Continuous glucose monitors, effective tools for diabetes management, are generally covered by private health plans, but not by Medicare. Now, a new Centers for Medicare & Medicaid Services ruling is laying the groundwork for Medicare coverage of the devices.
CGMs include a glucose sensor, which is inserted just under the skin and measures glucose levels in the interstitial fluid. A transmitter sends glucose information wirelessly to a receiver and/or a mobile device, where a patient may see a graph showing their glucose levels over time.
The CMS ruling, published Thursday, recognizes continuous glucose monitors as durable medical equipment under Medicare Part B. This allows the program to cover CGMs on a case-by-case basis, opening the possibility for broader coverage in the future.
However, the ruling only designates “therapeutic” CGMs as durable medical equipment, that is, CGMs that are used to inform treatment decisions. Most CGM systems are FDA-approved as adjunctive devices; the information they provide is meant to be used alongside blood glucose data from other devices, namely glucose monitors that return glucose readings from a drop of blood. Currently, Dexcom’s G5 CGM is the only device that meets this requirement—the FDA expanded the system’s indication to include the replacement of fingerstick blood glucose testing in making diabetes treatment decisions, such as changing one’s diet or insulin dosage.
“This landmark CMS Ruling will make available the most important technology in diabetes management to the Medicare population,” said Dexcom CEO Kevin Sayer, 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.”
Previously, Type 1 diabetics on Medicare—even those who previously had their CGMs covered by private insurers—had to pay out of pocket for their device, or go without, said JDRF in a statement.
“JDRF is heartened by today’s decision and will continue to work with officials at the Centers for Medicare & Medicaid Services to ensure robust coverage of CGMs for people with Type 1 diabetes on Medicare,” the nonprofit said.