Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type 1 Diabetes Mellitus with hypoglycemia with coma.

Treatment: E0784, external ambulatory infusion pump, insulin.

The insurer denied coverage for E0784, external ambulatory infusion pump, insulin. 

The denial is overturned.

The patient is a female with a diagnosis of type 1 diabetes mellitus. She is currently using an Omnipod insulin pump with frequent episodes of hypoglycemia and frequently needs glucagon and/or medical assistance as 21% (percent) of her blood sugar readings are very low. The current pump that she utilizes is not able to adjust insulin delivery. Per the provider, these occurrences of hypoglycemia could be prevented by the Tandem X2 [smallest durable pump] (insulin pump and Dexcom G6 [latest generation continuous glucose monitoring (CGM) system] sensor used together in the setting of Control IQ [advanced hybrid closed-loop system] Technology.

In a meta-analysis of trials by Bekiari E. et al.,, comparing the use of any hybrid closed-loop system with any insulin-based treatment in nonpregnant patients with type 1 diabetes, "the proportion of time spent near normoglycemia (70 to 180 mg/dL [milligrams per deciliter] [3.9 to 10 mmol/L]) over 24 hours was modestly, albeit significantly, higher with the hybrid closed-loop system (weighted mean difference 9.62 percent, 95% confidence interval [CI] 7.54-11 percent). Overall, the incidence of severe hypoglycemia was low in both groups."

In a six-month trial by Brown, S. A., et al., , comparing a hybrid closed-loop system with a sensor-augmented insulin pump in 168 patients 14 years of age, "the percentage of time in target range (70 to 180 mg/dL [3.9 to 10 mmol/L[millimole per liter]]) as measured with continuous glucose monitor (CGM) was higher in the closed-loop group (71 versus 59 percent, risk-adjusted difference 11 percent, 95% CI 9-14). A1C(a blood test for type 2 diabetes and prediabetes) levels improved in patients using the closed-loop system (7.4 to 7.06 percent) but did not change in controls (7.4 to 7.39 percent). Although there were no serious hypoglycemic events in either group, the percentage of time spent in hypoglycemia was lower in patients assigned to the closed-loop system (eg, <54 mg/dL, 0.29 versus 0.35 percent, risk-adjusted difference -0.10, 95% CI -0.19 to -0.02)."

The E0784, external ambulatory infusion pump, insulin to manage E10.641 (tandem and control IQ hybrid closed loop system), type 1 diabetes mellitus with hypoglycemia with coma is considered medically necessary for the patient. The patient has been experiencing multiple and frequent episodes of hypoglycemia and has, at times, required medical attention to prevent adverse effects. The patient's current technology is unable to meet her needs and is putting her at risk. The treatment of hypoglycemia is costly and can also lead to significant morbidity or even death.                                          

The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient.  

The insurer's denial of coverage for E0784, external ambulatory infusion pump, insulin to manage E10.641, type 1 diabetes mellitus with hypoglycemia with coma is overturned. Medical necessity is substantiated.