Novitas Solutions and First Coast Service Options, collectively representing 12 states and the District of Columbia, issue draft policies initiating open public comment period
MINNEAPOLIS, Aug. 29, 2019 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (INSP) (the “Company or “Inspire”), 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 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 U.S. 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,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems.
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.
About Inspire Medical Systems
Inspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspire’s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
For additional information about Inspire, please visit www.inspiresleep.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding future local coverage determinations and additional draft policies for Inspire therapy. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential,’’ ‘‘continue,’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.
These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, estimates regarding the annual total addressable market for our Inspire therapy in the U.S. and our market opportunity outside the U.S.; future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; commercial success and market acceptance of our Inspire therapy; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system or any future products we may seek to commercialize; competitive companies and technologies in our industry; our ability to enhance our Inspire system, expand our indications and develop and commercialize additional products; our business model and strategic plans for our products, technologies and business, including our implementation thereof; our ability to accurately forecast customer demand for our Inspire system and manage our inventory; our dependence on third-party suppliers, contract manufacturers and shipping carriers; consolidation in the healthcare industry; our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire system in markets outside of the U.S.; risks associated with international operations; our ability to manage our growth; our ability to increase the number of active medical centers implanting Inspire therapy; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; risks related to information technology and cybersecurity; risk of damage to or interruptions at our facilities; our ability to commercialize or obtain regulatory approvals for our Inspire therapy and system, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the U.S. and international markets; the timing or likelihood of regulatory filings and approvals; risks related to our debt and capital structure; our ability to establish and maintain intellectual property protection for our Inspire therapy and system or avoid claims of infringement; tax risks; risks that we may be deemed an investment company under the Investment Company Act of 1940; regulatory risks; the volatility of the trading price of our common stock; and our expectations about market trends. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this presentation can be found under the captions “Risk Factors” and "Management's Discussion and Analysis of Financial Condition and Results of Operations“ in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this presentation. Any such forward-looking statements represent management’s estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
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