Becker's Healthcare January 12, 2021
CMS issued a final rule Jan. 12 that will speed up the FDA approval process for Medicare coverage of new and innovative medical devices and technologies.
Five things to know:
1. The Medicare Coverage of Innovative Technology final rule will reduce the lag time between the FDA’s approval of innovative medical tech products and Medicare establishing coverage for the devices.
2. When the proposed rule was published in August 2020, CMS Administrator Seema Verma referred to the approval process as a “chicken and egg issue,” adding that “Innovators had to prove their technologies were appropriate for seniors, but that was almost impossible since the technology was not yet covered by Medicare and thus not widely used enough to demonstrate their...
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