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Centers for Medicare & Medicaid Services (CMS) Classify Therapeutic Continuous Glucose Monitors (CGM) as "Durable Medical Equipment" under Medicare Part B

Freitag, 13.01.2017 03:30



SAN DIEGO --(BUSINESS WIRE)--

DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for people with diabetes, is pleased to announce the determination of a benefit category and coverage for CGM by CMS. In order to be included in this category, the system must be defined as “therapeutic” CGM, meaning you can make treatment decisions using the device. Today, the Dexcom G5 Mobile is the only CGM system that falls within this classification. A link to the full CMS Ruling No. CMS-1682-R can be found at www.cms.gov/Regulations-and-Guidance/Guidance/Rulings/Downloads/CMS1682R.pdf.

“This landmark CMS Ruling will make available the most important technology in diabetes management to the Medicare population,” said Kevin Sayer, Dexcom President and Chief Executive Officer. “We are pleased with this important step forward and we look forward to working with Medicare on implementing coverage in the coming months to ensure beneficiaries have access to this life-saving device.”

About Diabetes and Continuous Glucose Monitoring

With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.i,ii

Continuous glucose monitoring (CGM) is considered the most significant breakthrough in diabetes management in the past 40 years.iii CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high with built-in and customizable alarms. A recent study showed that after one year, patients with type 1 diabetes who used CGM alone had significant A1C reductions regardless of the type of insulin delivery method used, including insulin pumps.iv

About DexCom, Inc.

DexCom, Inc., headquartered in San Diego, CA, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. With exceptional performance, patient comfort and lifestyle flexibility at the heart of its technology, users have consistently ranked DexCom highest in customer satisfaction and loyalty. For more information on the DexCom CGM, visit www.dexcom.com.

References

i Hyperglycemia (High blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html. Updated August 5, 2013. Accessed December 3, 2013.

ii Hypoglycemia (Low blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Updated July 16, 2013. Accessed December 3, 2013.

iii Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus. Br J Biomed Sci. 2012;(3)2:83-93.

iv J. Soupal, J. Skrha Prazny, M. Flekac, L. Petruzelkova, J. Skrha, et al. Comparison of different treatment modalities for Type 1 diabetes including Sensor-Augmented Insulin Regimens (SAIR), in 52 weeks of follow ups: A COMISAIR Study. Diabetes Technology and Therapeutics. Vol 18, No. 9, Sept. 2016.

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