MEDICAL POLICY
This medical policy manual outlines the criteria for coverage of insulin infusion pumps, automated insulin delivery, and artificial pancreas device systems.
The policy is developed to provide guidance for members and providers regarding coverage of these devices, which are intended to help manage blood glucose levels in patients with diabetes mellitus.
ELIGIBILITY CRITERIA
Eligibility criteria for coverage include:
- A patient with type 1 diabetes mellitus and a glycated hemoglobin (HbAlc) level between 5.8% and 10.0%
- A patient with gestational diabetes or preconception/pregnancy-related suboptimal glycemic control
DEVICE SPECIFICATIONS
Approved devices include:
- MiniMed 530G System
- MiniMed 630G System with SmartGuard
- MiniMed 670G System
- MiniMed 770G System
- MiniMed 780G System
- kSleep X2 Insulin Pump with Basal-IQ Technology
- kSleep X2 Insulin Pump with Control-IQ Technology
- Omnipod 5 (hybrid closed-loop)
- Bionic Pancreas (closed-loop)
The device specifications include FDA-approved automated insulin delivery systems (artificial pancreas device systems) that are designed to automatically adjust insulin delivery based on real-time glucose levels.
REGULATORY STATUS
The devices are regulated by the Food and Drug Administration (FDA) as class III device systems.
This summary is intended to provide a concise overview of the medical policy manual and its content. For a complete understanding of the policy, it is recommended that the reader review the full manual.
Manual:
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