CMS: Evidence 'inadequate' to cover CT colonography
The agency said it evaluated the test characteristics and performance of CTC and the impact on health outcomes for individuals aged 65 years and older. They determined that there is "insufficient evidence on the test characteristics and performance of screening CTC in Medicare aged individuals and that the evidence is not sufficient to conclude that screening CTC improves health benefits for asymptomatic, average risk Medicare beneficiaries. While it is a promising technology, many questions on the use of CTC need to be answered with well designed clinical studies that focus on health outcomes for the Medicare population."
In early February, CMS stunned the imaging community with a statement that the evidence was "inadequate" to suggest that CTC is an appropriate colorectal cancer screening test. Additionally, the agency stated that should it determine that CTC is clinically effective, it would still need to conduct further analysis into whether it is cost effective.
The agency's proposed decision shocked experts like University of Chicago radiology professor Abraham H. Dachman, MD, due to the plethora of clinical evidence in support of the study.
"It is very hard to believe their specific concerns based on the science; and I think the scientific concerns raised are a veil for what boils down to economic issues and perhaps to the current economic crisis," Dachman told Health Imaging News. "Even with the current economic conditions, there are strong scientific data to support a positive decision as three large payors have done--payors who wouldn't be reimbursing for a procedure if they didn't think it was cost-effective.".
Numerous peer-reviewed scientific studies have been published that highlight the benefits of virtual colonoscopies. In September 2008, the New England Journal of Medicine published findings from the American College of Radiology Imaging Network (ACRIN) study that endorsed CTC as a primary screening tool--CTC screening identified 90 percent of subjects with adenomas measuring 10 mm or more in diameter.
Just last month, a study presented at the American Roentgen Ray Society (ARRS) conference in Boston found that CTC allows radiologists to predict, with a high degree of confidence, whether or not a polyp needs to be evaluated through colonoscopy or removed through polypectomy.
Also, a study in the May issue of the American Journal of Roentgenology addressed the cost-effectiveness concerns, with the authors concluding that CTC is "a highly cost-effective and clinically efficacious screening strategy for the Medicare population." The researchers found that the base-case costs for CTC and optical colonoscopy were $674 and $795, respectively. They also included costs of the imaging workup for extracolonic findings from CTC.
The American College of Radiology (ACR) was quick to condemn the decision.
“Make no mistake: If let stand, this CMS decision not to pay for CT colonography will cost lives. More than 140,000 Americans are diagnosed with colorectal cancer each year. Nearly 50,000 of them die due to late detection. How can CMS ignore the fact that people are dying because they do not want to have the tests that are currently covered?” said James H. Thrall, MD, FACR, chair of the ACR Board of Chancellors. “For CMS to turn its back to a technology that can attract more patents to be screened and save countless lives is deeply concerning. CMS should reverse this determination immediately or Congress should step in and vote to mandate coverage of CTC.”
“The percentage of patients at risk for the disease who have opted to be screened has not dramatically increased in more than 30 years. CTC is the technology that can overcome many stigmas associated with colorectal cancer screening, get more patients to be screened, and dramatically reduce the number of people who die unnecessarily each year from this disease,” said Elizabeth McFarland, MD, chair of the ACR Colon Cancer Committee.
“Providing Medicare patients an effective and less invasive screening tool for colorectal cancer can help overcome the disparity in colorectal care that exists in minority communities. This noncoverage determination is a setback to efforts to provide better care to underserved areas of the population. Congress needs to act now to help minority and underserved populations gain access to this potentially life saving care,” said McFarland.
Since the February proposed decision, lawmakers joined forces with associations and industry including the American College of Radiology (ACR) and the American Gastroenterological Association (AGA), to urge CMS to reverse their proposal.
During the review process, CMS received a total of 100 comments during the public comment period, which were summarized in the proposed decision memorandum and can be viewed at http://www.cms.hhs.gov/mcd/viewpubliccomments.asp?nca_id=220.