Implantable Continuous Glucose Monitors (I-CGM)

Jurisdiction: J8 MAC Part B. States: Indiana, Michigan. Type: Active LCD

Compliance 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 Information Covered Indications I-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/non-adjunctive and non-therapeutic/adjunctive CGM. 1 The FDA recently approved expanding the indications of an implantable CGM product to replace finger stick blood glucose measurements for diabetes treatment decisions. Therapeutic/non-adjunctive and non-therapeutic/adjunctive 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 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 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 A history of one level 3 hypoglycemic event (glucose I-CGM Continued Coverage Every six (6) 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. 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/non-adjunctive and non-therapeutic/adjunctive 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.