As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
On June 15, 2022, in a win for hospitals, the Supreme Court issued its opinion in American Hospital Association et. al. v. Becerra (“Becerra”), overturning massive reimbursement reductions in the 340B drug pricing program...more
Now approaching a year-long battle, drug manufacturers and 340B covered entities, which include hospitals and community health centers, participating in the 340B Drug Pricing Discount Program (“340B Participants”) continue to...more
In a setback to hospitals challenging deep cuts to reimbursement for prescription drugs acquired through the 340B drug pricing program (“340B Program”), the U.S. Court of Appeals for the District of Columbia, on October 19,...more
On Friday, President Trump announced four executive orders directed at decreasing prescription drug prices by ordering certain actions by the Department of Health and Human Services (“HHS”). One order – which has received the...more
In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more
7/26/2019
/ Ambulatory Surgery Centers ,
Conflicts of Interest ,
Congressional Budget Office ,
Drug Pricing ,
Health Insurance ,
Hospitals ,
Managed Care Contracts ,
Manufacturers ,
Medicaid ,
Medicare ,
Medicare Part D ,
Outpatient Services ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Physician Fee Schedule ,
Prescription Drug Coverage ,
Prescription Drugs ,
Price Transparency ,
Public Disclosure ,
Rebates ,
Risk-Sharing