Recent years have seen eye-popping judgments and settlements involving cases brought under the federal False Claims Act (FCA) and federal Anti-Kickback Statute (AKS). And healthcare companies have, unsurprisingly, focused...more
The First Circuit will decide the causation standard required in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS), deepening a circuit split on the issue and potentially teeing up Supreme Court...more
Several days ago, Biogen Inc. announced that it had reached a settlement to resolve a whistleblower lawsuit under the False Claims Act (FCA). Relator’s claims were based on allegations that Biogen’s speaker and consultant...more
8/1/2022
/ Anti-Kickback Statute ,
Consultants ,
Enforcement ,
False Billing ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
OIG ,
Physicians ,
Prescription Drugs ,
Settlement ,
Speaker Programs ,
Whistleblowers
The year 2021 marks the 10th anniversary of the Bradley False Claims Act Year in Review. In that decade, much has remained the same in FCA enforcement. To start with the obvious: It continues to result in billions of dollars...more
2/3/2022
/ Alternate Remedy ,
Anti-Kickback Statute ,
CARES Act ,
Causation ,
Class Action ,
Cybersecurity ,
Damages ,
Department of Justice (DOJ) ,
Dismissals ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Government Investigations ,
Healthcare ,
Local Coverage Determination (LCD) ,
Materiality ,
Overpayment ,
Pleading Standards ,
Public Disclosure Bar ,
Request for Equitable Adjustment ,
Scienter ,
Settlement
This year saw substantial activity in FCA settlements and litigated court cases. Although no single case or development dominated the discourse this year, several important court decisions were issued, including two that may...more
2/1/2021
/ Ambiguous ,
Anti-Kickback Statute ,
Damages ,
Deficit Reduction ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Department of Veterans Affairs ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Aviation Administration (FAA) ,
Fee-Shifting ,
First-to-File ,
Fraud ,
Materiality ,
Medicaid ,
Medicare ,
Qualified Immunity ,
Reasonable Interpretations ,
Retaliation ,
Speaker Programs ,
Statute of Limitations
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the...more
11/20/2020
/ Anti-Kickback Statute ,
Enforcement Actions ,
Fair Market Value ,
False Claims Act (FCA) ,
FDA Approval ,
Fraud ,
Health Care Providers ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
As many healthcare practitioners and attorneys can attest, private equity investment has become an increasingly prevalent feature of the healthcare industry. From blockbuster deals like KKR’s purchase of Envision Healthcare...more
10/22/2020
/ Anti-Kickback Statute ,
Compliance ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fraud and Abuse ,
GDP ,
Health Care Providers ,
Investment ,
Investors ,
Physicians ,
Portfolio Companies ,
Private Equity