When I first read about this a couple
of weeks ago, I was not happy with the American Association of
Clinical Endocrinologists. My first thoughts were that the AACE
would undo some of the good that the group Strip Safety had
accomplished. But the more I thought about it, I soon realized that
Alan J. Garber, M.D. of nefarious fame of the AACE was not calling
the shots. I also realized that the more help for diabetes and the
tools for diabetes, the better off we all could be.
The letter, signed by AACE president
Mack Harrell, MD, and president-elect George Grunberger, MD, called
for the passage of two bills: the Medicare CGM Access Act
(HR5644/S2689), and the National Diabetes Clinical Care Commission
Act (HR1074/S539). The latter would establish a public/private
commission to coordinate activities that currently span 35 federal
departments, agencies, and offices, according to the statement.
The letter also asks Congress to
conduct follow-up hearings to examine FDA's pre- and postmarketing
surveillance and enforcement activities for medical devices, along
with a call for a review of Medicare's competitive bidding practices.
With regard to the FDA, the AACE is asking for more rigorous pre-
and postmarket surveillance of glucose testing supplies and the
prohibition of devices that don't meet current quality standards.
The above are all needed and if
accomplished, could be a big help for all people with diabetes. The
Medicare CGM Access Act promotes Medicare coverage of continuous
glucose monitors. Currently, Medicare does not reimburse for CGM,
which means that well-controlled patients with type 1 diabetes lose
an important means of monitoring once they hit the eligibility age of
65. Grunburger said it is unclear why Medicare does not cover the
devices, despite the evidence of benefit and cost savings. The
device has been associated with a reduction in hospitalizations for
hypoglycemia.
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