The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more
4/15/2025
/ Administrative Procedure Act ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Requirements ,
Vacated
On December 23, 2023, CMS issued its Final Rule, establishing new Clinical Laboratory Improvement Amendments (CLIA) regulations (the Final Rule). Several provisions only became effective December 28, 2024. CMS was driven to...more
CMS published its FY 2025 Medicare Hospital Inpatient Prospective Payment System (IPPS) final rule on August 1, 2024. Under this final rule, CMS is implementing several changes to its Hospital Inpatient Quality Reporting...more
9/6/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Hospitals ,
Inpatient Prospective Payment System (IPPS) ,
Medicare ,
Payment Systems ,
Safety Standards ,
Social Security Act