In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...more
President Trump issued an Executive Order on April 15, 2025, titled "Lowering Drug Prices by Once Again Putting Americans First," with the express goal of providing Americans and taxpayers access to prescription drugs. One...more
Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more
4/2/2025
/ Administrative Procedure Act ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Statutory Interpretation
The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more
3/25/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Foreign Workers ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Fraud ,
Medicare ,
Medicare Part A ,
Medicare Part B ,
Medicare Part C ,
Medicare Part D ,
New Legislation ,
OIG ,
Overpayment ,
Physicians ,
Regulatory Reform ,
Regulatory Requirements ,
Settlement ,
Skilled Nursing Facility
South Carolina Governor Henry McMaster declared a State of Emergency on September 25, 2024, to prepare for Hurricane Helene. On September 29, 2024, the Federal Emergency Management Agency (FEMA) issued a Federal Major...more
10/7/2024
/ Centers for Medicare & Medicaid Services (CMS) ,
Critical Access Hospitals ,
Department of Health and Human Services (HHS) ,
Disaster Aid ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Facilities ,
Home Health Agencies ,
Hurricane Season ,
Natural Disasters ,
Public Health Emergency ,
Severe Weather ,
Skilled Nursing Facility ,
Waivers