In a comment letter on CMS’s proposed approval of the Cologuard stool DNA test, ACR reminds the agency that CT colonography (CTC) does a superior job of detecting large advanced adenomas and asks that the same coverage standard used for the stool test be applied to CTC, for which CMS denied coverage in 2009.
In the letter dated August 27, Judy Yee, MD, FACR, chair, ACR Colon Cancer Committee, commends the agency for its proposed decision memo approving Cologuard, thus adding another option in the armamentarium for colorectal cancer screening.
“At the same time,” she writes, “this precedent-setting approval should serve as the new evidence standard for Medicare coverage of colorectal cancer screening tests-including CT colonography (CTC).”
Yee compares the ability to Cologuard and CTC in their abilities to detect both colorectal cancer and large advanced adenomas, a cancer precursor. “While Cologuard may successfully detect up to 92% of CRC, the sensitivity for large advanced adenomas is only 42%, falling well short in this critical area of cancer prevention.
“In comparison, CTC is 96% sensitive for cancer detection, but also has a sensitivity of 90% or greater for large adenomas, providing for robust cancer prevention over at least a 5-year time horizon. In fact, CTC detection of advanced adenomas and cancer matches or exceeds that of the more invasive and expensive optical colonoscopy procedure in actual practice.
Yee notes that specificity and positive predictive value data are not weighted as much as sensitivity when considering the performance of colorectal cancer screening tests, a practice with negative implications for cost-effectiveness, resource utilization and patient anxiety.
In closing the letter, Yee cites the September 2013 unanimous decision by the FDA joint meeting of the Gastroenterology–Urology Devices Panel and the Radiological Devices panel that CTC should be made available for screening of asymptomatic patients.
“…we anticipate that CMS will agree with the recent FDA conclusion and that it should soon cover CTC as a safe and effective minimally invasive option as well to further benefit the Medicare population,” she concludes.
In 2012, CMS refused calls to reopen a national coverage decision for CTC after the publication of an ACRIN paper based on data from the National CT Colonography Trial. That paper found CTC comparable to conventional optical colonography in patients aged 65 and older.
Vice President, Executive Editor, Radiology Business
Cheryl began her career in journalism when Wite-Out was a relatively new technology. During the past 16 years, she has covered radiology and followed developments in healthcare policy. She holds a BA in History from the University of Delaware and likes nothing better than a good story, well told.