CG-DME-50 Automated Insulin Delivery Systems

This policy addresses automated insulin delivery (AID) systems that integrate an insulin pump with continuous glucose monitoring, specifically open-loop and hybrid closed-loop systems. Coverage is medically necessary for individuals with type 1 or type 2 diabetes using the device within FDA-labeled age ranges (e.g., ≥2 years) who meet personal CGM long-term use criteria (require multiple daily injections or an insulin pump), can understand and reliably use the technology as part of a comprehensive diabetes plan, and have ongoing suboptimal glycemic control despite optimized self-monitoring and insulin therapy. AID is not covered when these criteria are not met, for continued use or replacement when continued-use/replacement criteria are unmet, and for any non–FDA-approved systems; fully closed-loop systems are not included in the medically necessary indications.

"Use of an open-loop or hybrid closed-loop automated insulin delivery system is consideredmedically necessaryfor individuals who meet the following criteria:"