The Court’s rejection of the condition of payment analysis and adoption of a rigorous materiality standard represents a significant shift in how courts must analyze FCA cases premised on underlying regulatory or contractual...more
6/17/2016
/ Conditions of Payment ,
Failure To Disclose ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Medicare ,
Mental Health ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers
The penalties are potentially astronomical for entities with FCA exposure.
In addition to treble damages, the False Claims Act (FCA) provides for mandatory penalties for each false claim submitted “of not less than...more
In qui tam case, Supreme Court oral argument addresses practical implications of limiting the scope of the implied certification theory of liability under the FCA....more
The US Department of Justice has announced the creation of a one-year pilot program intended to encourage companies to self-report bribery violations and provide extensive cooperation in exchange for reduced penalties,...more
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more
8/11/2015
/ Amarin ,
Caronia ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Misbranding ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Physicians ,
Preliminary Injunctions ,
Prescription Drugs
The court’s interpretation complicates the already difficult task providers face in having sufficient time to assess and quantify potential overpayments.
An August 3 decision in United States v. Continuum Health Partners...more
8/6/2015
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Hospitals ,
Medicaid ,
Medicare ,
Overpayment ,
Qui Tam ,
Relators
Revisions bring DOJ and SEC guidance in line with FCPA statutory language.
In June, the US Department of Justice (DOJ) and Securities and Exchange Commission (SEC) quietly revised its manual, A Resource Guide to the U.S....more
8/6/2015
/ Accounting Standards ,
Compliance ,
Criminal Penalties ,
Department of Justice (DOJ) ,
Enforcement ,
FCPA Resource Guide ,
Foreign Corrupt Practices Act (FCPA) ,
Good Faith ,
Internal Controls ,
Joint Venture ,
Securities and Exchange Commission (SEC) ,
Transparency
The decision highlights the US government’s focus on effective compliance programs.
The US Department of Justice (DOJ) is creating a new compliance counsel position in the Criminal Division to assess the effectiveness of...more
The squads will extend the capabilities of the US Department of Justice and the US Securities and Exchange Commission to gather evidence and enforce the Foreign Corrupt Practices Act....more
Companies doing business in the country should evaluate their compliance programs to avoid the law's sanctions on violators.
On August 2, Brazilian President Dilma Rousseff signed Law No. 12,846/2013—unofficially...more