Continuous Glucose Monitoring System denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for external continuous glucose monitoring system (sensor, transmitter, and monitor) for treatment of the enrollee who has been diagnosed with diabetes type 2. Findings: The physician reviewer found that The requested equipment is medically necessary for treatment of this patient’s medical condition. The Health Plan has approved the insulin pump but not the CGM system prescribed to use with the pump. This patient has diabetes mellitus type 2 that is managed with intensive insulin therapy. The continuous glucose monitor (CGM), in conjunction with the insulin pump, has been prescribed to decrease/prevent hypoglycemic reactions in this patient with labile diabetes and hypoglycemia unawareness. Her comorbidities place her at risk for severe hypoglycemic reactions with unawareness.

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for a continuous glucose monitoring system. Both the medical literature and the submitted documentation support the medical necessity of the requested CGM system. In 2016, the American Association of Clinical Endocrinologists published a consensus statement favoring the use of CGM on patients with diabetes. The statement indicates that CGM improves glycemic control and reduces hypoglycemia. Expanding CGM coverage and utilization is likely to improve the health outcomes of people with diabetes. CGM alerts patients to impending or actual low or high glucose values and thereby facilitates prompt action and prevention of hospitalizations. Multiple studies cited in the statement have documented the superiority of CGM in improving HbA1c levels by decreasing hypoglycemia and hyperglycemia.

Where the denial was upheld

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 patient’s 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.

The patient is a 53-year-old female with type I diabetes. Her comorbidities include retinopathy, very mild neuropathy, peripheral vascular disease and hypertension. She uses Humalog, Lantus and Novolog to manage her blood glucose levels. She has also been prescribed Adipex, Celexa, Diovan, L-Arginine, Levoxyl, Lexapro, Vicodin, Xanax, Singulair and Zonegran. The patient’s provider noted that the patient’s fasting glucose and hemoglobin A1C were inappropriately high, apparently based on a review of her home-glucose monitoring. There is no data available for her home-glucose monitoring or hemoglobin A1c laboratory analysis. CGMS data are available for eighteen hours in July 2005 as well as the results of her sensory testing. The patient has requested reimbursement for the procedures.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Continuous Glucose Monitoring System, then check the rights and deadlines that apply to your plan.