[Congressional Record Volume 161, Number 47 (Thursday, March 19, 2015)]
[Senate]
[Pages S1663-S1664]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Ms. COLLINS (for herself and Mrs. Shaheen):
  S. 804. 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 the cochair of the 
Senate Diabetes Caucus, I have learned much about this devastating 
disease affecting nearly 29 million Americans. Fortunately, due to the 
Special Diabetes Program and to increased investments in diabetes 
research, we have seen some exciting breakthroughs and we are on the 
threshold of a number of important new discoveries.
  This is particularly true for the estimated 1.2 million Americans 
living with type 1 diabetes. Advances in technology such as continuous 
glucose monitors are helping patients control their blood glucose 
levels, which is key to preventing costly and sometimes deadly diabetes 
complications. We are moving closer and closer to our goal of an 
artificial pancreas.
  The National Institutes of Health and the Food and Drug 
Administration have been extremely supportive of these innovations in 
diabetes care. I was, therefore, shocked and troubled to learn that 
insulin-dependent Medicare beneficiaries are being denied coverage for 
continuous glucose monitors because the Centers for Medicare and 
Medicaid Services has determined that they do not meet the definition 
for 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 monitors on 
their private insurance, only to lose that coverage when they get old 
enough to become eligible for Medicare.
  Let me give some brief background. A continuous glucose monitor is a 
physician-prescribed, FDA-approved medical device that can provide 
real-time readings and data about trends in glucose levels every 5 
minutes, thus enabling someone with insulin-dependent diabetes to eat 
or take insulin and prevent dangerously high or low glucose levels.
  There has been essential and extensive clinical evidence that shows 
that individuals using this device have improved overall glucose 
control and, thus, reduced rates of hypoglycemia or low blood glucose 
levels. That is why professional medical societies have recognized the 
clinical evidence and have published guidelines recommending that these 
monitors be used in appropriate patients with type 1 diabetes.
  Now, here is the fact that is astonishing to me. About 95 percent of 
commercial insurers provide coverage for continuous glucose monitors, 
but Medicare is refusing to provide coverage for those devices. I 
recently heard about this problem from one of my constituents, 74-year-
old Prudence Barry of Portland, ME. Diabetes treatments have changed 
dramatically since Pru was diagnosed with type 1 diabetes back in 1954. 
Back then, it was very difficult for her to control her insulin levels 
and to get her glucose levels properly read. Well, Pru has led an 
active and fulfilling life. Living with type 1 diabetes for more than 
60 years has taken its toll.
  Today, Pru no longer feels it when her blood glucose levels drop to 
dangerous levels, causing her to lose consciousness and suffer seizures 
more frequently. Nighttime low sugars are particularly troubling. She 
fears the possibility of her blood sugar developing so low during the 
night that she never wakes up. The continuous glucose monitor is a 
potential lifesaver for Pru because it prevents these dangerously high 
or low blood glucose levels by alarming the wearer when the glucose 
levels fall outside of the safe range.
  So even though 95 percent of private insurers cover this technology, 
Medicare does not. As a consequence, Pru does not have access to the 
potentially lifesaving device because she cannot afford to pay for it 
out of pocket. Pru is not alone. There are thousands of seniors with 
type 1 diabetes who like my constituent are denied access to this

[[Page S1664]]

technology that would help keep them healthy and safe.
  The ironic thing is it is only because of advances in diabetes care, 
such as continuous glucose monitors, that people with type 1 diabetes 
can expect to live long enough to become Medicare beneficiaries. So I 
am very concerned about this decision by CMS. It makes absolutely no 
sense. It contradicts all the work NIH and the FDA are doing to get new 
innovative treatments and technologies to patients.
  I brought this up in a recent hearing of the HELP Committee and asked 
the outgoing FDA Commissioner what she thought. She expressed her 
regret about the lack of consultation between her agency and CMS about 
payments for FDA-approved devices and drugs. 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.

