Frequently Asked Questions

What does a positive* result mean?

A positive result does not necessarily mean your 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. Patients with a negative diagnostic colonoscopy following a positive Cologuard result do not require additional clinical evaluation

*If a result cannot be obtained due to insufficient sample size, low DNA capture, etc., the lab will automatically request a second sample, at no additional cost to the patient

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. Cologuard is recommended by the ACS every 3 years.

*If a result cannot be obtained due to insufficient sample size, low DNA capture, etc., the lab will automatically request a second sample, at no additional cost to the patient

What are the benefits and risks of the Cologuard Test?

Cologuard detects 92% of cancers and 69% of high-risk precancerous lesions (high-grade dysplasia). Cologuard is a noninvasive, stool DNA (sDNA) test to screen for colorectal cancer. The Cologuard collection kit lets the patient collect their sample at home. There are no dietary restrictions and no bowel preperation is required.

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 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 kits 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.

How will I learn the results?

Once the lab receives your patient’s Collection Kit (it must be received within 72 hours of the time the sample was collected), it takes about two weeks for the laboratory to test the sample and report the result back to you.

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

CMS' most recent guidance for coverage of Cologuard indicates that, in order to successfully process claims for Medicare/Medicare Advantage patients, claims must include both 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).

However, please know that these codes are given as a convenience only. Ordering providers should report the diagnosis code that best describes the reason for performing the test, regardless of whether that is the code listed above or not. Only tests that are medically reasonable and necessary for the diagnosis or treatment of a Medicare or Medicaid patient will be reimbursed.

What CPT or HCPCS code will be used to bill services?

Cologuard is 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.

As of 1/1/2016, Exact Labs does not use code G0464. We are required to use 81528.

Where can I get more information?

Please call Exact Sciences at 1-844-870-8870. For patient information, visit the Cologuard patient website.