MINNEAPOLIS, Feb. 03, 2020 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (INSP) (“Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (“OSA”), announced today that three Medicare Administrative Contractors (“MACs”) have announced the effective release date of March 15, 2020, for their final Local Coverage Decision (“LCD”) policies covering Inspire therapy. In addition, the Wisconsin Physician Services (“WPS”) Government Health Administrators issued their draft LCD proposing coverage of Inspire therapy.
“Following the standard public comment periods and formal review meetings, we are excited to announce that the first three LCD policies will be formally issued during the first quarter,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “Secondly, the draft LCD from WPS will provide coverage for the remaining six states, and once issued, will signify 100% Medicare coverage across the United States for Inspire therapy.”
The effective release dates for First Coast Service Options, Inc. (“First Coast”), Noridian Healthcare Solutions, LLC (“Noridian”) and Novitas Solutions, Inc. (“Novitas”) were announced to be March 15, 2020. First Coast covers Medicare patients in Florida. Noridian covers Medicare patients in Alaska, Arizona, California, Hawaii, Idaho, Montana, Nevada, North Dakota, Oregon, South Dakota, Utah, Washington and Wyoming. Novitas covers Medicare patients in Colorado, New Mexico, Arkansas, Delaware, Louisiana, Maryland, Mississippi, New Jersey, Oklahoma, Pennsylvania, Texas and the District of Columbia.
WPS covers Medicare patients in Indiana, Iowa, Kansas, Michigan, Missouri, and Nebraska, and their draft LCD proposing coverage of Inspire therapy was published on January 30, 2020. We expect the review process will require several months prior to formal release, as with the other six MACs.
The three final LCDs, as well as the draft LCD from WPS, are consistent with the criteria for medical necessity. Specifically, the policies state that U.S. Food and Drug Administration-approved hypoglossal nerve neurostimulation is considered medically reasonable and necessary for the treatment of moderate to severe OSA when the following criteria are met:
Beneficiary is 22 years of age or older;
Body mass index is less than 35 kg/m2;
A sleep study is performed within 24 months of first consultation for an Inspire implant;
Beneficiary has predominantly obstructive events (defined as central and mixed apneas less than 25% of the total Apnea-Hypopnea Index (“AHI”);
AHI is 15 to 65 events per hour;
Beneficiary has documentation that demonstrates CPAP failure or intolerance; and
Absence of complete concentric collapse at the soft palate level as seen on a drug-induced sleep endoscopy procedure.
The other three additional MACs, National Government Services, Inc., CGS Administrators, LLC and Palmetto GBA, LLC, which collectively represent 19 states, are completing their respective review processes and Inspire expects these formal release dates to be announced in the near future.
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 OSA. 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 decisions 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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