Inspire Medical Systems, Inc., a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea, announced that two draft Local Coverage Determinations (LCDs) were published proposing coverage of Inspire therapy.
The proposed draft LCDs are available on the Medicare Coverage Database site for public review. The Medicare Administrative Contractors (MACs) issuing these first two policies are Noridian and Palmetto, which collectively represent 19 states. Following the public comment period, which is expected to be 60 days, Noridian and Palmetto will host formal review meetings in September and October, respectively. Final policies are expected to be issued by Noridian and Palmetto in 2020.
Both draft LCDs from Noridian and Palmetto state that for individuals with obstructive sleep apnea who are treated with hypoglossal nerve stimulation, the evidence is sufficient to determine that the technology
results in a meaningful improvement in the net health outcomes when utilized as outlined in the LCDs. The criteria for potential patients identified in the draft policy are closely aligned with the approved U.S. Food and Drug Administration indication statement for Inspire therapy.
“This is a very positive advancement for the Medicare-aged population that has the potential to streamline their access to Inspire therapy. 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,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems.
Noridian covers Medicare patients in Alaska, Arizona, California, Hawaii, Idaho, Montana, North Dakota, Oregon, South Dakota, Utah, Washington and Wyoming. Palmetto covers Medicare patients in Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia and West Virginia.
Source: Inspire Medical Systems