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

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

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

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

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...

Why a Duck — Episode 5, Horsefeathers and the Juniper Networks FCPA Enforcement Action

Why a Duck — Episode 5, Horsefeathers and the Juniper Networks FCPA Enforcement Action

From Vaudeville to the Silver Screen to the Small Screen, the Marx Brothers made an impact wherever people found them. Now Tom Fox and Mike Volkov have wedded their love of the Marx Brothers with their passion for compliance and bring them into the boardroom to help explain and explore the sometimes-chaotic world of governance, risk-management, ethics and compliance. Listen HERE. In this episode they...

House of Representatives Passes Bill Aimed at Marijuana Industry Financial Reforms

House of Representatives Passes Bill Aimed at Marijuana Industry Financial Reforms

Noah Smith, an Associate at The Volkov Law Group, rejoins us for an update on the banking and marijuana industries. Noah can be reached at [email protected]. A new bill that would make it easier for financial institutions to provide services to “marijuana-related businesses” has passed the U.S. House of Representatives 321-103 with strong bipartisan support. The Secure and Fair Enforcement Banking Act of 2019 (colloquially...

Sign Up for NAVEX Global’s 2019 Ethics & Compliance Virtual Conference

Sign Up for NAVEX Global’s 2019 Ethics & Compliance Virtual Conference

When: October 24, 2019 Sign Up HERE On October 24, 2019, NAVEX Global is holding its 2019 Ethics & Compliance Virtual Conference, an online conference that gives you access to multiple educational tracks, over a dozen webinars, solution experts and a huge resource library. I will be conducting a session on Supply Chain and Third Party Distributor Sanctions Risks. ECVC2019 has all the perks of an in-person conference, without...

What Does “Business Ethics” Mean?

What Does “Business Ethics” Mean?

Forgive me for the title of this posting – I am trying to make a point; a rather obvious one.  I confess I did not take philosophy classes in high school or college.  So, I may have missed the boat on this issue.  But from my limited vantage point with respect to the compliance industry, everyone needs to take a breath and reevaluate their use...

The Importance of Whistleblowers to a Speak Up Culture

The twist and turns of our political world amid the ongoing controversy surrounding whistleblower reporting has focused  attention on an important issue – encouraging whistleblowers as part of a speak up culture and protecting them from retaliation is critical. Without getting into the merits of the specific allegations raised by the CIA whistleblower, the political debate concerning the identity, motives and protection of the whistleblower...

Episode 112 — Implementing an Effective Training Program

Episode 112 — Implementing an Effective Training Program

The government has stated that a well-designed compliance program includes “appropriately tailored training and communications.”  Compliance policies cannot work unless effectively communicated throughout a company. Communications and training programs ensure that directors, officers and employees are aware of and follow compliance policies and procedures.  Indeed, the Justice Department’s recent Evaluation of Compliance Program Guidance noted that integration of a company’s policies and procedures should include periodic training...