Sunflower Health Plan Concert Genetic Oncology: Cancer Screening (PDF) Form

Concert Genetics Oncology: Cancer Screening V2.2023 Date of Revision: 3/1/2023 CONCERT GENETICS ONCOLOGY: CANCER SCREENING See Important Reminder at the end of this policy for important regulatory and legal information. OVERVIEW This policy relates to genetic and biomarker tests that aim to screen for specific cancers in individuals who are at risk to develop them. These screening tests can be designed for asymptomatic individuals that are at an average risk level for cancer, or for individuals that are known to be at a higher risk to develop a specific cancer. Genetic and biomarker cancer screening tests aim to identify the presence of cancer before symptoms appear and when treatment is often most effective. These tests are not currently diagnostic for cancer, but typically determine if an individual has an increased chance that cancer is present. Screening tests for colorectal cancer may be performed by analyzing specific DNA present in fecal matter or peripheral blood. Cancer screening tests may also be performed on urine samples to screen for bladder cancer and colon polyps. These methods offer a noninvasive alternative to currently available screening approaches such as colonoscopy. Screening tests for lung cancer are potentially useful adjuncts to the low-dose CT (LDCT), recommended lung cancer screening tool in high-risk populations. Biomarkers such as autoantibodies, metabolites, proteins, and microRNA may be sampled from many different bodily sources, including whole blood, serum, plasma, bronchial brushings, and sputum. Circulating blood-based and serum based biomarkers are a convenient compartment to sample as they are relatively easy and inexpensive to collect. a POLICY REFERENCE TABLE Below are a list of higher volume tests and the associated laboratories for each coverage criteria section. This list is not all inclusive. Coding Implications 1 Concert Genetics Oncology: Cancer Screening V2.2023 Date of Revision: 3/1/2023 This clinical policy references Current Procedural Terminology (CPT®). CPT® is a registered trademark of the American Medical Association. All CPT codes and descriptions are copyrighted 2022, American Medical Association. All rights reserved. CPT codes and CPT descriptions are from the current manuals and those included herein are not intended to be all-inclusive and are included for informational purposes only. Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. Coverage Criteria Coverage Criteria Sections Sections Example Tests (Labs) Example Tests (Labs) Common CPT Common CPT Codes Codes Common ICD Common ICD Codes Codes Ref Ref Colorectal Cancer Screening Tests Colorectal Cancer Screening Tests FIT- FIT-DNA Testing (Stool DNA Testing) Urinary Biomarker Tests for Pre- cancerous Colon Polyps - Blood-based Biomarker Colorectal Cancer Screening Tests Cologuard (Exact Sciences Corporation) PolypDx (Metabolomic Technologies) 0002U PolypDx (Metabolomic Technologies)0002U 81528 Z12.10 through Z12.13 Z12.10 through Z12.10 through Z12.13 Z12.13 1, 3 1, 3 1 1 BeScreened (Beacon Biomedical) BeScreened (Beacon Biomedical) 0163U 0163U FirstSightCRC (CellMax Life) FirstSightCRC (CellMax Life) 0091U 0091U Z12.10 through Z12.10 through Z12.13 Z12.13 1, 2, 4, 1, 2, 4, 9 9 ColonSentry (StageZero Life ColonSentry (StageZero Life Sciences) Sciences) Epi proColon (Epigenomics) Epi proColon (Epigenomics) 81599 81599 81327, G0327 81327, G0327 ColoVantage (Quest Diagnostics) ColoVantage (Quest Diagnostics) ColoScape Colorectal Cancer ColoScape Colorectal Cancer Detection (DiaCarta Clinical Lab) Detection (DiaCarta Clinical Lab) 0368U 0368U Lung Cancer Screening Tests Lung Cancer Screening Tests EarlyCDT-Lung (Oncimmune) EarlyCDT-Lung (Oncimmune) 83520 83520 Z12.2 Z12.2 Blood-based Blood-based Biomarker Lung Biomarker Lung Cancer Screening Cancer Screening Tests Tests 5, 6, 7, 5, 6, 7, 8 8 2 Concert Genetics Oncology: Cancer Screening V2.2023 Date of Revision: 3/1/2023 OTHER RELATED POLICIES This policy document provides coverage criteria for cancer screening tests. Please refer to: ● Oncology: Molecular Analysis of Solid Tumors and Hematologic Malignancies for criteria related to DNA testing of a solid tumor or a blood cancer. ● Genetic Testing: Hereditary Cancer Susceptibility Syndromes for criteria related to genetic testing to determine if an individual has an inherited cancer susceptibility syndrome. ● Oncology: Algorithmic Testing for criteria related to gene expression profiling and tumor multianalyte assays with algorithmic analyses. ● Oncology: Circulating Tumor DNA and Circulating Tumor Cells (Liquid Biopsy) for criteria related to circulating tumor DNA (ctDNA) or circulating tumor cell testing performed on peripheral blood for cancer diagnosis, management and surveillance. ● Genetic Testing: General Approach to Genetic Testing for coverage criteria related to cancer screening that is not specifically discussed in this or another non-general policy. CRITERIA It is the policy of health plans affiliated with Centene Corporation® that the specific genetic testing noted below is medically necessary when meeting the related criteria: COLORECTAL CANCER SCREENING TESTS FIT-DNA Testing (Stool DNA Testing) I. The use of FIT-DNA Testing (stool DNA testing) (81528) to screen for colorectal cancer may be considered medically necessary when: A. The member/enrollee is 45 years of age or older, AND B. The member/enrollee is an individual who is at average risk for colorectal cancer, because the member/enrollee does not have any of the