Appeal type: Medical necessity
Decision: Upheld

Endocrine/Metabolic/Nutritional/Type 1 Diabetes
Diabetic Equipment, Supplies and Self Management Education/Tandem T-slimX2
The health plan denied the requested Diabetic Equipment, Supplies and Self Management Education/Tandem T-slimX2 as not medically necessary. The health plan's determination is upheld.

This is a male diagnosed with Type 1 Diabetes Mellitus (T1 DM). This request is for Tandem T-slim X2. As reported, he has previously used a Medtronic 670 G insulin pump. He is on Dexcom G6.
His hemoglobin A1C levels were 11.6 %, greater than 14, 11.4 %, and 10.4 %.
At issue is the medical necessity for the requested health service/treatment of Tandem T-slimX2.

I uphold, in whole, the health plan's determination of medical necessity, as the request is not medically necessary.

No. In multiple studies collected in these meta-analyses, insulin pumps have been proven to improve mean blood glucose concentration, glucose variability, hemoglobin 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 American Diabetes Association (ADA), 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 OmniPod 5 insulin pump, [11, 12, 13] the MiniMed Medtronic 670 G and 770 G, [14, 15] as well as the Tandem T- slim insulin pump, [16, 17, 18, 19, 20] communicate with continuous glucose monitors and have automated insulin delivery (a hybrid closed-loop system) which have been shown to be superior to standard therapy with either injections or insulin pumps without hybrid closed-loop systems in improving hemoglobin A1c and reducing hypoglycemia.
The patient is currently on the Medtronic insulin pump. The insulin pump is out of warranty, however, there is no documentation of malfunction. There is no submission of medical records indicating current hemoglobin A1c and compliance with diabetes treatment plan. The request is not consistent with generally accepted standards of medical practice and is therefore, not medically necessary.