Diabetic Supplies – NC Standard

• Continuous Glucose Monitors 
  • Dexcom G6 (and supplies) 
  • Dexcom G7 (and supplies) 
  • Freestyle Libre (and supplies) 
  • Freestyle Libre 2 (and supplies) 
  • Freestyle Libre 3 (and supplies) 
• Glucose Test Strips 
  • Roche, including but not limited to Accu-Chek products 
  • Abbott, including but not limited to FreeStyle products 
  • Other 
• Insulin Delivery Devices 
  • Omnipod DASH 
  • Omnipod 5 

• Dexcom G6
  • The Dexcom G6 Continuous Glucose Monitoring System (Dexcom G6 System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older. The Dexcom G6 System is intended to replace finger stick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes. 
• Dexcom G7 
  • The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a real time, continuous glucose monitoring system indicated for the management of diabetes in persons age 2 years and older. The Dexcom G7 CGM System is designed to replace fingerstick blood glucose (BG) testing for treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. The Dexcom G7 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.  
• Freestyle Libre 
  • Indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions.
  • The system detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system readings should be based on the glucose trends and several sequential readings over time. The system is intended for single patient use and requires a prescription. 
• Freestyle Libre 2 
  • Indicated for the management of diabetes in persons age 4 and older. It is designed to replace blood glucose testing for diabetes treatment decisions with the addition of real time alarms capability. 
  • The system also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system readings should be based on the glucose trends and several sequential readings over time. 
  • The system is also intended to autonomously communicate with digitally connected devices. The system can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. 
• Freestyle Libre 3 
  • The Freestyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions with the addition of real time alarms capability. 
    • Freestyle Libre 3 Plus sensors are indicated for use in persons age 2 and older. 
  • The system also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the system readings should be based on the glucose trends and several sequential readings over time. 
  • The system is also intended to autonomously communicate with digitally connected devices. The system can be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions.
• Omnipod products 
  • For the subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus 

1. The patient is utilizing insulin to manage their diabetes; AND

2. If the request is for Freestyle Libre, Freestyle Libre 2 or Freestyle Libre 3:

a. The patient has a physical or mental limitation that makes utilization of Dexcom G6 or G7 unsafe, inaccurate or otherwise not feasible (e.g., manual dexterity); OR

b. The patient is already utilizing the Freestyle Libre, Freestyle Libre 2 or Freestyle Libre 3 system; AND

3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 Days (1 year) 

Criteria for Approval of Glucose Test Strips

1. The patient has an insulin pump and is not able to test their blood sugar utilizing Bayer/Ascensia Contour Next or OneTouch/Lifescan products; OR

2. The patient is visually impaired and transitioning to Bayer/Ascensia Contour Next or OneTouch/Lifescan products places the patient at risk; OR

3. The patient has a mental or physical disability which transitioning to Bayer/Ascensia Contour Next or OneTouch/Lifescan products places the patient at risk; OR

4. The provider gives a written statement which provides a clinical rationale for which transitioning to Bayer/Ascensia Contour Next or OneTouch/Lifescan products places the patient at risk (to be evaluated by clinical review team); AND 

5. For formularies that exclude (non-formulary) the requested medication, a formulary exception may be considered when the criteria above is met.

Duration of Approval: 365 Days (1 year)

Criteria for Approval of Insulin Delivery Devices:

1. ONE of the following:

a. The patient has been diagnosed with type 1 diabetes mellitus; OR

b. The patient is currently utilizing or has utilized an insulin pump within the past 6 months; OR

c. The patient requires ≥ 3 injections of insulin per day; AND

i. The patient has a history of suboptimal blood glucose control despite appropriate insulin regimen (e.g., repeated hypoglycemic events, DKA, wide variations in blood sugars); AND

ii. The patient has demonstrated compliance with blood glucose monitoring; AND

2. The patient requires ≤ 200 units per day; AND

3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

 quantity limitations apply to brand and associated generic products.

1. The provider has supplied clinical documentation that the patient requires additional supplies for clinical/physiological reasons (ex. Sensitivity to adhesive) [Clinical Documentation Required]. 

Duration of Approval: 365 days (1 year) 

all information referenced is from FDA package insert unless otherwise noted below. 

Nuha A. ElSayed, Grazia Aleppo, Vanita R. Aroda, et al. Diabetes Technology: Standards of Care in Diabetes – 2023. Diabetes Care 2023; 46 (Suppl. 1): S111–S127. 

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually. 

November 2024: Criteria update: Condensed Omnipod 5 G6 and G7 in Restricted Products and QL chart for simplification.

October 2024: Criteria update: Added new to market Freestyle Libre 2 Plus sensor kit to policy. 

July 2024: Criteria update: Added new to market Freestyle Libre 3 Plus sensor kit. Removed Freestyle Libre 10 day products. 

April 2024: Criteria update: Removed Omnipod GO from policy. May be covered under medical benefit.

February 2024: Criteria update: Added new to market Omnipod 5 G7 kit and pods to policy.

January 2024: Criteria change: Removed OneTouch/Lifescan from restricted products.

November 2023: Criteria update: Added new to market Freestyle Libre 3 Reader Kit to policy.

August 2023: Criteria change: Combined CGM, Omnipod and Glucose Test Strip policies. Quantity limit criteria aligned across all products on policy. Continuation criteria for Omnipod removed. Duration of approval changed to 365 days.

May 2023: Criteria update (Omnipod): Added new to market Omnipod GO to policy. 

Dec 2022: Criteria update: Added new Dexcom G7 to policy.

June 2022: Criteria update: Added new Freestyle Libre 3 to policy. 

April 2022: Criteria change (Omnipod):  Added new to market Omnipod 5 G6 kit and pods to policy.  Change policy name to from Omnipod DASH to Omnipod. 

January 2022: Criteria change (Omnipod): Annual criteria review. QL on Dash system updated to 1 kit per 2 years. September

2020: Criteria update (Test Strips): Annual Criteria Review. No changes.

Aug 2020:  Criteria update:  Added new Freestyle Libre 2 to the policy.

April 2020: Criteria change: Added requirement to Freestyle Libre of physical or mental limitation making utilization of Dexcom not feasible.

*Additional historical revisions available upon request from Corporate Pharmacy