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
Following a jury's verdict, a federal court slashed civil penalties under the False Claims Act ("FCA") as violative of the Constitution's 8th Amendment....more
3/28/2025
/ Constitutional Challenges ,
Damages ,
Eighth Amendment ,
Excessive Fines Clause ,
False Billing ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Facilities ,
Healthcare Fraud ,
Medicare ,
Penalties ,
Treble Damages
The Situation: The False Claims Act ("FCA") imposes treble damages on defendants, as well as mandatory penalties per false claim. Because alleged false claims often involve much smaller amounts—for example, in cases with a...more
8/19/2024
/ Corporate Counsel ,
Due Process ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Treble Damages
In Short -
The Situation: Under 42 U.S.C. § 1320a-7b(g), a claim that "includes items or services resulting from a violation" of the Anti-Kickback Statute ("AKS") is a false claim for purposes of the False Claims Act...more
A defendant who violates the FCA can be liable for treble damages plus a civil penalty of $5,500 to $11,000 (adjusted for inflation) for each false claim. Meanwhile, FCA lawsuits often involve tens of thousands of alleged...more
2/3/2022
/ Civil Monetary Penalty ,
Eighth Amendment ,
Excessive Fines Clause ,
False Claims Act (FCA) ,
False-Certification of Conformance ,
Fines ,
Health Care Providers ,
Medicare ,
Qui Tam ,
Reimbursements ,
Relators ,
Statutory Violations ,
Treble Damages
A recent split decision from the United States Court of Appeals for the Seventh Circuit strengthens an argument many defendants of False Claims Act ("FCA") cases have been advancing for years: the violation of an ambiguous...more
8/23/2021
/ Enforcement Actions ,
False Billing ,
False Claims Act (FCA) ,
Fraud ,
Medicaid ,
Medicare ,
Pharmacies ,
Qui Tam ,
Relators ,
Safeco ,
Statutory Requirements
The Situation: A provision in the False Claims Act ("FCA") had clarified when Anti-Kickback Statute ("AKS") violations can make a claim false, but the provision's rule of per se falsity does not answer when a claim "result[s]...more
2/1/2018
/ Anti-Kickback Statute ,
Appeals ,
Charitable Donations ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Physicians ,
Relators ,
Stark Law ,
Summary Judgment