Type 1 Diabetes Mellitus denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: A female enrollee has requested authorization and coverage for automated insulin delivery device for monitoring the enrollee’s diabetes type 1.Findings: The physician reviewer found that The Medtronic MiniMed 670 G system was approved by the U.S. Food and Drug Administration on June 2016 with the following description: “The Medtronic MiniMed 670 G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin”. The system is the closest to an automated closed loop system device for insulin delivery in the management of diabetes mellitus type 1.

Nature of Statutory Criteria/Case Summary: The patient has requested authorization and coverage for an automated insulin pump for treatment of the enrollee’s type 1 diabetes mellitus. Findings: The physician reviewer found that a multicenter, open-label, randomized, controlled trial published by Bergenstal and colleagues showed that “use of the threshold-suspend feature in sensor-augmented insulin-pump therapy significantly reduced” the nocturnal hypoglycemic events, nighttime hypoglycemic events, and the nocturnal time spent with sensor glucose values in the hypoglycemic range. In this case, the patient has poorly controlled diabetes mellitus type 1. He benefitted from participating in a study using a sensor augmented insulin pump which was associated with an improvement of hemoglobin A1C.

Where the denial was upheld

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 patient’s endocrinologist has requested a 72-hour continuous glucose monitor system (CGMS) study to more fully evaluate her glycemic highs and lows.

Physician 1: The patient is a 36-year-old female with type 1 diabetes mellitus and multiple microvascular complications including hypoglycemia unawareness, diabetic retinopathy, etc. Her most recent A1C is in the mid 5% (normal) range. At present these problems are ongoing. The patient is requesting authorization for a continuous monitoring product called a Glucowatch. The Health Plan has denied coverage for the requested equipment indicating it is considered investigational at this time.Though the Glucowatch has several potential benefits, the device has never been shown in practice to substantially improve diabetes control, prevent or reverse microvascular complications or reverse hypoglycemic unawareness. With diabetes autonomic neuropathy (DAN), sweating patterns are dysregulated and sweating defeats the hypoglycemic alarm system, thus not solving the patient’s problem.

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 type 1 diabetes mellitus, then check the rights and deadlines that apply to your plan.