Implantable Continuous Glucose Monitors (I-CGM)

Jurisdiction: JM Part B. States: North Carolina, South Carolina, Virginia, West Virginia. Type: Active LCD

Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits. Covered Indications Continuous glucose monitors (CGMs) are class III medical devices that require premarket approval by the United States Food and Drug Administration (FDA). In order to be considered reasonable and necessary, the FDA approved indication must include use as a therapeutic CGM. 1 The FDA recently approved expanding the indications of an implantable CGM (I-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 (DM) (Refer to the ICD-10 code list in the LCD-related Billing and Coding Article for applicable diagnoses); and, The beneficiary’s treating practitioner has concluded that the beneficiary (or beneficiary’s 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 1 of the criteria below: The beneficiary is insulin-treated; or, The beneficiary has a history of problematic hypoglycemia with documentation of at least 1 of the following: Recurrent (more than one) level 2 hypoglycemic events (glucose A history of one level 3 hypoglycemic event (glucose CGM Continued Coverage Every 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. Limitations I-CGM devices will not be considered reasonable and necessary for short-term (72 hours to 1 week) diagnostic use. Exception: For those beneficiaries who have previously met the coverage criteria for a non-implantable therapeutic CGM through the Medicare durable medical equipment (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.