Category: General

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...

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...

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...

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 nsmith@volkovlaw.com. 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

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?

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...