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
On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
On the heels of recent scrutiny of health care professional (“HCP”) arrangements with brokers and agents and Medicare Advantage Organization (“MAO”) arrangements with providers, including through the U.S. Department of...more