Medicare Covers FreeStyle Libre 3 CGM
Abbott has announced that its latest continuous glucose monitor, the FreeStyle Libre 3, is now covered under Medicare.
Following news in April that the FDA cleared a separate handheld reader for Abbott’s latest continuous glucose monitoring (CGM) system, the FreeStyle Libre 3, Abbott has announced that the Libre 3 system is now available for people on Medicare.
This announcement follows Medicare’s April 2023 expansion of CGM coverage to include people with type 2 diabetes. Based on this expansion, Abbott estimates that an additional two million people will now have access to the Libre 3 CGM system, which has been shown to improve health outcomes, including Time in Range.
The Libre 3 was previously ineligible for Medicare coverage because it did not include a separate handheld reader. Before the reader was cleared in April 2023, Libre 3 users could only use a smartphone app to view their glucose readings.
What’s the difference between the FreeStyle Libre 3 and Libre 2?
Abbott’s FreeStyle Libre 3 was cleared as an integrated CGM (iCGM) in May 2022. Unlike previous editions, the Libre 3 does not require users to manually scan for a glucose reading, because it sends real-time glucose readings directly to the FreeStyle Libre 3 mobile app via Bluetooth.
For Libre 3 users who do not have a smartphone or prefer to use a separate handheld reader, the FreeStyle Libre 3 reader received FDA clearance in April 2023. The reader is a handheld device that displays glucose readings from the wearable sensor in real-time.
With the clearance of the FreeStyle Libre 3 reader, those using Libre 3 now have a choice about which display they would prefer. In a statement, Abbott highlighted that the clearance of the reader will not affect the mobile app; the app will still be available.
Users can also switch between the reader and mobile app, but they must change sensors to do so, meaning that if someone chooses to use a reader, they must stick to it for the full wear period of the sensor (up to 15 days) before switching to the mobile app.
The FreeStyle Libre 2 was cleared as iCGM in June 2020. Compared to the original FreeStyle Libre, the Libre 2 includes Bluetooth connectivity, which enables high and low blood glucose alerts.
FreeStyle Libre 2 | FreeStyle Libre 3 |
14-day wear | 14-day wear |
Factory calibrated with one-hour warm up time | Factory calibrated with one-hour warm up time |
Optional alarms | Optional alarms |
Scanned with a separate handheld reader | Real-time readings sent to mobile app via Bluetooth – no need to manually scan for a glucose reading |
Sensor size: two stacked quarters | Sensor size: two stacked pennies |
Cleared for use in people with diabetes 4 and older |
Cleared for use in people with diabetes 4 and older Cleared for use in gestational diabetes and pregnant women with type 1 diabete |
Both the Libre 2 and Libre 3 are approved for people with diabetes ages 4 and older. As iCGMs, they can be used in Automated Insulin Delivery (AID) systems.
How to upgrade to the FreeStyle Libre 3 on Medicare
Abbott did not share any specific information regarding when users can expect to receive their new Libres, but those who are currently using the FreeStyle Libre 2 and wish to switch to the Libre 3 can request a new prescription from their healthcare providers.
The FreeStyle Libre 14-day, FreeStyle Libre 2 and FreeStyle Libre 3 are all available for Medicare beneficiaries following the expansion of Medicare CGM coverage.