The US Centers for Medicare & Medicaid Services (CMS) has modified its policy for coverage of continuous glucose monitors (CGMs) for diabetes to allow beneficiaries to use the devices with smartphones.
In March 2017, CMS agreed to cover the Dexcom Mobile G5 CGM System as durable medical equipment under Medicare Part B for beneficiaries with type 1 or type 2 diabetes who receive intensive insulin therapy.
That move was enabled by the US Food and Drug Administration’s (FDA’s) determination in December 2016 that the Dexcom G5 could be used “nonadjunctively,” meaning that the device could be used as a replacement for fingerstick blood glucose testing.
But at the time CMS stipulated that Medicare would only cover the Dexcom G5 when used with its dedicated receiver device and would not cover use with Dexcom’s smartphone app (available for iOS and Android) because the receiver is the only nondisposable (that is, “durable”) part of the system. (The sensors are worn for 7 days and the transmitters for 3 months, and then discarded.)
Although diabetes advocates had praised CMS for the overall coverage decision, they also decried the agency’s lack of recognition for the use of modern-day technology, which also left seniors without access to the “share” function, whereby loved ones could remotely follow blood glucose readings.
One endocrinologist deemed the lack of coverage for use of the device with the smartphone app “absolutely ridiculous.”
Turns out, CMS was listening. “CMS heard from numerous stakeholders who shared their concerns that Medicare’s CGM coverage policy limited their use of CGMs in conjunction with their smartphones…After a thorough review of the law and our regulations, CMS is announcing that Medicare’s published coverage policy for CGMs will be modified to support the use of CGMs in conjunction with a smartphone, including the important data sharing function they provide for patients and their families,” the agency said in a statement.
As per its January 2017 ruling about coverage for “therapeutic CGMs,” the CMS statement applies to CGMs with nonadjunctive indications in general, without specifying brand or version.
The Dexcom G6 system was recently approved by the FDA but is not yet covered by Medicare. It also just received a CE mark in Europe for people with diabetes ages 2 years and older, and is expected to be available in the UK and Ireland later this month, the company has just announced
The only other nonadjunctive CGM approved thus far in the United States, the Abbott FreeStyle Libre Glucose Monitoring System, is covered by Medicare but its smartphone app is not yet FDA-approved.
The CMS statement notes that the Durable Medical Equipment Medicare Administrative Contractors will issue a revised policy article in the near future, at which time the published change will be effective.