Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician #1:  The patient is a 60-year-old male with diabetes mellitus type 2.  His diabetes was initially managed with Avandia and Glucophage.  The patient had a CGMS study done prior to starting therapy with an additional new medication, Byetta. The patient currently appears to have lost weight and has improved glycemic control on the Byetta treatment alone.  The patients request for reimbursement of the CGMS was denied by the Health Plan based upon a determination that the procedure is experimental/investigational in nature.The purpose of the CGMS study is unclear.  There is no evidence that Avandia and/or Glucophage are likely to cause hypoglycemia. Additionally, there is no evidence that Byetta in combination with Avandia and/or Glucophage tends to cause hypoglycemia.  Current research provides no basis for CGMS studies in patients treated exclusively with oral agents. Laboratory studies and blood glucose monitoring are the standard for patients such as this one. Therefore, I have determined that the procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician #2:  The patient is a 60-year-old male with type 2 diabetes mellitus.  The July 2005 CGMS study was ostensibly ordered by the patients endocrinologist to look for asymptomatic hypoglycemia prior to adding Byetta (exenatide) to the treatment regimen.    The patient proceeded with the continuous glucose testing and is now requesting reimbursement.  The Health Plan deemed the procedure experimental/investigational and reimbursement was denied.It is extremely unlikely that a regimen of Glucophage and a very low dose of Avandia would cause hypoglycemia. As the plan was to discontinue these medications, monitoring for asymptomatic hypoglycemia while taking them is of questionable value.  Furthermore, the addition of Byetta to a regimen of Glucophage and Avandia is unlikely to increase the risk of hypoglycemia.  At any rate, continuous glucose monitoring prior to the initiation of a proposed therapy is not the standard of care and not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician #3:  The patient is a 60-year-old male with type 2 diabetes mellitus. He was started on Byetta in July 2005. Continuous glucose monitoring was performed prior to starting the therapy due to a concern for potential hypoglycemia. Avandia, Glucophage, Diovan and Pravachol were eventually discontinued in November of 2005.  The Byetta dosage was increased to 10mcg twice daily. No laboratory data was provided in the record, but the patient apparently had a 10-pound weight loss.  The Health Plan deems CGMS experimental/investigational in this context, and the patients request for reimbursement was denied.Although clinical studies have shown an increased rate of hypoglycemia in patients who took sulfonylureas when Byetta was initiated, this patient did not manage his diabetes with sulfonylureas. Clinical studies have not shown that there was an increase in hypoglycemic episodes in patients who took Glucophage. Frequent self-glucose monitoring, before and after meals, at bedtime and occasionally in the middle-of-the-night will provide information similar to that obtained with CGMS.  The clinical benefit of CGMS prior to beginning therapy with Byetta has not been scientifically established.  Based upon the information set forth above, I have determined that the procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.