Inspire Medical Systems, Inc. Announces Additional Draft Local Coverage Determinations Proposing Coverage of Inspire Therapy

October 8, 2019

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 today that two additional draft Local Coverage Determinations (“LCDs”) were published proposing coverage of Inspire therapy.

The Medicare Administrative Contractors (“MACs”) issuing these two policies are National Government Services, Inc. (“NGS”) and CGS Administrators, LLC (“CGS”), which collectively represent 12 states. The two additional draft LCDs are available on the Medicare Coverage Database site for public review. The NGS public comment period runs from September 26, 2019 to November 9, 2019, and the CGS public comment period runs from October 30, 2019 to December 14, 2019. NGS and CGS will host formal review meetings during this process. The final LCDs are expected to be published in early 2020. Four other MACs, Noridian, Palmetto, Novitas Solutions, and First Coast Service Options, previously published their draft coverage policies. In total, these six MACs represent Medicare patients in 44 states and the District of Columbia.

The draft LCDs from NGS and CGS are consistent with the previous publication of proposed LCDs from Noridian, Palmetto, Novitas Solutions and First Coast Service Options, 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 U.S. Food and Drug Administration indication statement for Inspire therapy.

“With these two additional LCDs, Medicare patients in 44 states are expected to have access to Inspire therapy.  We look forward to the potential issuance of formal policies from NGS and CGS, and anticipate that the one remaining MAC will also soon issue a draft policy for Inspire therapy,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems.

NGS covers Medicare patients in Connecticut, Illinois, Maine, Massachusetts, Minnesota, New Hampshire, New York, Rhode Island, Vermont, and Wisconsin. CGS covers Medicare patients in Kentucky and Ohio.

One remaining MAC, Wisconsin Physicians Service Government Health Administrators, which covers Medicare patients in Indiana, Iowa, Kansas, Michigan, Missouri, and Nebraska, has yet to publish a draft LCD proposing coverage of Inspire therapy.

For additional information about Inspire, please visit www.inspiresleep.com.

 

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