By Abe Sutton
On January 12th, the Centers for Medicare & Medicaid Services (CMS) finalized a prior proposal to establish Medicare coverage for breakthrough medical devices approved by the U.S. Food and Drug Administration (FDA).
While some have expressed concerns about the proposal, I believe it is a balanced attempt to encourage innovation and CMS was right to finalize it.
In this post, I give an overview of the general regulatory standards, walk through what the Medicare Coverage of Innovative Technologies (MCIT) proposal does, and lay out a case for why it deserved to be finalized.