Appeal type: Medical Necessity
Decision: Overturned

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for FreeStyle Libre continuous glucose monitoring system (CGMS) and sensors, and brand name Crestor 20 mg tablets. The records provided for review document that this patient has poorly controlled diabetes, with a hemoglobin A1C of 11.6%. The patient has refused treatment with oral agents, citing allergies to oral medications metformin and sulfa antibiotics. The patient reports that she is unable to do finger sticks and she has requested FreeStyle Libre CGMS for monitoring her glucose levels. The FreeStyle Libre System is a wireless method for self-monitoring of glycemic control, which uses a sensor for monitoring interstitial fluid glucose. Per the U.S. Food and Drug Administration (FDA), the FreeStyle Libre reduces the need for fingerstick testing by using a small sensor wire inserted below the skins surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing. This patient has very poorly controlled diabetes and requires an immediate treatment with an oral agent and adherence to a strict diet. Use of the FreeStyle Libre should help the patient visualize her glucose control and motivate her to accept therapy recommendations, and be compliant with her diet, in order to achieve goals. For these reasons, the requested FreeStyle Libre CGMS and sensors are medically necessary for treatment of this patient. Regarding request for brand statin Crestor 20 mg, the American Diabetes Association (ADA) states that for patients with diabetes who are at higher risk, especially those with multiple atherosclerotic cardiovascular disease risk factors or aged 50-70 years, it is reasonable to prescribe high-intensity statin therapy. According to the American College of Cardiology (ACC) and American Heart Association (AHA) guidelines, high intensity statin therapy includes atorvastatin and rosuvastatin (Grundy, et al.). The brand name formulation of rosuvastatin is Crestor. There is a lack of studies or guidelines demonstrating that brand name Crestor has an advantage over the generic rosuvastatin in cardiovascular outcomes. According to this patients records, there is no indication that the patient has tried a generic statin with adverse side effects. Therefore, the requested brand name Crestor is not medically necessary for treatment of this patient. For these reasons, the requested FreeStyle Libre CGMS and sensors are medically necessary for this patient, while the brand name Crestor 20 mg tablets are not medically necessary for treatment of this patient. Final Result: The reviewer determined that the requested equipment is medically necessary and the requested brand name medication is not medically necessary for treatment of the patients medical condition. Therefore, the Health Plans denial should be partially overturned. Credentials/Qualifications: The reviewer is board certified in internal medicine with subspecialty certification in diabetes, endocrinology, 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.