Pharmaceutical and medical device manufacturers (as well as group purchasing organizations “GPOs”) have a major compliance challenge ahead — the Physician Payment Sunshine Act regulations.  The Sunshine Act requires drug and device manufacturers and GPOs to report to HHS/CMS any “payment or other transfer of value” to physicians and teaching hospitals. The Payment Sunshine Act reporting is scheduled to start on March 31, 2014, for...

The Volkov Law Group is conducting four free webinars over the next three weeks — Sign Up Now for these important and informative webinars. How to Conduct High-Stakes, High-Profile Internal Investigations: July 18, 2013, 12 Noon – 1 PM EST: Sign Up Here Companies caught in the government cross-hairs for potential corruption, antitrust, fraud, export violations and other significant civil and criminal violations initiate internal investigations...

We have all watched the familiar scene on Capitol Hill – the latest public scandal like officials from the Internal Revenue Service are dragged up to Capitol Hill to appear before a Committee, raise their right hands, take the oath and then assert their Fifth Amendment right against self-incrimination.  Senators and Congresspersons make comments on the scandal, vilify the witnesses, and promise a thorough Congressional...

The internet is filled with articles written by lawyers, consultants and government officials on when a company should disclose a potential FCPA violation or a government FCPA investigation.  It is not an easy question and lawyers often disagree on when a matter is “material” for a publicly-traded company. The disclosure has major ramifications for a company.  I am amazed at how quickly the plaintiff’s bar...

Several years ago, Canada was regularly cited for its lack of commitment to anti-corruption enforcement.  Canada got the message and it ramped up its anti-corruption program. The Royal Canadian Mounted Police dedicated additional resources to enforcement, and they have been busy.  They are conducting a major anti-corruption investigation against SNC-Lavilin, which appears to be the largest anti-corruption case brought by the Canadians.  SNC-Lavilin has suffered...

Let’s start with a few basic assumptions – we all know that third parties are often the most significant risk for corruption.  Of course, a company’s own sales staff can be a significant risk, just as much as a third-party.  However, most companies recognize that they have a greater ability to control the actions of their sales staff than their third parties. Knowing that your...

The story of “The Boy Who Cried Wolf” applies with full force to the securities industry and the FCPA.  Since 2010, FCPA practitioners have been crying out about FCPA risks in the securities industry. First, in 2010, it was the SEC letters issued to various investment banks, private equity and hedge funds.  The SEC was concerned about anti-corruption compliance and interactions with sovereign wealth funds...

Webinar – FCPA Compliance Programs: A Review of Best Practices July 9, 2013 12 Noon – 1 PM EST Register: Here  In response to aggressive FCPA enforcement, the compliance industry has embraced innovative strategies and tools. As companies increase resources for compliance programs, it is important to stay abreast of industry best practices. Join Michael Volkov, CEO of The Volkov Law Group, for an examination of FCPA compliance...

Doctors better get used to government regulation.  The Affordable Healthcare Act contains a lengthy complement of new laws and regulations.  Physicians are under greater government scrutiny.  As Medicare expands and inevitably grows, physicians face a growing number of risks. Some doctors have sworn off Medicare and Medicaid patients because of government regulation.  Not all doctors can afford to do that.  As a result, physicians are...

People love to make mountains out of mole hills.  Or to put in another way (as my daughter might say), “She/he is a drama freak.” When it comes to structuring a compliance and ethics program, and the reporting lines, I have been accused of being a “drama freak,” meaning that I have advocated for an independent and empowered chief compliance officer.  What does an independent...