Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Diabetes mellitus type 1
Treatment: External ambulatory insulin infusion pump
The insurer denied the External ambulatory insulin infusion pump.
The determination is overturned.

The patient has diabetes mellitus type 1. He has been treated with the insulin pump system Medtronic 670G. However, the Medtronic continuous glucose monitor (CGM) has consistently failed for this patient, according to doctors' letters, office medical notes and the patient's statement. The Medtronic CGM detaches frequently, has been inaccurate, resulting in errors in insulin doses and has caused the patient to be left with no supplies due to the frequent CGM failures. The patient has been obliged to change the CGM to the DEXCOM G6 system, which has been accurate for the patient. He has been able to keep the DEXCOM CGM on him 100% of the time. However, he continues to have wide glucose fluctuations. According to the patient's most recent DEXCOM CGM 90-days report, he is in a hypoglycemic state about 9% of the time and above target 20% of the time. The patient's treating physicians have requested that the patient be changed to the Tandem t:slim X2 insulin pump, which communicates with the DEXCOM G6 CGM. The Tandem t:slim X2 insulin pump will allow him to control his diabetes on a closed loop system with the DEXCOM G6 CGM. The system is designed to titrate the delivery of basal insulin based on real time CGM data and has the ability to stop the delivery of insulin if hypoglycemia is predicted. The system also works to titrate the delivery of basal insulin to avoid hyperglycemia and optimize the amount of time that glucose is in range, between 80-180 milligrams per deciliter (mg/dl).
The patient's health plan has denied this request, indicating that the patient's insulin pump is still within warranty and that the pump is not malfunctioning, therefore the request for a Tandem insulin pump is not medically necessary.
At issue is the medical necessity of the requested external ambulatory insulin pump.

The Medtronic 670G insulin pump was intended to be used with the Medtronic CGM as an integrated system, in order to function as a hybrid closed loop system. The insulin pump/CGM system is supposed to interact wirelessly so that the delivery of insulin is held when hypoglycemia is about to occur based on a predictive algorithm, thus preventing the occurrence of the hypoglycemic event. The CGM component of the Medtronic 670G system does not work for this patient: the sensor does not adhere to the patient's skin, comes off and is inaccurate, causing errors in insulin dose calculations. Therefore, the whole Medtronic 670G system is malfunctioning. The patient had no choice but to use a different CGM system, the DEXCOM G6, which has been consistently accurate for the patient and is able to keep it working in place 100% of the time. The patient's physicians have therefore prescribed the insulin pump Tandem t:slim X2, that works with the DEXCOM G6 CGM that the patient is currently using successfully. The Tandem t:slim X2 pump communicates wirelessly with the DEXCOM G6 CGM as an integrated system to deliver insulin in an automated fashion, titrating in real time the amount of insulin delivered to the patient, so that the patient's basal glucose remains within the desired target range of 80-120. The system is able to automatically hold the delivery of insulin if hypoglycemia is predicted, prior to its occurrence, therefore preventing a hypoglycemic event. With the current insulin pump Medtronic 670G, that is not possible, as the pump does not communicate wirelessly with the DEXCOM G6 CGM.
The insulin pump-CGM system must be considered a system as a whole to function properly, as intended, and treat the patient's diabetes in optimal and safest conditions. The Medtronic 670G system, which includes the pump, is malfunctioning for this patient, and is not effective for him. The patient is having dangerous hypoglycemic and hyperglycemic events that are detrimental for this patient's health and daily living. The risks incurred with each hypoglycemic and hyperglycemic event include loss of consciousness, hospitalization and even death. It is important to make medical decisions based on the patient's response to therapy. "Closed-loop insulin delivery systems (also known as "artificial pancreas" systems) take the technology to the next level by integrating continuous glucose monitoring with an insulin pump and an algorithm which automates insulin delivery. Hybrid closed-loop systems are characterized by the coexistence of automated insulin delivery (via the algorithm) and user-initiated insulin delivery, for example, providing mealtime boluses. These insulin delivery systems offer better glucose control and reduced risk of hypoglycemia and represent the most advanced form of insulin delivery available for people with type 1 diabetes" (1). Both, Medtronic and Tandem systems offer advantages and disadvantages to consider for the individual patient (1).
In this case, the physician's medical judgement has determined that the Medtronic system has failed the patient and it is medically indicated to change to a therapy system that will be effective for the patient. The Tandem t:slim X2 insulin pump has retained, and to some extent exceeded, the results obtained in randomized controlled trials, showing glycemic improvements in a broad age range of people with different types of diabetes (2).
The insulin pump-CGM system must be considered a system as a whole. In this case, the Medtronic 670G system (pump+CGM) is malfunctioning and is not effective for this patient. The patient is having dangerous hypoglycemic events 9-10% of the time and hyperglycemia 20% of the time. Both states are detrimental for this patient's health and daily living. The requested Tandem t:slim X2 insulin pump communicates wirelessly with the DEXCOM G6 CGM (that the patient already uses) as a system, titrating the delivery of insulin in real time thus preventing hypoglycemic and hyperglycemic events, with little or no patient input and little or no disruption of patient's sleep or daytime activities. Technology is rapidly changing, but there is no "one-size-fits-all" approach to technology use in people with diabetes. Use of technology should be individualized based on a patient's needs, desires, skill level, and availability of devices (3). The Tandem t:slim X2 insulin pump is medically necessary for this patient.