Medicare and Insurance Policy Updates in 2023 Will Improve Cancer Screening Access by Removing Patient Colonoscopy Cost Following a Positive Cologuard Test

MADISON, Wis., Dec. 20, 2022 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, supports recent policy changes that help increase access to recommended non-invasive colorectal cancer screening tests. These policy changes require Medicare and most commercial insurers to pay for colonoscopy after a positive Cologuard® test without cost to the patient. For most patients, these financial protections take effect starting January 1, 2023.

Exact Sciences is the maker of Cologuard, an FDA-approved, noninvasive stool-based DNA and hemoglobin screening test for adults 45 and older who are at average risk for colorectal cancer (CRC). Since its launch in 2014, more than 10 million Cologuard tests have been completed, allowing patients to provide screening samples in the privacy of their homes. Recent data from Exact Sciences, published in the American Journal of Gastroenterology, found that eliminating patient cost sharing for follow-up colonoscopy can lead to positive shifts in test use patterns, increase overall participation rates, and improve both economic and clinical outcomes.^[i] 

"This is a huge win for our patients. This change will help providers address a major CRC screening gap for people who were previously burdened by the cost of a follow-up colonoscopy," said Dr. David Lieberman, gastroenterologist, and chairperson of the American Gastroenterological Association committee on CRC screening. "We know disparities exist in CRC screening. There are data which show that when we increase access to colorectal cancer screening and help navigate patients needing a follow-up colonoscopy after a non-invasive screening test, those disparities are greatly reduced."

Non-invasive screening provided crucial options during the pandemic. However, patients have noted that out-of-pocket costs for colonoscopy following positive stool-based testing, remain a barrier to increasing CRC screening rates.^[ii]

"As a cancer diagnostics leader, we must continue to partner with all stakeholders across healthcare to increase access and make it easy for all Americans to receive recommended cancer screenings," said Kevin Conroy, Chairman and CEO of Exact Sciences. "These changes help remove a key financial barrier."

Cancer advocacy organizations led the efforts to eliminate out-of-pocket cost barriers to screening. Together, the American Gastroenterological Association, the American Cancer Society Cancer Action Network, and Fight Colorectal Cancer, formed a coalition of advocacy groups and industry partners, including Exact Sciences, to improve these policies for patients.  

"Non-invasive colorectal cancer screening tests are an important tool in the fight against colorectal cancer, particularly in light of challenges patients have faced due to COVID-19, and as we expand our efforts to reach medically underserved communities," said Anjee Davis, MPPA, president of Fight Colorectal Cancer. "This guidance will help ensure that patients can choose the test that is best for them without worrying about out-of-pocket costs for a follow-up colonoscopy. Ultimately, we believe this will save lives and support an increase in the early detection of colorectal cancer." 

These policy updates come from further implementation of Affordable Care Act (ACA) guidelines and revised regulations adopted by the Centers for Medicare and Medicaid Services (CMS). CMS designed the changes to, "Expand access to quality care and improve health outcomes through early detection, more effective treatment, and reduce mortality."^[iii] For most Medicare beneficiaries and commercially-insured patients, no cost sharing will be incurred for either a Cologuard test or a follow-on colonoscopy. The changes may not apply to certain commercial plans exempted under the ACA.

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.

About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included as a non-invasive screening option in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016).

The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had adenomas, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative). Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit cologuard.com. Rx only.

^[i] Fendrick AM, Chen JV, Ozbay AB, Vahdat V, Limburg PJ. S266 Lifetime Impact of the Change in Modality as a Result of Eliminating Cost-Sharing for Follow-Up Colonoscopy After a Positive Stool Test for Colorectal Cancer Screening. Am J Gastroenterol. 2022;117(10)Se189-e190. doi:10.14309/01.ajg.0000857704.03887.bd https://journals.lww.com/ajg/Fulltext/2022/10002/S266_Lifetime_Impact_of_the_Change_in_Modality_as.266.aspx
^[ii]A.M. Fendrick, N. Princic, L.-A. Miller-Wilson, K. Wilson, P. Limburg, Out-of-Pocket Costs for Colonoscopy After Noninvasive Colorectal Cancer Screening Among US Adults with Commercial and Medicare Insurance
^[iii] Fact sheet Calendar Year (CY) 2023 Medicare Physician Fee Schedule Final Rule. CMS. Updated November 1, 2022. Accessed December 8, 2022. https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule 

SOURCE EXACT SCIENCES CORP