Medicare coverage is available for FreeStyle Libre systems if their respective readers are used to review glucose data on some days every month. Medicare and other third party payor criteria apply.
Abbott provides this information as a courtesy; 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.
* Patients must meet Medicare eligibility coverage criteria.
† Data based on total active Medicare patients with CGM readers.
‡ Data from this study was collected with the outside US version of FreeStyle Libre 14 day system. FreeStyle Libre 2 has the same features as FreeStyle Libre 14 day system with optional, real-time glucose alarms. Therefore, the study data is applicable to both products.
§ Data from this study was collected with the outside US version of the FreeStyle Libre 14 day system. FreeStyle Libre 3 has the same features as FreeStyle Libre 14 day system with real-time glucose alarms. Therefore the study data is applicable to both products.
‖ FreeStyle Libre 2 and 3 systems: 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.
¶ Glucose readings are not available during 1-hour warm-up, when sensor is too hot or too cold, when you see an error or "LO" or "HI" message, or no current glucose reading.
# Sensor is water-resistant in up to 1 meter (3 feet) of water. Do not immerse longer than 30 minutes.
** 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.
†† The FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check our website 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.
§§ The FreeStyle Libre 2 app also has a mandatory Urgent Low Glucose Alarm that lets users know when their glucose value is below 55mg/dL.
‖‖ The user's device must have internet connectivity for glucose data to automatically upload to LibreView and to transfer to connected LibreLinkUp app users.
¶¶ The FreeStyle Libre 3 app and the FreeStyle Libre 3 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.
## The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. Please check our website for more information about device compatibility before using the app.
*** Notifications will only be received when alarms are turned on and the sensor is within 33 feet unobstructed of the reading device. You must enable the appropriate settings on your smartphone to receive alarms and alerts, see the FreeStyle Libre 3 User’s Manual for more information.
††† Among patient-applied sensors.
§§§ NOTICE OF FINANCIAL INCENTIVE. Abbott offers the MyFreeStyle program, which provides individuals who enroll with personalized discounts, product vouchers, promotional opportunities, and/or other benefits ("Program Benefits"). Program participants opt in by signing up for the Program on this form. Abbott collects and uses your personal information, including information you voluntarily provide us above and commercial information (such as your purchase history), information we collect automatically, and information from other sources to operate the Program and related services, including to send you promotions, content, special offers, and other personalized benefits and the other uses described on this form. Based on our reasonable and good faith estimate, Abbott receives value from the Program through increased customer loyalty and sales, but we do not assign an independent monetary value to the personal information we collect in connection with the Program. Further, the precise value of your participation in the Program will vary by the Program participant depending on purchases made, which offers a participant takes advantage of, as well as other factors. Some benefits to participants may also be intangible, such as the ability to streamline ordering of products and/or payment process. In general, however, Abbott estimates in good faith that the value provided by Program Benefits to customers is equal to or greater than the value we receive from the personal information collected through the Program. Abbott incurs a variety of expenses for providing financial incentives, including administrative and technical expenses associated with maintaining the Program and costs associated with discounts on purchases. Participation in our financial incentives is voluntary. By providing your personal information when signing up for the Program, you are affirmatively opting-in to our financial incentive Program. You may unsubscribe from Program emails you receive at any time by clicking the unsubscribe link in the emails. You can also request to opt out at any time by calling (888) 332-0121 or you can submit a privacy rights request by submitting your information here: https://www.abbott.com/privacy-policy/dsar.html. Please mention the name of the Program in your request to opt-out.
References: 1. Local Coverage Determination (LCD) L33822, Glucose Monitors, https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?LCDId=33822. 2. Data on File. Abbott Diabetes Care. 3. Evans, Mark, et al. "The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: a Meta-analysis of Clinical Trials and Real-world Observational Studies." Diabetes Therapy 11, no. 1 (2020): 83-95. https://doi.org/10.1007/s13300-019-00720-0. 4. Kroeger, Jens, Peter Fasching, and Helene Hanaire. "Three European Retrospective Real-World Chart Review Studies to Determine the Effectiveness of Flash Glucose Monitoring on HbA1c in Adults with Type 2 Diabetes." Diabetes Therapy 11, no. 1 (2020): 279-291. https://doi.org/10.1007/s13300-019-00741-9. 5. Evans, Mark, et al. "Reductions in HbA1c with flash glucose monitoring are sustained for up to 24 months: a meta analysis of 75 real-world observational studies." Diabetes Therapy (2022). https://doi.org/10.1007/s13300-022-01253-9. 6. FreeStyle Libre 3 User's Manual. 7. Haak, Thomas, et al. “Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-treated Type 2 Diabetes: a Multicentre, Open-label Randomised Controlled Trial.” Diabetes Therapy 8, no. 1 (2017): 55-73. https://doi.org/10.1007/s13300-016-0223-6. 8. FreeStyle Libre 2 User’s Manual.