Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type 1 Diabetes Mellitus (T1DM)

Treatment: durable medical equipment, insulin pump (E0784 x 1)

The insurer denied coverage for durable medical equipment, insulin pump (E0784 x 1)

The denial is overturned.

This is a female diagnosed with Type 1 Diabetes Mellitus (T1DM). This request is for a Tandem slim X2 insulin pump. The provider states she recently experienced a severe low blood sugar and she needed help to bring up her blood glucose. She manages with 8 to 10 injections of insulin per day and Dexcom sensor. Her sensor average is increasing as well as her A1C (glycated hemoglobin) as she is traumatized by severe low blood glucoses (BGs). She was noted to have 6% [percent] low BGs on her CGM (Continuous Glucose Monitoring). She is on Admelog with insulin to carb ratio (ICR) of 1:10 and (insulin sensitivity factor (ISF) of 1:55; Lantus 17 units. Her A1C was 6.8%

Multiple log sheets reveal hypoglycemic events with glucoses less than 70. In multiple studies collected in these meta-analyses, insulin pumps have been proven to improve mean blood glucose concentration, glucose variability, A1c and to reduce insulin requirements by 14% over multiple daily injections of insulin in patients capable and motivated to use the pump [1], [2]. It remains the best available option for type 1 diabetes [3]. According to the American Association of Clinical Endocrinologists medical guidelines [4], insulin pump therapy is indicated for the following subsets of patients: Patients who are unable to achieve acceptable control using a regimen of multiple daily injections, patients with histories of frequent hypoglycemia and/or hypoglycemia unawareness, patients who are pregnant, patients with extreme insulin sensitivity (pump therapy facilitates better precision than subcutaneous injections), patients with a history of dawn phenomenon (these patients can program a higher basal rate for the early morning hours to counteract the rise in blood glucose concentration), patients who require more intensive diabetes management because of complications including neuropathy, nephropathy, and retinopathy, patients taking multiple daily injections who have demonstrated willingness and ability to comply with prescribed diabetes self-care behavior including frequent glucose monitoring, carbohydrate counting, and insulin adjustment

According to the ADA (American Diabetes Association), the accepted criteria for initiation of insulin pumps in type 1 diabetes [5], [6], [7] state that an insulin pump is medically necessary when a patient/caregiver is disciplined, motivated, compliant, and knowledgeable, takes multiple daily injections, self-adjusts insulin doses and is able to monitor blood glucoses 4-6x per day [8]. The new insulin pumps include calculation software which has been shown to be beneficial [9, [10]. 

The patient is reported to be on long-acting insulin once daily and short acting 4 or more times per day. The patient has wide fluctuations in BG levels including hypoglycemia and is currently on Dexcom.  She is unable to achieve acceptable control despite an intensive insulin regimen. The requested insulin pump is a hybrid closed-loop system. The requested system is clinically appropriate. The request is consistent with generally accepted standards of medical practice and is therefore medically necessary.

Based on the above, the insurer's denial must be overturned. The health care plan did not act reasonably and with sound medical judgment and in the best interest of the patient. The medical necessity for durable medical equipment, insulin pump (E0784 x 1) services is substantiated.