This IFC also clarified that statutory reasonable and necessary statutory requirements are not being waived due to the PHE. 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). “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. “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. ‡‡ Compared to self-monitoring blood glucose testing. Local Coverage Article: Glucose Monitor Policy Article (A52464), July 2021 †† Patients must meet Medicare eligibility coverage criteria. Product availability may vary by retailer. ** Participating pharmacies are subject to change without notice. See Local Coverage Determination: Glucose Monitors (元3822), July 2021 and Local Coverage Article: Glucose Monitors (A52464), July 2021 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. 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.
#Freestyle libre flash glucose monitoring system ndc 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. 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 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. Therefore the study data is applicable to both products.
FreeStyle Libre 2 has the same features as FreeStyle Libre 14 day system with optional real-time glucose alarms. ‡ Data from this study was collected with the outside US version of FreeStyle Libre 14 day system. † Based on a comparison of list prices of the FreeStyle Libre 2 system versus competitors’ CGM systems. 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 customer is ultimately responsible for determining the appropriate codes, coverage, and payment policies for individual patients. * As a courtesy to its customers, Abbott provides the most up-to-date information available, but it is subject to change and interpretation.
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