Exact Sciences Applauds Proposed CMS Change to Colorectal Cancer Screening Policy

MADISON, Wis., July 8, 2022 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, applauds the recently announced Centers for Medicare and Medicaid Services (CMS) Calendar Year 2023 Physician Fee Schedule proposal, which considers follow-up colonoscopy to an at-home test as a preventive service. 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 racesⁱ 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.

About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard^® and Oncotype^® tests, Exact Sciences is investing in its product pipeline to support patients before and throughout their cancer diagnosis and treatment. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook and LinkedIn.

Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions, and events to differ materially from those anticipated. For example, there can be no assurance that the CMS proposal described in this news release will become final. You should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

ⁱ Cancer facts & figures 2021. American Cancer Society; 2021.
ⁱⁱ Siegel RL, Miller KD, Goding Sauer A, et al. Colorectal cancer statistics, 2020. CA Cancer J Clin. 2020;70(3):145-164. doi:10.3322/caac.21601
ⁱⁱⁱ NCI. Genetics of colorectal cancer (PDQ) - health professional version.  Accessed February 4, 2022. https://www.cancer.gov/types/colorectal/hp/colorectal-genetics-pdq#_235_toc
^iv Piscitello A, Edwards DK. Estimating the screening-eligible population size, aged 45 to 74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res.2020;13(5):443-448. *Estimate based on the US population aged 45-74 as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.

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