CMS, FDA announce new program to speed up Medicare coverage of breakthrough medical devices

fiercehealthcare - The Trump administration unveiled a new program to speed up Medicare coverage for breakthrough devices, touting that the new pathway cuts red tape for medical device companies to gain reimbursement. CMS said it will pause the existing TCET pathway.

AI Summary: CMS and the Food and Drug Administration launched a coordinated program to accelerate Medicare coverage for breakthrough medical devices, aiming to shorten the gap between regulatory approval and patient access. The initiative aligns agency review processes, defines eligibility, and seeks faster coverage decisions while maintaining safety and evidentiary standards.

• New imaging and monitoring devices promise faster, remote patient care. (3)
• On scene: agencies align to speed device approvals and coverage. (6)

New imaging and monitoring devices promise faster, remote patient care.

On scene: agencies align to speed device approvals and coverage.