Proposed LCD - Implantable Continuous Glucose Monitors (I-CGM) (DL38664)

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 NecessityCompliance 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.1To 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: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 InformationPlease refer to the related Local Coverage Article: Billing and Coding Article: Implantable Continuous Glucose Monitors (I-CGM) (DA58136) 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.