Key Insights for Pharma Manufacturers Regarding the AKS -
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more
4/29/2025
/ Abbreviated New Drug Application (ANDA) ,
Anti-Kickback Statute ,
Compliance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements
Long Island Businessman Arrested in $22 Million Medicare Fraud Scheme -
A Long Island, New York, businessman was arrested on conspiracy, kickback, and money laundering charges stemming from an alleged scheme to defraud...more
Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions -
In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more
1/13/2025
/ Anti-Kickback Statute ,
Appeals ,
Appointments Clause ,
Article III ,
Constitutional Challenges ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud ,
Health Care Providers ,
Healthcare Fraud ,
Medicare ,
Misrepresentation ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Qui Tam ,
SCOTUS ,
Settlement ,
Stark Law ,
Unconstitutional Condition ,
Whistleblowers
Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims -
Last week, the Second Circuit Court of Appeals affirmed the district court’s ruling that dismissed allegations from a whistleblower who claimed that...more
1/6/2025
/ Anti-Kickback Statute ,
Appeals ,
Department of Justice (DOJ) ,
Digital Assets ,
False Claims Act (FCA) ,
False Statements ,
Foreign Agents Registration Act (FARA) ,
Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Misleading Statements ,
Motion to Dismiss ,
New Regulations ,
Non-Fungible Tokens (NFTs) ,
Popular
US Supreme Court Declines to Consider AKS ‘Willfulness’ Question -
On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether a “willful” act under the federal...more
10/14/2024
/ Anti-Kickback Statute ,
Bribery ,
Criminal Conspiracy ,
Denial of Certiorari ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Home Health Care ,
Kickbacks ,
Medicaid ,
Money Laundering ,
Popular ,
Scienter ,
SCOTUS ,
Telehealth ,
Whistleblowers
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional -
On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
10/7/2024
/ Anti-Kickback Statute ,
Appointments Clause ,
Criminal Convictions ,
Department of Health and Human Services (HHS) ,
False Claims Act (FCA) ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Health Care Programs (FHCP) ,
Healthcare Fraud ,
Kickbacks ,
Medicaid ,
Medicare ,
Misrepresentation ,
OIG ,
Qui Tam ,
Sentencing ,
Settlement ,
Unconstitutional Condition
Precision Lens Pays $12 Million to Resolve FCA and AKS Violations -
Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more
8/5/2024
/ Anti-Kickback Statute ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Fraud ,
Healthcare ,
Insurance Fraud ,
Kickbacks ,
Medicare ,
Reimbursements ,
Settlement ,
Stark Law ,
Telemarketing ,
Whistleblowers
District Court Declines to Stay Case Pending Resolution of FCA Causation Standard Issue Before Court of Appeals -
Earlier this week, a Massachusetts federal judge denied a motion to stay proceedings filed by Medtronic,...more
6/10/2024
/ Anti-Kickback Statute ,
Appeals ,
Causation ,
Criminal Convictions ,
Cryptocurrency ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Healthcare Fraud ,
Mail Fraud ,
Ponzi Scheme
Nevada Man Sentenced to 51 Months Imprisonment for Prize-Notification Fraud Scheme -
Earlier this week, a Nevada man was sentenced to 51 months in prison for perpetrating a prize-notification scheme that defrauded...more