Medmarc Blog (blog.medmarc.com)
Breakthrough Devices
CMS Issues Final Policy For Breakthrough Device Coverage
The Centers for Medicare & Medicaid Services has delivered its final policy for the Transitional Coverage for Emerging Technologies (TCET) program, which incorporates existing coverage mechanisms....
Medicare Rule for Breakthrough Devices Returns
The Centers for Medicare and Medicaid Services has resubmitted the rule for Medicare coverage of FDA breakthrough devices with a modified plan for the application and for the process of...
FDA Draft Guidance For Predetermined Change Control Plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Since the publication of the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan in 2021, interested parties have been awaiting guidance from...
CMS Announces Full Withdrawal of MCIT Rule
The Centers for Medicare & Medicaid Services has fully withdrawn the rule for Medicare Coverage of Innovative Technology (MCIT), which eliminates any prospect for automatic coverage of...
CMS Adds Administrator, Hits Pause on MCIT
CMS Adds Administrator, Hits Pause on MCIT The Center for Medicare & Medicaid Services has a new administrator, Chiquita Brooks-LaSure, signaling an end to a leadership void at an agency that is...
FDA Releases Action Plan for AI
The FDA announced an action plan for artificial intelligence in mid-January, which comes across largely as a follow-up to a discussion paper the agency posted in April 2019. The plan lays out a...
CMS Floats Coverage Policy for Breakthrough Devices
The Centers for Medicare & Medicaid Services recently unveiled a new plan to offer four years of Medicare coverage for any medical devices cleared or approved through the FDA’s breakthrough...