Statements on Introduced Bills and Joint Resolutions

Floor Speech

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Ms. COLLINS. Mr. President, as the founder and co-chair of the Senate Diabetes Caucus, I have learned a great deal about this devastating disease affecting nearly 29 million Americans. Fortunately, due to the Special Diabetes Program and increased investments in diabetes research, we have seen some encouraging breakthroughs and are on the threshold of a number of important new discoveries.

This is particularly true for the estimated 3 million Americans living with type I diabetes. Advances in technology, like continuous glucose monitors, are helping patients control their blood glucose levels, which is key to preventing costly and sometimes deadly diabetes complications. We are also moving closer and closer to our goal of an artificial pancreas, which would control blood glucose levels automatically and revolutionize diabetes care.

The National Institutes of Health and the Food and Drug Administration have been extremely supportive of these innovations in diabetes care. I was therefore surprised and extremely troubled to learn that insulin-dependent Medicare beneficiaries are being denied coverage for continuous glucose monitors, or CGMs, because the Centers for Medicare and Medicaid Services, CMS, has determined that they do not meet the Medicare definition of durable medical equipment and do not fall under any other Medicare category. As a consequence, we are seeing situations--similar to what we saw with insulin pumps in the late 1990s--where individuals with type 1 diabetes have had coverage for their continuous glucose monitor on their private insurance, only to lose it when they age into Medicare.

A CGM is a physician-prescribed, FDA-approved medical device that can provide real-time readings and data about trends in glucose levels every five minutes, thus enabling someone with insulin-dependent diabetes to eat or take insulin and prevent dangerous low or high glucose levels. As demonstrated by extensive clinical evidence, adults using a CGM have had improved overall glucose control and have reduced rates of hypoglycemia or low blood glucose levels. Professional medical societies, including the American Association of Clinical Endocrinologists and the Endocrine Society, recognize this clinical evidence and have published guidelines recommending CGM be used in appropriate patients with type 1 diabetes. Today, about 95 percent of commercial insurers provide coverage for CGM devices.

The ironic thing is that it is only because of advances in diabetes care like the continuous glucose monitor that people with type 1 diabetes can expect to live long enough to become Medicare beneficiaries. I am particularly concerned given the implications that this coverage decision will have for future decisions regarding artificial pancreas systems, which will combine a continuous glucose monitor, insulin pump, and sophisticated algorithm to control high and low blood sugar around the clock.

I am therefore joining my colleague from New Hampshire and my Co-Chair of the Senate Diabetes Caucus in introducing the Medicare CGM Access Act of 2014 to create a separate benefit category under Medicare for the continuous glucose monitor and require coverage of the device for individuals meeting specified medical criteria.

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