Frequently asked questions

  • Addressing Coronavirus (COVID-19)

    Is colorectal cancer (CRC) screening still important right now?

    Yes. Colorectal cancer continues to affect our communities, even as they are affected by the COVID-19 pandemic.

    It is the second-deadliest cancer among men and women in the US, even though it is one of the most preventable cancers.1,2 Early detection of CRC is associated with significantly higher survival rates compared to late detection,1 yet 44 million eligible people are still not getting screened as recommended.3* A decline in cancer preventive care now may negatively impact our communities in the future.

    *Estimate based on the US population aged 45 to 74 years as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.

    References: 1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70(1):7-30. 2. Itzkowitz SH. Incremental advances in excremental cancer detection tests. J Natl Cancer Inst. 2009;101(18):1225-1227. 3. Piscitello A, Edwards DK. Estimating the screening-eligible population size, ages 45 to 74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res. 2020;13(5):443-448.

    Is Exact Sciences still conducting Cologuard® testing?

    Yes. As a company, we take our responsibility to protect our patients, our partners, and our team very seriously. As such, we have had procedures and protocols in place to safely handle clinical testing specimens both at Exact Sciences Laboratories and during sample transport. Our procedures include utilizing universal precautions when handling specimens to protect against stool pathogen exposure, including COVID-19. Exact Sciences performs functions that are essential to the community’s well-being, including healthcare and laboratory services. Cologuard testing will continue for any specimens that are submitted, and the Customer Care Center will continue to assist you and your patients with any questions or concerns.

    Will UPS® still pick up a Cologuard® collection kit from a patient’s home?

    Yes. UPS® will continue to pick up your patient’s completed Cologuard® collection kit, except where limited by government restrictions. Cologuard shipments have not been affected. Your patients can schedule a UPS pickup in several ways, including calling the Customer Care Center at 1-844-870-8870.

    Will Cologuard® test results be delayed due to COVID-19?

    No. Typically, it takes up to two weeks for the laboratory to test the sample and report the result back to the ordering prescriber. Exact Sciences Laboratories is fully operational and no delays to patient testing are anticipated at this time.

    Please note that other issues, such as the need for the laboratory to confirm patient information, may delay a patient’s results.

    If a patient might have COVID-19, should they collect their stool sample and send it back?

    If a patient has symptoms of COVID-19, then it is important to address those acute issues first. If a patient has gastrointestinal symptoms such as acute diarrhea or blood in the stool, then they should wait until their symptoms have resolved before collecting a stool sample.1

    If a patient might have COVID-19 but has already collected a sample, the Cologuard® collection kit may still be sent in as long as there has not been any diarrhea or blood in the stool.1

    Reference: 1. Cologuard® Patient Guide. Madison, WI: Exact Sciences Corporation.

    If a patient might have COVID-19, will handling their Cologuard® collection kit or stool sample transmit the virus?

    There should be no direct contact with the stool sample during the entire collection process, including scraping it for hemoglobin testing.1 COVID-19 concerns do not change this. Before and after stool sample collection, patients should practice safe hygienic measures by washing their hands with soap and water for 20 seconds.2

    The Centers for Disease Control and Prevention (CDC) website states, "The CDC has stated that while the coronavirus virus can survive for a short period of time on some surfaces, it is unlikely to be spread from mail, products or packaging."3

    Like Exact Sciences, UPS® is closely monitoring the situation. They have plans to maintain their operations while also ensuring the health and well-being of their employees. They have hygiene practices in place, in line with suggestions from agencies such as the World Health Organization.4

    References: 1. Cologuard® Patient Guide. Madison, WI: Exact Sciences Corporation. 2. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): how to protect yourself & others. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Updated July 31, 2020. Accessed August 14, 2020. 3. Centers for Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): frequently asked questions. https://www.cdc.gov/coronavirus/2019-ncov/faq.html#anchor_1584386553767. Updated August 4, 2020. Accessed August 14, 2020. 4. United Parcel Service of America. How UPS is responding to the Coronavirus. Frequently asked questions about the Coronavirus. https://www.ups.com/us/en/about/news/important-updates.page. Accessed August 14, 2020.

    Should patients take any additional precautions while they are collecting their stool sample?

    No. There should be no direct contact with the stool sample during the entire collection process, including scraping it for hemoglobin testing.1 COVID-19 concerns do not change this. Before and after stool sample collection, patients should practice safe hygienic measures by washing their hands with soap and water for 20 seconds.2

    Collecting a stool sample for the Cologuard® collection kit does not increase the risk of infection transmission over normal defecation, because there is no need for anyone else in the home to handle the stool sample.

