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CGM = continuous glucose monitoring

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Woman with CGM sensor

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Man wearing a FreeStyle Libre sensor

As a courtesy to its customers, 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 of payment for our products or reimburse customers for claims that are denied by third party payors.

*On May 8, 2020, CMS published a second interim final rule with comment, CMS-5531-IFC, that expanded the non-enforcement of clinical indications of coverage to therapeutic continuous glucose monitors (CGMs). (www.govinfo.gov/content/pkg/FR-2020-05-08/pdf/2020-09608.pdf) The Durable Medical Equipment Medicare Administrative Contractors (DME MAC) subsequently issued guidance on the IFC policies, including discussing that clinical indications for coverage in the therapeutic CGM LCD (Glucose Monitors, L33822) will not be enforced. See “CMS Issues Interim Final Rules with Comment (CMS-1744-IFC & CMS-5531-IFC) – COVID-19 Public Health Emergency – Revised May 21, 2020.” (www.cgsmedicare.com/jc/pubs/news/2020/05/cope1733) As a courtesy to its customers, 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 of payment for our products or reimburse customers for claims that are denied by third-party payors.

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 of the reading device. You must have Critical Alerts enabled to receive alarms and alerts on your smartphone.

§Medicare coverage is available for the FreeStyle Libre 2 system if a smartphone with the FreeStyle Libre 2 app is used in conjunction with the FreeStyle Libre 2 reader to review glucose data. Medicare coverage is not available if a patient never uses the FreeStyle Libre 2 reader, and patients must meet other applicable coverage criteria. See Local Coverage Determination: Glucose Monitors (L33822), July 2021 and Local Coverage Article: Glucose Monitors (A52464), Jan 2020.

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 Check Blood Glucose symbol and when your glucose alarms and readings from the system do not match symptoms or expectations.

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 don’t start your FreeStyle Libre 2 sensor with your phone, you will not get the Urgent Low Glucose Alarm on your phone.

#FreeStyle Libre 14 day sensors communicate with the FreeStyle Libre 14 day readers that started them or the FreeStyle LibreLink app that started it. A sensor started by the FreeStyle Libre 14 day reader will also communicate with the FreeStyle LibreLink app once the FreeStyle LibreLink app is used to scan the sensor.

**You cannot use both the FreeStyle Libre 2 reader and the FreeStyle Libre 2 app to scan the same FreeStyle Libre 2 sensor for glucose readings. If you start the Sensor with the App, then you cannot use the Reader to scan for glucose readings and if you start the Sensor with the Reader, then you cannot use the App to scan for glucose readings. Whichever device you start the Sensor with will receive alarms.

††Medicare coverage is available for FreeStyle Libre 14 day systems for cell phone use if FreeStyle LibreLink is used in conjunction with the FreeStyle Libre 14 day readers. Patients must meet Medicare eligibility coverage criteria LCD L33822 (July 2020). Local Coverage Article: Glucose Monitor Policy Article (A52464), May 2017.

 

ADC-37051 Ver 2.0 08/21

Important Safety Information

FreeStyle Libre 14 day system: Failure to use FreeStyle Libre 14 day system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.

FreeStyle Libre 2 system: Failure to use FreeStyle Libre 2 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us for safety info.

The product images are for illustrative purposes only.

The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners.

No use of any Abbott trademark, trade name, or trade dress in this site may be made without prior written authorization of Abbott Laboratories, except to identify the product or services of the company.

This website and the information contained herein is intended for use by residents of the United States.

ADC-29111 Ver 7.0 08/21