The PharmaCertify™ Team

Ghouls, ghosts and goblins are on the way. It’s Halloween – time to dress up and march the kiddies out for trick-or-treating. Then you’ll want to “inspect” their haul, and in our book, it just isn’t a proper inspection if there isn’t taste testing involved. Have you figured out your costume yet? While you mull over your ideas, we present the scary tales of the week that was…the News Week in Review.

The final rules for the Sunshine Act may be a barely more than a ghost of an idea at this point, but the American Medical Association has written to CMS to express concerns regarding the proposed rule. The AMA again expressed concerns about the accuracy and public perception of the data. The group urged CMS to make changes in physicians’ ability to review pharmaceutical and medical device companies spend data. The AMA would like to have access to companies’ databases and be able to refute the data before it becomes public. The agency fears the data could create misperceptions about the relationships between physicians and the industry.

All the information received from the Sunshine Act could be a treat for enforcement agencies. A client alert from Morrison and Forester summarizes a discussion from a recent conference on aggregate spend, at which a panel of representatives from healthcare fraud enforcement agencies discussed how the data could be used in identifying possible fraud. Enforcers said the data could be reviewed to determine if groups of physicians are being paid a disproportionate amount from a particular company.

It’s alive, well, at the federal and state level of governments. We’re talking about none other than the False Claims Act. Federal and state enforcers are getting more aggressive with their enforcement of False Claims Act violations, and with $9 billion in recoveries this year is it any wonder? Allegations of violations rarely stand a judicial test as most cases are settled. This allows prosecutors to push the bounds of how the law is applied. A federal appeals court recently reined in federal prosecutors though, as it rejected the government’s attempt to expand certain aspects of the law in recent renal care cases.

No trick here, the U.K. Justice Ministry is moving forward in making Deferred Prosecution Agreements (DPA) a tool in dealing with crimes such as bribery, fraud and corruption. The Justice Ministry sought feedback on the use of the DPAs, and 86% of those who responded said they would be in favor of the idea. Those who supported the use of DPAs believed they were a “pragmatic means of investigating and penalizing more corporate crimes.”

Boehringer Ingelheim will have a smaller bag of candy this Halloween, with the announcement of a $95 million settlement with the government for the illegal marketing of three of its drugs. The government alleged that BI promoted the drugs for off-label uses and paid kickbacks to doctors. The case was brought by former sales representative under the qui tam provisions of the False Claims Act of the company, and he will receive $17 million as a whistleblower award. The states will receive $16.5 million of the settlement.

That brings us to the end of our spooky tome. Before we wrap it up, we’d like to send out our best wishes for anyone in the path of the Frankenstorm, Sandy. With all the rain, surf, winds and snow, the next few days will be very difficult for all of us in the northeast. Stay safe everyone!