As recently reported, the Senate Finance Committee has issued a report and requested HHS OIG to investigate the increased use of physician-owned distribution companies in the medical device industry, and whether PODs violate the federal anti-kickback statutes. The federal health care anti-kickback statute (“Anti-Kickback statute”) is a criminal statute that prohibits, among other things, giving or receiving any financial benefit or “remuneration” in exchange for,...

The Senate Finance Committee issued a letter to the HHS Office of Inspector General (OIG) requesting that the OIG investigate the growth of physician owned distribution companies (“PODs”) to distribute medical devices. The Senate Finance Committee’s inquiry is in response to the proliferation of PODs and the possible violation of fraud and abuse laws. A POD is an arrangement under which physicians invest and own...

The Senate Finance Committee issued a letter to the HHS Office of Inspector General (OIG) requesting that the OIG investigate the growth of physician owned distribution companies (“PODs”) to distribute medical devices. The Senate Finance Committee’s inquiry is in response to the proliferation of PODs and the possible violation of fraud and abuse laws. A POD is an arrangement under which physicians invest and own...

In keeping with my Russian heritage, I wanted to dedicate this blog entry to my Russian roots.  Not that anyone in my family was corrupt. Russia is the new China – economic opportunities abound and companies are rushing to enter into the Russian market. And for good reason. Income in Russia is expected to increase by 60 percent in the next four years Russia has great...

In a telephone conference call sponsored by the ABA, Lorin Reisner, Deputy Director of Enforcement at the SEC, disclosed that the SEC is relying on data analytics and industry-specific risk analysis to initiate FCPA investigations.  Reisner’s disclosure is extremely significant because he specifically explained that investigations initiated as a result of voluntary disclosures by companies constitute a smaller percentage of the SEC’s investigations. What does...

Money laundering continues to be a significant problem. The precise amount involved in the global economy is very hard to measure with estimates ranging from $1.5 to $4 trillion. For compliance officers, money laundering is not a new risk, especially since the USA PATRIOT Act was passed in 2001, which imposed a new set of laws and regulations on the financial industry. But make no mistake,...

A number of large multinational companies are allegedly under investigation for FCPA violations in Indonesia.  That should not be a surprise.  The United States and Indonesia have established cooperative arrangements to investigate bribery.  Indonesia’s Corruption Eradication Commission (“KPK”) has been a victim of its own success — rival law enforcement agencies and a small number of businesses have launched challenges to KPK’s authority and aggressive...

A number of large multinational companies are allegedly under investigation for FCPA violations in Indonesia.  That should not be a surprise.  The United States and Indonesia have established cooperative arrangements to investigate bribery.  Indonesia’s Corruption Eradication Commission (“KPK”) has been a victim of its own success — rival law enforcement agencies and a small number of businesses have launched challenges to KPK’s authority and aggressive...

A number of large multinational companies are allegedly under investigation for FCPA violations in Indonesia.  That should not be a surprise.  The United States and Indonesia have established cooperative arrangements to investigate bribery.  Indonesia’s Corruption Eradication Commission (“KPK”) has been a victim of its own success — rival law enforcement agencies and a small number of businesses have launched challenges to KPK’s authority and aggressive...

For those companies dedicated to compliance, the first and most critical step is a commitment to empower its compliance office.  A company must assign adequate personnel and allocate adequate resources to fulfill its mission.  An effective compliance officer must be regarded as equal to, or even senior to, the company’s Chief Financial Officer or General Counsel.  Gone are the days when compliance offices are a...