    References: 1. Cologuard® Patient Guide. Madison, WI: Exact Sciences Corporation. 2. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19): how to protect yourself & others. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Updated July 31, 2020. Accessed August 14, 2020.

    If a patient’s Cologuard® test is positive, would there be a change in follow-up recommendations?

    No. A positive Cologuard result is not a diagnosis of cancer. However, a positive Cologuard result is associated with an increased chance for colorectal cancer or for advanced precancer.1 Therefore, if a patient has a positive Cologuard result, they should get a follow-up colonoscopy as soon as possible.2 Please be aware that during the COVID-19 pandemic, colonoscopy availability may be limited in many areas. It will be important to work with your endoscopy colleagues to determine a suitable plan for completing a follow-up colonoscopy. If a delay in follow-up colonoscopy evaluation could cause undue anxiety for any of your patients, you may wish to discuss the pros and cons of screening for colorectal cancer with them at this time.

    Additional Information on a positive Cologuard test

    References: 1. 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. 2. Cologuard® Physician Brochure. Madison, WI: Exact Sciences Corporation.

    Should I be concerned if a patient with a positive Cologuard® result can’t get a follow-up colonoscopy right away?

    Positive Cologuard results are associated with an increased chance for colorectal cancer or for advanced precancer.1 Therefore, if a patient has a positive Cologuard result, they should get a follow-up colonoscopy.2

    Under normal circumstances, a follow-up colonoscopy within 3 months of a positive stool test has been recommended.3 However, because different parts of the country are affected in different ways, the recommendation may differ based on individual areas of the country. In the beginning of the COVID-19 pandemic, the major GI societies (AASLD, ACG, AGA, ASGE) advised that, for most asymptomatic patients with either a positive Cologuard or FIT test, “colonoscopy should be considered non-urgent and can be delayed by at least 4-6 weeks and reassessed.”4 The AGA and DHPA have recently updated guidance for the resumption of elective endoscopies. If a delay in follow-up colonoscopy evaluation could cause undue anxiety for any of your patients, you may wish to discuss the pros and cons of screening for colorectal cancer with them at this time.

    AASLD=American Association for the Study of Liver Diseases; ACG=American College of Gastroenterology; AGA=American Gastroenterology Association; ASGE=American Society for Gastrointestinal Endoscopy; DHPA=Digestive Health Physician Association.

    References: 1. 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. 2. Cologuard® Physician Brochure. Madison, WI: Exact Sciences Corporation. 3. Doubeni CA, Gabler NB, Wheeler CM, et al. Timely follow-up of positive cancer screening results: a systematic review and recommendations from the PROSPR Consortium. CA Cancer J Clin. 2018;68(3):199-216. 4. American College of Gastroenterology. COVID-19 and GI. Gastroenterology professional society guidance on endoscopic procedures during the COVID-19 pandemic. https://webfiles.gi.org/links/media/Joint_GI_Society_Guidance_on_Endoscopic_Procedure_During_COVID19_FINAL_impending_3312020.pdf. Accessed August 14, 2020.

    Can patients get novel coronavirus (COVID-19) from the Cologuard collection kit?

    Cologuard kit manufacturers have hygiene protocols in place and are following recommendations from the Centers for Disease Control and Prevention (CDC) and the World Health Organization. These protocols prevent infections from being transmitted to patients. Additionally, Cologuard kits that are returned to the laboratory are not reused. The CDC has stated that the coronavirus has a very low risk of spreading from mail or packaging. However, they recommend washing hands with soap and water for 20 seconds or using hand sanitizer with at least 60% alcohol after accepting deliveries.1,2

    References: 1. Centers of Disease Control and Prevention. Coronavirus disease 2019 (COVID-19). Cleaning and Disinfection. https://www.cdc.gov/coronavirus/2019-ncov/faq.html#Cleaning-and-Disinfection. Accessed August 31, 2020. 2. Centers of Disease Control and Prevention. Coronavirus disease 2019 (COVID-19): how to protect yourself & others. https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/prevention.html. Updated July 31, 2020. Accessed August 14, 2020.

  • How is Cologuard ordered?
    Ordering information is available on the How to Order page
  • 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 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 diagnostic 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® Physician Brochure. Madison, WI: Exact Sciences Corporation.

  • What does a negative Cologuard result mean?

    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® Physician Brochure. Madison, WI: Exact Sciences Corporation.

  • How does Cologuard detect the presence of colorectal cancer?

    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® Physician Brochure. Madison, WI: Exact Sciences Corporation.

  • What is Cologuard sensitivity?

