CMS’ Rule Granting Speedy Coverage to FDA-Designated ‘Breakthrough’ Devices Delayed Again

CMS delayed the start date of its rule that would provide expedited Medicare coverage for products the FDA deems “breakthrough devices” from May 15 to Dec. 15. CMS wants more time to examine concerns expressed about the rule, including that devices may gain coverage despite limited evidence of their use among seniors.

Source: https://medcitynews.com/2021/05/cms-rule-granting-speedy-coverage-to-fda-designated-breakthrough-devices-delayed-again/