The PharmaCertify™ Team
Did the bons temps rouler for you earlier this week? Get your fill of green, gold and purple, or maybe catch a few beads tossed from a parade float? We enjoyed some King Cake, and hope you did too as the Carnival season drew to a close on Fat Tuesday. The party isn’t over for us though as we keep the good times rolling with this week’s News Week in Review.
The good times rolled to a stop for the government in the FCPA sting trial. Last week the government filed a motion opposing a request by the defense to have some of the charges dropped against the next group of defendants. Their trial was scheduled to begin in March. Then, earlier this week, the government changed direction and decided it would no longer pursue indictments against the remaining defendants. Factors that led to the decision included the outcome of the first two trials and the large number of resources required to continue with the remaining trials.
A number of industry groups are feeling less than golden about certain aspects of the draft regulations from CMS for the Sunshine Act. The groups are concerned that information on payments to physicians will not clearly explain the reason the payment is being made. In a blog post for The Hill, PhRMA’s CEO echoed the need for context around payments in order for the public to understand the nature of the payments and to be able to make the best use of the information. The Association of Clinical Research Organizations (ARCO) said reporting requirements around research payments were “highly problematic.” In a letter to HHS, ARCO’s executive director cited a study that showed a quarter of physicians said they would be less likely to participate in clinical trials if the financial proceeds were reported to HHS. He believes physicians are concerned the information will be misinterpreted.
Not to be left out of the “let’s send a letter to a government agency” parade, the U.S. Chamber of Commerce and twelve other trade organizations representing the business community have sent a letter to the DOJ and SEC asking for clarity around the FCPA. In addition to the ever popular request for clarity around the definition of a foreign official, the groups are looking for more information on the issue of successor liability in an acquisition and clarification on when donations to a charity connected to a foreign government are considered a bribe.
On the legal front, a medical equipment sales representative pled guilty to defrauding Medicaid of more than $70,000. Sentencing in the case will be in May, and the sales representative faces up to ten years in prison.
Carmen Ortiz, the U.S. Attorney for the District of Massachusetts, announced that her office collected $1.67 billion in health care fraud penalties during fiscal 2011. (Now that’s a lot of doubloons!) The total represents 40 percent of all healthcare fraud criminal and civil penalties collected nationwide.
As we wind down this Mardi Gras edition of the News in Review, we leave you with a reminder that PharmaCertify now offers iPad-compatible versions of our customizable off-the-shelf modules covering critical topics like on-label promotion, HIPAA, Good Promotional Practices and anti-bribery. Visit the mobile solutions page on Pharmacertify.com to learn how we can help roll your compliance training to where your reps need it most – in the field and at their fingertips.
Have a great weekend! We’ll see you right back here next Friday with all the news that sets us a Twitter for the week.