Minneapolis-based Inspire’s sleep apnea device uses hypoglossal nerve stimulation to treat obstructive sleep apnea.
The two LCDs will be issued by Noridian Medicare and Palmetto GBA. The two companies collectively represent 19 states.
According to a release, the LCDs were based on evidence that Inspire’s sleep apnea therapy delivers a meaningful improvement in net health outcomes. The release added that criteria for potential patients identified in the draft policy are closely aligned with the approved FDA indication for the Inspire therapy.
Following a 60-day comment period, Noridian is slated to hold formal review meetings in September, while Palmetto is due for the same in October. Inspire expects Noridian and Palmetto to issue their final policies in 2020.
“This is a very positive advancement for the Medicare-aged population that has the potential to streamline their access to Inspire therapy,” president & CEO Tim Herbert said in prepared remarks. “The Inspire team has worked closely with the MACs, and specifically Noridian and Palmetto, to provide the published clinical literature for Inspire therapy, and to respond to any questions raised during their policy reviews. We look forward to the formal policies from Noridian and Palmetto, and anticipate that other MACs will also soon issue their draft policies for Inspire therapy.”
INSP shares were up 1.1% to $64.75 apiece today in early trading.