If adopted, the rule would eliminate all cost to Medicare patients for a follow-up colonoscopy after a positive at-home colorectal cancer screening test. Additionally, CMS has proposed covering the service for individuals 45 years of age or older who participate in Medicare, which aligns with the previous recommendation from the United States Preventive Services Task Force (USPSTF) and the American Cancer Society. The final CMS rule is expected to be published in the fall of this year and take effect on January 1, 2023.

“Colorectal cancer is the most preventable, yet least prevented cancer, because approximately 44 million average risk adults remain unscreened in the United States,” said Kevin Conroy, Chairman and CEO of Exact Sciences.  “Exact Sciences supports the CMS proposal to encourage wider utilization of non-invasive colorectal cancer screening tests, which has the potential to close the screening gap by reducing barriers to screening, prevention and earlier detection for individuals aged 45 and older.”

The proposed CMS policy builds on President Biden’s Cancer Moonshot proposal to ensure equitable access to screening and prevention through at-home screening, particularly for colorectal cancer. The Administration’s focus on removing barriers to cancer prevention and early detection advances health equity within rural communities and communities of color that are especially impacted by the incidence of colorectal cancer. The proposed policy also builds upon the recent Department of Labor guidance that mandates coverage for follow-up colonoscopy for most commercial insurance plans.

“This proposal helps patients across the country who are seeking to complete the colorectal cancer screening process but can’t due to financial barriers. This is a huge victory for patients,” said Anjee Davis, president, Fight Colorectal Cancer, a leading patient empowerment and advocacy organization.

Colon cancer is the third most common cancer in both men and women of all races^[i] and is on the rise for people younger than 50.^[ii] Approximately 70 percent of people diagnosed with colon cancer have no family history.^[iii] Despite efforts by leading medical and government organizations to raise awareness, approximately 44 million average-risk Americans aged 45-plus remain unscreened.^[iv]

Exact Sciences is the maker of Cologuard®, an FDA-approved, noninvasive stool-based DNA screening test for adults 45 and older who are at average risk for colon cancer. Since its launch in 2014, 9 million people have used Cologuard to screen for colon cancer at home.