Dexcom CGM Granted Medicare Coverage

The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System will now be covered as durable medical equipment under Medicare Part B for people with Type 1 or Type 2 diabetes who are on intensive insulin therapy.

The Dexcom G5 Mobile is composed of a sensor, a transmitter, and either a compatible mobile device, such as a smartphone or tablet, or a receiver. The sensor is inserted under the skin, where it continuously monitors the glucose level of the interstitial fluid (the fluid between cells). These values are sent to the mobile device or receiver via the transmitter every five minutes.

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According to the U.S. Centers for Medicare & Medicaid Services (CMS), to qualify for coverage, a system must be defined as therapeutic CGM, meaning that treatment decisions can be made using the device. The Dexcom G5 Mobile CGM is the only system designated as a therapeutic CGM, having received approval from the U.S. Food and Drug Administration (FDA) in January 2017 as a replacement for traditional fingerstick monitoring to determine insulin dosing in people two years of age and older with diabetes.

Medicare may cover therapeutic CGM 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.

Coverage is in effect for claims with dates of service after January 12, 2017.

“This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM,” noted Kevin Sayer, president and CEO of Dexcom. “This decisions supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”

For more information, see the Dexcom press release “Medicare Announces Criteria Covering Dexcom G5 Mobile CGM for All People With Diabetes on Intensive Insulin Therapy.” And to learn more about using a CGM, read “Making More Effective Use of Your Continuous Glucose Monitor,” by certified diabetes educator Gary Scheiner.

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