Statements on Introduced Bills and Joint Resolutions

Floor Speech

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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
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.

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