Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Diabetes. 
Treatment: Durable Medical Equipment (insulin pump). 

The insurer denied the Durable Medical Equipment (insulin pump). 
The denial is upheld. 

The patient is a male diagnosed with T1DM (type 1 diabetes mellitus). This request is for Tandem X2 insulin pump. 

As reported, the patient he has wide fluctuations in BG (blood glucose) levels ranging from 45 to 355. He has dawn phenomenon; hypoglycemia unawareness; nocturnal hypoglycemia; neuropathy. His current pump's warranty expires. He is currently using as in-warranty Medtronic 670 G with a sensor to treat his diabetes. The note reports that he is 72% of the time in range with insignificant hypoglycemia. The estimated A1c (glycated hemoglobin) based on the glucose log is 6.8%. He checked his BG (blood glucose) 4 to 6 times per day. He is on Admelog via insulin pump 100 units max daily and Steglatro 15 mg (milligrams) daily. He was on Lantus and Humalog. The letter reports that the patient is testing 4 to  6 times per day and following all provide recommendations. The provider is requesting this pump because of its ability to function as a hybrid closed-loop system. 

The patient's A1C (glycated hemoglobin) was 8 %; earlier in the year it was 7.7 %. 

No, the requested insulin pump is not medically necessary. 

The standard of care regarding insulin pump therapy is described below. 

In multiple studies collected in these meta-analyses, insulin pumps have been proven to improve mean blood glucose concentration, glucose variability, A1c (glycated hemoglobin) 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 (5-7) 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 (times) per day (8). The new insulin pumps include calculation software which has been shown to be beneficial (9, 10). 

The medical literature does not support replacement of insulin pumps every four years at the end of their warranty or to upgrade to the latest technology. There are no clear standards of care with regards to this issue (4, 19, 20). There are no randomized controlled trials. There are no retrospective studies. The ADA (American Diabetes Association) and AACE (American Association of Clinical Endocrinologists) make no specific recommendations regarding types of insulin pumps or when to upgrade (4, 19).  Pump companies generally warranty their pumps for 4 years. During this warranty, if the pump malfunctions, the patient can call the pump company and be provided with a "loaner" replacement within 24 hours while the pump is being fixed. 

Once a pump is out of warranty, the consequence of a malfunctioning pump is to have to inject subcutaneous insulin while the patient awaits a new pump from either the same or another company. This out of warranty process may take 1-2 weeks when one opts for a pump from another company. Upon pump failure, if one opts for a replacement pump from the same company as their out of warranty pump, the company will usually ship them a new pump within 24-48 hours, necessitating the use of subcutaneous insulin for the hiatus. 

The time to replace an insulin pump is once it malfunctions and is out of warranty or once a pediatric patient outgrows the pump reservoir. 

The patient in this case has a functioning insulin pump that is in warranty. The provider is requesting a new insulin pump to allow the patient to use a hybrid closed-loop system, as the patient's A1c (glycated hemoglobin) is not at goal using the current insulin pump. The patient has an insulin pump the Medtronic 670 G that uses a hybrid closed-loop system. The patient is reportedly using a continuous glucose monitor but is not evidenced to be using this pump with the auto mode feature (hybrid closed-loop system). The patient can use the current insulin pump as a hybrid closed-loop system. There are no studies showing superiority of the requested pump over the patient's current pump as a hybrid closed-loop system. The request is not consistent with generally accepted standards of medical practice and is therefore not medically necessary. 

Yes, the health plan did act reasonably, with sound medical judgment, and in the best interest of the patient, as the request is not medically necessary, as described above.