CMS will cover percutaneous LAAC therapy for Medicare beneficiaries consistent with the FDA label when specific conditions are met
MARLBOROUGH, Mass., Feb. 8, 2016 /PRNewswire/ -- Boston Scientific Corporation announced the Centers for Medicare and Medicaid Services (CMS) will cover percutaneous left atrial appendage closure (LAAC) therapy under specific criteria, as outlined in the agency's final National Coverage Determination (NCD). This decision, effective immediately, provides consistent and uniform access to the WATCHMAN™ LAAC Device as a non-pharmacological treatment option for stroke risk reduction for appropriate Medicare beneficiaries.
"We are very pleased CMS has established national coverage for this life-changing therapy for Medicare beneficiaries who have a reason to seek an alternative to long-term anticoagulation," said Mike Mahoney, president and chief executive officer, Boston Scientific. "The final decision reflects more than a decade of robust clinical evidence and will facilitate additional data collection via a prospective national registry."
The WATCHMAN Device, the first and only percutaneous LAAC therapy approved by the U.S. Food and Drug Administration (FDA) in March 2015, is indicated for patients with non-valvular atrial fibrillation (AF) who are at high stroke risk, suitable for warfarin, and are seeking an alternative to long-term warfarin therapy.
According to the NCD, CMS will cover percutaneous LAAC therapy when specific conditions are met. CMS adopted the majority of physician and professional medical society feedback received in the 30-day public comment period, specifically as it relates to patient coverage criteria and future data collection requirements.
Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the WATCHMAN Device. The remaining population is represented by private payers. Prior to the CMS final decision, a number of private payers, including several Blue Cross Blue Shield plans, have updated their policies to now cover the WATCHMAN Device.
About the WATCHMAN LAAC Device
The WATCHMAN LAAC Device is a catheter-delivered heart implant designed to close the left atrial appendage (LAA) in order to prevent the migration of blood clots from the LAA, and thus, reduce the incidence of stroke and systemic embolism for higher risk patients with non-valvular AF. The LAA is a thin, sack-like appendix arising from the heart and is believed to be the source of >90 percent of stroke-causing clots that come from the left atrium in patients with non-valvular AF. Images of the WATCHMAN Device are available at http://www.bostonscientific.com/Watchman-Images.
About Boston Scientific
Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 35 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans our products, CMS coverage of the WATCHMAN Device and its impact, and markets for our products. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
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Boston Scientific Corporation
Boston Scientific Corporation
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