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

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 shall 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 policy may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationCovered IndicationsI-CGMs are class III medical devices that require premarket approval by the FDA. In order to be considered reasonable and necessary, the FDA approved indication must include use as a therapeutic CGM.1The FDA recently approved expanding the indications of an implantable CGM product to replace fingerstick blood glucose measurements for diabetes treatment decisions.Therapeutic I-CGMs are considered reasonable and necessary by Medicare when all of the following coverage criteria (1-4) are met:The beneficiary has diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for applicable diagnoses); 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 a 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 persist 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 hypoglycemiaCGM Continued CoverageEvery six (6) months following the initial prescription of the CGM, the treating practitioner conducts an in-person or Medicare-approved telehealth visit with the beneficiary to document adherence to their CGM regimen and diabetes treatment plan.LimitationsI-CGM devices will not be considered reasonable and necessary for short-term (72 hours to 1 week) diagnostic use.ExceptionFor those beneficiaries who have previously met the coverage criteria for a non-implantable therapeutic continuous glucose monitor through the Medicare DME benefit and subsequently choose to switch to the implantable device, they may do so with a provider order. However, all other coverage criteria above must be fulfilled in order for Medicare payment.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/ABibliography