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Medicare will cover LAA closure device
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Boston Scientific announced that CMS will cover percutaneous left atrial appendage closure therapy under specific criteria outlined in the agency’s final national coverage determination. This decision is effective immediately, according to a company press release.
The left atrial appendage (LAA) closure device (Watchman, Boston Scientific) was approved by the FDA in March 2015 as an alternative to long-term warfarin therapy for patients with nonvalvular atrial fibrillation who are at high risk for stroke and systemic embolism.
According to the national coverage determination, coverage depends on meeting specific conditions. CMS implemented this change in response to physician and professional medical society feedback on patient coverage criteria and future data collection requirements received during the 30-day public comment period, according to the release.
The Society for Cardiovascular Angiography and Interventions said in a release, that as they requested, the national coverage determination was more specific as to patient eligibility based on stroke risk and suitability of oral anti-coagulation. According to the release, there will also be more open opportunity for future FDA-approved devices.
“SCAI is pleased that CMS elected not to place extensive restrictions on patient access to this new therapy,” said SCAI president James Blankenship, MD, FSCAI in a release.
Medicare beneficiaries account for the majority of patients deemed candidates for the Watchman device, according to the release.
“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,” Mike Mahoney, president and CEO of Boston Scientific, said in the release. “The final decision reflects more than a decade of robust clinical evidence and will facilitate additional data collection via a prospective national registry.”
Disclosure: Mahoney is president and CEO of Boston Scientific. Blankenship is president of the Society for cardiovascular Angiography and Intervention.