Appeal type: Experimental/Investigational
Decision: Overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested reimbursement and prospective authorization and coverage for continuous glucose monitor (CGM) Eversense (including CPT 0448T) was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Real-time CGM devices have been shown to be superior to manual CGM equipment in improving hemoglobin A1C and reducing time spent in hypoglycemia in patients with type 1 diabetes. In the peer-reviewed medical literature, van Beers and colleagues found that real-time CGM devices increased time spent in normoglycemia and reduced severe hypoglycemia in patients with type 1 diabetes and impaired awareness of hypoglycemia, compared with self-monitoring of blood glucose. Per the American Diabetes Association (ADA), the efficacy of CGM is related to the consistency and adherence in its use. For patients with type 1 diabetes using real-time CGM devices, an important predictor of A1C lowering for all age groups was frequency of sensor use. This is a patient with type 1 diabetes currently on insulin. As per the medical records, this patient is at high risk for hypoglycemia. She has been wearing the Eversense sensor for nearly six months and she has been able to decrease her hemoglobin A1C to a non-diabetes range. At the same time, the sensor is able to alarm her when hypoglycemia is about to occur. The patient indicates that she will not be able to keep an external sensor, as she is allergic to adhesives. The Eversense CGM requires implantation and changing every 90 days. The patient and her provider report that the Eversense implantable CGM has contributed to the patients improved diabetes control. Given these findings, the CGM Eversense (including CPT 0448T creation of subcutaneous pocket with insertion of implantable interstitial glucose sensor, including system activation and patient training) already provided, and future CGM Eversense (including CPT 0448T) was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Findings:  Two of the three physician reviewers found the CGM Eversense (including CPT 0448T) was and is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy.Final Result: The reviewers determined that the equipment was and is likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned. Credentials/Qualifications: Physician reviewer 1 is board certified in internal medicine with subspecialty certification diabetes, endocrinology, and metabolism and is actively practicing. Physician reviewer 2 is board certified in internal medicine with subspecialty certification diabetes, endocrinology, and metabolism and is actively practicing. Physician reviewer 3 is board certified in internal medicine and is actively practicing. The reviewers are experts 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.