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New definition opens the door to full Medicare coverage for CGMs.
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.
JDRF has advocated for coverage of CGM for years. This ruling could have a significant impact on the lives of people with type 1 diabetes, specifically, because by the time they reach the age where they are eligible for Medicare they are often in the fourth, fifth or sixth decade of their disease and are even more susceptible to episodes of hypoglycemia.
“CGMs can help prevent these episodes by providing trend information and warnings when blood sugar is becoming low,” Rice said. “CGMs enable people to eat something or take other action to prevent severe low blood sugar.”
Prior to this decision, many people with type 1 diabetes who were not privately insured had to pay for these devices out of pocket, which could cost anywhere from $4,000 to $5,000, according to Rice.
Moving forward, Rice recommended that Medicare beneficiaries work with their doctors and CGM providers to get their devices covered.
“The decision lays out a number of parameters that the agency is going to follow moving forward,” Rice explained. “They will make case-by-case decisions about whether a CGM is medically necessary for given beneficiaries.”