Medicare coverage is available for the FreeStyle Libre 2 system if a compatible smartphone is used in conjunction with the FreeStyle Libre 2 reader to review glucose data. Medicare and other third party payor criteria apply.
As a courtesy, Abbott provides the most up-to-date information available, but it is subject to change and interpretation. The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Abbott does not guarantee third party coverage or payment for our products or reimburse customers for claims that are denied by third party payors.
* Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours.
† or ♢ Eligible patients will receive one (1) FreeStyle Libre 2 sensor for users with a compatible mobile phone operating system at $0 copay. The expiration date of the voucher is 60 days from the issue date. This program is available for patients with Type 1 and Type 2 diabetes; it is not available for patients with gestational diabetes. Only patients ages 18 and older are eligible to sign up and receive an offer for the FreeStyle Libre 2 sensor and patients ages 4-17 are eligible to receive an offer for the FreeStyle Libre 2 sensor through their parent or guardian. This offer is void where prohibited by law. Abbott may modify or rescind this offer at any time without notice. The discounts are not available to beneficiaries of Medicare, Medicaid or other federal or state healthcare programs or residents of Massachusetts, Puerto Rico and other US territories. The free FreeStyle Libre 2 sensor is provided as a sample and is limited to one NDC per eligible person. The FreeStyle Libre 2 sensor cannot be re-sold, traded nor submitted to any third-party payer for reimbursement and is not provided as any inducement for future purchases. The free sample card is not health insurance.
‡ The FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check our compatibility guide for more information about device compatibility before using the app. Use of the FreeStyle Libre 2 app requires registration with LibreView.
§ Notifications will only be received when alarms are turned on and the sensor is within 20 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 2 User’s Manual for more information.
ǁ Glucose readings are not available during 1-hour warm-up, when the sensor is too hot or too cold, or when you see an error, "LO" or "HI" message, or no current glucose reading.
¶ To get the Urgent Low Glucose Alarm on your phone with the FreeStyle Libre 2 app, you will first need to start your FreeStyle Libre 2 sensor with your phone. If you do not start your FreeStyle Libre 2 sensor with your phone, you will not get the Urgent Low Glucose Alarm on your phone.
# The LibreLinkUp app is only compatible with certain mobile devices and operating systems. Please check www.LibreLinkUp.com for more information about device compatibility before using the app. Use of the LibreLinkUp app requires registration with LibreView. Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system. This device is not intended to replace self-monitoring practices as advised by a physician.
** The FreeStyle Libre 2 app and the FreeStyle Libre 2 reader have similar but not identical features. Fingersticks are required for treatment decisions when you see the Check Blood Glucose symbol and when your glucose alarms and readings from the system do not match symptoms or expectations.
†† Glucose alarms will transfer to the LibreLinkUp app users when users are connected and alarms are enabled on the FreeStyle Libre 2 app.
‡‡ The user's device must have internet connectivity for glucose data to automatically upload to LibreView and to transfer to connected LibreLinkUp app users.
§§ In comparison to the FreeStyle Libre 2 reader.
ǁǁ The LibreView data management software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management. The LibreView software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
¶¶ The reader captures data from the sensor within 1 cm to 4 cm of the sensor.
## Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 2 has the same features as the FreeStyle Libre 14 day system with optional real-time glucose alarms. Therefore, the study data is applicable to both products.
*** Sensor is water-resistant in up to 1 meter (3 feet) of water. Do not immerse longer than 30 minutes.
††† Data based on the number of users worldwide for FreeStyle Libre family of personal CGMs compared to the number of users for other leading personal CGM brands and based on CGM sales dollars compared to other leading personal CGM brands.
‡‡‡ Based on FDA iCGM special controls.
§§§ Based on a comparison of list prices of the FreeStyle Libre 2 system versus competitors’ CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
ǁǁǁ Based on a comparison of list prices of the FreeStyle Libre 2 system versus competitors’ CGM systems, assuming annual use of one receiver (or equivalent hardware) and quantity of transmitters and/or sensors according to use life. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
¶¶¶ Based on a comparison to Dexcom G6.
### The user's device must have internet connectivity for glucose data to automatically upload to LibreView and to transfer to connected LibreLinkUp app users.
**** Based on a comparison of list prices of the FreeStyle Libre 2 system versus competitors’ CGM systems, assuming annual use of one receiver (or equivalent hardware) and quantity of transmitters and/or sensors according to use life.
References: 1. FreeStyle Libre 2 User’s Manual. 2. Campbell, Fiona M., et al. “Outcomes of Using Flash Glucose Monitoring technology by Children and young people with Type 1 Diabetes in a Single Arm Study.” Pediatric Diabetes 19, no. 7 (November 2018): 1294-1301. https://doi.org/10.1111/pedi.12735. 3. iCGM Special Controls. Accessed May 2021. https://www.accessdata.fda.gov/cdrh_docs/pdf17/DEN170088.pdf. 4. Data on File. Abbott Diabetes Care. 5. Dexcom G6 CGM User Guide. 6. Alva, Shridhara. “FreeStyle Libre 2 - A New iCGM Device.” (2020). Accessed Mar 2021 from: https://www.danatech.org/media/okfhq1gu/adc-23842v3-revised-august-3-2020.pdf.
ADC-33111 Ver 4.0 01/22
