Description. Coverage Determination/ Clinical Indications. Medicare-specific Coverage Determinations. Exclusions. Definitions.

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1 Page 1 of 5 Disclaimer Refer to the member s specific benefit plan and Schedule of Benefits to determine coverage. This may not be a benefit on all plans or the plan may have broader or more limited benefits than those listed in this Medical Policy. Coverage Determination/ Clinical Indications Medicare-specific Coverage Determinations Exclusions Definitions Background Cologuard is a noninvasive, multitarget fecal DNA for the qualitative detection of colorectal neoplasia-associated DNA markers in addition to the presence of occult hemoglobin in stool. The test must be prescribed by a healthcare provider. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in people at high risk for colorectal cancer (CRC). The test is covered once every three years for beneficiaries meeting specific criteria. Only used in people who have no signs or symptoms of CRC and who have no risk factors associated with development of the disease. Patients with a positive Cologuard result should be referred for diagnostic colonoscopy. Patient Selection Criteria: Age 50 to 85 years, and Asymptomatic (no signs or symptoms of colorectal disease, including but not limited to, lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test [FOBT or gfobt] or fecal immunochemical test [FIT]), and At average risk of developing CRC (no personal history of adenomatous polyps, CRC, or inflammatory bowel disease including Crohn s disease and ulcerative colitis; no family history of CRC or adenomatous polyps, familial adenomatous polyposis, or hereditary nonpolyposis CRC). Centers for Medicare and Medicaid Services (CMS) issued a Decision Memorandum for coverage of the Cologuard test for Medicare beneficiaries. For Commercial and Centennial Care beneficiaries, Cologuard is not a covered benefit. CRC is the second leading cause of cancer deaths and the fourth most common cancer in the United States in Overall mortality rates for CRC have declined over the past decade. Primary prevention, early detection, and early treatment have contributed to the reduction in mortality, however, CRC is projected to account for greater than 50,000 deaths in United States Preventive Services Task Force (USPSTF) recommends screening for CRC using fecal occult blood testing, sigmoidoscopy, or

2 Page 2 of 5 Medical Terms colonoscopy in adults beginning at age 50 years and continuing until age 75 years. (Recommendation Level: A). For the population 75 to 85 years, decision to screen for colorectal cancer should be an individual one, taking into account the patient s overall health and prior screening history. (Recommendation Level: C). USPSTF guidelines currently states that there is insufficient evidence to evaluate the benefits and harms of fecal DNA (sdna or FIT-DNA) testing for CRC screening. Hayes Level: C For the use of Cologuard to screen for CRC in individuals who satisfy the criteria for the intended use of this test (men or women who are at least 50 years of age, have an average risk of CRC, and have not had a positive result from another CRC screening test). Hayes Level: D -- For the use of Cologuard to screen for CRC in individuals who do not satisfy the criteria for the intended use of this test (men or women who are at least 50 years of age have an average risk of CRC, and have not had a positive result from another CRC screening test). The American College of Gastroenterology (ACG) colorectal cancer (CRC) that CRC screening tests are now grouped into cancer prevention tests and cancer detection tests. Colonoscopy every 10 years, beginning at age 50, remains the preferred CRC screening strategy. It is recognized that colonoscopy is not available in every clinical setting. It is also realized that not all eligible persons are willing to undergo colonoscopy for screening purposes. In these cases, patients should be offered an alternative CRC prevention test (flexible sigmoidoscopy every 5-10 years, or a computed tomography (CT) colonography every 5 years) or a cancer detection test (fecal immunochemical test for blood, FIT). References Center for Medicare & Medicaid Services (CMS). Decision Memo for Screening for Colorectal Cancer Stool DNA Testing (CAG-00440N). October 9, CMS Manual System, Pub Medicare National Coverage Determinations, Transmittal 183, August National Coverage Determination (NCD) for COLORECTAL Cancer Screening Tests (210.3). United States Preventive Services Task Force (USPSTF). Screening for Colorectal Cancer: U.S. Preventive Services Task Force Recommendations. June 2016.

3 Page 3 of 5 Hayes Document. Genetic Test Evaluation. Cologuard for Colorectal Cancer Screening. October 16, Updated: October 7, American College of Gastroenterology Guidelines for Colorectal Cancer Screening National Comprehensive Cancer Network. Guidelines Version Colorectal Cancer Screening. Coding The coding listed in this Medical Policy is for reference only. Covered and non-covered codes are within this list. CPT Oncology (colorectal) screening, quantitative real-time target and signal amplification of 10 DNA markers (KRAS mutations, promoter methylation of NDRG4 and BMP3) and fecal hemoglobin, utilizing stool, algorithm reported as a positive or negative result

4 Page 4 of 5 CPT HCPCS No specific code identified. ICD9 Diagnosis V76.51 Special Screening for malignant neoplasms: Colon ICD-10 Diagnosis Z12.11 Encounter for screening for malignant neoplasm of colon Z12.12 Encounter for screening for malignant neoplasm of rectum

5 Page 5 of 5 Reviewed by: 1. Approval Signatures: Clinical Quality Committee: Norman White MD Medical Director: Pedro Cardona MD Approval Date: Publication History: August 10, : Original effective date : Updated with CMS NCD reference. mm-dd-yy: This Medical Policy is intended to represent clinical guidelines describing medical appropriateness and is developed to assist Presbyterian Health Plan and Presbyterian Insurance Company, Inc. (Presbyterian) Health Services staff and Presbyterian medical directors in determination of coverage. This Medical Policy is not a treatment guide and should not be used as such. For those instances where a member does not meet the criteria described in these guidelines, additional information supporting medical necessity is welcome and may be utilized by the medical director in reviewing the case. Please note that all Presbyterian Medical Policies are available on the Presbyterian Healthcare Services website at: