FDA Approves Dosing for Dexcom G5 CGM, Could Pave Way for Medicare Coverage

December 20, 2016

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 FDA today expanded its approval for Dexcom’s G5 mobile continuous glucose monitor (CGM), which would allow people with diabetes to use the device for dosing decisions and could pave the way for Medicare to more routinely cover CGM technology. The change, long sought by patient advocates and prominent clinicians, allows CGM users to make treatment decisions without a finger stick blood test.

“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 FDA advisory panel approved the change, following a daylong hearing where dozens of witnesses said that the expanded approval would catch up with how persons with diabetes were using the Dexcom G5 in the real world. But the official change from an “adjunctive” use, to one that states users can safely decide when to use insulin and how much based on the data they see, has huge importance in the world of reimbursement.

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 commentary for JAMA that discussed the need for the 2 agencies to collaborate on sharing evidence, especially as the use of data to improve population health increases. FDA’s Califf has previously spoken of how the use of electronic health records could reduce the cost of clinical trials, while Medicare is moving toward more reliance on value-based payment models to control cost while improving quality.

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 diabetes test strips, which allow persons with T1D to check blood glucose levels.

Dan Patrick, who has lived with T1D more than 50 years and wrote about his experience with a Medicare CGM appeal for Evidence-Based Diabetes Management, said today’s FDA decision will call attention to CMS’ current thinking on what it will cover for persons with diabetes.

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 several studies at the 76th Scientific Sessions of the American Diabetes Association in June that showed how the G5 could be used safely for dosing, that patients who used it were more attentive to their disease management, and that these patients had less variability in their blood glucose levels.