
FDA Approves Dosing for Dexcom G5 CGM, Could Pave Way for Medicare Coverage
On the day of the approval, top FDA and CMS officials write in JAMA of the need to share data for better healthcare delivery.
The
“The FDA works hard to help ensure that novel technologies, which can reduce the burden of daily disease management, are safe and accurate,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the agency’s Center for Devices and Radiological Health. “Although this system still requires calibration with 2 daily finger sticks, it eliminates the need for any additional finger stick blood glucose testing in order to make treatment decisions.
“This many allow some patients to manage their disease more comfortably and may encourage them to have routine dialogue with their healthcare providers about the use of real-time continuous glucose monitoring,” he said.
The decision comes nearly 5 months after and
As CGM use has increased, persons with type 1 diabetes (T1D) who reached at 65 found themselves at crossroads: if they wanted to continue using CGM, they would likely have to pay out of pocket, since Medicare approval for the technology was extremely rare and involved a multi-step appeal.
Thus, the patients who arguably needed CGM the most—those who have lived with T1D for decades and were “hypo-unaware”—would suddenly lose access to technology that stood the greatest chance of preventing an event that could lead to hospitalization or death.
FDA’s move comes the same day Commissioner Robert M. Califf, MD, and CMS Acting Administrator Andrew Slavitt, MBA, co-authored a
As the commentary noted, however, FDA approves drugs and devices based on a standard of “substantial evidence,” while CMS makes coverage decisions based on whether products that have already met FDA muster are “reasonable and necessary.” Patients have told The American Journal of Managed Care that Medicare has increasingly narrowed choices for those with diabetes, from which pumps it will pay for, to which insulin it approves, to its controversial bidding program for
Dan Patrick, who has lived with T1D more than 50 years and wrote about his experience with a
For example, Patrick said, using the Dexcom G5 mobile CGM for dosing demands that users commit to recalibrating with a blood test twice a day (Dexcom officials say the same thing, and in fact, have said they need to educate patients on this point.)
But, if Medicare ultimately pays for the Dexcom CGM, the quality of the test strip becomes critical. “The choice of any blood glucose strip will not work,” he said.
Dexcom presented
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