Appeal type: Experimental
Decision: Insurer Denial Upheld

Summary Reviewer 2 
 
A 24-year-old male enrollee has requested reimbursement for an implantable interstitial glucose 
sensor on 1/7/22. The Health Insurer has denied this request and reported that the device at 
issue was investigational for the treatment of the enrollees type 1 diabetes. The physician 
reviewer found that in this case, the service at issue concerns the surgical procedure to remove 
and  implant  the  subcutaneous  Eversense  CGMS.  Deiss  and  colleagues  explain,  The  first 
implantable long-term real-time continuous glucose monitoring (LTI rtCGM) has the tradename 
Eversense (Senseonics, Maryland) and is the only implantable glucose monitoring technology 
currently available on the market. This system extends the possible average CGM wear time from 
seven to fourteen days to up to 180 days. The Eversense system received CE Marking in 2016 
with approved use for up to 90 days. Subsequently, the product use time was extended for up to 
180 days, and this product (Eversense XL) received CE Marking in 2017. In the United States, the 
Eversense system received U.S. Food and Drug Administration (FDA) approval for use up to 90 
days in June of 2018. In a three-way comparison between the Dexcom G5, Abbott Freestyle Libre 
Pro, and Senseonics Eversense, Jafri and colleagues concluded that the point accuracy of the 
Eversense was better than two other CGMs when compared with point-of-care (POC) plasma-
glucose (PG) values. Cowart concludes, Based on the available evidence, the Eversense LTI CGM 
appears to be safe and accurate. Additional clinical trial investigation is warranted to evaluate 
the glycemic efficacy of the Eversense LTI CGM, especially as compared with intermittent-
scanned CGM (isCGM) and rtCGM devices, which are widely used in clinical practice. Based on 
limited efficacy data, the Eversense LTI CGM may reduce hemoglobin A1c and improve time in  glycemic range. Garg and colleagues report that the next-generation Eversense CGM system had 
sustained accuracy and safety up to 180 days. The American Diabetes Association Professional 
Practice Committee notes, Real-time continuous glucose monitoring or intermittently scanned 
continuous glucose monitoring should be offered for diabetes management in adults with 
diabetes on multiple daily injections or continuous subcutaneous insulin infusion who are 
capable of using devices safely (either by themselves or with a caregiver). The choice of device 
should be made based on patient circumstances, desires, and needs. In this patient with 
diabetes type 1 on an insulin pump, a CGM is indicated to maintain glucose control, stay in target 
range, and prevent or decrease the adverse impact of wide glucose fluctuations. The records note 
that the patient has been using the sensor successfully with hemoglobin A1c and time in range 
at goal. In this clinical setting, the implantation of the Eversense CGM device was likely to have 
been  more  beneficial  for  treatment  of  the  patient  than  any  available  standard  therapy. 
Therefore, an implantable interstitial glucose sensor on 1/7/22 was likely to have been more 
beneficial for treatment of the patients condition than any available standard therapy.