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
Indications for Use
The Cologuard and Cologuard Plus tests are 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)/advanced precancerous lesions (APL) and should be followed by a colonoscopy. The Cologuard test and Cologuard Plus test are indicated to screen adults of either sex, 45 years or older, who are at average risk for CRC. These tests are not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals.
Contraindications
The Cologuard products are not for high-risk individuals, including patients who have the following:
- a personal history of colorectal cancer and adenomas
- a positive result from another colorectal cancer screening method within a test recommended timeframe
- have been diagnosed with a condition associated with high risk for colorectal cancer such as IBD, chronic ulcerative colitis, Crohn’s disease
- have a family history of colorectal cancer, or certain hereditary syndromes
No, the Cologuard test and the Cologuard Plus test are not the same test. They utilize different molecular panels to analyze stool samples for colorectal cancer (CRC). The Cologuard Plus test utilizes 5 biomarkers including DNA methylation markers and hemoglobin, whereas the Cologuard test utilizes 11 biomarkers including altered DNA and hemoglobin. This new molecular panel was designed to increase specificity without decreasing sensitivity.1,2
However, both the Cologuard and Cologuard Plus tests are ordered the same way, follow the same collection process, and come with the same unparalleled patient support.
- Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
In a clinical study, the Cologuard Plus test had 95% sensitivity in detecting colorectal cancer in stages I to IV and 94% sensitivity in stages I to III.1*†
In terms of specificity, the Cologuard Plus test had 91% specificity overall. There was 94% specificity in adults with no colorectal neoplasia.1‡
- P<0.0001 for the comparison of the next-generation multitarget stool DNA test with FIT.1
- Disease stage was defined according to the American Joint Committee on Cancer staging system.1
- Cologuard Plus specificity: 91% overall specificity, including all participants who did not have advanced neoplasia. Specificity for no colorectal neoplasia was age-weighted to the US population and defined as negative colonoscopy, no adenocarcinoma of the colorectum, no adenomas, and no sessile serrated polyps/sessile serrated adenomas.1
- Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
Cologuard Plus Test FAQs
All eligible patients whose insurance covers the Cologuard Plus test will receive it. When you place an order, Exact Sciences will determine which test is covered by a patient’s insurance and send them the latest test that is covered and appropriately reimbursed.
Exact Sciences is committed to getting patients screened with the test that is accessible to them. Eligible patients will only receive the Cologuard Plus test if their insurance covers and appropriately reimburses it. Other patients whose insurance does not yet offer coverage will continue to be screened with the Cologuard test. Therefore, we can continue to provide effective colorectal cancer screening without any disruptions in coverage.
The Cologuard ordering process is the same easy process you’re used to. If your patient’s insurance covers the Cologuard Plus test, that is the test that Exact Sciences will ship to them. If not, they will receive the Cologuard test.
No. To ensure access to noninvasive colorectal cancer (CRC) screening, both tests will still be available. This way, Exact Sciences can maintain broad coverage.1 As the Cologuard Plus test is on the market for a longer period, more insurers will begin to cover it. Until then, eligible patients whose insurance does not cover the Cologuard Plus test will still receive best-in-class noninvasive CRC screening with the Cologuard test.2,3
- Data on file for coverage. Market Access. 2024. Exact Sciences Corporation. Madison, WI.
- Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
- Cologuard® Clinician Brochure. Madison, WI: Exact Sciences Corporation.
In a clinical study, the Cologuard Plus test had 95% sensitivity in detecting colorectal cancer in stages I to IV and 94% sensitivity in stages I to III.1*†
In terms of specificity, the Cologuard Plus test had 91% specificity overall. There was 94% specificity in adults with no colorectal neoplasia.1‡
- P<0.0001 for the comparison of the next-generation multitarget stool DNA test with the fecal immunochemical test (FIT).1
- Disease stage was defined according to the American Joint Committee on Cancer staging system.1
- Cologuard Plus specificity: 91% overall specificity, including all participants who did not have advanced neoplasia. Specificity for no colorectal neoplasia was age-weighted to the US population and defined as negative colonoscopy, no adenocarcinoma of the colorectum, no adenomas, and no sessile serrated polyps/sessile serrated adenomas.1
- Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
The Cologuard Plus test analyzes patient stool for the presence of 5 biomarkers, including hemoglobin and methylated DNA markers, that are associated with colorectal cancer and advanced adenomas.1
- Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
In a clinical study of 18,911 patients, the Cologuard Plus test demonstrated 95% sensitivity across colorectal cancer (CRC) stages I to IV compared to 71% sensitivity for the fecal immunochemical test (FIT).*† In terms of specificity, the Cologuard Plus test demonstrated 91% overall specificity vs 95% with FIT.1‡
- OC FIT-CHEK, Polymedco, Inc.
- P<0.0001 for the comparison of the next-generation multitarget stool DNA test with the fecal immunochemical test.1
- Cologuard Plus specificity: 91% overall specificity, including all participants who did not have advanced neoplasia. Specificity for no colorectal neoplasia was age-weighted to the US population and defined as negative colonoscopy, no adenocarcinoma of the colorectum, no adenomas, and no sessile serrated polyps/sessile serrated adenomas.1
- Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
The Cologuard Plus test has an overall sensitivity of 95% and specificity of 91%.1*†‡
- Stage I sensitivity: 88% (22/25)
- Stage II sensitivity: 93% (13/14)
- Stage III sensitivity: 100% (30/30)
- Stage IV sensitivity: 100% (12/12)
- Advanced precancerous lesion sensitivity: 43% (849/1,962)
- High-grade dysplasia sensitivity: 74% (78/106)
- P<0.0001 for the comparison of the next-generation multitarget stool DNA test with the fecal immunochemical test (FIT).1
- Disease stage was defined according to the American Joint Committee on Cancer staging system.1
- Cologuard Plus specificity: 91% overall specificity, including all participants who did not have advanced neoplasia. Specificity for no colorectal neoplasia was age-weighted to the US population and defined as negative colonoscopy, no adenocarcinoma of the colorectum, no adenomas, and no sessile serrated polyps/sessile serrated adenomas.1
- Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
There is no head-to-head study that compares these 2 tests, so no conclusions can be drawn about which is more effective. In their respective clinical trials, both tests were shown to effectively detect colorectal cancer in comparison to the fecal immunochemical test.1,2
- Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. N Engl J Med. 2024;390(11):984-993.
- Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
Cologuard Test 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.
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).1,3
- Imperiale 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, 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 colorectal cancer (CRC) stages I to IV compared to 74% sensitivity for the fecal immunochemical test (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 CRC 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.
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.
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 and Precautions
All positive results should be referred to colonoscopy.
The Cologuard products may produce false positive and false negative results. A false positive result occurs when a result is positive, even though a colonoscopy will not find CRC or APL. A false negative result occurs when a result is negative, even when a colonoscopy identifies APL or CRC.
A negative result does not guarantee the absence of colorectal 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. Performance when used for repeat testing has not been established.
Refer to the Cologuard test Clinician Brochure or the Cologuard Plus test Clinician Brochure for additional information about the benefits and risks of using each version of the Cologuard product for CRC screening.
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:
- Adherence to the Cologuard test on the Cologuard Adherence page
- Adherence to continued screening with the Cologuard test on the Continued Screening 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 Patient Resources 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 September 18, 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 for coverage. Market Access. 2024. 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 September 18, 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 September 18, 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 ACS 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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