November 2, 2014
AACE Urges Congress to Act
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.