getting a clear sense that the agency allowed economics, and maybe politics, to trump science.

If CMS goes through with this decision as proposed-a final announcement is due in March-we can anticipate that the so-far rapid development of coronary CTA will grind to a halt and the benefits it brings to cardiac care will, at best, be delayed and, at worst, lost.

What we will get are lower claims expenditures for Medicare and for the commercial insurers that will follow suit. Is this a good trade-off? Not if it means that potential coronary artery disease patients are triaged to the wrong type of care or denied care in ways that lead to morbidity or death and ultimately greater costs.

Everyone understands the need to control costs in medicine. But when controlling costs appears to be the primary motivation, and relevant data showing the efficacy of a procedure is ignored, as it was here, the regulatory process is subverted and quality of care compromised.

If CMS wants a national coverage decision, it should abandon this ill-advised proposal and start over, this time considering much of the evidence it ignored. Better yet would be to skip the national coverage decision completely and let carrier medical directors and professional societies perfect the use of coronary CTA technology.

What are your thoughts on this topic? Please
e-mail me at jhayes@cmp.com.