Posted by Michael Wonder on 29 Apr 2021
CMS should offer immediate reimbursement coverage to FDA approved breakthrough devices
29 April 2021 - In 2016 the U.S. Congress passed, and President Barack Obama signed, the 21st Century Cures Act. Section 3501 of the law granted the FDA authority to designate certain medical devices as “breakthrough.”
The program, FDA Commissioner Scott Gottlieb explained in a report to Congress, “is intended to expedite the development and prioritise the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”
