A perspective in the May 27 New England Journal of Medicine stated that the Centers for Medicare and Medicaid Services' (CMS) recent decision to deny coverage of CT colonography (CTC) for cancer screening reflects an evidence-based approach that acknowledges "the crucial importance of age-specific data on clinical effectiveness, as well as cost-effectiveness in the population for which the CMS is responsible."
In its decision, CMS noted that the mean age of participants in the studies offered/presented to support CTC coverage was significantly lower than that of Medicare beneficiaries. In fact, there were "no studies evaluating this technology in the elderly, nor were there analyses of subgroups of participants over 65 years of age," according to the perspective's lead author, Sanket S. Dhruva, MD, from the University of California, San Francisco, School of Medicine and colleagues.
The authors suggested that CMS' strict application of evidence-based analysis for this decision could "herald a shift in its approach to national coverage decisions."
In 2007, Dhruva and colleagues said they surveyed 141 clinical trials that the CMS had used as the basis for six decisions regarding coverage of interventions for cardiovascular disease in the past decade. They found an age disparity similar to that cited in the decision regarding CTC: the mean age of study participants in the cardiovascular trials was 60.1 years, which is below the average age of Medicare beneficiaries.
As the CMS found with CTC, the trials they reviewed largely did not report outcomes according to age group. "These findings suggest that many previously approved interventions may lack evidence of benefit in the Medicare population--the group for which U.S. taxpayers are footing the bill. We believe that the CMS's decision in the CTC case, therefore, is a long-overdue step toward meaningful validation of clinical-trial evidence in Medicare beneficiaries," according to the authors.
Dhruva and colleagues also cautioned CMS about radiologist groups and manufacturers of CT equipment, along with members of the U.S. House of Representatives, which "quickly mobilized" to exert "powerful pressure," to have the agency reconsider its decision.
Finally, the authors applauded the "landmark decision," stating that they "hope that the agency remains firm in its evidence-based approach and extends its application as healthcare reform proceeds."