false claims act

sample cup

OIG Raises Compliance Expectations

Taking a page from pharma CIAs, the OIG has recently required that lab company Millennium Health hire a compliance expert. The drug testing provider came under fire for multiple years of violations of the Stark Law and Anti-Kickback Statute; relying on the insights of an expert should better equip the Millennium Board to ensure compliance going forward.

belgrade bridge

Berger FCPA Settlement: Back to the Future

Louis Berger International has agreed to pay $17 million and retain a compliance monitor for three years to settle bribery charges. At the same time, the Department of Justice handed down judgment on two Berger executives. The case, which was settled a few weeks ago, raises questions about the DOJ's handling of similar cases -- specifically regarding ...


Are Disclosures a Pathway to Off-Label Promotion?

Pharma companies' promotion of their products for off-label use has to date met with legal action from the FDA, but that may change. Last month, Amarin Corporation filed a complaint against the FDA, contending that its First Amendment rights were impinged upon. The forthcoming ruling in this case could mean huge benefits for the pharma industry.

police with radar gun

Regulatory Compliance Has No Speed Traps

Formed through legislation signed by President Gerald Ford in 1976, the OIG is one federal agency that should never be underestimated by those in the health care industry. In its pursuit to protect the integrity of health care programs and the welfare of their beneficiaries, the OIG boasts the power ...

White Collar Investigations: What Lies Ahead?

It seems like white collar investigations and prosecutions—as well as related civil fraud or enforcement actions—are everywhere these days. From headline-grabbing insider trading cases in the Southern District of New York like Galleon and SAC Capital, to what seems like newly-unfolding FCPA ...


Feds Use Tougher Tactics To Fight Healthcare Fraud

  • September 10, 2012

In a recent webinar Michael F. Ruggio and Michael Volkov outline how the government's ongoing crackdown translates into unprecedented risk of civil and criminal enforcement for a wide variety of healthcare organizations.

fraud corporate integrity agreement

Your Corporate Compliance and the Corporate Integrity Agreement

Management that turns deaf ears when subordinates report false billing or illegal marketing in dealing with federal or state governments can unleash a torrent of financial and reputational harm on the company. Indeed, that scenario is just the sort of situation that can turn into a full-blown, multi-million-dollar whistleblower settlement brought by a company insider under qui tam provisions ...