Status of Insurance Coverage for the Guardian® Continuous Glucose Monitor

REAL-Time Continuous Glucose Monitoring is a brand new therapy, and it is not yet covered by most insurance companies. At this time the Guardian continuous glucose monitor components – the monitor, the transmitter and glucose sensors – are an out-of-pocket expense. However, Medtronic Diabetes is continuing to build the clinical evidence and work with insurance companies to obtain coverage for this exciting technology.

Although we are unable to process insurance claims for you today, we have included information and links that may assist you in requesting reimbursement directly from your insurance company should you choose to pursue coverage from them.

The following documents may be helpful in working with your insurance company:

  1. Letter of Medical Necessity:
    • To support your request for reimbursement, ask your doctor for a letter of medical necessity. This letter should serve as a rationale to support why you are a candidate for Continuous Glucose Monitoring and should include the following information:
      • Purpose of letter (to request coverage for Continuous Glucose Monitoring device).
      • Specific information from your plan on what is considered to be "medically necessary".
      • Description of the device (see product information link).
      • Medical History to demonstrate clinical necessity. For example, detail how often you have experienced hypoglycemia (unawareness or nocturnal). Provide specifics as to incidents requiring medical intervention. Explain how current treatment of self monitoring blood glucose (SMBG) is not working (i.e., elevated A1C and/or hypoglycemia in spite of frequent SMBG). Detail all important clinical data that makes tight glycemic control particularly important for you (i.e., pre-conception and/or pregnancy management, diabetes complications, gastroparesis, etc).
      • Request approval for device and ongoing supplies.
      • Inquire about appeal process. Be prepared if your initial request for coverage is denied, to follow the appeal process with your insurance company.
      • Provide documentation supporting the clinical rationale for medical necessity (i.e., blood glucose logs showing wide glycemic excursions with frequent testing, documented hypoglycemic episodes, medical records showing adherence to prescribed therapies, lab reports, etc.)
  2. Clinical studies
    • Deiss D, Bolinder J, Riveline J-P, Battelino T, Bosi E, Tubiana-Rufi N, Kerr D, Phillip M. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care, Volume 29, Number 12, Page 2730-2732.
    • Bode B, Gross K, Rikalo N, Schwartz S, Wahl T, Page C, Gross T, Mastrototaro J. Alarms Based on Real-Time Sensor Glucose Values Alert Patients to Hypo-and Hyperglycemia: The Guardian Continuous Monitoring System™. Diabetes Tech & Therapeutics 6:105-113, 2004.
    • Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose monitor. Diabetes Care 29(1):44-50, 2006.
  3. Paradigm REAL-Time product information.
  4. FDA approval letters for the MiniMed Paradigm REAL-Time System and Guardian REAL-Time System.