Frequently asked questions

Cologuard 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.
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A positive result does not necessarily mean a patient has cancer. It means that Cologuard 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 Cologuard, 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).

Reference: 1. Cologuard^® Clinician Brochure. Madison, WI: Exact Sciences Corporation.

A negative result means that Cologuard 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 Cologuard, 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).

Reference: 1. Cologuard^® Clinician Brochure. Madison, WI: Exact Sciences Corporation.

Indications for Use
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.

Contraindications
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.

Reference: 1. Cologuard^® Clinician Brochure. Madison, WI: Exact Sciences Corporation.

To process claims for Medicare/Medicare Advantage patients, claims must include either ICD-10 diagnosis code Z12.11 (encounter for screening for malignant neoplasm of colon) or Z12.12 (encounter for screening for malignant neoplasm of rectum). These codes are for convenience only. Providers should report the diagnosis code that best describes the reason for the test. Only tests that are medically reasonable and necessary for the diagnosis or treatment of a Medicare or Medicaid patient will be reimbursed.

Cologuard analyzes patient stool for the presence of 11 biomarkers, including hemoglobin and DNA markers, that are associated with colorectal cancer and advanced adenomas.^1,2 Learn more

References: 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. 2. Cologuard^® Clinician Brochure. Madison, WI: Exact Sciences Corporation.

No. Cologuard can be completed in the comfort of home and does not require special preparation, dietary or medication changes, sedation, or time off from work.

In a clinical study, Cologuard had 92% sensitivity in detecting colorectal cancer in stages I to IV.¹*

Cologuard also had 94% sensitivity in detecting colorectal cancer in stages I to II.^1-3*

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

References: 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. 2. Ahlquist DA. Multi-target stool DNA test: a new high bar for noninvasive screening. Dig Dis Sci. 2015;60(3):623-633. 3. Cologuard^® Clinician Brochure. Madison, WI: Exact Sciences Corporation.

In a clinical study of patients aged 50 to 84 years, Cologuard 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.

In a separate study of patients at average risk aged 45 to 49 years, Cologuard demonstrated 95.2% specificity in patients with nonadvanced adenomas, nonneoplastic findings, and negative results on colonoscopy.²

References: 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. 2. Imperiale, TF, Kisiel JB, Itzkowitz SH, et al. Specificity of the multi-target stool DNA test for colorectal cancer screening in average-risk 45–49 year-olds: a cross-sectional study. Cancer Prev Res (Phila). 2021;14(4):489-496.

In a retrospective electronic health record (EHR)–based medical record review from October 2014 to September 2015, 77 primary care physicians offered Cologuard to 393 patients on Medicare who were nonadherent with colorectal cancer screening recommendations. Over 12 months, 88.3% of patients were adherent with proper use of Cologuard.¹

Study limitations: A relatively smaII study size from a single health center; findings may not be generalizable to patients not on Medicare or to patients outside this particular geographic area (Dallas, TX).¹

Reference: 1. Prince M, Lester L, Chiniwala R, Berger B. Multitarget stool DNA tests increases colorectal cancer screening among previously noncompliant Medicare patients. World J Gastroenterol. 2017;23(3):464-471.

Personalized outreach from Exact Sciences helps ensure screening completion with a welcome call, as well as reminders via mail, email, and/or text. Customer care is available 24 hours a day, 7 days a week by telephone (1-844-870-8870) 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.

The following are major screening guidelines that include Cologuard as a screening option^1-9:

• U.S. Preventive Services Task Force (USPSTF)¹*
• American Cancer Society (ACS)^2†
• Healthcare Effectiveness Data and Information Set (HEDIS^®)^3‡
• National Comprehensive Cancer Network^® (NCCN^®)^4§
• American College of Obstetricians and Gynecologists (ACOG)⁵
• Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)⁶
• Medicare Advantage Star Rating System⁷
• Electronic Clinical Quality Measure (eCQM)⁸
• Health Resources and Services Administration Uniform Data Set (UDS)⁹

The USPSTF concludes with moderate certainty that screening for CRC in adults aged 45 to 49 years has moderate net benefit (Grade B).¹

The ACS concludes that there is clear evidence of benefit (or harm) but some uncertainty on the balance of benefits/harms or patient values/preferences, which can influence individual decisions and recommendations for screening patients aged 45 to 49 years (qualified recommendation).²

sDNA (ie, Cologuard) is one of the methods permitted as part of the National Committee for Quality Assurance's (NCQA) HEDIS^® quality measures for colon cancer screening. Third-party guidelines and quality measures do not specifically "endorse" commercial products, and inclusion in same does not imply otherwise. HEDIS^® is a registered trademark of the National Committee for Quality Assurance (NCQA).³

