Product Coverage: Insulin Pump and Continuous Glucose Monitoring

For insurance purposes, the two parts of the MiniMed Paradigm REAL-Time System (the insulin pump and the continuous glucose monitoring components) are handled separately. Insulin pump therapy has a 25 year history and insurance companies are familiar with this technology. Therefore, there is an established process for authorization and payment of insulin pumps. Medtronic Diabetes will verify coverage with your insurance company and will help process claims for your insulin pump and on-going pump supplies.

Because REAL-Time Continuous Glucose Monitoring is a relatively new therapy, many insurance companies are covering them on a case by case basis, and some have developed specific policies. Much like our insulin pump verification process, Medtronic Diabetes will verify coverage for continuous glucose monitoring products with your insurance company. If for some reason your health insurance company does not approve the request for coverage of continuous glucose monitoring products, it may be necessary for you or your physician to appeal the decision for further review. Health insurers each have a system for reviewing appeals, so it is important for you to understand what that process is.

The following documents and resources may be helpful when building an appeal for your insurance company:

  1. Letter of Medical Necessity:
    • To support your request for reimbursement or coverage for continuous glucose monitoring products, ask your doctor for a letter of medical necessity. The purpose of the letter is to confirm why you are a candidate for Continuous Glucose Monitoring and should include the following information:
      • A brief description of the patient and their demographics, history and duration of the disease, and current challenges the patient is experiencing.
      • Medical and clinical references to the physicians experience with CSII or CGM therapy and any relevant clinical references such as those listed below.
      • Clear explanation of the medical necessity from the prescribing physician and the justification and expected results by placing the patient on the therapy.
  2. Patient Letter
    • If you are submitting the appeal yourself, a letter outlining the appeal is suggested. The letter should demonstrate the following:
      1. The purpose of letter (to request coverage for Continuous Glucose Monitoring device).
      2. Your understanding of the specific information from your insurance plan on what is considered to be “medically necessary”.
      3. Description of the device (see Product Information section of this website).
      4. Personal medical history to demonstrate clinical necessity. For example, detail how often you experience hypoglycemia (unawareness or nocturnal). Provide specific incidences requiring medical intervention. Explain how current treatment with self monitoring blood glucose (fingerstick meters) is not effective.
      5. Request approval for device and ongoing supplies, and inquire about appeal next steps.
  3. Clinical studies
    • Early clinical evidence clearly supports the use of continuous glucose monitoring for patients with hypoglycemia unawareness, nocturnal hypoglycemia, elevated A1C levels and diabetes management during preconception and pregnancy. The following are studies demonstrating the effectiveness of continuous glucose monitoring.
      • The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. N Engl J of Med 10.1056/NEJMoa0805017
      • 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 SystemT. 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.
  4. Product Support Links
  5. FDA approval letters
  6. Other Resources