FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CMS Proposes to Boost Payments for Breakthrough Devices

May 14, 2019
A A

The Centers for Medicare and Medicaid Services proposed a new rule that would increase payments for breakthrough medical devices.

The CMS rule proposes an alternative new technology add-on payment pathway for a medical device that receives FDA marketing authorization and has received breakthrough device clearance.

The FDA’s breakthrough designation can help expedite the development and review of transformative new devices that meet expedited program criteria, CMS said. The agency said “it is appropriate to similarly facilitate access to these transformative technologies for Medicare beneficiaries.”

View today's stories