SAN DIEGO--(BUSINESS WIRE)--DexCom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for people with diabetes, is pleased to announce that the U.S. Centers for Medicare & Medicaid Services (CMS) has published an article clarifying criteria for coverage and coding of the Dexcom G5 Mobile system, the only therapeutic CGM under this CMS classification. People covered by Medicare who have either Type 1 or Type 2 diabetes and intensively manage their insulin will now be able to obtain reimbursement.
“This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM,” said Kevin Sayer, President and Chief Executive Officer, Dexcom. “This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”
According to CMS, therapeutic CGM may be covered by Medicare when all of the following criteria are met:
- The beneficiary has diabetes mellitus; and,
- The beneficiary has been using a home blood glucose monitor (BGM) and performing frequent (four or more times a day) BGM testing; and,
- The beneficiary is insulin-treated with multiple daily injections (MDI) of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,
- The patient’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results.
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. Dexcom G5 Mobile is the only system approved by the FDA to meet that criteria.
See the Medicare Administrative Contractor (MAC) website for instructions for individual claim adjudication. Coverage is effective for claims with dates of service on or after January 12, 2017. A link to the article on coding and coverage can be found at: https://med.noridianmedicare.com/web/jddme/policies/dmd-articles/coding-and-coverage-therapeutic-continuous-glucose-monitors.
To learn more about CGM, visit www.dexcom.com.
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.
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.