- #Freestyle libre flash glucose monitoring system implant registration
- #Freestyle libre flash glucose monitoring system implant pro
The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. IMPORTANT: The device may inaccurately indicate hypoglycemia. The system is intended for use by health care professionals and requires a prescription.
#Freestyle libre flash glucose monitoring system implant pro
Seek medical attention when appropriate or contact Abbott at 855‑632‑8658 or for safety info.įreeStyle Libre Pro: The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. 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 85 or for safety info.įreeStyle Libre 2 and FreeStyle Libre 3 systems: Failure to use FreeStyle Libre 2 or FreeStyle Libre 3 systems 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. įreeStyle 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. 2. Local Coverage Determination (LCD) 元3822, Glucose Monitors. 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. ‡‡ The FreeStyle Libre 2 app and the FreeStyle Libre 2 reader have similar but not identical features. Medicare coverage is not available if a patient never uses the FreeStyle Libre 2 reader, and patients must meet other applicable coverage criteria. †† 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. ** DMEs are subject to change without notice.
# Patients must meet Medicare eligibility coverage criteria: Local Coverage Determination, Glucose Monitors (元3822) February 2022. Product availability may vary by retailer. ¶ Participating pharmacies are subject to change without notice.
#Freestyle libre flash glucose monitoring system implant registration
Use of the FreeStyle Libre 2 app requires registration with LibreView. Please check our compatibility guide for more information about device compatibility before using the app. ǁ 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. § The FreeStyle Libre 3 app is only compatible with certain mobile devices and operating systems. ‡ Patients must meet Medicare eligibility coverage criteria. 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 of list prices of the FreeStyle Libre personal CGM systems versus competitors’ CGM systems, assuming annual use of one receiver (or equivalent hardware) and quantity of transmitters and/or sensors according to use life. Participating pharmacies are subject to change without notice. This does not apply to beneficiaries of Medicare, Medicaid or other federal or state healthcare programs. This applies to commercially insured patients. * No prior authorization needed at participating pharmacies. Abbott does not guarantee third party coverage or payment for our products or reimburse customers for claims that are denied by third party payors.
The customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. Medicare and other third party payor criteria apply.Īt this time, FreeStyle Libre 3 is not currently eligible for Medicare reimbursement, and Medicaid eligibility may vary by state.Ībbott provides this information as a courtesy, it is subject to change and interpretation. Medicare coverage is available for the FreeStyle Libre 2 system if the FreeStyle Libre 2 reader is used to review glucose data on some days every month.
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