Advocating for patient choice in colorectal cancer (CRC) screening
Consider the benefits of informed decision-making for CRC screening
Higher follow-up colonoscopycompletion rates
The Centers for Medicare & Medicaid Services has expanded their definition of CRC screening to include follow-up screening colonoscopies after a Medicare covered noninvasive test, such as the Cologuard test, returns a positive result.6
References
- Volk RJ, Leal VB, Jacobs LE, et al. From guideline to practice: new shared decision-making tools for colorectal cancer screening from the American Cancer Society. CA Cancer J Clin. 2018;68(4):246-249.
- Laiyemo AO, Adebogun AO, Doubeni CA, et al. Influence of provider discussion and specific recommendation on colorectal cancer screening uptake among U.S. adults. Prev Med. 2014;67:1-5.
- Data on file. Exact Sciences Corporation. Madison, WI.
- Finney Rutten LJ, Jacobson DJ, Jenkins GD, et al. Colorectal cancer screening completion: an examination of differences by screening modality. Prev Med Rep. 2020;20:101202.
- Austin G, Kowalkowski H, Guo Y, et al. Pattern of initial colorectal cancer screening after turning 50 years old and follow-up rates of colonoscopy after positive stool-based testing among the average-risk population. Curr Med Opin. 2023;39(1):47-61.
- Pub 100-03 Medicare national coverage determinations. Centers for Medicare & Medicaid Services. October 12, 2023. Accessed April 19, 2024. https://www.cms.gov/files/document/r12299ncd.pdf
- CAHPS for Merit-Based Incentive Payment System (MIPS) survey. Agency for Heathcare Research and Quality. October 2018. Updated July 2022. Accessed June 6, 2024. https://www.ahrq.gov/cahps/surveys-guidance/cg/cahps-mips.html
- About the Medicare Health Outcomes Survey (HOS). Centers for Medicare & Medicaid Services. Updated February 15, 2024. Accessed June 6, 2024. https://hosonline.org/en/program-overview/
Indications and Important Risk Information
The Cologuard® test is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by colonoscopy. The Cologuard test is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. The Cologuard test is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
The Cologuard test is not for high-risk individuals, including patients with a personal history of colorectal cancer and adenomas; have had a positive result from another colorectal cancer screening method within the last 6 months; have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease; or have a family history of colorectal cancer, or certain hereditary syndromes.
Positive Cologuard results should be referred to colonoscopy. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient.
False positives and false negatives do occur. In a clinical study, 13% of patients without colorectal cancer or advanced adenomas received a positive result (false positive) and 8% of patients with cancer received a negative result (false negative). The clinical validation study was conducted in patients 50 years of age and older. Cologuard test performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.
Cologuard test performance when used for repeat testing has not been evaluated or established. Rx only