    Cologuard has 92% sensitivity in detecting colorectal cancer in stages I to IV.1

    Cologuard also has 94% sensitivity in detecting colorectal cancer in stages I to II.1,2*

    The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group 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

    Reference: 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.

  • What is Cologuard specificity?

    Cologuard has 87% specificity overall excluding colorectal cancer and advanced adenoma 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

    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). The clinical validation study was conducted in patients 50 years of age and older. Cologuard performance in patients ages 45 to 49 years was estimated by sub-group analysis of near-age groups.

    Reference: 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.

  • Is there any evidence of how Cologuard is used among patients who are noncompliant with screening recommendations?

    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 noncompliant with colorectal cancer screening recommendations. Over 12 months, 88.3% of patients were compliant 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.

  • What kind of support is available to patients to encourage proper use of Cologuard?

    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.

  • What major screening guidelines include Cologuard?

    The following are major screening guidelines that include Cologuard1-8:

    • US Preventive Services Task Force (USPSTF)1
    • American Cancer Society (ACS)2
    • National Comprehensive Cancer Network® (NCCN®)3
    • American College of Obstetricians and Gynecologists (ACOG)4
    • Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)5
    • Medicare Advantage Stars Rating System6
    • Electronic Clinical Quality Measure (eCQM)7
    • Health Resources and Services Administration Uniform Data Set (UDS)8

    References: 1. Bibbins-Domingo K, Grossman DC, Curry SJ, et al; for US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2016;315(23):2564-2575. 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. NCCN Guidelines® version 2.2019: colorectal cancer screening. National Comprehensive Cancer Network® website. https://www.nccn.org/professionals/physician_gls/pdf/colorectal_screening.pdf. Updated August 2, 2019. Accessed November 12, 2019. 4. Well-woman recommendations: ages 40–64 years: laboratory and other tests—ACOG. American College of Obstetricians and Gynecologists website. https://www.acog.org/About-ACOG/ ACOGDepartments/Annual-Womens-Health-Care/Well-Woman-Recommendations/Laboratory-Testing-Ages-40-64-Years. Accessed November 12, 2019. 5.Decision Memo for Screening for Colorectal Cancer-Stool DNA Testing (CAG-00440N). Centers for Medicare & Medicaid Services website. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAld=277. Updated October 9, 2014. Accessed November 12, 2019. 6.Announcement of Calendar Year (CY) 2019 Medicare Advantage Capitation Rates and Medicare Advantage and Part D Payment Policies and Final Call Letter. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2019.pdf. Updated April 2, 2018. Accessed November 12, 2019. 7. Colorectal cancer screening. Electronic Clinical Quality Improvement Resource Center website. https://ecqi.healthit.gov/system/files/ecqm/measures/CMS130v8.html. Updated May 9, 2019. Accessed November 12, 2019. 8.Uniform Data System Reporting Instructions for 2018 Health Center Data. Health Resources and Services Administration website. https://bphc.hrsa.gov/datareporting/reporting/2018-uds-reportingmanual.pdf. Updated June 1, 2018. Accessed November 12, 2019.

  • What credit is provided by HEDIS® for the use of Cologuard?

    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.

  • What warnings, precautions, and risks are associated with Cologuard?
    • 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 that 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 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
    Reference: 1. Cologuard® Physician Brochure. Madison, WI: Exact Sciences Corporation.
  • 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, 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® Physician Brochure. Madison, WI: Exact Sciences Corporation.
  • How long does it take for Exact Sciences Laboratories to return results?

    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.

  • For average-risk patients, why did the American Cancer Society recently lower the recommended age of CRC screening to as early as age 45 years?

    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 45-49 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.1

    Reference: 1. 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.

  • Why is screening from ages 45 to 49 a “qualified” recommendation when screening in adults aged ≥50 years is a “strong” recommendation by the American Cancer Society?

    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 adults aged 45-49 years. Because of differences in the type and quality of evidence for screening in adults younger than 50 years, the recommendation to start screening at age 45 has been designated as “qualified.”1

    Reference: 1. 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.

  • Are instructions for use of Cologuard different for patients aged 45-49 vs patients aged ≥50 years?

    Change of age is the only difference in indication and use of Cologuard.

  • 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
    • Nationwide, >94% of all Cologuard patients have no out-of-pocket costs 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
    • Currently, 80% of Cologuard patients aged 45-49 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 hours a day. When patients call 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 January 31, 2020. Rate of coverage varies by state and region. Exceptions for coverage may apply; only your patients' insurers can confirm how Cologuard would be covered.

  • 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 Cologuard.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 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.

  • What are the CPT, HCPCS, and ICD-10 diagnosis codes as well as Tax ID and NPI 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