By Craig Idlebrook/GluCraig
There has been a curious quirk in Medicare policy that has caused many people with diabetes to have to choose between dumbing down a medical device or forgoing coverage for it. At long last, that quirk will be confined to red tape history.
On June 11th, the Centers for Medicare and Medicaid Services (CMS) announced on its website that it would finally allow Medicare recipients who use the Dexcom G5 continuous glucose monitor (CGMs) to connect this device to mobile smart devices. These Dexcom users will also be allowed to share their blood glucose readings with others using an app. This may sound like common sense usage for a bluetooth-enabled medical device, but until now CMS had insisted that Medicare recipients disable the bluetooth feature of the Dexcom G5 if they wanted Medicare to cover the costs of the device and supplies.
The CMS announcement that the change was made partly because of community feedback, and Dexcom senior vice president Claudia Graham praised in a press release the efforts of the diabetes community in advocating for this change.
According to a JDRF position statement on CGM coverage, the Dexcom G5 was caught up in regulatory limbo because it was perceived that bluetooth connectivity rendered the receiver of the CGM useless; regulators reasoned that the CGM without the receiver could therefore not be considered a medical device.
This is not the first time that CMS regulations have been slow to provide coverage for CGMs. While CGMs have been on the market since 1999, they didn’t receive CMS coverage until early 2017. It was only after the FDA ruled that the Dexcom G5 could be used for dosing decisions in place of fingersticks in 2016 that CMS finally granted coverage for the G5 shortly thereafter. CMS coverage currently only applies, however, to CGMs that are considered accurate enough to replace fingersticks; right now, that list only includes the G5 and the Abbott Freestyle Libre.
The new ruling on bluetooth-connected CGMs currently only applies to the Dexcom G5. It also doesn’t officially take effect until the outside contractors who process CMS claims “issue a revised policy article in the near future,” according to the CMS announcement.
The announcement did not give a definition of what the “near future” meant.
You can read Dexcom’s press release on the announcement here.
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