On July 31, 2025, the Health Resources and Services Administration (“HRSA”) announced the availability of a voluntary 340B Rebate Model Pilot Program (the “340B Rebate Pilot” or the “Pilot”) that would test, for a limited...more
8/4/2025
/ Covered Entities ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
HRSA ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare ,
Pharmaceutical Industry ,
Pilot Programs ,
Prescription Drugs ,
Public Comment ,
Section 340B
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
1/10/2025
/ Biotechnology ,
Business Strategies ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Inflation Reduction Act (IRA) ,
Investigational New Drug Application (IND) ,
Licensing Rules ,
Life Sciences ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Pricing ,
Regulatory Reform ,
Regulatory Requirements ,
Variable Rates