Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38659)

General InformationAssociated InformationPlease refer to the related Billing and Coding Article: Implantable Continuous Glucose Monitors (I-CGM) (A58138) for documentation and utilization requirements as applicable.Sources of InformationN/ABibliographyDepartment of Health and Human Services. Centers for Medicare & Medicaid Services. CMS Rulings. CMS-1682-R. Accessed August 16, 2023,https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/CMS-Rulings-Items/CMS1682RSapra A, Bhandari P. Diabetes. StatPearls Publishing. Accessed August 9, 2023,https://www.ncbi.nlm.nih.gov/books/NBK551501/Centers for Disease Control and Prevention (CDC). What is Diabetes? Accessed August 10, 2023,https://www.cdc.gov/diabetes/basics/diabetes.htmlCenters for Disease Control and Prevention (CDC). Prevalence of Both Diagnosed and Undiagnosed Diabetes. Accessed August 10, 2023,https://www.cdc.gov/diabetes/data/statistics-report/diagnosed-undiagnosed-diabetes.htmlAmerican Diabetes Association (ADA). Economic Costs of Diabetes in the U.S. in 2017.Diabetes Care. May 2018;41(5):917-928. doi:10.2337/dci18-0007American Diabetes Association (ADA). Standards of Care in Diabetes-2023 Abridged for Primary Care Providers.Clin Diabetes. Winter 2022;41(1):4-31. doi:10.2337/cd23-as01Solano L. Seven facts you need to know about continuous glucose monitors.Jaapa. Sep 1 2022;35(9):41-45. doi:10.1097/01.JAA.0000854536.09072.5eAdolfsson P, Parkin CG, Thomas A, Krinelke LG. Selecting the Appropriate Continuous Glucose Monitoring System - a Practical Approach.Eur Endocrinol. Apr 2018;14(1):24-29. doi:10.17925/ee.2018.14.1.24Cowart K. A Review of the First Long-term Implantable Continuous Glucose Monitoring System Available in the United States.J Diabetes Sci Technol. Jan 2021;15(1):160-166. doi:10.1177/1932296819890865Heinemann L, Schoemaker M, Schmelzeisen-Redecker G, et al. Benefits and Limitations of MARD as a Performance Parameter for Continuous Glucose Monitoring in the Interstitial Space.J Diabetes Sci Technol. Jan 2020;14(1):135-150. doi:10.1177/1932296819855670Freckmann G. Basics and use of continuous glucose monitoring (CGM) in diabetes therapy. 2020;44(2):71-79. Journal of Laboratory Medicine. doi:doi:10.1515/labmed-2019-0189Barnard KD, Kropff J, Choudhary P, et al. Acceptability of Implantable Continuous Glucose Monitoring Sensor.J Diabetes Sci Technol. May 2018;12(3):634-638. doi:10.1177/1932296817735123Boscari F, Vettoretti M, Amato AML, et al. Comparing the accuracy of transcutaneous sensor and 90-day implantable glucose sensor.Nutr Metab Cardiovasc Dis. Feb 8 2021;31(2):650-657. doi:10.1016/j.numecd.2020.09.006Boscari F, Vettoretti M, Cavallin F, et al. Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance.J Endocrinol Invest. Jan 2022;45(1):115-124. doi:10.1007/s40618-021-01624-2Christiansen MP, Klaff LJ, Bailey TS, Brazg R, Carlson G, Tweden KS. A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study.Diabetes Technol Ther. May 2019;21(5):231-237. doi:10.1089/dia.2019.0020Christiansen MP, Klaff LJ, Brazg R, et al. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II.Diabetes Technol Ther. Mar 2018;20(3):197-206. doi:10.1089/dia.2017.0142Dehennis A, Mortellaro MA, Ioacara S. Multisite Study of an Implanted Continuous Glucose Sensor Over 90 Days in Patients With Diabetes Mellitus.J Diabetes Sci Technol. Jul 29 2015;9(5):951-6. doi:10.1177/1932296815596760Fokkert M, van Dijk PR, Edens MA, et al. Performance of the Eversense versus the Free Style Libre Flash glucose monitor during exercise and normal daily activities in subjects with type 1 diabetes mellitus.BMJ Open Diabetes Res Care. Aug 2020;8(1)doi:10.1136/bmjdrc-2020-001193Garg SK, Liljenquist D, Bode B, et al. Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study.Diabetes Technol Ther. Feb 2022;24(2):84-92. doi:10.1089/dia.2021.0182Jafri RZ, Balliro CA, El-Khatib F, et al. A Three-Way Accuracy Comparison of the Dexcom G5, Abbott Freestyle Libre Pro, and Senseonics Eversense Continuous Glucose Monitoring Devices in a Home-Use Study of Subjects with Type 1 Diabetes.Diabetes Technol Ther. Nov 2020;22(11):846-852. doi:10.1089/dia.2019.0449Kropff J, Choudhary P, Neupane S, et al. Accuracy and Longevity of an Implantable Continuous Glucose Sensor in the PRECISE Study: A 180-Day, Prospective, Multicenter, Pivotal Trial.Diabetes Care. Jan 2017;40(1):63-68. doi:10.2337/dc16-1525Mortellaro M, DeHennis A. Performance characterization of an abiotic and fluorescent-based continuous glucose monitoring system in patients with type 1 diabetes.Biosens Bioelectron. Nov 15 2014;61:227-31. doi:10.1016/j.bios.2014.05.022Sanchez P, Ghosh-Dastidar S, Tweden KS, Kaufman FR. Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor.Diabetes Technol Ther. Dec 2019;21(12):677-681. doi:10.1089/dia.2019.0234Tweden KS, Deiss D, Rastogi R, Addaguduru S, Kaufman FR. Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor over Multiple Sensor Insertion and Removal Cycles.Diabetes Technol Ther. May 2020;22(5):422-427. doi:10.1089/dia.2019.0342Wang X, Ioacara S, DeHennis A. Long-Term Home Study on Nocturnal Hypoglycemic Alarms Using a New Fully Implantable Continuous Glucose Monitoring System in Type 1 Diabetes.Diabetes Technol Ther. Nov 2015;17(11):780-6. doi:10.1089/dia.2014.0375American Diabetes Association (ADA). Understanding A1C. A1c Does it All. Accessed August 16, 2023,https://diabetes.org/diabetes/a1cIrace C, Cutruzzol A, Nuzzi A, et al. Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes.Diabetes Obes Metab. Jul 2020;22(7):1056-1061. doi:10.1111/dom.13993Renard E, Riveline JP, Hanaire H, Guerci B. Reduction of clinically important low glucose excursions with a long-term implantable continuous glucose monitoring system in adults with type 1 diabetes prone to hypoglycaemia: the France Adoption Randomized Clinical Trial.Diabetes Obes Metab. May 2022;24(5):859-867. doi:10.1111/dom.14644American Diabetes Association (ADA). CGM & Time in Range. Accessed June 6, 2023,https://diabetes.org/tools-support/devices-technology/cgm-time-in-range#:~:text=What%20is%20time%20in%20range,mg%2FdL%20for%20most%20people.Deiss D, Irace C, Carlson G, Tweden KS, Kaufman FR. Real-World Safety of an Implantable Continuous Glucose Sensor Over Multiple Cycles of Use: A Post-Market Registry Study.Diabetes Technol Ther. Jan 2020;22(1):48-52. doi:10.1089/dia.2019.0159Fonseca VA, Grunberger G, Anhalt H, et al. CONTINUOUS GLUCOSE MONITORING: A CONSENSUS CONFERENCE OF THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY.Endocr Pract. Aug 2016;22(8):1008-21. doi:10.4158/ep161392.CsNational Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management. Accessed August 16, 2023,https://www.nice.org.uk/guidance/ng28Wada E, Onoue T, Kobayashi T, et al. Flash glucose monitoring helps achieve better glycemic control than conventional self-monitoring of blood glucose in non-insulin-treated type 2 diabetes: a randomized controlled trial.BMJ Open Diabetes Res Care. Jun 2020;8(1)doi:10.1136/bmjdrc-2019-001115American Diabetes Association Professional Practice Committee. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2022.Diabetes Care. Jan 1 2022;45(Suppl 1):S97-s112. doi:10.2337/dc22-S007Holt RIG, DeVries JH, Hess-Fischl A, et al. The Management of Type 1 Diabetes in Adults. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).Diabetes Care. 2021;44(11):2589-2625. doi:10.2337/dci21-0043Grunberger G, Sherr J, Allende M, et al. American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus.Endocr Pract. Jun 2021;27(6):505-537. doi:10.1016/j.eprac.2021.04.008Deiss D, Szadkowska A, Gordon D, et al. Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable Continuous Glucose Monitoring System.Diabetes Technol Ther. May 2019;21(5):254-264. doi:10.1089/dia.2018.0397U.S. Food & Drug Administration (FDA). Approval Order - Eversense Continuous Glucose Monitoring System. Accessed August 16, 2023,https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160048A.pdfGehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in Type 2 DiabetesMore Common Than You Think: A Continuous Glucose Monitoring Study.J Diabetes Sci Technol. Apr 27 2015;9(5):999-1005. doi:10.1177/1932296815581052Munshi MN, Segal AR, Suhl E, et al. Frequent hypoglycemia among elderly patients with poor glycemic control.Arch Intern Med. Feb 28 2011;171(4):362-4. doi:10.1001/archinternmed.2010.539