  This coverage decision on the part of CMS--which, after all, is also 
part of the Department of Health and Human Services--directly 
counteracts all of the work that the NIH and the FDA are doing to get 
new innovative treatments and technologies to patients. As I said, I 
recently had the opportunity at a HELP Committee hearing to ask 
outgoing FDA Commissioner Hamburg whether CMS consults with her agency 
when making these kinds of coverage decisions. In response to my 
question, Commissioner Hamburg expressed regret that her agency does 
not routinely consult with CMS about payments for FDA-approved drugs 
and devices, saying that the FDA should ``look at the whole ecosystem 
of biomedical product development and use, and recognize that each of 
the different components that often operate in silos actually are very 
interdependent.'' I completely agree with her assessment.
  I am therefore joining my colleague from New Hampshire and the 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.
  Our legislation is strongly supported by a coalition of 
organizations, including the American Association of Clinical 
Endocrinologists, the American Association of Diabetes Educators, the 
Endocrine Society and the JDRF.
  I encourage my colleagues to join us as cosponsors of this important 
legislation.
  I see Senator Leahy has come to the floor and undoubtedly wants to 
speak on the pending business. Let me conclude my remarks by saying I 
am very pleased the Senator from New Hampshire, Jeanne Shaheen, who is 
the cochair of the Senate Diabetes Caucus, is joining me in introducing 
the Medicare CGM Access Act to create a separate benefit category under 
Medicare for these monitors and to require coverage of the device for 
seniors who are meeting specified medical criteria.
  Mr. President, I ask unanimous consent that a letter of endorsement 
be printed in the Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                   March 15, 2015.
     Hon. Susan Collins, 
     U.S. Senate, Dirksen Senate Office Building,
     Washington, DC.
     Hon. Jeanne Shaheen,
     U.S. Senate, Hart Senate Office Building,
     Washington, DC.
       Dear Senators Collins and Shaheen, Therapy innovation is 
     moving forward at a rapid pace for those living with insulin-
     dependent diabetes. As leaders of the Senate Diabetes Caucus, 
     you have worked to catalyze these efforts by ensuring 
     American patients have access to these life-saving 
     technologies that can transform quality of life. Advancements 
     in integrated insulin pump and continuous glucose monitoring 
     (CGM) technologies are progressing toward closed-loop 
     ``artificial pancreas'' systems that will enable greater 
     patient care and improved health outcomes. With these 
     technology advancements, thankfully, most children with type 
     1 diabetes will be Medicare beneficiaries one day, something 
     that could not have been said with such certainty even 20 
     years ago.
       While thousands of people with insulin-dependent diabetes 
     benefit from advanced diabetes technologies, including CGM, 
     Medicare beneficiaries do not. CGM is covered by nearly all 
     private health plans. Numerous studies have demonstrated 
     conclusively that use of CGMs improves glucose control, 
     enabling better patient care, thereby improving patient 
     health. Studies have also shown that use of CGM devices 
     reduce severe hypoglycemia events, which particularly impact 
     elderly patients and can lead to falls, fractures and other 
     complications. The average cost of an inpatient hypoglycemia 
     admission is over $17,500.
       The undersigned organizations strongly support your 
     legislation, the Medicare CGM Access Act that would remedy 
     this disparity for those in Medicare. Your legislation 
     creates a new benefit category for FDA approved CGM devices, 
     including stand-alone CGM, CGM integrated with an insulin 
     pump, and future artificial pancreas device systems. This 
     therapy would be covered for those meeting appropriate 
     medical criteria consistent with private coverage and 
     professional clinical guidelines. Again, thank you for your 
     continued leadership on behalf of those with diabetes and we 
     look forward to working with you to move this legislation 
     forward quickly.
         American Association of Clinical Endocrinologists (AACE); 
           American Association of Diabetes Educators (AADE); 
           Dexcom; Endocrine Society; JDRF; Johnson & Johnson; 
           Medtronic.
                                 ______