Inspire Medical Systems, Inc, a medical technology company focused on the development and commercialization of solutions for patients with obstructive sleep apnea, announced that two additional draft Local Coverage Determinations (LCDs) were published proposing coverage of Inspire therapy.

The two additional proposed draft LCDs are available on the Medicare Coverage Database site for public review. The Medicare Administrative Contractors (MACs) issuing these two policies are Novitas Solutions and First Coast Service Options, which collectively represent 12 states and the District of Columbia. Concurrently, First Coast has cancelled its existing negative policy on Inspire therapy.

The proposed policies are currently in the public comment period, which is expected to be 60 days, and Novitas and First Coast may host formal review meetings during this process. The final LCDs are expected to be published in early 2020. Two other MACs, Noridian and Palmetto, previously published their draft coverage policies. In total, these four MACs represent Medicare patients in 31 states and the District of Columbia.

The draft LCDs from Novitas and First Coast are consistent with the previous publication of LCDs from Noridian and Palmetto, which 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 US Food and Drug Administration indication statement for Inspire therapy.

“These two new LCDs represent another key step in establishing consistent Medicare coverage across the United States for Inspire therapy. Importantly, the reversal of the First Coast negative policy now provides access to Inspire therapy to Medicare patients in Florida,” Tim Herbert, president and chief
executive officer of Inspire Medical Systems, says in a statement.

Novitas covers Medicare patients in Colorado, New Mexico, Arkansas, Delaware, Louisiana, Maryland, Mississippi, New Jersey, Oklahoma, Pennsylvania, Texas and the District of Columbia. First Coast covers Medicare patients in Florida.

There are three remaining MACs and Inspire anticipates draft policies in the near future from these entities: CGS Medicare, representing Kentucky and Ohio; NGS Medicare, representing Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Rhode Island, Vermont and Wisconsin; and Wisconsin Physicians Service Government Health Administrators, representing Indiana, Iowa, Kansas, Michigan, Missouri, and Nebraska.