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

Physician 1: The patient is a 60-year-old female with a long-standing history of diabetes mellitus Type 1. She is noted to have no indication of significant microvascular disease, although her creatinine is increased to 1.3 giving her an estimated GFR of 46 (NL greater than 89) and placing her in stage 3 chronic kidney disease. Until December 2005, she was receiving an insulin regimen of regular and NPH insulins in varying amounts. She has since been switched to a more up to date regimen of Lantus and Novolog insulins. The patients endocrinologist has requested a 72-hour continuous glucose monitor system (CGMS) study to more fully evaluate her glycemic highs and lows.  The Health Plan has denied authorization for the requested diagnostic study based upon their determination that it is experimental/investigational in this clinical setting.Although no long-term benefit in outcomes is documented for CGMS studies, long-term outcomes are not the purpose of CGMS; the goal is short-term improvement in the level and frequency of blood glucose highs and lows. In the case of this patient, a CGMS study would be appropriate due to the patients significant risk for cardiovascular disease after 56 years of diabetes and the risk of silent hypoglycemia, especially overnight, causing a life threatening vascular event. However, the patient has very recently been started on a totally new regimen of insulin therapy, which may dramatically improve and narrow her glycemic range.  Although the patients severe hypoglycemic unawareness is a situation where the use of CGMS is of potentially critical importance, the study should be delayed for three months from the start of the patients new insulin protocol so that the full benefit of the study can be realized.  Based upon the information set forth above, I have determined the requested diagnostic study is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy at this time. The Health Plans denial should be upheld at this time. If after three months on the patients current regimen the patients provider indicates a CGMS study would be of clinical value, the request for the CGMS study should be authorized.Physician 2: The patient is a 60-year-old woman with Type 1 diabetes mellitus. She has requested coverage for a 72-hour continuous glucose monitor system (CGMS) study to monitor the effects of her insulin therapy. She was initially taking NPH and regular insulin and apparently had symptoms of hypoglycemia when her sugars were less than 50 mg/dl when monitored on her One-Touch Basic glucose meter. Her A1c was 8.3% suggesting poor control probably associated with prolonged periods of hyperglycemia. Subsequently, she was switched to a regimen of Lantus and Novolog insulin and she received a more modern glucose meter. Her subsequent course is unknown. The CGMS study measures interstitial glucose values every five minutes for 72 hours. It can be useful in helping to change insulin regimens in patients who are in poor control despite best efforts by a diabetes team. Controlled studies have shown that the use of CGMS can reduce the exposure to hyperglycemia without increasing the risk of hypoglycemia. In the case of this patient, she was under poor control with an old meter on an old insulin regimen. Both were appropriately changed. Her response to the new regimen is not known. Although the patient is not an appropriate candidate for use of the CGMS study at this time, the study would be medically reasonable and indicated if the patients A1c is not improved after three months on her new regimen.Based upon the information set forth above, I have determined that the requested diagnostic study is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy at this time. The Health Plans denial should be upheld at this time. If the patients A1c is not improved after three months on her new regimen and the patients provider indicates a CGMS study is necessary, the study should be authorized.Physician 3: The patient is a 60-year-old patient with Type 1 diabetes mellitus for 50 years. She had hypoglycemic unawareness. She has no signs of retinopathy or nephropathy. She has some numbness in her feet and occasional shooting pains. Her insulin regimen until December 2005 was NPH 1-15 units twice a day and a regular insulin sliding scale before meals. She checks her blood sugar four times daily. Her blood glucose value ranges from 29-279. She has frequent low blood sugar readings. Since December 2005 she has been injecting Lantus and Novolog before meals. Her hemoglobin A1c in September 2005 was 7.5%.A continuous glucose monitoring system (CGMS) study has been requested to assist in adjusting the patients insulin regimen. The Health Plan has denied authorization for the CGMS study on the basis it is considered investigational.The patient has long-standing Type 1 diabetes mellitus. She has substantial blood glucose fluctuations and hypoglycemia. She was recently switched to a more effective insulin regimen. Continuous glucose monitoring may be helpful to adjust her insulin management, however, 6-8 point blood glucose monitoring will be equally effective as a CGMS study. The patient should also be taught carbohydrate counting. Furthermore, the safety and efficacy of CGMS has not been established. Therefore, I have determined that the requested diagnostic study is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.