FAQs
Frequently Asked Questions (FAQs)
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Featured FAQs
A positive result does not necessarily mean a patient has cancer. It means that the Cologuard test detected DNA and/or hemoglobin biomarkers in the stool that are associated with colorectal cancer or advanced adenoma. False positives and false negatives occur with the Cologuard test, and appropriate follow-up is important. Patients with a positive result should have a colonoscopy.1
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).
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
The Cologuard test is only billed under CPT code 81528. This code was established by the American Medical Association CPT Editorial Panel (and recognized by Medicare) with an effective date of 1/1/2016. It is also known as a HCPCS Level I or CPT Category I code.
Cologuard, Exact Sciences Laboratories Tax ID: 46-3095174
Cologuard, Exact Sciences Laboratories NPI: 1629407069
Cologuard 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. Cologuard is indicated to screen adults of either sex, 45 years or older, who are at typical average risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Contraindications1
Cologuard is intended for use with patients, age 45 years and older, at average risk who are typical candidates for CRC screening. Cologuard was not clinically evaluated for the following types of patients:
- Patients with a history of colorectal cancer, adenomas, or other related cancers
- Patients who have had a positive result from another colorectal cancer screening method within the last 6 months
- Patients who have been diagnosed with a condition that is associated with high risk for colorectal cancer. These include but are not limited to:
- Inflammatory bowel disease (IBD)
- Chronic ulcerative colitis (CUC)
- Crohn’s disease
- Familial adenomatous polyposis (FAP)
- Family history of colorectal cancer
- Patients who have been diagnosed with a relevant familial (hereditary) cancer syndrome, such as hereditary nonpolyposis colorectal cancer syndrome (HNPCC) or Lynch syndrome, Peutz-Jeghers syndrome, MYH-associated polyposis (MAP), Gardner’s syndrome, Turcot’s (or Crail’s) syndrome, Cowden’s syndrome, juvenile polyposis, Cronkhite-Canada syndrome, neurofibromatosis, or familial hyperplastic polyposis.
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
The Cologuard test analyzes patient stool for the presence of 11 biomarkers, including hemoglobin and DNA markers, that are associated with colorectal cancer and advanced adenomas.1
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
Product FAQs
In a clinical study, the Cologuard test had 92% sensitivity in detecting colorectal cancer in stages I to IV and 94% sensitivity in detecting colorectal cancer in stages I to II.1-3*
In a clinical study of patients aged 50 to 84 years, the Cologuard test had an 87% specificity overall, excluding colorectal cancer and advanced adenomas, and including all nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy. There was 90% specificity in participants with no findings on colonoscopy and no histopathological review.1
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). This clinical validation study was conducted in patients 50 years of age and older.
The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients aged 45 to 49 years was estimated by subgroup analysis of near-age groups.
- Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).1
- lmperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
- Ahlquist DA. Multi-target stool DNA test: a new high bar for noninvasive screening. Dig Dis Sci. 2015;60(3):623-633.
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
In a clinical study of patients aged 50 to 84 years, the Cologuard test demonstrated 92% sensitivity across CRC stages I to IV compared to 74% sensitivity for FIT.* In terms of specificity, the Cologuard test demonstrated 87% specificity overall† vs 95% with FIT.1
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). This clinical validation study was conducted in patients 50 years of age and older.
- OC FIT-CHEK, Polymedco, Inc.
- Cologuard specificity: 87% overall specificity, excluding CRC and advanced adenomas, and including all nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy. There was 90% specificity in participants with no lesions biopsied on colonoscopy.1
- lmperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
A negative result means that the Cologuard test did not detect significant levels of DNA and/or hemoglobin biomarkers in the stool that are associated with colorectal cancer or advanced adenoma. False positives and false negatives occur with the Cologuard test, and appropriate follow-up is important. Patients with a negative result should continue in a screening program appropriate for the patient.1
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).
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
Once our lab receives the sample, it is tested as soon as possible, usually within 2 weeks. Your office will receive the results shortly thereafter.
No, there are no changes in instructions. Change of age is the only difference in indication and use of the Cologuard test. The indication was changed to include screening for adults 45 and older to reflect updated national guidelines.
Clinical FAQs
Warnings, Precautions, and Risks1
- The performance of Cologuard has been established in a cross-sectional study (ie, single point in time). Programmatic performance of Cologuard (ie, benefits and risks with repeated testing over an established period of time) has not been studied. Performance has not been evaluated in adults who have been previously tested with Cologuard. Noninferiority or superiority of Cologuard programmatic sensitivity as compared to other recommended screening methods for CRC and AA has not been established
- The clinical validation study was conducted in patients 50 years of age and older. ACS guidelines recommend screening begin at age 45. Cologuard performance in patients aged 45 to 49 years was estimated by subgroup analysis of near-age groups
- CRC screening guideline recommendations vary for persons over the age of 75. The decision to screen persons over the age of 75 should be made on an individualized basis in consultation with a healthcare provider. Cologuard test results should be interpreted with caution in older patients, as the rate of false positive results increases with age
- A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Patients with a negative Cologuard test result should be advised to continue participating in a colorectal cancer screening program with another recommended screening method. The screening interval for this follow-up has not been established
- Cologuard may produce false-negative or false-positive results. A false-positive result occurs when Cologuard produces a positive result, even though a colonoscopy will not find cancer or precancerous polyps. A false-negative result occurs when Cologuard does not detect a precancerous polyp or colorectal cancer, even when a colonoscopy identifies the positive result
- Patients should not provide a sample for Cologuard if they have diarrhea or if they have blood in their urine or stool (eg, from bleeding hemorrhoids, bleeding cuts or wounds on their hands, rectal bleeding, or menstruation)
- To ensure the integrity of the sample, the laboratory must receive the patient specimens within 96 hours of collection. Patients should send stool samples to the laboratory according to the instructions stated in the Cologuard Patient Guide
- Patients should be advised of the caution listed in the Cologuard Patient Guide. Patients should NOT drink the preservative liquid
- The risks related to using the Cologuard collection kit are low, with no serious adverse events reported among people in a clinical trial. Patients should be careful when opening and closing the lids to avoid the risk of hand strain
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
No. It can be completed in the comfort of home and does not require special preparation, dietary or medication changes, sedation, or time off from work.
