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.
If you want to see how the SEC’s whistleblower program may look in a few years, all you need to do is take a look at the False Claims Act and the role that whistleblowers play in the enforcement of the act.
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 of federal and state False Claims Acts.
Companies complain about the burdens of anti-corruption compliance. They need to put things in perspective. The “greatest” risk of them all may be the False Claims Act (FCA).
The turn of the year is an occasion not only for reflecting on the past, but also for considering the future. For hospitals and their compliance professionals, it is a good time to take stock of regulatory vulnerabilities, determine which ones should receive priority attention, and resolve to address these concerns in the coming year. Adhering to the following three resolutions may help make 2012 a happy and healthy New Year for many hospitals.
Federal sales truly turn the old adage of buyer beware on its head, making seller beware more accurate. J. William Eshelman of Butzel Long Tighe Patton reviews two cases that illustrate why complying with government contracts is anything but simple.
Legal requirements are of concern to compliance personnel. But “compliance” as a mantra does not end there. Instead, fraud prevention only begins with legal prohibitions. Stated differently, “compliance” is not a destination. Rather, it is a goal that will evolve as business necessities and circumstances change.
Fox Rothschild’s David Restaino covers corporate compliance holistically, from the laws that govern compliance to consequences of inadequate compliance and the benefits of a robust compliance program.
The Food and Drug Administration is responsible for ensuring that prescription drug products sold in the United States are safe and effective for their intended uses. The FDA’s Division of Drug Marketing, Advertising, and Communications, soon to be reorganized as the Office of Prescription Drug Promotion, is responsible for ensuring that prescription drug information disseminated by drug company representatives, in any form, is truthful, balanced, and not misleading.
Reed Smith’s Areta Kupchyk investigates the required elements of all promotion materials and the FDA’s enforcement surveillance and tools.
News is breaking today that the United States government has slapped a suit against Johnson & Johnson and two of its subsidiaries for allegedly paying kickbacks to nursing homes in an effort to boost sale for a new antipsychotic drug.
By Joel Hesch, Liberty University
The government has honed in on three primary areas where it alleges that a pharmaceutical company commits fraud. In addition, there is an emerging new area, adulterated products, where the DOJ is beginning to investigate and just may be the next huge compliance risk.