Diagnosis: Type 2 diabetes mellitus

Treatment: K0553: supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service

The insurer denied coverage for K0553: supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service.

The denial is upheld.

This is a male patient with a medical history of type 2 diabetes, morbid obesity, and depression. He has benefited from continuous glucose monitor (CGM) real time data for dietary, lifestyle adjustments to improve and control his diabetes. The patient is treated with metformin hydrochloride (HCL) extended-release (ER) 500 milligrams (mg) twice a day and he does not use insulin. The patient's provider asked for coverage for a CGM device.

As per Young et al. (2017) open-label randomized trial, "[self-monitoring of blood glucose (SMBG)] is generally unnecessary in patients who are treated with diet alone or who take oral or injectable agents that do not cause hypoglycemia. SMBG is less effective in improving glycemic control in patients with type 2 diabetes not receiving insulin."

As per Kudva et al. (2018), "large randomized controlled trials demonstrated that use of the FreeStyle Libre system resulted in significant reductions in hypoglycemia, increased time in target range, reduced glycemic variability, and greater patient satisfaction compared with fingerstick monitoring [6, 7]. These benefits were seen in well-controlled type 1 diabetes (T1D) [6] as well as suboptimally controlled type 2 diabetes (T2D) treated with intensive insulin therapy [7]. Studies also showed high device utilization, suggesting that the FreeStyle Libre system may enhance patient engagement [6, 7]. Smaller observational and prospective studies have also shown improvements in both A1c and a reduction in hypoglycemic events [810]."

Janapala et al. (2019)'s systemic review with meta-analysis further supports that while the benefits of continuous glucose monitoring in patients with type 1 diabetes mellitus (T1DM) is well establish, it is less so for type 2 diabetes mellitus (T2DM).

Based on the review of the documentation submitted and literature, and from the perspective of Endocrinologist Diabetes & Metabolism/Internal Medicine, the patient was placed on metformin for treatment of type 2 diabetes mellitus (T2DM) which is appropriate but the prescription of a continuous ambulatory CGM is not medically necessary since metformin does not carry a high risk of hypoglycemia and the patient is not on multiple daily insulin injections. The patient has no disability such as poor vision or tremors which would preclude the usage of regular glucose monitors over the CGM device. The health plan acted reasonably with sound medical judgment, and in the best interest of the patient.

Based on the above, the medical necessity for K0553: supply allowance for therapeutic continuous glucose monitor (CGM), includes all supplies and accessories, 1 month supply = 1 unit of service is not substantiated. The insurer's denial should be upheld.