Shortened ‘Cures’ Draft Retains Breakthrough Pathway, Device Reforms

But the April 29 updated draft of the broad-based House reform package for medical innovation is missing some significant items floated earlier this year, including a Medicare breakthrough device program, a revamp of diagnostics regulations and device supply-chain security reform. A significant new addition to the legislative proposal would double the number of people that could be treated per year with a humanitarian device exemption product from 4,000 to 8,000.