Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Type 2 diabetes. 

Treatment: Continuous glucose monitoring system (K0553, K0554). 

The insurer denied coverage for Continuous glucose monitoring system (K0553, K0554). 

The denial is overturned. 

This is a male patient who has Type 2 diabetes and is on Lantus every day, Tradjenta and Metformin.  Farxiga was prescribed.  

"The use of flash glucose-sensing technology for glycemic management in individuals with type 2 diabetes treated by intensive insulin therapy over 12 months was associated with a sustained reduction in hypoglycemia and safely and effectively replaced SMBG [self-monitoring of blood glucose]" (Haak, T. et al. 2017).

"Flash glucose monitoring (FGM) systems have been suggested to have clinical beneficial effects in patients with diabetes mellitus, although their improvements in terms of quality of life (QoL) and patients' satisfaction are not always addressed or are considered a secondary outcome ...Evidence suggests that FGM systems seem to improve patients' satisfaction and QoL compared with self-monitoring of blood glucose, although the high variability in the measurement tools, the clinical significance and the quality of the systematic reviews included do not allow us to state FGM benefits with any certainty.  Further research, including high-quality randomized clinical trials, differentiating the needs of both type 1 and type 2 diabetes patients and focusing on psychosocial benefits for these patients is needed to optimize clinical decisions between patients and professionals by developing the right health technology assessment for FGM systems" (Diez-Fernandez, A. et al. 2021).

"Continuous glucose monitoring measures glucose levels in the interstitial fluid as a way to optimize glucose control by keeping levels in their target range for a longer period of time, thereby improving HbA1c [hemoglobin A1c] ...If we compare the benefits of continuous glucose monitoring to those of SMBG [Self-Monitoring of Blood Glucose], the former has the unique ability to automatically measure blood glucose as often as every five minutes, which is equivalent to approximately 288 readings daily ...Certain continuous glucose monitors (CGMs) can also be integrated with an insulin pump, which allows the monitor to automatically adjust or pause insulin delivery in response to any significant changes in glucose.  The sensors have been known to fail on occasion, however, which is one disadvantage in choosing this type of technology.  By contrast, SMBG produces approximately four to seven measurements daily and requires a large commitment from patients to carry out the measurements themselves... (Funtanilla, V. D. et al. 2019).             

Finally an editorial discussing recently published randomized studies stated "the studies by Karter et al  and Martens et al provide additional evidence that patients with type 2 diabetes benefit from the use of CGM [continuous glucose monitoring] in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes... (Peek et al).          

The health plan did not act within the best interest of the patient by denying the Dexcom (CGM).               
              
This will help him detect low blood sugars that he is having 3x/week overnight.  The plan calls for approval of the CGM if using 3 shots of insulin.  He is not using this number of shots of insulin daily so he does not meet coverage criteria but approving the Dexcom would be in the best interest of the patient to help him prevent low blood sugars.      

CGM use should be individualized according to patient's needs.  As this patient is having nocturnal hypoglycemia, it would be useful for him.  

The insurer's denial of continuous glucose monitoring system (K0553, K0554) is overturned. Medical Necessity is substantiated.