Featured Articles:

Two Charitable Foundations Pay $6 Million for Anti-Kickback Violations

Two charitable foundations that helped patients pay for drug co-payments settled anti-kickback charges for $6 million.  The Patient Access Network Foundation (PANF) agreed to pay $4 million and Good Days agreed to pay $2 million to resolve AKS allegations.  The charitable foundations were used as pass throughs for Denderon, Astellas, Amgen and other drug companies to funnel money to Medicare patients taking their drugs.  The...

Justice Department Unseals Unaoil Executives’ FCPA Guilty Pleas

The Justice Department announced that three Unaoil executives entered FCPA guilty pleas last year.  The three executives cooperated with law enforcement in the investigation and prosecution of other companies and individuals.  In March 2018, the former Unaoil CEO, Cyrus Ahsani, and former Unaoil chief operations officer, Saman Ahsani, plead guilty to one count of FCPA conspiracy for paying millions in bribes to foreign officials in...

Episode 115 — Review of Recent Healthcare Fraud Enforcement Actions

The Justice Department has aggressively continued to pursue False Claims Act prosecutions against healthcare companies and physicians.  By the mid-point of 2019, DOJ had collected over $800 million against pharmaceutical and healthcare professionals.  In the last few months, DOJ has brought several significant prosecutions. In this Episode, Michael Volkov reviews recent healthcare fraud enforcement cases.

Five Steps to Improve Board Monitoring of Compliance

In today’s aggressive enforcement environment, corporate board members have a target on their respective backs.  Even with robust liability insurance, corporate boards are operating in a state of “ignorance is bliss.”  Chief compliance officers face enormous challenges, and perhaps their greatest challenge is enlisting and securing the support of the corporate board.  We often hear about  happy-talk about senior management and board support – but...

Why A Duck — Episode 6, Coconuts and the OFAC Compliance Framework

In this Episode, Tom Fox and Mike Volkov discuss the Marx Brothers movie, Coconuts, and the new OFAC Compliance Framework. Listen HERE Tom and Mike address the following issues: Why has Mike Volkov called the OFAC Compliance Framework a ‘game-changer’? How does the OFAC Framework illustrate regulatory convergence? What are some of the highlights of the OFAC Framework? What are some of the key lessons...

Episode 114 — Update on Board Member Liability for Compliance Oversight Failures

Corporate board members have an obligation to oversee and monitor a company’s compliance program.  In two recent cases, Delaware courts have tightened the standard governing board liability under the Caremark decision.  Several months ago, in a case involving the Blue Bell Ice Cream listeria outbreak, the Delaware Supreme Court applied a heightened standard when relating to “mission-critical” issues involving food safety to a food company.  In another...

Department of Justice Brings Criminal Charges Against 35 Individuals for Involvement in $2.1 Billion in Fraudulent Genetic Testing Results

The Justice Department, in coordination with HHS-OIG and the FBI recently announced the arrest and prosecution of 35 individuals for a massive genetic testing fraud scheme involving dozens of telemedicine companies and cancer genetic testing laboratories (CGx). The defendants fraudulently billed Medicare more than $2.1 billion for CGx testing.  Among those charged were 10 medical professionals, including nine doctors.  In addition, CMS took administrative action...

Avanir Pharmaceuticals Pays More than $108 Million to Settle Kickback Violations

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and device firms, a relative risk analysis is likely to reveal that False Claims Act risks significantly outweigh FCPA risks (not to diminish FCPA risks, but relatively speaking). As an...

Delaware Court Increases Scrutiny of Corporate Board Oversight and Monitoring of Compliance Programs

On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation (here), a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to monitor the development of the biotech firm’s experimental drug and allowing it to permit inflated performance results.  The Court’s decision was the second opinion issued by the Delaware courts in...

Episode 113 — Managing Conflict of Interests Risks

Chief compliance officers are often responsible for managing a company’s conflicts of interest policy. A company can suffer serious legal and reputational harm if it fails to identify and mitigate conflicts of interest. The nature and scope of conflicts of interest vary across the organization, especially at senior management and board levels. Given the number and complexity of conflicts, CCOs have to devote adequate attention...