BALTIMORE, May 13 -- CT colonography for colorectal cancer screening will not be covered under Medicare, the Centers for Medicare and Medicaid Services has confirmed.
The agency issued a final decision memo yesterday that reiterates the coverage denial proposed in February in draft form. (See Medicare to Deny Coverage of CT Colonography Screening)
"The evidence is inadequate to conclude that CT colonography is an appropriate colorectal cancer screening test under § 1861(pp)(1) of the Social Security Act," according to the final CMS memo.
Although the 30-day comment period following publication of the draft memo brought many requests to allow at least some coverage for the procedure, CMS stuck to its conclusion that there is not enough evidence to support the procedure in the Medicare population.
Agency analysts cited evidence from numerous studies that found CT colonography less sensitive for smaller lesions.
One of the studies included in the agency's review found that the positive predictive value of CT colonography was only 25%, although the authors concluded that its accuracy was acceptable for screening purposes. (See: CT Colonography Screening Stacks Up Well Against Standard Colonoscopy)
Moreover, positive findings with the virtual procedure must be confirmed -- and polypectomy performed -- with an optical colonoscopy. As a result, costs of CT colonography scans with positive findings are markedly higher than screenings conducted with ordinary colonoscopy.
The agency also noted that many studies of CT colonography included only small numbers of Medicare-age patients or excluded them altogether.
Professional associations representing gastroenterologists and endoscopists, who conduct most standard colonoscopy-based screenings, generally opposed Medicare coverage of CT colonography.
In a statement, the American Gastroenterology Association said, "the limitations of CT colonography cannot be ignored and must be taken under advisement in the development of a coverage policy. . . . Concerns related to test sensitivity, specificity, reporting, training and technology requirements, radiation exposure, and appropriate surveillance intervals are well documented."
But the American Cancer Society condemned the CMS decision, saying that randomized trials "clearly show CT colonography is as effective as optical colonoscopy" in cancer screening.
"Medicare coverage for CT colonography, also known as virtual colonoscopy, would have provided an additional option for colorectal cancer screening," Otis Brawley, M.D., the group's chief medical officer, said in a statement. "Additional options are absolutely necessary as the supply of gastroenterologists is currently inadequate to supply optical colonoscopy to all of those who need it."
He suggested that Medicare coverage would likely increase the proportion of older Americans who are screened.
However, CMS rejected that argument in its response to public comments.
"The impact of adding screening CT colonography on overall [colorectal cancer] screening rates is important but has not been adequately addressed with well designed studies in general, and has not been specifically reported for individuals ≥ 65 years of age," according to the final decision memo.
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