The Cologuard kit is shipped directly to patients’ homes. Once completed, patients can schedule a no-contact pick-up from UPS® or drop it off at a local UPS store.
Yes, you can find more information regarding:
- Cologuard adherence among previously nonadherent patients on the Cologuard Adherence page
- Adherence to rescreening with the Cologuard test on the Cologuard Rescreening page
- Adherence to follow-up colonoscopy after a positive Cologuard result on the Follow-Up Colonoscopy Adherence page
Operational FAQs
Personalized outreach from the patient navigation program helps ensure screening completion, and patient support is available 24 hours a day, 7 days a week by telephone (1-844-870-8870) or via chat with specialists who speak English, Spanish, and can provide translation services for more than 200 languages.
Insurance support is also available, as well as financial support programs that include flexible payment plans, based on eligibility.
Cologuard support offers resources for healthcare providers and their offices on the HCP Resources page.
There are also educational resources for eligible patients, which can be found on the Information for Eligible Patients page.
Cologuard representatives attend conferences for primary care healthcare providers, gastroenterologists, nurse practitioners, and physician assistants. Attend to engage and learn more about CRC and the Cologuard test.
We highly encourage patients who receive a bill with out-of-pocket responsibilities after using the Cologuard test to call and speak with a member of our Patient Support Team to discuss appeal support. Patients can also get help with generating an appeal letter at Cologuard.com/appeal.
Stool DNA (ie, the Cologuard test) is one of the methods permitted as part of the National Committee for Quality Assurance’s (NCQA) Healthcare Effectiveness Data and Information Set* (HEDIS®) quality measure for CRC screening.1
The inclusion of the Cologuard test in the NCQA HEDIS® metrics allows payers, health systems, and providers the opportunity to receive quality credit for a 3-year look back period during HEDIS® audits.1
- Third-party guidelines and quality measures do not specifically “endorse” commercial products, and inclusion in same does not imply otherwise.
- Healthcare Effectiveness Data and Information Set (HEDIS®) Measurement Year 2022 Volume 2: Technical Update. National Committee for Quality Assurance. March 31, 2022. Accessed January 25, 2024. https://www.ncqa.org/wp-content/uploads/2022/03/MY-2022-Vol-2-Technical-Update.pdf
Cost & Coverage FAQs
Nationwide, >96% of eligible patients aged 45 and older have no out-of-pocket costs for screening.1*
If your patients have questions about coverage, they can contact our Customer Care Center at any time by calling 1-844-870-8870 or via chat. Our team of specialists can facilitate contact with their insurers and ask the right questions.
- Exact Sciences estimate based on historical patient billing. Rate of coverage varies by state and region. 95% of patients aged 45-49 pay no out-of-pocket costs. Exceptions for coverage may apply; only your patients’ insurers can confirm how the Cologuard test would be covered.1
- Data on file. Exact Sciences Corporation. Madison, WI.
Patients can contact the Customer Care Center 24/7 at 1-844-870-8870, or via chat on the patient site, with any questions regarding the cost and coverage for the Cologuard test.
They can also utilize the Exact Sciences patient assistance program, which helps patients facing challenges with insurance coverage receive their Cologuard screening at no cost.
As of 2023, the Affordable Care Act and Centers for Medicare & Medicaid Services require a colonoscopy after a positive Cologuard result be covered without cost sharing. Some exemptions may apply.1,2*
- For patients with traditional Medicare, a colonoscopy after a positive Cologuard result is still a screening colonoscopy based on updated Centers for Medicare & Medicaid Services regulations, effective January 1, 2023. Medicare does not apply cost sharing to screening colonoscopy. This update does not apply to commercial plans with exempted status.1,2
- CMS. FAQs about Affordable Care Act implementation part 51, Families First Coronavirus Response Act and Coronavirus Aid, Relief, and Economic Security Act implementation. Centers for Medicare & Medicaid Services. January 10, 2022. Accessed January 25, 2024. https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/Downloads/FAQs-Part-51.pdf
- CMS. Calendar year (CY) 2023 Medicare physician fee schedule final rule. Centers for Medicare & Medicaid Services. November 1, 2022. Accessed January 25, 2024. https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule
CRC Screening FAQs
In 2021, the USPSTF lowered the recommended screening age to 45 for patients at average risk for CRC. The USPSTF based the decision on a recent trend of increasing risk of CRC in adults younger than 50 and the potential for life-years gained and a decrease in CRC cases and deaths compared to beginning screening at age 50.1
The American Cancer Society Colorectal Cancer Screening Guideline (2018) lowered the recommended age to start screening from age 50 to age 45 for patients at average risk for CRC. The ACS based their recommendations on CRC incidence and mortality rates, results from microsimulation modeling, and the reasonable expectation that screening will perform similarly in adults aged 45 to 49 years as in persons for whom screening is currently recommended. The ACS recommendation includes the Cologuard test as a CRC screening option along with other stool-based noninvasive tests and structural (visual) examination options, depending on patient preference and test availability.2
- Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977.
- Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68(4):250-281.
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