No legislation has garnered more attention in the life sciences industry in recent past than the so-called Drug Price Negotiation Program of the Inflation Reduction Act (the "Program"). ...more
4/4/2025
/ Administrative Procedure Act ,
Appeals ,
Biden Administration ,
Bristol-Myers Squibb ,
Constitutional Challenges ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Fifth Amendment ,
First Amendment ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Prescription Drugs
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
The Anti-Kickback Statute ("AKS") is a federal criminal statute that prohibits "knowingly and willfully" offering or paying remuneration to induce a person to order or make a referral for an item or service reimbursable by a...more
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more
4/8/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, the government obtained more than $2.6 billion in overall recoveries,...more
4/1/2024
/ Anti-Kickback Statute ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Healthcare ,
Healthcare Fraud ,
Life Sciences ,
Medicare Advantage ,
OIG ,
Stark Law
The Situation: In U.S. ex rel. Kasowitz Benson Torres LLP v. BASF Corporation, the relator alleged reverse false claims liability under the False Claims Act ("FCA") for the defendants' purported failure to comply with...more