following: 1. A personal history of colorectal cancer or adenoma or sessile serrated polyp, OR 2. A family history of colorectal cancer in close relatives, OR 3 Concert Genetics Oncology: Cancer Screening V2.2023 Date of Revision: 3/1/2023 3. A personal history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease), OR 4. A personal history of cystic fibrosis, OR 5. A confirmed or suspected hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or Lynch syndrome (hereditary non- polyposis colon cancer or HNPCC), OR 6. A personal history of receiving radiation to the abdomen (belly) or pelvic area to treat a prior cancer. II. The use of FIT-DNA Testing (stool DNA testing) (81528) to screen for colorectal cancer is considered investigational for all other indications. Note: Fecal immunochemical testing (FIT) alone is not in the scope of this policy (see definitions) back to top Urinary Biomarker Tests for Pre-cancerous Polyps I. The use of urinary biomarker tests for pre-cancerous polyps (0002U) is considered investigational. back to top Blood-based Biomarker Colorectal Cancer Screening Tests I. The use of blood-based biomarkers to screen for colorectal cancer (0091U, 0163U, 0368U, 81327, 81599) is considered investigational. back to top LUNG CANCER SCREENING TESTS Blood-based Biomarker Lung Cancer Screening Tests I. The use of blood-based biomarker tests (83520) for lung cancer screening are considered investigational. back to top 4 Concert Genetics Oncology: Cancer Screening V2.2023 Date of Revision: 3/1/2023 NOTES AND DEFINITIONS Fecal immunohistochemical testing (FIT) is a screening test for colon cancer that detects human blood in the lower intestines. (FIT testing alone does not involve any genetic test and is outside of the scope of this policy). FIT-DNA test combines fecal immunochemical (FIT), which uses antibodies to detect blood in the stool, with a test that detects abnormal DNA from cancer or polyp cells in the stool. Low-dose computed tomography (LDCT) has been proposed as a method of screening asymptomatic, high risk individuals for lung cancer; it refers to a non contrast study with a multi- detector CT scanner during a single maximal inspiratory breath-hold with a scanning time of under 25 seconds. It has been suggested that LDCT may be an improved early lung cancer detection tool based on the advantages it appears to have over CXR and sputum cytology to detect lung cancer at an earlier stage. MicroRNAs (miRNAs) are tissue specific, small, non-coding RNAs regulating gene expression which may identify candidates for early detection of lung cancer. back to top CLINICAL CONSIDERATIONS Screening tests are not diagnostic tests. The results from a screening test put an individual into a lower risk or higher risk status. For an individual that is put into the higher risk status, following up with an appropriate diagnostic test would be necessary to make a definitive diagnosis of cancer. For lung cancer, approaches where a biomarker based initial screen is followed by low-dose computed tomography (LDCT) or in which a biomarker test is combined with LDCT show promise for use in early detection. However, more high quality evidence is needed to support and guide the implementation of these tests. BACKGROUND AND RATIONALE Colon Cancer Screening Tests - FIT-DNA Testing (Stool DNA Testing) back to top 5 Concert Genetics Oncology: Cancer Screening V2.2023 Date of Revision: 3/1/2023 National Comprehensive Cancer Network (NCCN) Current NCCN guidelines on colorectal cancer screening (3.2022) support the use of FIT-DNA in average-risk individuals aged 45 to 75 who might have a life expectancy greater than or equal to 10 years, and notes that the decision to screen individuals aged 76 to 85 should be individualized. Current NCCN guidelines (3.2022) do not include a recommendation for colorectal cancer screening via blood-based or urine-based screening. US Food and Drug Administration (FDA) Cologuard (Exact Sciences): On August 12, 2014, Cologuard (Exact Sciences) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process as an automated fecal DNA testing product (P130017). Cologuard is intended for the qualitative detection of colorectal neoplasia associated with DNA markers and occult hemoglobin in human stool. A positive result may indicate the presence of CRC or advanced adenoma and should be followed by diagnostic colonoscopy. (p. 1) On September 20, 2019, the FDA approved the expansion of the Cologuard label to include adults ages 45 years or older. Cologuard was previously indicated for those aged 50 years or older. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high- risk individuals. Colorectal Cancer Screening Tests - Urinary Biomarker Tests for Pre-cancerous Colon Polyps National Comprehensive Cancer Network (NCCN) Current NCCN guidelines on colon cancer screening (3.2022) do not include a recommendation for colorectal cancer screening via blood-based or urine-based screening. Colorectal Cancer Screening Tests - Blood-based Biomarker Colorectal Cancer Screening Tests Concert Genetics Technical Assessment 2021 This review focused on peer-reviewed, published evidence of the clinical utility of BeScreened, FirstSight CRC, ColonSentry, Epi ProColon, and Colovantage through October 2021. PubMed and ECRI Guidelines Trust searches were performed. Search terms included BeScreened, FirstSight 6 Concert Genetics Oncology: Cancer Screening V2.2023 Date of Revision: 3/1/2023 CRC, ColonSentry, Epi ProColon, Colovantage, colon cancer screen, circulating tumor cells, Cripto, ANXA3, CLEC4D, LMNB1, PRRG4, TNFAIP6, VNN1, SEPT9.