Continuous glucose monitors (CGM) have emerged as effective tools to measure and check glucose levels in real-time 24 hours per day, and are established devices for diabetes management in the growing diabetics population. Though these devices are covered under private health policies, they weren’t eligible for Medicare coverage. Although, that could soon change, in accordance to a recently released ruling.
Continuous glucose monitors (CGM) use a tiny electrode known as a glucose sensor which is inserted under the sufferer’s skin to measure glucose levels in the tissue fluid. The sensor connects to a transmitter to send the data through the wireless radio frequency to a monitoring and display device.
Most CGMs are passed by the U.S. Food and Drug Administration (FDA) as “adjunctive devices.” This means the data collected from them is supposed to be utilized in addition to the blood glucose data sourced from other devices for taking treatment decisions. Those decisions can’t be taken solely on the basis of adjunctive devices.
In the recent ruling, the Centers for Medicare & Medicaid Services (CMS) has identified continuous glucose monitors (CGM) as “durable medical equipment” under the Medicare Part B, which permits for Medicare coverage of CGMs on a case-to-case basis.
Although, merely those CGMs that are utilized to inform treatment decisions, like changing the diet of a sufferer or his insulin dosage based solely on the readings of the CGM, will be eligible for Medicare coverage.
FierceBiotech reports that merely one CGM, Dexcom’s G5, qualifies for the criteria, as the FDA expanded the indications in making the diabetes treatment decisions.
Kevin Sayer, Dexcom President and Chief Executive Officer, applauded the decision and reflected willingness to work with Medicare “to make sure beneficiaries have access to this life-saving device.”
JDRF, the leading international organization funding type 1 diabetes research, also hailed the decision. The nonprofit, which has been highly advocating for public and private payer coverage of such devices, claimed the latest CMS ruling as “a pathway toward the extension of coverage for the devices that will bring the nation’s greatest insurer in line with the huge majority of the private payers of country.
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