FreeStyle Navigator(R) - Purchase
Navigating Your Way to Better Diabetes Management – Getting Started
Now that you have decided to include continuous glucose monitoring as part
of your daily diabetes management program, you can begin the process of
obtaining a FreeStyle Navigator® Continuous Glucose Monitoring
System. To assist you through this process, 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 information on the
distribution process. For your convenience, we have included all materials
necessary to initiate the process for accessing the FreeStyle Navigator system
in your “Introduction to FreeStyle Navigator” literature packet. Please
complete the following four steps to expedite the process for obtaining your
FreeStyle Navigator system:
Step 1:
Complete and sign the Customer Enrollment Form.
The Authorization to Release Patient Information gives ADC permission to
contact your insurance company and physician on your behalf. All information is
personal and confidential. The Patient Information Questionnaire provides us
with the details we need to assist you.
The Statement of Medical Necessity is a document completed by your
healthcare provider, which functions as the prescription and provides key
information about your medical history necessary to justify why the FreeStyle
Navigator system is an appropriate therapy for you. In some cases, your
healthcare provider may submit this on your behalf.
Step 2:
Submit this information to the ADC Resource Center by Fax or Direct
Mail.
Fax:
Attention: ADC Resource Center, 1-888-423-2435
-OR-
Direct Mail: ADC Resource Center, P.O. Box 1087, San Bruno, CA
94066
As soon as you have completed this information and it is received by the ADC
Resource Center, an ADC Resource Counselor will contact you directly to discuss
how you wish to proceed. The Resource Counselor will work with your health
insurance plan to determine the level of coverage for this product. All
paperwork, including a Statement of Medical Necessity, must be received by the
ADC Resource Center prior to initiating the insurance verification
process.
Following these initial steps will allow Abbott Diabetes Care to contact
your healthcare professional and insurance carrier. Our primary objective is to
make the process of accessing the FreeStyle Navigator system as simple as
possible for you.
If you have any questions about the forms to be completed or
additional questions about the insurance coverage process, please contact
Abbott Diabetes Care at 1-877-4ADC-INFO (1-877-423-2463).
Note: By completing these forms, you are giving Abbott Diabetes Care and
any designated Durable Medical Equipment (DME) supplier permission to contact
your insurance company to review your benefits and your physician to discuss
your medical need of necessity for a continuous glucose monitoring system. This
does not obligate you to obtain a FreeStyle Navigator system.
Customer care available 24 hours a day, 7 days a week:
1-866-597-5520
Indications and Important Safety Information for the FreeStyle
Navigator® System
Safety Information: Users should read all of the
instructions in the User's Guide before using the FreeStyle
Navigator® Continuous Glucose Monitoring System. Adjustments to
treatment should be done under the guidance of the user's health care 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
health care 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. Performance of the
FreeStyle Navigator system has not been evaluated in pregnant women.
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