FreeStyle Navigator(R) - FAQs - How can I get a FreeStyle Navigator system?
Answers to Frequently Asked Questions
What is the FreeStyle Navigator system?
How does the FreeStyle Navigator system work?
How can I get a FreeStyle Navigator system?
- How can I get a FreeStyle Navigator system
- Do I need a prescription for getting the FreeStyle Navigator system?
- Will my insurance company pay for the FreeStyle Navigator system?
- What if my insurance doesn’t cover the FreeStyle Navigator system?
- How do I find out what my co-pay or out-of-pocket obligation is for the FreeStyle Navigator system?
- Why do I need a Statement of Medical Necessity (SMN)?
- If I’ve already paid for the FreeStyle Navigator system can I still get reimbursed by my insurance company?
- Is the FreeStyle Navigator system approved for use in children?
Additional Information for Healthcare Professionals
How can I get a FreeStyle Navigator system?
How can I get a FreeStyle Navigator system?
Follow the simple steps below.
- Complete and sign the Authorization to Release Patient Information. The Authorization to Release Patient Information gives ADC permission to contact your insurance company and physician on your behalf.
- Complete and sign the Patient Information Questionnaire. All information is personal and confidential. The Patient Information Questionnaire provides us with the details we need to assist you.
- Obtain a completed Statement of Medical Necessity from your physician. The Statement of Medical Necessity is a document completed by your health care provider, which functions as the prescription and provides key information about your medical history necessary to justify why the FreeStyle Navigator is an appropriate therapy for you. In some cases, your health care provider may submit this on your behalf.
- Submit this information to the ADC Resource Center by:
Fax: Attention: ADC Resource Center, 1-888-423-2435 or
Direct Mail: ADC Resource Center, P.O. Box 1087, San Bruno, CA 94066.
TopDo I need a prescription for getting the FreeStyle Navigator
system?
Yes. The FreeStyle Navigator system requires a prescription from your
doctor.
Will my insurance company pay for the FreeStyle Navigator
system?
At this time, no broad insurance coverage exists for the FreeStyle Navigator
system. Insurance coverage for the FreeStyle Navigator system varies by plan on
a case-by-case basis. Abbott Diabetes Care (ADC) has developed a Resource
Center to help you determine whether or not your health insurance plan covers
this product and to provide you information on the distribution process. The
ADC Resource Center can be contacted by phone at 1-877-423-2463 (Mon-Fri, 8 AM
– 8 PM Eastern Time) or by fax at 1-888-423-2435 (Attention: ADC Resource
Center).
What if my insurance doesn’t cover the FreeStyle Navigator
system?
If your health insurance plan doesn’t currently reimburse for the FreeStyle
Navigator system, you have two options:
You can continue to appeal the initial denial of your health insurance plan. The ADC Resource Center can help provide assistance/direction with your appeal; or
You can pay for the FreeStyle Navigator system directly. The ADC Resource Center can also provide you with information about a DME (Durable Medical Equipment) supplier that best meets your needs.
How do I find out what my co-pay or out-of-pocket obligation is for
the FreeStyle Navigator system?
You can gain information regarding any co-pays or out-of-pocket financial
obligations related to purchasing the FreeStyle Navigator system in one of two
ways: either by contacting your health insurance plan directly or by using the
benefit verification services provided through the ADC Resource Center.
Why do I need a Statement of Medical Necessity (SMN)?
Insurance plans determine whether or not a device is medically necessary by
carefully weighing the information provided in the statement of medical
necessity by your physician. Thus, it is very important that your physician
complete the entire SMN thoroughly and include as much information as possible
about why the FreeStyle Navigator system is medically necessary for you. The
Statement of Medical Necessity also serves as your physician’s
prescription.
If I’ve already paid for the FreeStyle Navigator system can I still
get reimbursed by my insurance company?
Currently, insurance coverage for continuous glucose monitoring systems varies.
However, insurers may be willing to reimburse you for medically necessary
durable medical equipment if you have already paid for the product. Thus,
customers who have already paid for the product are encouraged to submit a
claim with their insurer regardless of whether they feel they will be
reimbursed or not. The ADC Resource Center can help you initiate this
process.
Is the FreeStyle Navigator system approved for use in
children?
It is indicated for people with diabetes who are 18 years of age or older. At
this time, the FreeStyle Navigator system is not indicated for children under
the age of 18. However, we at Abbott Diabetes Care realize the importance of
continuous glucose monitoring for specific populations including children with
diabetes. We are committed to seeking a pediatric indication for this
revolutionary technology. We appreciate your patience as we strive to achieve
this goal.
Tired of questions?
Want to see the FreeStyle Navigator system in action?
Call us 24 hours a day, 7 days a week: 1-866-597-5520
| * | Note: Movement of the sensor support mount or excessive perspiration at the sensor insertion site due to activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support mount to the skin and cause the sensor to dislodge. If the sensor dislodges due to the sensor support adhesive failing to adhere to the skin, you may get unreliable results or no results. The system may not provide a warning in such circumstances. Choose the proper sensor insertion site when inserting the sensor and prepare the site by following the instructions for site preparation. |
Safety Information: Users should read all of the instructions in the User's Guide before using FreeStyle Navigator® Continuous Glucose Monitoring System. Adjustments to treatment should be done under the guidance of the user's healthcare team.
Indications for Use: The FreeStyle Navigator® Continuous Glucose Monitoring System is indicated for continually recording interstitial fluid glucose levels in people (ages 18 and older) with diabetes mellitus for the purpose of improving diabetes management. Readings and alarms about glucose levels from the FreeStyle Navigator® Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring. Before adjusting therapy for diabetes management based on results and alarms from the FreeStyle Navigator® Continuous Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle Navigator® Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result.
The FreeStyle Navigator® Continuous Glucose Monitoring System provides real-time readings, graphs, trends, and glucose alarms directly to the user. The FreeStyle Navigator® Continuous Glucose Monitoring System is intended to be used in home settings to aid people with diabetes in predicting and detecting episodes of hypoglycemia and hyperglycemia and in clinical settings to aid healthcare professionals in evaluating glucose control. The FreeStyle Navigator® Continuous Glucose Monitoring System is available only by prescription.
Contraindications: The FreeStyle Navigator® Continuous Glucose Monitoring System must be removed prior to Magnetic Resonance Imaging (MRI).
Prescription Device: Federal law restricts the sale of this device by or on order of a physician.
Warnings/Precautions: Infection, inflammation, or bleeding at the glucose sensor insertion site are possible risks of inserting a sensor into your skin. If you believe your results are not reliable, or are inconsistent with how you feel, perform a blood glucose mode test to measure your glucose. If the problem continues, discard the old sensor and insert a new sensor. Performance of the system under conditions of fluctuating hydration levels such as during renal dialysis has not been evaluated. Unintended dislodging of the sensor due to excessive perspiration, exercise, or bumping, may cause unreliable or no results without warning. A portion of the membrane polymer will remain in the skin each time the sensor is removed. Although no health effects were observed or reported in clinical studies, the long term effects of the sensor membrane fragments remaining in the skin have not been determined. Performance of the FreeStyle Navigator system has not been evaluated in pregnant women.
DOC13810_Rev-A 01/08
