The new definition applies to CGM devices that have FDA approval for dosing decisions. Right now, Dexcom's G5 meets the 5-part test.
CMS on Thursday added continuous glucose monitors (CGM) approved for dosing to its definition of durable medical equipment, which an advocacy group called “a significant step toward making them eligible for coverage under Medicare.”
JDRF, which has led the drive for CGM coverage in Medicare, announced the change in a statement late Thursday, saying that change created a “pathway toward the extension of coverage for the devices that will bring the nation’s largest insurer in line with the vast majority of the country’s private payers.”
“JDRF is encouraged by this decision, which will bring us one step closer to Medicare coverage for continuous glucose monitors,” said Aaron Kowalski, PhD, chief mission officer. The group thanked leaders in Congress who had pressed for this change, including US Senators Susan M. Collins (R-Maine) and Jeanne Shaheen (D-New Hampshire). (Collins authored a commentary in support of CGM coverage in Evidence-Based Diabetes Management.™)
CGM, which gives patients real-time data on their blood glucose levels—and where they are headed—has been shown to help patients reduce glycated hemoglobin (A1C) and greatly limit glucose variability—the highs and lows in levels that have harmful health effects. Because the original FDA approval required patients to take a separate finger-stick test each time they decided how much insulin to use, Medicare had labeled the devices “adjunctive,” and thus not eligible for reimbursement. Thursday’s decision reclassifies devices with proper FDA labeling as “therapeutic,” which should open the door to payer coverage.
Dexcom, the manufacturer of a CGM that last month won FDA approval for use in deciding insulin doses, hailed the decision. “This landmark CMS ruling will make available the most important technology in diabetes management to the Medicare population,” said Kevin Sayer, president and CEO of Dexcom.
Sayer vowed last July to work for Medicare coverage of CGM, the day after an FDA panel voted to amend approval of Dexcom’s mobile G5 to allow patients to make dosing decisions without a separate finger stick.
The lack of coverage for CGM has been a growing concern among patients, especially those with type 1 disease (T1D). As CGM use gained wider acceptance among T1D patients, frustration mounted that patients over age 65 had to pay for CGM out of pocket or go without, even though they might benefit the most from the technology. As individuals with T1D age and live with diabetes for longer periods, they become “hypo-unaware,” which means they stop experiencing symptoms that signal they are heading into hypoglycemia. Use of CGM warns patients their blood glucose is plummeting and allows time to take action, avoiding a trip to the emergency department.
Allowing CGM coverage for Medicare patients would potentially help more hospitals and health systems avoid 30-day readmissions, which is a key quality indicator as the nation’s health system moves to a value-based payment system. JDRF has frequently cited a 2011 study by The American Journal of Managed Care® that found each inpatient admission from hypoglycemia costs $17,564.
CMS spelled out 5 specific criteria for a device to meet the definition of durable medical equipment:
· It can withstand repeated use
· It has an expected life span of at least 3 years
· It serves a medical purpose
· It is generally not useful in the absence of a disease or injury
· It is appropriate for home use
Right now, the Dexcom G5 meets these criteria, but rapid developments in “artificial pancreas” technology make it possible, and even likely, that other devices will meet the definition in the future.