INSIGHTEC's MR-Guided Focused Ultrasound Treatment for Essential Tremor Now Covered by Medicare

Monday, June 4, 2018 General News
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Coverage established in 16 states with positive draft policies for 22 additional states

HAIFA, Israel and MIAMI, June 4, 2018 /PRNewswire/ --


a global medical technology innovator of incisionless surgery, today announced that Medicare benefit coverage is available to patients in 10 U.S. states for MR-guided focused ultrasound (MRgFUS) for the treatment of essential tremor (ET). Six more states will follow on July 1, 2018. Additional Medicare Administrative Contractors (MAC) have issued positive Draft Local Coverage Determination (LCD) with potential to further expand Medicare coverage to a total of 38 states.

"The decision from these Medicare Administrative Contractors to cover INSIGHTEC's MRgFUS essential tremor treatment is a welcome recognition of the clinical and economic benefits of incisionless brain surgery for people living with essential tremor," said Maurice R. Ferré, MD, Chief Executive Officer and Chairman of the Board of INSIGHTEC. "By formalizing insurance coverage, Medicare is expanding access to focused ultrasound for many more patients and physicians."  

Currently, MRgFUS for the treatment of essential tremor is covered by National Government Services (NGS) Medicare in 10 states: Connecticut, Maine, New Hampshire, Rhode Island, Vermont, New York, Massachusetts, Illinois, Wisconsin and Minnesota. Effective July 1, 2018, Wisconsin Provider Services (WPSIC) Medicare will begin providing coverage in Indiana, Iowa, Kansas, Nebraska, Michigan and Missouri.

Additionally, CGS Medicare, Noridian Medicare and Palmetto GBA, local MACs for 22 other states, have posted positive draft LCDs specific for MRgFUS for the treatment of ET. The LCDs will be open for comments, which will be reviewed by the MACs prior to publication of the final LCDs. The pending coverage for these local MACs include Alabama, Alaska, Arizona, Georgia, California, Hawaii, Idaho, Kentucky, Montana, Nevada, North Carolina, North Dakota, Ohio, Oregon, South Carolina, South Dakota, Tennessee, Utah, Virginia, Washington, West Virginia and Wyoming. The status of these LCDs is available on the Medicare Coverage Database on the Centers for Medicare and Medicaid Services (CMS) website.

"These insurance provider decisions further validate the published data on the safety and efficacy of focused ultrasound and, more importantly, provide patients with an innovative, incisionless treatment option that provides immediate and significant improvement in tremor and quality of life," said Ali Rezai, MD, Executive Chair, Associate Dean and Vice President of the West Virginia University Rockefeller Neuroscience Institute, one of a growing number of neurosurgeons using INSIGHTEC's Exablate Neuro™ device in the USA.

"As we look to the future, we hope to continue expanding access for incisionless focused ultrasound to all Medicare beneficiaries," said Dee Kolanek, Vice President of Reimbursement, INSIGHTEC.


INSIGHTEC is a global healthcare technology innovator transforming patient lives through incisionless brain surgery. The company develops groundbreaking treatments using image-guided focused ultrasound, through partnerships with leading academic and medical institutions to deliver effective, gentler patient care. INSIGHTEC is headquartered in Haifa, Israel and Miami, with offices in Dallas, Tokyo and Shanghai.

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Forward-looking Statements   

This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives and future events. INSIGHTEC intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, and the Private Securities Reform Act of 1995. In some cases, forward-looking statements can be identified by the following words: "may," "can," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "promise," "continue," "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond INSIGHTEC's ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. INSIGHTEC does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

"Exablate," and "Exablate Neuro," as well as the "INSIGHTEC" logo, whether standing alone or in connection with the word " INSIGHTEC" are protected trademarks of INSIGHTEC.

Alyssa Chard CooperKatz & Company, Inc. for INSIGHTEC 917-595-3063


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