evekhm/cms_iom_500 huggingface dataset:
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Implantable Continuous Glucose Monitors (I-CGM). Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Implantable Continuous Glucose Monitors (I-CGM) and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:IOM Citations:CMS IOM 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Coverage Indications, Limitations, and/or Medical Necessity
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationDiabetes mellitus (DM) is a chronic metabolic disease involving an underproduction or resistance to insulin, resulting in elevated blood glucose levels. The two most common types of diabetes are type 1 (T1DM) and type 2 (T2DM).1T1DM comprises approximately 5-10% of diabetes cases and describes an etiology in which an autoimmune response damages the insulin-producing beta cells of the pancreas, resulting in insufficient insulin production. Conversely, T2DM is characterized by insulin resistance.1,2In T2DM, an individuals insulin production fails to offset the deficit that is created by the resistance.1T2DM constitutes an estimated 90%-95% of diabetes cases.2Approximately 11.3% of Americans have diagnosed diabetes, and an additional 3.4% of Americans are estimated to have undiagnosed diabetes. The prevalence of diabetes is known to increase with age. In Medicare-aged populations in the United States ( 65 years of age), 22.4% of the population has diagnosed diabetes, with an additional 4.7% estimated to have undiagnosed diabetes.3Economic evaluations have estimated that diabetes annually accounts for $237 billion in direct US medical expenditure, and an additional $90 billion in lost productivity.4Acute complications of diabetes include hypoglycemia, hyperglycemia, diabetic coma, and nonketotic hyperosmolar coma. Chronic hyperglycemia, resulting from poorly controlled diabetes, may result in serious and life-threatening damage, including dysfunction and failure of the eyes, kidneys, nervous system and cardiovascular system. The complications of diabetes mellitus are far less common and less severe in people who have well-controlled blood sugar levels.1
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
To prevent and/or delay the development of both short- and long-term complications of diabetes, the American Diabetes Association (ADA) recommends person-centered care aimed at timely treatment decisions following evidence-based guidelines. Person-centered care goals include minimizing the progression of hyperglycemia with more intensive approaches for individuals at higher risk which include those with higher glucose levels (e.g., fasting blood glucose 110-125 mg/dL, 2-hour post-challenge glucose 173-199 mg/dL, A1C  6.0%).5Diabetes treatment relies on diet, exercise, lifestyle modifications, and in many, medications in order to keep their blood sugar under a stable and controlled level. Close glucose monitoring either multiple times a day or continuously may be warranted in those diabetics that are having difficulty maintaining that level.1,6Continuous glucose monitoring (CGM) devices measure glucose via interstitial fluid instead of blood. CGM systems traditionally rely on a multi-part system that often involves: 1.) a sensor that is inserted into subcutaneous tissue; 2.) a receiver/mobile application consisting of a display and interface; 3.) a transmitter component that is attached to the sensor and worn externally.6,7The sensors for these subcutaneous CGM systems need to be removed and replaced every 4 to 6 days depending upon the system.6Despite the number of benefits that subcutaneous CGM offer in the DM management paradigm, some CGM studies have reported relatively high attrition rates that patients attributed to discomfort, contact dermatitis, issues changing the sensors, and physical interference with activities of daily living.8The rationale for implantable continuous glucose monitoring (I-CGM) seeks to circumvent these negative patient experiences. Unlike with subcutaneous CGM, I-CGM involves a sensor that is surgically implanted for longer spans of time between replacement, allowing for skin barrier closure, and less frequent manipulation.Covered IndicationsTherapeutic I-CGMs are considered medically reasonable and necessary by Medicare when all of the following coverage criteria (1-4) are met:
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
The beneficiary has diabetes mellitus;and,The beneficiarys treating practitioner has concluded that the beneficiary (or beneficiarys caregiver) has sufficient training using the I-CGM prescribed as evidenced by providing a prescription;and,The I-CGM is prescribed in accordance with its FDA indications for use;and,The beneficiary for whom an I- CGM is being prescribed, to improve glycemic control, meets at least one of the criteria below:The beneficiary is insulin-treated; or,The beneficiary has a history of problematic hypoglycemia with documentation of at least one of the following:Recurrent (more than one) level 2 hypoglycemic events (glucose <54mg/dL [3.0mmol/L]) that persists despite multiple (more than one) attempts to adjust medication(s) and/or modify the diabetes treatment plan; or,A history of one level 3 hypoglycemic event (glucose <54mg/dL [3.0mmol/L]) characterized by altered mental and/or physical state requiring third-party assistance for treatment of hypoglycemia.ICGM Continued CoverageEvery six months following the initial prescription of the I-CGM, the treating practitioner conducts an in-person or Medicare-approved telehealth visit with the beneficiary to document adherence to their I-CGM regimen and diabetes treatment plan.LimitationsI-CGM devices will be considered not medically reasonable and necessary for short-term (72 hours to 1 week) use.Exception:Beneficiaries who have previously met the coverage criteria for a non-implantable therapeutic/non-adjunctive and non-therapeutic/adjunctive continuous glucose monitor through the Medicare DME benefit may subsequently choose to switch to the implantable device with a provider order. However, all other coverage criteria above must be fulfilled in order for Medicare payment.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated Information
