Automated Insulin Delivery Systems
An FDA-cleared or approved automated insulin delivery system with a low glucose suspend feature may be considered medically necessary for type 1 diabetes in individuals age 6 years and older with HbA1c between 5.8% and 10.0%, more than 6 months of insulin pump therapy, and at least 2 documented nocturnal hypoglycemic events in a 2-week period. A hybrid closed-loop system may be considered medically necessary for type 1 diabetes in individuals over age 6 who meet the same HbA1c and pump criteria, or in ages 2 to 6 with type 1 diabetes for 3 months or more, pump therapy for more than 3 months, HbA1c below 10.0% and a total daily dose of at least 8 units; a closed-loop system may be considered for individuals age 6 and older with type 1 diabetes for 12 months or more who have used insulin for at least 12 months. For type 2 diabetes, a hybrid closed-loop system may be considered medically necessary in individuals age 18 and older diagnosed for at least 12 months who take at least 3 insulin injections daily or use an insulin infusion pump for at least 3 months and have HbA1c of 7% or higher or significant hypoglycemia, and use for individuals who do not meet these criteria or for systems not cleared or approved by the FDA is investigational.