ADVAMED MAKES HEADWAY ON LEGISLATIVE PRIORITIES

AdvaMed has reached an agreement with the FDA on user fees through negotiations on the reauthorization of the Medical Device User Fee and Modernization Act.

Under the previous user fee system, the number of industry applications -- which could change from year to year -- affected fee rates, AdvaMed President and CEO Stephen Ubl said. The newest agreement will lead to "much more predictable" year-over-year increases in those fees and lower fees overall, he added.

More consistency in user fees was one of the legislative goals AdvaMed discussed last week, along with the establishment of Medicare coverage for remote patient monitoring and speedier approval and reimbursement for gene-based tests.

The 2006 election "was really a sea change election for a lot of industries in the healthcare sector," Ubl said. He added that the medical technology sector in some regions of the country has been strengthened by the election.

( http://www.fdanews.com/ddl/34_10/ )