The healthcare industry always has taken the lead in compliance issues, developing innovative compliance tools and programs.   Anti-corruption compliance borrows heavily from many healthcare compliance ideas. Healthcare companies are dependent on the government for revenues.   As the government plays a greater role in our healthcare system, healthcare companies can expect compliance to become even more important.   At the same time, the government is dedicating more...

Patrick Kellermann from LeClairRyan, an expert in e-discovery and data compliance issues, joins us again as a contributor.  His profile can be viewed here.  In all honesty, document collection and review during an internal investigation is not a very sexy issue.  It is not like interviewing techniques, strategy calls on how to conduct the investigation, or even like reporting to the Board on an investigation. Like...

Tom Cohn, a shareholder at LeClairRyan, is our guest contributor today.  Tom is a former Director of the Federal Trade Commission’s Northeast Region.  Tom’s full profile is here.     As we noted last week, the Consumer Financial Protection Bureau (“CFPB”) is fast becoming a powerful, important player in the consumer finance market.  It has broad powers to ensure compliance with consumer protection laws for big...

Today’s posting is written by Donna Boehme.  She  is an internationally recognized authority and practitioner in the field of organizational compliance and ethics, designing and managing compliance and ethics solutions within the U.S. and worldwide. As principal of Compliance Strategists LLC, Donna is the former group compliance and ethics officer for two leading multinationals and currently advises a wide spectrum of private, public, governmental, academic,...

Sometimes it is easy to overlook the importance of human resources and compliance issues.  In fact, human resource departments face significant enforcement and compliance risks.  In addition, the head of human resources is an important partner on compliance.  If a company suffers from weak compliance programs, its human resource department is sure to be a liability for the company. The Human Resources Chief has significant...

The 2012 settlements with Pfizer, Data Systems and Solutions and NORDAM all underscore an important point – when a company discovers potential violations, the company should consider implementing appropriate remediation while completing its internal investigation in order to improve its compliance program.  The Justice Department has cited this factor in determining the “discount” for cooperation and acceptance of responsibility.  In past years, early remediation has...

The Supreme Court’s decision upholding most of the Affordable Care Act increased compliance responsibilities for healthcare companies.  The ACA amended the False Claims Act (FCA), which was amended in 2009 in the Fraud Enforcement and Recovery Act. The FCA amendments in 2009 and 2010 have had a dramatic impact on businesses.  The 2009 amendments expanded the definition of “claim” and the definition of “obligation” to...

Mexico is an important trading partner with the United States.  It attracts a lot of foreign investment by United States companies.  Corruption risks are substantial and getting worse.  Mexico is ranked 100 out of 182 countries by the Transparency International’s Corruption Perceptions Index.  It has been moving down the list in the last five years. FCPA prosecutors have focused on Mexico operations.  In the last...

Pharmaceutical and medical device companies are fast becoming the enforcement punching bag, eclipsing the long-suffering status of the oil and gas energy.  If you ignore the political and public relations challenges facing the pharmaceutical and medical device industries, you are being naive.  In almost every possible area for enforcement, pharmaceutical and medical companies have been the targets of aggressive criminal, civil and regulatory action. While...

The ultimate outcome of an internal investigation is, in many respects, dictated by the investigation report.  But not all reports are created equal.  Every report reflects the specific external and internal circumstances facing a company. On the external front, the key issues are whether the government has initiated a civil and/or criminal investigation(s)?  Is there a potential whistleblower action?  Is there pending related civil litigation?...