On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more
9/5/2024
/ AHRQ ,
Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Food and Drug Administration (FDA) ,
Health Technology ,
Loper Bright Enterprises v Raimondo ,
MACs ,
Medical Devices ,
Medicare ,
Notice Requirements ,
SCOTUS ,
Social Security Act
On September 29, 2023, the Food & Drug Administration (“FDA” or the “Agency”) published the long-awaited proposed rule on laboratory developed tests (“LDT Proposed Rule”). The proposed rule is open for public comment through...more
10/3/2023
/ CLIA ,
Draft Guidance ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Jurisdiction ,
Laboratory Developed Tests ,
Litigation Strategies ,
Medical Devices ,
Proposed Rules ,
Public Comment ,
Reporting Requirements ,
Warning Letters
Biden Administration Delays Effective Date and Opens Another Comment Period for New Medicare Coverage Pathway for Breakthrough Medical Devices and Definition of “Reasonable and Necessary” -
To the dismay of the medical...more
On February 21, 2018, the Food and Drug Administration (FDA) issued a final rule amending the Agency’s regulations on acceptance of data from clinical investigations form medical devices. The final rule amends requirements...more