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The final coverage decision issued May 12 reflected objections that CMS raised in February when it proposed withholding reimbursement for CTC as an alternative to invasive optical colonoscopy for colon cancer screening.
It also falls in line with a 2008 recommendation by the influential U.S. Preventive Services Task Force. It concluded that evidence was insufficient to assess the benefits and harms of CTC as a screening modality for colorectal cancer.
The ruling appears to have disregarded overwhelming public support for CTC. Of 357 comments received during a 30-day comment period, only 16 agreed with CMS's proposal to withhold reimbursement.
Included among professional groups that opposed holding back on reimbursement are the American Cancer Society, American College of Radiology, American Gastroenterological Association, Advanced Medical Technology Association, Medical Imaging & Technology Alliance, and UnitedHealthcare.
The American College of Radiology cautioned in a written statement that the decision against CTC may result in tens of thousands of unnecessary deaths from colorectal cancer, particularly among minority and underserved populations.
"CMS should reverse this determination and provide full coverage of CT colonography, or Congress should pass legislation in this session to require Medicare coverage of the exam," it said.
Health concerns expressed by the ACR also appeared in the public comments about CTC payment from Dr. Robert S. Sandler, president of the 16,500-member American Gastroenterological Association (AGA). He noted that late detection is responsible for many of the 50,000 deaths annually attributed to colorectal cancer in the U.S. With early detection, the cure rate for the 140,000 new cases diagnosed annually is 90%.
In an e-mail response to the decision, Dr. Perry J. Pickhardt, a radiologist who led one of the two key trials testing CTC, said the decision was not surprising.
"CMS seemed oblivious to the facts in this case -- not to mention the clear support from the American Cancer Society, AGA, ACR, and Congress," he said. "Legislative action is the next logical step, but it will take time unless it can be attached to an upcoming spending bill."
CMS's decision will do nothing to help address the 50% compliance rate with recommended guidelines for colon cancer screening, said Dr. Judy Yee, a CTC pioneer and vice chair of radiology at the University of California, San Francisco.
In an interview, Yee said the decision was understandable in light of economic pressures on healthcare, but she believes CMS's opinion about the adequacy of clinical evidence about CTC is invalid.
Organizations supporting CMS's decision against reimbursement included the American College of Gastroenterology, American College of Preventive Medicine, American Society for Gastrointestinal Endoscopy, and America's Health Insurance Plans.
In his comments, Dr. John L. Petrini, president of the American Society for Gastrointestinal Endoscopy, a professional society representing 10,000 gastroenterologists, urged CMS to stick with its proposed rejection of reimbursement for colonography.
Petrini argued that reimbursement would be premature because colonography falls short of the agency's evidence-based criteria for approval. Echoing CMS's critique, Petrini noted that clinical trials have yet to show that CT colonography yields measurable benefits compared with conventional colonoscopy for average-risk Medicare beneficiaries.
As with other critics, Petrini complained that the landmark CTC trials were performed on patients who were too young to qualify for Medicare. He also reiterated concerns about CT-related radiation exposure, the cost implications of extracolonic findings, and quality standards.
In the final decision, CMS cited six external technology assessments, including a 2008 USPSTF review. Six internal technology assessments included two landmark studies that CTC supporters believe provide definitive evidence of CTC's ability to screen for colorectal cancer.
In 2008, the American College of Radiology Imaging Network National CT Colonography Trial found that CT colonography, using 16-slice or 64-slice CT technologies, was 90% sensitive and 86% specific to detecting large adenomas and cancers measuring more than 10 mm in diameter (NEJM 2008;12(359):1207-1217). The study was performed at 15 sites and involved 2531 participants. Principal investigator Dr. Daniel Johnson also reported good results for detecting smaller polyps.
Five years earlier, a Department of Defense trial involving 1233 subjects established the clinical value of a standard protocol involving multislice CT, stool tagging, 3D for primary review, and segmental unblinding.
In that study, Pickhardt concluded that CT colonography is equivalent to optical colonoscopy for the detection of clinically relevant polyps (NEJM 2003:349(23):2191-2200). Its sensitivity for identifying polyps greater than 6 mm was 89%, close enough to the 92% sensitivity of optical colonoscopy to establish equivalence for the two technologies.
