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Permanent LVAD Implants Appropriate For End-Stage Heart Failure – CMS

This article was originally published in The Gray Sheet

Executive Summary

Left-ventricular assist device implants for destination therapy will be limited to 60 U.S. centers under the terms of a positive CMS national coverage determination for the therapy, Thoratec estimates

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CMS reconsiders VAD facility selection

Agency reopens its ventricular assist device (VAD) destination therapy national coverage decision July 10 to revise the facility selection criteria. CMS said it is "concerned that facilities are not maintaining the volume of VAD procedures that originally qualified them for approval," noting that only 10 of the 69 Medicare-certified facilities operated on seven or more patients during the last four years. The agency will consider third party certification standards, such as those developed by The Joint Commission on Accreditation of Healthcare Organization, which requested the facility criteria reconsideration. CMS began national coverage of VADs in October 2003 as a destination therapy for patients requiring permanent mechanical cardiac support (1"The Gray Sheet" Oct. 6, 2003, p. 5) To date, Thoratec's HeartMate is the only device with FDA approval for the indication...

CMS reconsiders VAD facility selection

Agency reopens its ventricular assist device (VAD) destination therapy national coverage decision July 10 to revise the facility selection criteria. CMS said it is "concerned that facilities are not maintaining the volume of VAD procedures that originally qualified them for approval," noting that only 10 of the 69 Medicare-certified facilities operated on seven or more patients during the last four years. The agency will consider third party certification standards, such as those developed by The Joint Commission on Accreditation of Healthcare Organization, which requested the facility criteria reconsideration. CMS began national coverage of VADs in October 2003 as a destination therapy for patients requiring permanent mechanical cardiac support (1"The Gray Sheet" Oct. 6, 2003, p. 5) To date, Thoratec's HeartMate is the only device with FDA approval for the indication...

Thoratec CEO Recollects HeartMate Reimbursement Planning Experience

Device companies seeking national coverage decisions should initiate discussions with CMS concerning the economic impact of their new technology, according to Thoratec President & CEO Keith Grossman

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