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
General InformationAssociated InformationPlease refer to the related Local Coverage Article: Billing and Coding Article: Implantable Continuous Glucose Monitors (I-CGM) (DA58110) for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationN/ABibliographyThis bibliography presents those sources that were obtained during the development of this policy. The Contractor is not responsible for the continuing viability of Website addresses listed below.
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Sapra 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:10.1177/1932296819890865
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Heinemann 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: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. 2019;21:231-237.Christiansen 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. 2018;3:20:197-206.
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Dehennis 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. 2017;40:63-68.Mortellaro 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.2014.05.022
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Sanchez P, Ghosh-Dastidar S, Tweden K, Kaufman F. Real-world data from the first US commercial users of an implantable continuous glucose sensor.Diabetes Technol Ther. 2019;21:677-68. 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. Nov 2019. 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. 2020;22:1056-1061. doi:10.1111/dom.13993.Renard 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
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
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. 2016;22(8):1008-21.National Institute for Health and Care Excellence (NICE). Type 2 diabetes in adults: management.2015.updated 2022.Wada 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. 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.2021.04.008
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Deiss D, Szadkowska A, Gordon D, et al. Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable System.Diabetes Technol Ther. 2019;21(5). 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.pdf.Gehlaut 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.2010.539Food and Drug Administration Department of Health & Human Services. Premarket Approval (PMA). Food and Drug Administration Department of Health & Human Services. https://www.fda.gov/medical-devices/eversense-e3-continuous-glucose-monitoring-system-p160048s016. Accessed April 8, 2022.American Diabetes Association. Statistics About Diabetes. American Diabetes Association. https://www.diabetes.org/resources/statistics/statistics-about-diabetes. Updated March 2018. Accessed February 21, 2020.Department of Health and Human Services. Centers for Medicare & Medicaid Services. CMS Rulings. CMS-1682-R. https://www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/CMS-Rulings-Items/CMS1682R. January 2017. Accessed March 3, 2020.
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Food and Drug Administration Department of Health & Human Services. P160048/S006 Eversense Continuous Glucose Monitoring System. Food and Drug Administration Department of Health & Human Services. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160048S006c.pdf . Accessed February 27, 2020.Chamberlain JJ, Doyle-Delgado K, Peterson L, Skolnik N. Diabetes Technology: Review of the 2019 American Diabetes Association Standards of Medical Care in Diabetes.Annals of Internal Medicine. 2019;171(6):415. doi:10.7326/m19-1638Danne T, Nimri R, Battelino T, et. al. International Consensus on Use of Continuous Glucose Monitoring.Diabetes Care. 2017;40(12):16311640. doi: 10.2337/dc17-1600Food and Drug Administration Department of Health & Human Services. FDA Summary of Safety and Effectiveness Data. Food and Drug Administration Department of Health & Human Services. https://www.fda.gov/media/112153/download. June 2018. Accessed February 24, 2020.ADA. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2019.Diabetes Care. 2019;42:S71-S80.American Diabetes Association. Classification and diagnosis of diabetes. Sec. 2. In Standards of Medical Care in Diabetes -2017.Diabetes Care. 2017;40:S11-s24.Aronson R, Abitbol A, Tweden KS. First assessment of the performance of an implantable continuous glucose monitoring system through 180 days in a primarily adolescent population with type 1 diabetes.Diabetes Obes Metab. 2019;16. doi:10.1111/dom.13726Battelino T, Danne T, Bergenstal RM, et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range.Diabetes Care. 2019;42:1593-1603.Beck RW, Bergenstal RM, Riddlesworth TD, et al. Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.Diabetes Care. 2019 Mar;42:400-405.
