Appeal type: Medical necessity
Decision: Overturned

Diagnosis Diabetes 
Treatment DEXCOM G6 Continuous Glucose Monitor
The insurer denied the DEXCOM G6 Continuous Glucose Monitor.
The determination is overturned.

The patient has multiple medical problems. He was diagnosed with Diabetes type 2 in 2013. He was initially treated with oral agents, but he failed oral agents and is now treated with multiple doses of insulin, Ozempic, Jardiance and metformin. His diabetes is still uncontrolled.
He had a hemoglobin A1c (HbA1c of 8.4% ( uncontrolled diabetes). He wore a continuous glucose monitor ( Freestyle Professional continuous glucose monitor (CGM)) that showed hypoglycemia (glucose below 70 milligrams per deciliter (mg/dl)) 6% of the time and hyperglycemia ( glucose above 180 mg/dl) 38% of the time. He was in target range of 70-180 mg/dl only 56% of the time. His endocrinologist prescribed a DEXCOM G6 continuous glucose monitor, The endocrinologist has revised the diagnosis to diabetes mellitus type 1/ insulin dependent diabetes.
The issue under review is the medical necessity of the continuous glucose monitor (Dexcom G 6).

The DEXCOM G6 continuous glucose monitor device was approved by the Food and Drug Administration (FDA) for use in patients with diabetes. Unlike the earlier model, the DEXCOM G6 is factory calibrated and does not require calibration with fingerstick blood glucose measurements (1) . "The DEXCOM G6 is a patch device, about the size of a quarter, that is applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid. The device transmits real-time glucose readings every five minutes to a compatible display device such as a mobile medical app on a cell phone and will trigger an alarm when a patient's blood sugar enters a danger zone soaring too high or dropping too low"(1)
CGM provides extensive 24/7 glucose data which allows the physician and patient to analyze the information in more detail than with manual and episodic fingersticks. It allows the diabetes management team ( which includes the physician and the patient) to identify trends and make therapeutic and lifestyle management decisions to improve diabetes control. It allows the patient to make moment to moment decisions in the context diabetes self-management, which is the best practice.
The following are statements and recommendations from the American Diabetes Association 2020 Standards of Medical Care in Diabetes (2) . The benefits apply to both, type 1 and type 2 diabetes on insulin therapy.
"The abundance of data provided by CGM offers opportunities to analyze patient data more granularly than was previously possible, providing additional information to aid in achieving glycemic targets"
"Data exist to support the use of real-time CGM in adults, both those on multiple daily injections (MDI) and continuous subcutaneons insulin infusion (CSII)"
"7.9 When used properly, real-time continuous glucose monitors in conjunction with insulin therapy are a useful tool to lower A1C levels and/or reduce hypoglycemia in adults with type 1 diabetes who are not meeting glycemic targets, have hypoglycemia unawareness, and/or have episodes of hypoglycemia. A"
"7.11 When used properly, real-time and intermittently scanned continuous glucose monitors in conjunction with insulin therapy are useful tools to lower A1C and/or reduce hypoglycemia in adults with type 2 diabetes who are not meeting glycemic targets. B"
"7.13 Real-time continuous glucose monitoring (CGM) devices should be used as close to daily as possible for maximal benefit. Intermittently scanned CGM devices should be scanned frequently, at a minimum once every 8 hours (h)"
"7.15 Blinded continuous glucose monitor data, when coupled with diabetes self-management education and medication dose adjustment, can be helpful in identifying and correcting patterns of hyper- and hypoglycemia in people with type 1 diabetes and type 2 diabetes. E
7.16 People who have been using continuous glucose monitors should have continued access across third-party payers. E"
The DEXCOM G6 is medically necessary for this patient with insulin dependent diabetes. He is managed as a patient with type 1 diabetes with multiple doses of insulin, i.e. basal insulin and short acting insulin that he adjusts based on his carbohydrate intake and glucose level. The professional continuous glucose monitor (CGM) report indicated that this patient is in hypoglycemic range 6% of the time and in hyperglycemic range 38% of the time. His diabetes control is poor and this patient is in danger of short and long term complications from hypoglycemia and hyperglycemia, which includes loss of consciousness, stroke, heart attack and death, among others.
The DEXCOM G6 CGM will be recording the glucose levels every 5 minutes and will provide alarms to the patient if there is an imminent trend to hypoglycemia, allowing the patient to react before the critical drop happens. It also can be fit to announce hyperglycemia, which allows the patient to correct with insulin as instructed.
An analysis of the patient's glucose trend is done at each patient's visit or virtually as needed, which allows the diabetes team and the patient make adjustment to the multiple doses of insulin regimen.
Improvement in diabetes control is not only measured in a HbA1c number but also in terms of the percentage of time in range (TIR). This goal has been shown to be important in the prevention of short and long term complications of diabetes (3).
According to the American Diabetes Association, regarding glycemic targets and TIR (3) :
"Time in range (TIR) is associated with the risk of microvascular complications and should be an acceptable end point for clinical trials and can be used for assessment of glycemic control. Additionally, time below target (< 70 and < 54 mg/dL [3.9 and 3.0 mmol/L]) and time above target (>180 mg/dL [10.0 mmol/L]) are useful parameters for reevaluation of the treatment regimen" and "CGM has evolved rapidly in both accuracy and affordability. As such, many patients have these data available to assist with both self-management and assessment by providers. Reports can be generated from CGM that will allow the provider to determine time in range (TIR) and to assess hypoglycemia, hyperglycemia, and glycemic variability...Published data suggest a strong correlation between TIR and A1C, with a goal of 70% TIR aligning with an A1C of ~7% in two prospective studies" (3) This patient's time in range is only 54% of the time.
The type of diabetes is not relevant in this case, as the patient required multiple injections of insulin and, effectively, has insulin dependent diabetes. Studies have shown the benefits of CGM in patients that require insulin in type 1 and type 2 diabetes (4,5)
Therefore, the DEXCOM G6 CGM is medically necessary.