Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for an automated insulin pump for treatment of the enrollees type 1 diabetes mellitus.  Findings:  The physician reviewer found that a multicenter, open-label, randomized, controlled trial published by Bergenstal and colleagues showed that use of the threshold-suspend feature in sensor-augmented insulin-pump therapy significantly reduced the nocturnal hypoglycemic events, nighttime hypoglycemic events, and the nocturnal time spent with sensor glucose values in the hypoglycemic range. In this case, the patient has poorly controlled diabetes mellitus type 1. He benefitted from participating in a study using a sensor augmented insulin pump which was associated with an improvement of hemoglobin A1C. Review of the patients logs show at least three hypoglycemic events of glucose levels within one week. The log indicates that the patient has been in hypoglycemic. Testing will prevent the patient from getting into further hypoglycemia. The ability to prevent hypoglycemia and the automated suspension of insulin delivery when the patient is in hypoglycemic range will also facilitate improved control of hyperglycemia as most patients with hypoglycemic experiences choose to remain hyperglycemic to avoid hypoglycemia. Automated loop systems facilitate diabetes control and increase the time that patients stay in range, decreasing glycemic variability and decreasing risk of long term diabetes complications.  All told, the requested automated insulin pump is therefore likely to be more beneficial than any available standard therapy.  Final Result: Two of the 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.