2008 new-tech add-on payments

Boston Scientific's Wingspan intracranial stent with Gateway balloon catheter is the only applicant for an inpatient new technology add-on payment in fiscal 2008 after CMS extended the deadline until Dec. 30, 2006, to allow time for more submissions (1"The Gray Sheet" Nov. 27, 2006, p. 14). Boston Scientific applied for a new-tech add-on for the device in fiscal 2006, but the bonus payment was denied because WingSpan was not FDA-approved at the time of the decision. WingSpan gained a humanitarian device exemption from FDA in August 2005. CMS maintained longstanding noncoverage for the device, except when used in FDA trials, in a November 2006 coverage decision, but may soon expand coverage to other research settings (2"The Gray Sheet" Dec. 18, 2006, p. 6). A "town hall" meeting to discuss the lone applicant is scheduled for Feb. 22 in Baltimore...