All recommendations are category 2A unless otherwise indicated. The National Comprehensive Cancer Network (NCCN^®) makes no representations or warranties of any kind regarding their content, use, or application and disclaims any responsibility for their application or use in any way. National Comprehensive Cancer Network (NCCN), NCCN, and NCCN Guidelines are registered trademarks of the National Comprehensive Cancer Network, Inc.⁴

References: 1. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. 2. 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. 3. Colorectal cancer screening (COL). National Committee for Quality Assurance (NCQA). Accessed September 9, 2021. https://www.ncqa.org/hedis/measures/colorectal-cancer-screening/. 4. NCCN clinical practice guidelines in oncology (NCCN Guidelines^®): colorectal cancer screening version 2.2021. National Comprehensive Cancer Network. Accessed September 9, 2021. https://www.nccn.org/professionals/physician_gls/pdf/colorectal_screening.pdf. 5. ACOG endorsed. The American College of Obstetricians and Gynecologists. Accessed September 9, 2021. https://www.acog.org/clinical/clinical-guidance/acog-endorsed. 6. Quality measure specifications. Quality ID#113 (NQF 0034): colorectal cancer screening. Centers for Medicare & Medicaid Services. Accessed September 9, 2021. https://qpp.cms.gov/docs/QPP_quality_measure_specifications/Claims-Registry-Measures/2020_Measure_113_MedicarePartBClaims.pdf. 7. Announcement of calendar year (CY) 2020 Medicare Advantage capitation rates and Medicare Advantage and Part D payment policies and final call letter. Centers for Medicare & Medicaid Services. Accessed September 9, 2021. https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2020.pdf. 8. Colorectal cancer screening. eCQM for 2021 performance period. Electronic Clinical Quality Improvement Resource Center. Accessed September 9, 2021. https://ecqi.healthit.gov/sites/default/files/ecqm/measures/CMS130v9.html. 9. 2021 Uniform Data System (UDS) program assistance letter (PAL): Uniform Data System changes for calendar year 2021; October 21, 2020. US Health Resources and Services Administration (HRSA). Accessed September 9, 2021. https://bphc.hrsa.gov/datareporting/reporting/udspals/2020-07.

Stool DNA (ie, Cologuard) 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 colon cancer screening. HEDIS^® is a helpful tool used by more than 90% of health plans in America. The quality measures analyze the performance of healthcare services and care. The data and results are used to make improvements in the healthcare provider's quality of care and service.*

The inclusion of Cologuard in the NCQA HEDIS^® metrics allows payers, health systems, and providers the opportunity to receive quality credit for a 3-year lookback period during HEDIS^® audits.

Third-party guidelines and quality measures do not specifically “endorse” commercial products, and inclusion in same does not imply otherwise.

• 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

Reference: 1. 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.

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 years.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 Cologuard 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

References: 1. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. 2. 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.

The USPSTF concludes with moderate certainty that screening for CRC in adults aged 45 to 49 years has moderate net benefit (Grade B) as opposed to convincing evidence of a substantial benefit (Grade A) in patients aged 50 to 75. Because there is little evidence of harm in screening ages 45 to 49 years while still having a benefit, the recommended screening age was lowered.¹

Due to the long history of the American Cancer Society’s strong recommendation to initiate CRC screening at age 50 years, there is limited data on screening outcomes in patients aged 45 to 49 years. Because of differences in the type and quality of evidence for screening in patients younger than 50 years, the recommendation to start screening at age 45 has been designated as "qualified," indicating clear evidence of benefit of screening but less certainty about the balance of benefits, harms, and patient preferences.²

References: 1. US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. 2. 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.

Change of age is the only difference in indication and use of Cologuard. The indication was changed to include screening for adults 45 and older to reflect updated national guidelines.

• Nationwide, >94% of all Cologuard patients have no out-of-pocket costs for screening*
• Currently, ~80% of Cologuard patients aged 45 to 49 years have had no out-of-pocket costs.* Many national and regional payers have begun updating their medical policies to begin coverage of colorectal cancer screening at age 45

If patients have questions about coverage, they can contact our Customer Care Center, available 24/7 at 1-844-870-8870. Our team of specialists can help them contact their insurer and ask the right questions.

View details on the Cologuard patient website.

Exact Sciences estimate based on historical patient billing as of June 30, 2021. Rate of coverage varies by state and region. Exceptions for coverage may apply; only your patients' insurers can confirm how Cologuard would be covered.

We highly encourage patients who receive a bill with out-of-pocket responsibilities after using Cologuard 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.