Inspire Medical Systems, Inc. Announces Medicare Policy Release Dates and New Draft Local Coverage Determination for Remaining Region

Download as PDF

MINNEAPOLIS, MN – February 3, 2020 – Inspire Medical Systems, Inc. (NYSE: 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

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

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 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.

Investor and Media Contact:
Bob Yedid
LifeSci Advisors
[email protected]