FDA Panel Examines CT Colonography Value

CT colonography is less expensive and more preferred by patients compared to traditional colonoscopy for colon cancer screening, but the question of whether it is as good a test has so far kept it out of reach for most Medicare patients. A U.S. Food and Drug Administration (FDA) panel convened Monday examined this question about the relative benefits and risks of the technology. While the stated aim of the joint meeting of the Gastroenterology-Urology Panel and Radiological Devices Panel held September 9 was merely to “provide advice that will assist FDA’s consideration of evolving research on this topic and inform the Agency’s continuing regulation of these devices,” the chance to present the latest research on CT colonography in a high profile setting that would make it part of an official government record had additional implications. CT colonography, also known as virtual colonoscopy, is covered by many private insurance plans, including Anthem Blue Cross Blue Shield, CIGNA and UnitedHealthcare, but because colon cancer risk increases with age, many patients in need of colon cancer screening are Medicare beneficiaries. For them, flexible sigmoidoscopy or screening colonoscopy are covered, but CT colonography is not. The Medical Imaging & Technology Alliance (MITA) was one of the groups that was able to present research evidence to the panel. It highlighted the February 2012 American College of Radiology Imaging Network (ACRIN) paper published in Radiology, which showed that CT colonography is comparable to optical colonography for Americans ages 65 years and older. In addition, it asked the panel to consider the new research led by Brooks Cash, MD, of the National Naval Medical Center/Walter Reed Army Medical Center. Published in the July 2012 issue of the American Journal of Roentgenology, Cash’s study confirmed that CT colonography is an effective tool for detecting colorectal cancer for Medicare-eligible beneficiaries. “An abundance of evidence confirms that CT colonography is a valuable diagnostic tool, particularly for patients who are resistant to customary, optical colonoscopy and would otherwise avoid a diagnostic procedure,” stated Gail Rodriguez, executive director of MITA, on the Alliance’s website. “Expanding access to this technology will allow for earlier detection and treatment of this disease and turn more colon cancer patients into survivors.”