Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Dexcom continuous glucose monitoring system. The Health Plan has denied this request indicating that the requested device is not medically necessary for management of the enrollees medical condition. Findings: The review of the medical literature supports the use of CGM system in diabetes mellitus type 1 and 2. Appropriate use of real time CGM improved glycometabolic control in type 1 patients. The effects of CGM were more evident in patients under multiple daily insulin treatment, compared with insulin pump therapy. Glucose variability, in addition to glycemic control, was improved in compliant diabetic patients (Tumminia, et al). Subjects with type 2 diabetes not on prandial insulin who used real time (RT)-CGM intermittently for 12 weeks significantly improved glycemic control at 12 weeks and sustained the improvement without RT-CGM during the 40 week follow up period, compared with those who used only self monitoring of blood glucose (SMBG)  (Vigersky, et al). Continuous glucose monitoring (CGM) is a tool to help personalize a diabetes treatment plan. The value of CGM in individuals with type 1 diabetes (T1D) has been well demonstrated when compared with utilizing SMBG to guide treatment decisions. Likewise, there are many studies on type 2 diabetic male adults that show significant reduction in HbA1c level with CGM compared with SMBG. The systematic review by Carlson and colleagues suggested that real time CGM provided better glycemic control in type 2 diabetic male adults compared with SMBG. In this case, this patient is managed with intensive insulin therapy, basal bolus therapy, which is the same way that type 1 diabetes patients are managed. The patient is managed like a patient with insulin deficiency, akin to a type 1 patient. The patient has wide glucose fluctuations and cases of severe hypoglycemia, which required him to call the emergency department twice. The HbA1c is not a reflection of individual glucose control but it reflects the average glucose in three months. The goal of patients on multiple doses of insulin is to improve the average glucose or HbA1c but at the same time minimize the glucose fluctuations or variability. This is more likely to be accomplished with the CGM system. In this case, the patient has concerns about increasing or administering insulin for fear of hypoglycemia. As such, his HbA1c is now suboptimal at 8.3%. With real time DEXCOM CGM, the patient will be alerted to an impending low glucose with an alarm, which will allow the patient to prevent the hypoglycemia by immediate action. It will also allow the patient to recognize his glucose patterns and the effect of his food choices, allowing him and his provider to make adjustments to his insulin doses and make better food choices. Therefore, in this patients case, CGM has been demonstrated as medically necessary for this patient to achieve better glucose control, which has been proven to prevent or delay long term complications of diabetes and at the same time avoid life threatening hypoglycemia. As such, the Dexcom continuous glucose monitoring system is medically necessary for managing this patients medical condition.Final Result: The reviewer determined that the requested device is medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be overturned.Credentials/Qualifications: The reviewer 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.