CMS will cover some CGMs, starting with Dexcom G5

By Heather Mack
12:26 am

The Centers for Medicare and Medicaid Services has deemed certain therapeutic continuous blood glucose meters (CGMs) as durable medical equipment and thus are eligible for coverage.

It’s not all cut and dry, of course. Eligible devices must fit several definitions: they must be a class III, FDA-approved device, and they must be CGMs that measure blood glucose levels periodically by using sensors, a receiver and transmitter and eliminate the need for blood glucose strips, informing patients and their doctors in treatment decisions.

Those that are to be used as adjunctive devices, even if approved by the FDA, will still not be covered.

“In our view, such devices are not used for making diabetes treatment decisions, such as changing one’s diet or insulin dosage based solely on the readings of the CGM, and therefore, have not been covered under Medicare because they are not considered to serve the medical purpose of making diabetes treatment decisions,” CMS wrote in their ruling.

CGMs that fall in the benefit category must be used only for the purpose of monitoring glucose levels –  it must be by prescription, “primarily and customarily used to serve a medical purpose” and calibrated twice per day with a blood glucose monitor, it must be cleared by the FDA for appropriate use in the home, and must have an expected life of at least three years.

One such device does make the cut: the Dexcom G5 Mobile, and it’s currently the only one that falls within the CMS’s new benefit category classification.

“This landmark CMS ruling will make available the most important technology in diabetes management to the Medicare population,” Dexcom President and CEO Kevin Sayer said in a statement.  “We are pleased with this important step forward and we look forward to working with Medicare on implementing coverage in the coming months to ensure beneficiaries have access to this life-saving device.”