Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: A female enrollee has requested authorization and coverage for automated insulin delivery device for monitoring the enrollees diabetes type 1.Findings:  The physician reviewer found that The Medtronic MiniMed 670 G system was approved by the U.S. Food and Drug Administration on June 2016 with the following description: The Medtronic MiniMed 670 G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The system is the closest to an automated closed loop system device for insulin delivery in the management of diabetes mellitus type 1. Leelarathna and colleagues have shown that closed-loop insulin delivery at home reduces mean glucose and increases time in target without increasing the risk of hypoglycemia in adults with relatively well-controlled type 1 diabetes.  In addition, studies are also demonstrating the deleterious effect of wide glucose fluctuations as a factor in the development of diabetes related complications. As such, an automated insulin delivery device would assist in managing and controlling these wide glucose fluctuations. In this case, even though the patients hemoglobin (Hb) A1c is in target range, her diabetes control is suboptimal as demonstrated by the wide glucose fluctuations with hyperglycemia in the 200s and frequent hypoglycemic events (less than 70) while asleep according to the pumps continuous glucose monitor log and analysis. The MiniMed 670 G is a closed loop system insulin pump with continuous glucose monitor that will automatically make corrections when the patient is trending to hypoglycemia or hyperglycemic range. This system will allow the patient to remain within the recommended target range most of the time. She will be able to keep HbA1c at  goal and minimize hypoglycemic and hyperglycemic events. All told, the requested automated insulin delivery device is a diabetes management system that is likely to be more beneficial than any other available therapy for the management of this patients diabetes type 1. Final Result: Two of three reviewers determined that the requested device is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer number one is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number two is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.Physician reviewer number three is board certified in internal medicine with sub-specialty certification in endocrinology, diabetes and metabolism and is actively practicing. The reviewer is an expert in the treatment of the enrollees medical condition and knowledgeable about the proposed treatment through recent or current actual clinical experience treating those with the same or a similar medical condition.