Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Diabetes Mellitus, Type 1
Treatment: T-slim x2 insulin pump
The determination is overturned.

The patient has diabetes type 1, obesity, and vitamin D deficiency. He has managed his diabetes with an insulin pump. Additional medications are been prescribed to this patient for treatment of obesity. According to the medical notes, his hemoglobin (Hb) A1c remains above goal, over 8%, but has tendency to hypoglycemia. He is managing his diabetes with an insulin pump Tandem and a continuous glucose monitor Dexcom G6. The patient's Tandem pump is out of warranty and malfunctioning. He is requesting a Tandem T Slim X2 to manage his diabetes. The health plan has denied this replacement insulin pump indicating that the preferred insulin pump brand is Medtronic. At issue is the medical necessity of the replacement insulin pump, T-slim x2 insulin pump.
The replacement insulin pump is medically necessary. The patient already has a DEXCOM G6 continuous glucose monitor (CGM) that monitors the patient's glucose levels continuously, 24/7, with no need for painful and scarring fingersticks. This continuous glucose monitor (CGM) can be paired with the Tandem T slim X2 insulin pump to interact wirelessly, becoming an integrated closed loop system. When connected wirelessly, the Dexcom G6 CGM sends the data to the Tandem T slim X2, which can anticipate or predict a low glucose or a high glucose level. Therefore, due  to the predictive algorithms, the T slim X2 pump will withhold insulin delivery to avoid hypoglycemia, and will resume insulin delivery when the algorithm indicates that this action (withholding insulin) was able to modify the curse. Conversely, if the patient's glucose levels increase, and the predictive course goes beyond target values, the Tandem T slim X2 pump will increase the insulin delivery until the course goes back in target range. In a 6-month trial involving patients with type 1 diabetes, the use of a closed-loop system (Tandem T slim X2 pump with a Dexcom G6 CGM) was associated with a greater percentage of time spent in a target glycemic range than the use of a sensor-augmented insulin pump with no reported hypoglycemia (1). Overall, closed-loop systems typically reduce mean glucose, increase time in range, and reduce the risk of hypoglycemia (2). The Medtronic system, as of this review, is consistent with a sensor augmented insulin pump or hybrid system. The Medtronic CGM requires at least 3 calibrations with fingersticks a day. Currently, the Medtronic MiniMed 670G hybrid closed-loop system, is in commercial use in the United States, but randomized trials to assess its efficacy and safety are lacking. The Medtronic system, which modulates basal insulin delivery but does not administer automated boluses, is referred to as a "hybrid" closed-loop system (1,2).
The Tandem T slim X2 with a Dexcom G6 closed loop system, working together is a superior system at this time than the current Medtronic system with sensor augmented pump.
This patient requires better management of his diabetes mellitus. Because of his obesity, the patient requires controlling his food intake and carbohydrate intake for weight loss, which could put him at risk for hypoglycemia. This system will help him prevent dangerous hypoglycemic events. It also will help him avoid the hyperglycemia that drives his HbA1c high, which may hasten the development of diabetes related complications (3). With this system, he will not need to do the multiple fingersticks a day required with the Medtronic system.
Because the Tandem T slim X2 system is superior and not equivalent to the Medtronic system, as of this review, when working with the patient's current Dexcom G6 CGM, this system is medically necessary for this patient.