Implantable Continuous Glucose Monitors (I-CGM)

Covered: Medicare pays for implantable CGMs only if FDA‑approved as therapeutic CGMs for beneficiaries with diabetes who are insulin‑treated or have documented problematic hypoglycemia; devices without a therapeutic FDA indication and short‑term (72 hours–1 week) diagnostic use are excluded. Key requirements: a practitioner prescription documenting beneficiary/caregiver training, consistency with the device’s FDA indications, documentation of diabetes and either insulin use or specified hypoglycemia criteria (recurrent level 2 events despite treatment changes or ≥1 level 3 event), adherence to coding/documentation in Billing & Coding Article A58138, a provider order when switching from a covered non‑implantable CGM, and in‑person/telehealth follow‑up every 6 months to document adherence for continued coverage.

"I-CGMs are class III medical devices that require FDA premarket approval; in order to be considered reasonable and necessary, the FDA approved indication must include use as a therapeutic CGM."