CMS Announces RAPID Pathway for Breakthrough Devices; "Cuts Red Tape"
On April 23, CMS issued a press release annoucing a new CMS-FDA collaboration for Breakthrough Devices, called the RAPID Pathway. The pathway will RAPIDly see the release of a proposed NCD, for 30 days comment, concurrent with FDA approval. CMS will "pause" the TCET NCD-CED pathway ("Transitional Coverage for Emerging Technologies") to focus on RAPID.
We'll know more about the RAPID program when a full description is published in the Federal Register in the coming days.
The Federal Register publication should appear here when it's ready:
https://www.federalregister.gov/agencies/centers-for-medicare-medicaid-services
A couple days ago Politico noted that RKF Jr had mentioned pending pathways for FDA BT devicecs in one of his Hill testimony sessions.
