Frequently asked questions

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What does a positive Cologuard result mean?

A positive result does not necessarily mean a patient has cancer. It means that Cologuard detected DNA and/or hemoglobin biomarkers in the stool which are associated with CRC 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 diagnostic colonoscopy. 

What does a negative result mean?

A negative result means that Cologuard did not detect significant levels of DNA and/or hemoglobin biomarkers in the stool which are associated with CRC 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.

How does Cologuard detect the presence of colorectal cancer?

Cologuard analyzes patient stool for the presence of 11 molecular markers, including hemoglobin and DNA markers, which are associated with colorectal cancer and advanced adenomas.. Learn more.

What is Cologuard sensitivity?

Cologuard is 92% sensitive for detecting colorectal cancers stages I-IV.*2

*Cologuard sensitivity, per stage of cancer: I: 90% (n = 29); II: 100% (n = 21); III: 90% (n = 10); IV: 75% (n = 4).2

What is Cologuard specificity?

Cologuard specificity is 87%.*2

*Cologuard specificity: 87% overall specificity excluding colorectal cancer and advanced adenoma; and including all nonadvanced adenomas, non-neoplastic findings, and negative results on colonoscopy. 90% specificity in participants with no lesions biopsied on colonoscopy2

Are patients satisfied with Cologuard?

Yes. In surveys, 88% of Cologuard patients were very satisfied or satisfied with their testing experience.3

Are providers satisfied with Cologuard?

Yes. Over 120,000 providers have ordered Cologuard to date, with 96% reporting that the test met or exceeded expectations.4

What is the compliance rate for Cologuard?

Patient compliance is 68%.5

Cologuard's compliance rate represents the cumulative completed tests from kits shipped to patients during the six-month period ending 12 months prior to the end of the most recent quarter reported, excluding program orders.

What factors contribute to the patient compliance rate for Cologuard?

Cologuard has a built-in patient compliance program. The patient will receive a welcome call around the time the test kit is delivered to their home. If the patient does not complete the test, s/he will receive up to 2 reminder calls and a reminder letter as well as the ability to access a 24/7 patient support line (1-844-870-8870). Exact Sciences data shows this program has led to a 68% compliance rate*.

Cologuard is easy for patients to use in the privacy of their own homes. Cologuard requires no prep, no diet or medication restrictions, or time off work. Cologuard is as easy as “get, go, gone."

Is Cologuard included in any major screening guidelines?

Yes: US Preventative Services Task Force (USPSTF)6, American Cancer Society7, and National Comprehensive Cancer Network.8

Is Cologuard included in widely-used healthcare performance measures?

Yes, stool DNA (i.e. 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.*

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

What warnings, precautions and risks are associated with Cologuard?

  • The performance of Cologuard has been established in a cross sectional study (i.e., single point in time). Programmatic performance of Cologuard (i.e., 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. Non-inferiority or superiority of Cologuard programmatic sensitivity as compared to other recommended screening methods for CRC and AA has not been established.
  • 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 (e.g., 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 72 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.

What are the indications and contraindications for Cologuard?

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 diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 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 50 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 non-polyposis colorectal cancer syndrome (HNPCCC or Lynch Syndrome), PeutzJeghers 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.

How is Cologuard ordered?

Ordering information is available on the Ordering & Results page.

How long does it take for Exact Sciences Lab to return results?

Once our lab receives the sample, it is tested as soon as possible, usually within two weeks. Your office will receive the results shortly after.

Is Cologuard covered by insurance?

Cologuard is covered by Medicare and most major insurers.

  • Cologuard is covered by Medicare and Medicare Advantage with no co-pay or deductible for eligible patients.
  • More than 85%* of all Cologuard patients have no out-of-pocket cost for screening.
  • Based on the Affordable Care Act, Cologuard should be covered by most private insurers with no co-pay or deductible for eligible patients (ages 50-75; at average risk for colon cancer; without symptoms). Some exceptions may apply, so we recommend patients call their insurer to confirm.

View details on the Cologuard patient website.

*Rate of coverage varies by state and region. Coverage rate only applies to Cologuard screening population.

How can a patient get help writing an appeal letter?

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 CologuardTest.com/appeal.

What ICD-10/diagnosis code(s) should be used for Cologuard?

To process claims for Medicare/Medicare Advantage patients, claims must include either ICD-10 diagnosis codes Z12.11 (encounter for screening for malignant neoplasm of colon) and 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.

What are the CPT, HCPCS, ICD-10 Codes, Tax ID, NPI, and Diagnosis Codes for Cologuard?

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.

Cologuard, Exact Sciences Laboratories Tax ID: 46-3095174

Cologuard, Exact Sciences Laboratories NPI: 1629407069