[Congressional Record Volume 160, Number 121 (Wednesday, July 30, 2014)]
[Senate]
[Pages S5137-S5138]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS (for herself and Mrs. Shaheen):
  S. 2689. A bill to amend title XVIII of the Social Security Act to 
specify coverage of continuous glucose monitoring devices, and for 
other purposes; to the Committee on Finance.
  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

[[Page S5138]]

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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