CMS delayed a final rule that aims to speed up the FDA approval process for Medicare coverage of new medical devices and technologies.
Four things to know:
1. The Medicare Coverage of Innovative Technology rule will be delayed until May 15. CMS made the announcement in an interim final rule that is scheduled to be filed in the federal register on March 17.
2. The delay follows a Jan. 20 memorandum on regulatory freezes from the assistant to the president and chief of staff.
3. CMS said it's providing a 30-day comment period on the rule for affected parties. Information from the comment period may be used to decide "whether further actions are appropriate, which could include whether to revise or rescind" the rule, the agency said.
4. In a recent viewpoint article shared with The New England Journal of Medicine, physicians raised concerns about the final rule and called for it to be retracted. But organizations like AdvaMed, which represent medical device companies, have supported the rule.