Abbott announced yesterday that its recently cleared FreeStyle Libre 2 integrated continuous glucose monitoring (CGM) system is now covered by the Centers for Medicare and Medicaid Services (CMS), and available to Medicare beneficiaries with diabetes who meet eligibility criteria.
Indicated for diabetes management in patients aged four years or older, the updated version of Abbott's system can sound the alarm when a user's glucose is out of range. Data from a 14-day upper-arm sensor is transmitted to a handheld device, which the wearer can use to view their current readings and recent trends.
"Abbott designed the FreeStyle Libre portfolio for performance, access and affordability to make it broadly available to people with diabetes who need it," Jared Watkin, SVP of diabetes care at Abbott, said in a statement. "By securing reimbursement, Abbott is making sure our latest life-changing technology can get to everyone who needs it, whether they're children, adults or seniors eligible for Medicare."
WHAT'S THE IMPACT?
According to the CDC and CMS, diabetes affects roughly 25% of U.S. adults aged 65 years or older.
While prior devices in the FreeStyle Libre family have already been available to this population, access to the Libre 2's automated alert features could simplify the challenges of glucose management for these older adults.
Of note, the coverage also comes in the midst of a COVID-19 public health crisis where self-monitoring and remote patient monitoring tools are helping reduce unnecessary medical visits or avoidable exposures.
“Under normal circumstances, managing diabetes can be difficult. But with the global pandemic and the increased risk of complications people with diabetes face from COVID-19, we’re seeing an even greater role for technology to help manage this condition,” Dr. Mahmood Kazemi, divisional VP of global medical and scientific affairs and chief medical officer for diabetes care at Abbott, told MobiHealthNews in an email statement. “Now with Medicare reimbursement, people over 65 will have access to the latest advancement in diabetes technology, FreeStyle Libre 2, that enables remote monitoring, allowing users and their physicians to make more informed decisions about their care while minimizing in-person visits and risk of exposure.”
THE LARGER TREND
Abbott’s original Freestyle Libre system became the first CGM to be FDA-cleared for 10-day use without fingersticks back in 2017. Abbott followed up in 2018 with another clearance for its FreeStyle Libre 14 Day Flash Glucose Monitoring System, and just a few months ago saw the FreeStyle Libre 2 cleared by the FDA.
CGMs and other remote monitoring devices have picked up steam during COVID-19, thanks in part to federal policies allowing for temporary expanded use. Abbott noted in yesterday's announcement that its other FreeStyle systems have seen new use inside of the hospital, as well as expanded coverage and enforcement discretions from CMS.
And on that CMS medical-device-coverage front, the Centers proposed a new rule this week that would give devices with the FDA's Breakthrough Device designation automatic coverage for four years once authorized by the regulator.
