JD Supra

FDA Releases Guidances on Transition Plan for Devices Distributed Under Emergency Use Authorization (EUA) or Enforcement Policies During COVID-19

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to ...
STAT

Medicare finalizes reimbursement rule for breakthrough medical devices

The Centers for Medicare and Medicaid Services has finalized its rule easing reimbursement for medical device makers. Called Transitional Coverage for Emerging Technologies, the program gives device ...
Becker's Hospital Review

FDA finalizes PHE transition plan for medical devices

With the COVID-19 public health emergency set to expire May 11, the FDA is preparing to prevent any supply disruptions to medical devices after three years of shortages partly spurred by the pandemic.
JD Supra

A Break for Breakthrough Devices? CMS Issues Transitional Coverage for Emerging Technologies Notice

On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Notice with Comment Period (Notice) proposing a new Transitional Coverage for Emerging Technologies (TCET) pathway. 88 ...
Business Wire

CMS Grants Transitional Pass-Through (TPT) Payment for Carlsmed's aprevo® Personalized Interbody Devices

CARLSBAD, Calif.--(BUSINESS WIRE)--Carlsmed announced today that the Center for Medicare & Medicaid Services (CMS) has granted aprevo® a Transitional Pass-Through (TPT) payment as part of the ...