CGM automatically measure glucose values throughout the day, producing data that show the trends in glucose measurements, in contrast to the isolated glucose measurements of the traditional blood glucose measurements.

SHORT TERM INTERSTITIAL CGM 
Short term interstitial GCM (up to and including 72 hours) may be considered medically necessary for type I or type II diabetics when ANY ONE of the following criteria are met:

• Pregnant female that requires insulin therapy; or
• Pregnant female who develops gestational diabetes; or
• An individual who requires determination of basal insulin level measurements prior to insulin pump initiation; or
• An individual who has documentation of ALL of the following:
  • Received diabetes self-management education and instruction from a health care professional with expertise in the management of diabetes; and
  • Documented an average of at least three (3) glucose self-tests per day during the previous month; and
  • History of poorly controlled diabetes (i.e., unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis); and
  • Is on an intensive insulin regimen, requiring two (2) or more insulin injections per day, or utilizes an insulin pump; and
  • Has ONE or MORE of the following while on an intensive insulin regimen:
    • Glycated hemoglobin (HbA1c) values less than four (4) or greater than nine (9); or
    • Unexplained large fluctuations in daily glucose values before meals; or
    • Unexplained frequent hypoglycemic attacks (e.g., greater than one (1) per week or three (3) per month); or
    • Episodes of ketoacidosis or hospitalizations for significantly elevated glucose levels.

For short-term diagnostic use, no more than two (2) continuous glucose monitoring periods may be considered medically necessary within a 12-month period. 

All other uses for a short term interstitial CGM are considered investigational and therefore, non-covered because their safety and/or effectiveness cannot be established by review of the published peer-reviewed literature.

LONG-TERM INTERSTITIAL CGM 
Long term interstitial continuous glucose monitoring, including threshold suspend (TS) device systems (open loop systems), (i.e., greater than 72 hours) may be considered medically necessary for type I or type II diabetics when ANY ONE of the following criteria are met:

• Pregnant female with poorly controlled  diabetes (i.e., unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis); or  
• Recurrent, unexplained, severe (generally blood glucose levels less than 50 mg/dL) hypoglycemia that puts the patient or others at risk; or
• Documentation of ALL of the following:
  • The CGM is prescribed by a professional provider; and
  • Is on an intensive insulin regimen, requiring two (2) or more insulin injections per day, or utilizes an insulin pump; and
  • History of poorly controlled diabetes (i.e., unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis) and
  • Demonstrated mastery of the fundamentals of diabetes self-management, which includes:
    • Routine, regular testing of blood glucose levels at least three (3) times a day; and
    • Maintaining accurate records of blood glucose testing; and
  • Receive diabetes self-management education and instruction for mastering the CGM from a qualified health care professional within one (1) month of receiving device; these lessons include ALL of the following:
    • Basic care of the CGM (e.g., insertion, calibration, expectations); and
    • Use of real-time CGM application in diabetic care; and
    • Alarm use and problem solving.

Eversense® CGM system is considered investigational and therefore, non-covered. The safety of the device cannot be established by published peer-reviewed literature.

All other uses for a long-term interstitial CGM are considered experimental/investigational and therefore, non-covered because their safety and/or effectiveness cannot be established by review of the published peer-reviewed literature.

Services for replacement sensors may be considered medically necessary per coverage criteria and may be authorized for one (1) year.  A 90 day supply will be distributed (4) four times within the authorized year. If these services are billed in excess of 90 times in a 90 day period, these services will be denied as not medically necessary.

ARTIFICIAL PANCREAS DEVICE SYSTEM (Closed Loop CGM)
Artificial pancreas device system with low-glucose suspend feature may be considered medically necessary in patients with type 1 diabetes when ALL of the following criteria are met:

• Age 16 and older; and
• Type 1 diabetes; and
• Glycated hemoglobin (HbA1c ) value between 5.8% and 10.0%; and
• Used insulin pump therapy for greater than six (6) months; and
• At least two (2) documented nocturnal hypoglycemic episodes (hypoglycemic episode is defined as a sensor glucose value of 65 mg/dL or less between 10 P.M. and 8 A.M. for more than 20 consecutive minutes in the absence of a pump interaction within 20 minutes) in a two (2)-week period.  

Use of an artificial pancreas system for all other situations is considered experimental/investigational and therefore non-covered. The safety and/or effectiveness cannot be established by review of the published peer-reviewed literature.

Non-invasive CGM

Non-invasive CGM and related supplies are considered experimental/investigational, and therefore, non-covered. Despite the fact that these devices have received FDA approval, there is a lack of long-term studies demonstrating that the use of these devices is associated with an improvement in final health outcomes, i.e., improved diabetic control based either on decreasing hemoglobin A1c values and/or decreasing incidence of hypoglycemia.

Remote CGM

A remote interstitial CGM (e.g., mySentry™) is considered investigational and therefore, non-covered. Remote interstitial CGM does not provide new or additional clinical information or data that is substantially different from the base CGS.