![]() The Department assumes no responsibility for any error, omission, or other discrepancy in the database. The Department assumes no liability for the access to or your reliance upon any of the information provided. This database is provided solely for informational purposes and is intended to provide general information related to past external appeal decisions. However, it does not guarantee or warrant that the information provided on this website is complete, accurate, or up-to-date. ![]() ![]() The Department of Financial Services makes every effort to post accurate and reliable external appeal information. 6) Haak, T., et al., Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. 5) Haak, T., et al., Use of Flash Glucose-Sensing Technology for 12 months as a Replacement for Blood Glucose Monitoring in Insulin-treated Type 2 Diabetes. Ford, Flash Glucose Monitoring System for Diabetes, in CADTH Issues in Emerging Health Technologies. Kautzky-Willer, Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes. 2) Oskarsson, P., et al., Impact of flash glucose monitoring on hypoglycaemia in adults with type 1 diabetes managed with multiple daily injection therapy: a pre-specified subgroup analysis of the IMPACT randomised controlled trial. Therefore, the request is not medically necessary.ġ) Bolinder, J., et al., Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. The patient does not have documentation of self-checking of blood glucoses four or more times a day. ![]() The patient has no documentation of being on an intensive insulin regimen. It was associated with sustained reduction in hypoglycemia and safely and effectively replaces blood glucose monitoring. It has been shown to be effective in patients with type II diabetes who are on intensive insulin therapy. The requested device is a flash glucose monitoring system that is FDA approved for persons age 18 and older with diabetes. Note - there are no log sheets provided for review. As per the provider's note the patient suffers from highly fluctuating blood glucose (BG) levels with hyperglycemia that needs regular monitoring. As per the denial letter the patient uses insulin her A1C was 6.1 %. This request is for continuous glucose monitor (CGM) Libre Freestyle (K0553). This is a female diagnosed with type II diabetes mellitus (T2DM). The proposed CGM system is not medically necessary. The System is intended for single patient use and requires a prescription.Diagnosis: Type II diabetes mellitus Treatment:Continuous glucose monitoring system The insurer denied the Continuous glucose monitoring system. ![]() Interpretation of the System readings should be based on the glucose trends and several sequential readings over time. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. It is designed to replace blood glucose testing for diabetes treatment decisions. The FreeStyle Libre 14 Day Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. Labeling change - indications/instructions/shelf life/tradenameĪpproval for the FreeStyle Libre 14 Day Flash Glucose Monitoring System. Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated Be sure to look at the original PMA record for more information.įreeStyle Libre 14 Day Flash Glucose Monitoring System A supplement may have changed the device description/function or indication from that approved in the original PMA. Note: This medical device record is a PMA supplement. ![]()
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