This Week – September 13, 2014

This Week in Washington DC:

  1. ACG Supports Cologuard But Nothing Replaces Colonoscopy

ACG endorses Cologuard test as an additional option for Medicare beneficiaries

On Tuesday, September 9th, ACG submitted comments to the Centers for Medicare and Medicaid Services (CMS) in response to the proposed coverage determination to include under Medicare Part B the Cologuard colorectal cancer screening test. The Food and Drug Administration (FDA) approved the Cologuard test on the same day as CMS released this proposed coverage decision (August 11).

Cologuard is a stool-based DNA test but has been shown to be significantly more sensitive than the Fecal Immunochemical Test (FIT) in detecting colorectal cancers (92% vs. 74%; P = .002) and advanced precancerous lesions (adenomas and sessile serrated polyps) (42% vs. 24%; P < .001). However, Cologuard was significantly worse than FIT at correctly identifying patients who were negative for colorectal cancer or advanced lesions (87% vs 95%; P < .001).

CMS has proposed to cover the Cologuard test once every 3 years for Medicare beneficiaries who meet all of the following criteria:

  • Age 50 to 85 years,
  • Asymptomatic (no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test), and
  • At average risk of developing colorectal cancer (no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s Disease and ulcerative colitis; no family history of colorectal cancers or an adenomatous polyp, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer).

ACG applauds CMS for expanding options for colorectal cancer screening tests under Medicare and supports the Cologuard test, though noted that the unique characteristics of colonoscopy make it the best screening option. ACG appreciates the Agency using the ACG guidelines in this proposal and also recognizing that a follow-up colonoscopy is essential to reduce the incidence of and mortality from colorectal cancer. While the diagnostic colonoscopy is a required and necessary step to complete the continuum of colorectal cancer screening, adding this Cologuard test to the current list of screening benefits will improve overall screening utilization rates and health outcomes through early detection of precancerous adenomas and colorectal cancer at early stages for those unwilling or unable to undergo a screening colonoscopy. However, the medical literature continues to support the conclusion that the best screening test available to prevent and detect colorectal cancer is complete, optical colonoscopy. This underscores the need for CMS to continue providing screening colonoscopy, and the cost-sharing benefits associated with this recommended colorectal cancer screening test, as an option for Medicare beneficiaries even within this 3 year interval of undergoing a screening using the Cologuard test. In this proposal, CMS encouraged beneficiaries to continue using the current screening options available under Medicare as the Agency conducts post-market studies on Cologuard and screening intervals.

Please read ACG’s comments here.

Please stay tuned for further updates. Please also share and discuss your thoughts with fellow ACG members on the ACG GI Circle. To login and share your comments, go to and sign in as a member. Once you have done so, click here and then click the orange "Visit ACG GI Circle" button to be taken to the GI Circle site. If you have not yet activated your ACG GI Circle account, please email us at

Contact Brad Conway, VP Public Policy, with any questions or for more information.

Brad Conway