Medicare Plans Draft Rule to Accelerate Medical Device Coverage

New medical devices could start undergoing review for Medicare coverage before receiving FDA marketing authorization under a proposed rule the Biden administration plans to release in the coming months.

Officials from the Centers for Medicare & Medicaid Services announced Wednesday that the proposal would establish a pathway that medical device manufacturers can enter on a voluntary basis to start getting their products reviewed earlier. The action is part of a series of efforts by the CMS and the Food and Drug Administration to better coordinate their product reviews so that patients can get quicker access to novel treatments and emerging ...