Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Type 1 Diabetes Mellitus 
Treatment: Durable Medical Equipment (DME), Continuous Glucose Monitor (A9276, A9277 and A9278) 

The insurer denied the Durable Medical Equipment (DME), Continuous Glucose Monitor (A9276, A9277 and A9278). The denial was upheld. 

This is a young male patient with a diagnosis of type 1 diabetes mellitus. His endocrinologist requested Dexcom G6 CGM A9276, A9277 and A9278 in order to improve patient's diabetic management. He has used the Omnipod insulin pump with prandial insulin with Humalog. His had a hemoglobin A1C of 9.7%. It was reported that he had poor adherence with all aspects of his diabetic care. 

The continuous glucose monitoring systems (CGMS) including real-time systems have FDA approval. They are not the subject of Phase I-III clinical trials. The peer reviewed literature supports the long-term use of CGMS in adult (>=25 year old) patients. 

There is evidence that the real-time CGMS with an alarm function detects hypoglycemia. By doing so, CGMS leads to a reduction in duration of hypoglycemia and prevents hypoglycemic reactions in adult patients with type 1 diabetes, and improves glycemic excursion, [9-12]. Studies have shown that though not all hypoglycemic episodes were detected[13], the majority were detected. This represented a 60% reduction in patients with complete hypoglycemia unawareness. 

The literature supports that the requested Dexcom G6 is accurate and effective as a glucose monitoring system [14, 15]. It is particularly effective in patients on a compatible insulin pump as a hybrid closed-loop system [16-18]. The Diabetes Technology standards of medical care in Diabetes 2019 state, "Yet, in the JDRF CGM trial, when youth were analyzed by age-group (8 to 14 year-olds and 15 to 24 year-olds), no change in A1C was seen, likely due to poor CGM adherence (41). Indeed, in a secondary analysis of that randomized controlled trial's (RCT) data in both pediatric cohorts, those who utilized the sensor >=6 days/week had an improvement in their glycemic control (73). One critical component to success with CGM was near-daily wearing of the device (64, 74-76)."  The study's recommendation was that while real time CGM should be considered the benefits of continuous glucose monitoring correlate with adherence to ongoing use of the device. 

In their discussion of CGM, Up-to-Date states, "Subcutaneous glucose sensors that continuously measure interstitial fluid glucose levels are available and approved for use in children. They are useful for optimizing glycemic control in motivated patients and also for management of patients with a history of hypoglycemia unawareness [4]. While earlier versions of the continuous glucose sensor were used in conjunction with conventional capillary (fingerstick) blood glucose monitoring for calibration, newer versions of the continuous glucose sensor do not require calibration using fingerstick glucose [57]." They also note that with regard to CGM with real time feedback-"These devices have moderate efficacy for patients who are willing to use them consistently. This was shown in a randomized controlled study comparing the CGM versus the conventional home glucose monitoring, which reported a significant decrease in glycated hemoglobin (A1C) levels in adults using the CGM device [59]. There was no difference between groups in the number of episodes of severe hypoglycemia in any age group." 

The health plan acted reasonably with sound medical judgment and in the best interest of the patient. 

The carrier denial of coverage for the Durable Medical Equipment (DME), Continuous Glucose Monitor (A9276, A9277 and A9278) is upheld.  The medical necessity is not substantiated.