Abbott's Freestyle Libre CGM Gains Medicare Coverage

Just months after FDA approved Abbott’s Freestyle Libre continuous glucose monitoring (CGM) system, which requires no regular finger sticks, Medicare will cover the product for certain seniors, the company has announced.

“At Abbott, we are continuously challenging ourselves to ensure our innovative technology is accessible to the majority of people who need it,” Jared Watkin, senior vice president, Diabetes Care, Abbott, said in the statement. “CMS’ recognition of this revolutionary health technology, which removes the need for any user calibration, is ultimately going to empower Medicare beneficiaries with diabetes to live better, healthier lives.”

It’s a remarkable turn of events for people with diabetes, who a year ago faced the prospect of losing coverage for CGM technology once they reached age 65. Just before the end of 2016, however, FDA granted a new indication for the Dexcom G5 Mobile, a different type of CGM system, paving the way for CMS to create the “therapeutic CGM” code within the umbrella of durable medical equipment (DME).

To receive coverage for therapeutic CGM, a beneficiary must have type 1 diabetes or be receiving intensive insulin therapy for type 2 diabetes; those eligible must document that their condition requires frequent insulin dosing adjustments, based on checking blood glucose levels at least 4 times a day.

The Abbott product has a very thin glucose sensor worn under the skin and connected to a body patch, slightly larger than a silver dollar, which is worn on the upper arm. To get data, users wave a reader over the sensor patch until it beeps; they can then read the data. However, the device does not have alarms to tell users if they are heading toward hypoglycemia or hyperglycemia, so this product may not be the best option for seniors who have hypo-unawareness (a condition that becomes more common with age and diabetes duration).

Abbott is touting the price of the Freestyle Libre as a chief benefit for both payers and patients, as well as its planned distribution through the pharmacy chain. In an email, an Abbott spokeswoman said that under existing codes, the reimbursement rate will be $3000 a year, with Medicare paying $2400 and the patient responsible for the co-payment. Abbott’s device has a retail price of $70 while sensors cost $36. In the United States, sensors are approved for 10 days, although in Europe they are used for 14 days.

For years, Medicare deemed CGM systems “adjunctive” because their FDA approval called for confirming blood glucose levels with a finger stick test before insulin dosing. In practice, however, as the Dexcom systems improved, users would make dosing decisions based on CGM data. A daylong hearing before an FDA panel in July 2016 prompted a new indication to allow dosing directly off the CGM, which in turn caused CMS to create the “therapeutic” category.

But the rollout wasn’t easy. Medicare DME providers initially balked at shipping the device when it didn’t come with a meter for calibrating the CGM, and Dexcom partnered with Ascensia to meet requirements for a Medicare “bundle.” Dexcom added staff to help Medicare beneficiaries get through the process.

Meanwhile, the factory-calibrated Abbott Freestyle Libre, which had been approved in more than 40 countries, received FDA approval on September 27, 2017. Many people in the United States were already aware of it through a vibrant patient online community and product reviews.

Glenn Johnson, general manager for Market Access at Abbott, said in an interview with The American Journal of Managed Care^® that both DME providers and CMS went through a “learning curve,” but he said those difficulties have been worked out. Patient eligibility requirements released in March 2017 apply to all products in the category, Johnson said, so the Abbott Freestyle Libre CGM should be available in all Medicare regions “right away.” Because the product is factory-calibrated, Medicare will not require the meter to be bundled with the product, an Abbott spokeswoman said in an email.

As soon as patients submit required documentation, Johnson said, “There is nothing further required for them to service the beneficiaries.”