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Beck RW, Bergenstal RM, Riddlesworth TD, et al. Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.Diabetes Care. 2019 Mar;42:400-405.Beck RW, Riddlesworth T, Ruedy K, et al. Effect of Continuous Glucose Monitoring on Glycemic Control in Adults With Type 1 Diabetes Using Insulin Injections: The DIAMOND Randomized Clinical Trial.JAMA. 2017;317(4):371-8.Beck RW, Riddlesworth TD, Ruedy K, et al. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial.Ann Intern Med. 2017;167:365-374.Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of Sensor-Augmented Insulin-Pump Therapy in Type 1 Diabetes.NEJM. 2010; 363(4).Brown SA, Kovatchev BP, Raghinaru D, et al. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes.NEJM. 2019;381(18):1707-17.Curkendall SM, Zhang B, Oh KS, et al. Incidence and Cost of Hypoglycemia Among Patients with Type 2 Diabetes in the United States: Analysis of a Health Insurance Database.Jcomjournal. 2011;18(10):455-462.de Bock M, Cooper M, Retterath A, et al. Continuous Glucose Monitoring Adherence: Lessons From a Clinical Trial to Predict Outpatient Behavior.J Diabetes Sci Technol. 2016;10(3):627-632.Desai D, Mehta D, Mathias P, Menon G, Schubart UK. Health Care Utilization and Burden of Diabetic Ketoacidosis in the U.S. Over the Past Decade: A Nationwide Analysis.Diabetes Care. 2018;41:1631-1638.Edelman SV, Argento NB, Pettus J, Hirsch IB. Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring.Diabetes Care. 2018;41:2265-74.
Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38617)
Edelman SV, Argento NB, Pettus J, Hirsch IB. Clinical Implications of Real-time and Intermittently Scanned Continuous Glucose Monitoring.Diabetes Care. 2018;41:2265-74.Engler R, Routh T, Lucisano JY. Adoption Barriers for Continuous Glucose Monitoring and Their Potential Reduction With a Fully Implanted System: Results From Patient Preference Surveys.Clinical Diabetes Journals. 2018;36(1).Goyal RK, Sura SD, Mehta HB. Direct Medical Costs of Hypoglycemia Hospitalization in the United States.Value in Health.20.2017. A399 A811.Haak T, Hanaire H, Aijan R, Hermanns N, Riveline J, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial.Diabetes Ther. 2017;8:5573.Healthcare Cost and Utilization Project National Inpatient Sample 2001-2011. Issued June 2013. Updated November 2015.Implementation of treatment protocols in the Diabetes Control and Complications Trial.Diabetes Care. 1995;18:361-76.IQVIA, Report On Advancing Glycemic Management In Patients With Diabetes.Lind M, Polonsky W, Hirsch IB, et al. Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: the GOLD randomized clinical trial.JAMA. 2017;317:379-87.Mohammed KA, Bullard KM, Saaddine JB, Cowie CC, Imperatore G, Gregg EW. Achievement of Goals in U.S. Diabetes Care, 19992010.N Engl J Med. 2013;368:1613-24.Nathan DM. Long-Term Complications of Diabetes Mellitus.N Engl J Med. 1993;328(23):1676-1685.