On January 12, the Centers for Medicare & Medicaid Services (CMS) announced a ruling that would classify certain continuous glucose monitors (CGMs) as durable medical equipment (DME), a significant step toward making them eligible for coverage under Medicare.
“Continuous blood glucose monitors are important for people with diabetes because they help people to get better diabetes control,” Cynthia Rice, JDRF senior vice president for advocacy and policy for diabetes funding and research group JDRF told Medical Economics. “Extensive research has shown better diabetes outcomes when using CGMs, which is why all guidelines recommend them for patients with type 1 diabetes and why nearly all private insurance plans cover them.”
Until recently, CMS did not cover CGM devices under Medicare, although regular blood glucose monitors have been covered since the early 1980s. CMS defines DMEs as items that can withstand repeated use, have an expected life of at least 3 years, are primarily used for a medical purpose, are not useful to someone without illness and are appropriate for use in the home.
According to the ruling, the FDA recently approved expanding the indications of one CGM product to include replacement of blood glucose monitors for diabetes treatment decisions, as opposed to using CGM as a complement to regular blood glucose monitors. Under the FDA definition, interpretation of the CGM results should be based on the glucose trends and several sequential readings. In addition, the CGM can aid in detection of episodes of hyperglycemia and hypoglycemia, allowing for acute and long-term therapy adjustments.
“Based on this information, the therapeutic CGM is designed and approved to replace a blood glucose monitor currently classified as DME under the Medicare program,” the ruling states. “Because they are used directly in making diabetes treatment decisions, as opposed to alerting the patient to use a blood glucose monitor to make those decisions, they are not precautionary in nature.”
Put more simply, a CGM system could replace traditional blood glucose monitors for glucose monitoring purposes, and as a result the CGM would be considered a DME.