Cures 2.0 Draft Expands on MCIT, Supports Digital Health

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US lawmakers rolled out the long-awaited follow-up to the 2016 Cures Act with a draft bill that would put the yet-to-be-implemented Medicare Coverage of Innovative Technology program on the statutory books with some noteworthy changes compared to CMS’ original vision. (Image: Reps. Fred Upton and Diana DeGette)

A long-promised sequel to the 2016 21st Century Cures Act is out in “discussion draft” form this week and includes some provisions of importance to device companies. Most notably, the bill would legally establish the Medicare Coverage of Innovative Technology program that CMS finalized early this year but then pulled back on under the new administration. The proposed statutory version of the program sticks with the basic MCIT framework envisioned by CMS, establishing four years of automatic coverage for some FDA Breakthrough Devices. But it also includes some important departures from CMS’s plan. Notably, it would expand the breadth of products that could benefit from the automatic coverage pathway, and it would also give CMS more power to require evidence collection from companies leveraging MCIT.

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