Medicare Issues Rules for CGM Coverage - No Smartphones Allowed

The good news is that after years of waiting, Medicare enrollees with type 1 diabetes (and some with type 2) will be able to get coverage for continuous glucose monitoring (CGM), based on a notice published earlier this week.

The bad news? Those who want the reimbursement must use the receiver that comes with the CGM system—and cannot use a smartphone app or tablet to display their glucose data. If they use their smartphone at all, even alongside the receiver, Medicare won’t pay.

Dexcom, maker of the only CGM that meets the bar for Medicare coverage, didn’t mention the smartphone issue when it announced the criteria had been published. “This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM,” said Dexcom President and CEO Kevin Sayer in a statement. “This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”

The company spent years gathering evidence on its G5 Mobile system, which in December received a new FDA indication that lets patients use CGM to make insulin dosing decisions without taking a finger-stick blood glucose test each time. Dexcom G5 users must still calibrate the device with finger-stick tests twice a day.

FDA’s decision paved the way for the Dexcom G5 Mobile to meet Medicare’s definition of “durable medical equipment” (DME), making it eligible for coverage. In fact, this week’s article published by the Medicare Administrative Contractors (MACs) states that Medicare coverage will cover claims retroactive to the DME decision date.

Enrollees seeking Medicare coverage for CGM must be on “intensive” insulin therapy and meet the following criteria:

• The person has diabetes mellitus
• The person has been using a home blood glucose monitor and performing finger-stick tests at least 4 times a day
• The person receives insulin either through multiple daily injections or a continuous insulin pump
• The prescribed treatment requires the person with diabetes to make frequent insulin dosing adjustments, based on therapeutic CGM results.

The criteria will cover virtually every person with T1D and some with T2D whose disease has significantly progressed. Because of their age and duration of living with diabetes, Medicare enrollees are those most likely to benefit from CGM, as they are more likely to reach a stage of being “hypo-unaware.” This happens to people with diabetes who no longer experience symptoms as they near a hypoglycemic event. CGM alarm systems can warn family members that the person with diabetes is in danger, especially at night.

Dexcom’s G5 Mobile system works with a sensor that attaches to the body to read blood glucose levels, before sending data to a receiver through Bluetooth technology. Unlike traditional finger-sticks, CGM data show the person with diabetes blood glucose patterns that allow them to adjust insulin or food intake before their levels become too high or too low.

Like other CGM systems, Dexcom’s G5 can also interact with a smartphone app, giving the patient one less device to carry. Some CGM systems can be used with software that allows third-parties—like a parent or caregiver—to read the blood glucose data remotely.

The MAC article states that because smartphones are not DME as defined by Medicare, enrollees cannot use them if they want their CGM system to be covered. “If a beneficiary uses a non-DME device (smartphone, tablet, etc.) as the display device, either separately or in combination with a receiver classified as DME, the supply allowance is non-covered by Medicare,” the article states.

Debra M. Parrish, an attorney who handled a landmark appeal of a Medicare CGM reimbursement denial, wrote in an update that the restriction barring the use of smartphone apps is “nonsensical.”

“Durable medical equipment does not become non-durable if Medicare beneficiary uses a smartphone app with the device,” Parrish wrote. “This novel restriction appears to be designed to ensure that the only CGM that is covered by Medicare will not be covered for those individuals who use it to its full functionality to monitor their glucose levels.”