FreeStyle Navigator(R) - FAQs - For Healthcare Professionals
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?
Additional Information for Healthcare Professionals
- How can I help my patients apply for coverage for the FreeStyle Navigator® Continuous Glucose Monitoring System?
- How do I write a prescription for the FreeStyle Navigator system?
- What assistance is available to uninsured or underinsured patients who may be appropriate candidates for the FreeStyle Navigator system?
- Can my staff or I be reimbursed for the time we take to train patients on how to effectively use the FreeStyle Navigator system?
- Will insurance plans cover the FreeStyle Navigator system and its supplies as well as my patients’ current SMBG test strips?
- What can I do if patients come back saying their claims were denied?
- I understand that many insurers will ask for data showing improved health outcomes for the technology. With which key publications should I as a physician be familiar?
- If I have further questions as a healthcare professional, how can I contact you?
Additional Information for Healthcare Professionals
How can I help my patients apply for coverage for the FreeStyle
Navigator
Continuous Glucose Monitoring System?
By providing your patients with initial information about the FreeStyle
Navigator system, you are making them aware of this innovative technology and
familiarizing them with the concept of continuous glucose monitoring. Once a
patient has expressed an interest in obtaining the FreeStyle Navigator system,
you can assist him/her in the process by thoroughly completing the Statement of
Medical Necessity (which is considered the prescription) and faxing it to the
ADC Resource Center as quickly as possible. 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). Additionally, your
assistance may be required should an initial claim be denied in order to
provide additional medical information pertinent to the appeals process.
TopHow do I write a prescription for the FreeStyle Navigator
system?
The Statement of Medical Necessity (SMN) is the prescription for the product.
Thus, physicians only have to complete the SMN and send it back by fax or mail
to the ADC Resource Center. Physicians are encouraged to be as comprehensive as
possible in completing the SMN in order to optimize the patient’s chances of
having the product covered by his/her insurance plan.
What assistance is available to uninsured or underinsured patients
who may be appropriate candidates for the FreeStyle Navigator
system?
Currently, ADC does not have a Patient Assistance Program in place for
FreeStyle Navigator candidates who are uninsured and need financial support.
However, the ADC Resource Center can help patients who are uninsured or
underinsured to navigate the reimbursement process, thus strengthening their
chances for at least partial reimbursement of the product.
Can my staff or I be reimbursed for the time we take to train
patients on how to effectively use the FreeStyle Navigator
system?
There are currently no CPT (Current Procedural Terminology) codes to reimburse
specifically for the time healthcare professionals spend training patients on
how to effectively utilize the FreeStyle Navigator system. However, many
physician offices use the current CPT codes (“Self Management Diabetes
Education”) to invoice for the time spent to train diabetes patients about
glucose monitoring. While many private plans also include diabetes management
initiatives which provide some coverage of diabetes education, this is at the
discretion of each individual insurance plan.
Will insurance plans cover the FreeStyle Navigator system
and its supplies as well as my patients’ current SMBG test
strips?
Coverage by plan varies, but it is anticipated that most health insurance
programs that provide reimbursement for the FreeStyle Navigator system and
sensor kits will also continue to cover a patient’s current prescription for
SMBG (self monitoring of blood glucose) test strips.
What can I do if patients come back saying their claims were
denied?
HCPs may recommend patients to the Abbott Diabetes Care (ADC) Resource Center,
which provides assistance to customers in the claims and appeals process. HCPs
can also assist in the appeals process by sending a pre-developed appeals
packet and detailed appeals letter that provide more information about why the
device is medically necessary for a specific individual. ADC Resource Center
can be contacted by phone at 1-877-423-2463 (Mon-Fri, 8 AM - 8 PM Eastern
Time); by fax at 1-888-423-2435 (Attention: ADC Resource Center).
I understand that many insurers will ask for data showing improved
health outcomes for the technology. With which key publications should I as a
physician be familiar?
Several key articles have been published recently looking at the value of
continuous glucose monitoring in improving glycemic control and reducing the
time spent in hypoglycemia and hyperglycemia. For further information,
healthcare professionals may contact the ADC Resource Center and ask for an
appeals kit, which includes a number of key studies in the literature.
Additionally, a number of companies including Abbott Diabetes Care are
currently engaged in various clinical outcomes studies. Thus, there is a
significant chance that additional data will be available in the near future
which further strengthens the case for continuous glucose monitoring as a
valuable tool in diabetes management and control.
If I have further questions as a healthcare professional, how can I
contact you?
Abbott Diabetes Care has a dedicated healthcare professional hotline
(1-800-469-8989) available 24/7 to assist you with any and all questions.
Additional information including on-line training tools and our latest product information is available at www.continuousmonitor.com. Patients should call the ADC Resource Center at 1-877-423-2463 (Monday - Friday, 8 AM - 8 PM Eastern Time) if they have questions regarding the reimbursement process. For general questions and technical support, they should call customer care (available 24/7) at 1-866-597-5520.
Call us 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.
