Week in Review, December 16, 2011

The PharmCertify™ Team

The big day is almost here. Are you prepared? Do you have your list ready? Have you been working out? What about that aluminum pole? Yes, your aluminum pole…it’s Festivus of course! It’s just a week away, and there’s so much to prepare. However, the news doesn’t stop just because Festivus is almost upon us. So we’re taking a break from our list of grievances to bring you this week’s PC News Week in Review.

We’ll start out with what can only be described as a Festivus miracle! (Well, it didn’t really occur on Festivus, but you get the point). CMS released the Sunshine Act regulations this week! (cue the Hallelujah Chorus). The regulations are posted and open for comment through February 17, 2012. After which, CMS will write the final rules. Data collection is postponed from the beginning of 2012 to once the final rules are posted. This being the case, CMS is proposing that manufacturers submit a partial year report in March of 2013. Data will be available to the public in September of 2013. For more on the proposed rules, check out R-Squared’s summary here (registration required). You can read the rules in their entirety here.

At a panel discussion hosted by Main Justice.com, lawyers representing the government and the healthcare industry discussed the future of healthcare law enforcement. No feats of strength style wrestling matches occurred (wouldn’t you have paid to see that?!), but there was healthy discussion covering some of the options the government would be using in the future. New data analysis software has already been put in place to find fraudulent Medicare and Medicaid claims. Meanwhile, a representative from HHS said that despite backing off the debarment of Forest Lab’s CEO, the agency isn’t taking that option off the table for future cases. In fact, a bill before Congress would expand HHS’s legal authority to exclude executives from participating in federal healthcare programs.

Even if HHS has backed off ever so slightly in holding executives accountable, the DOJ and SEC have heard the cries from lawmakers that individuals need to be held accountable. This week, the DOJ indicted six former Siemens executives and two intermediaries for conspiracy to violate the FCPA. In other news of personal accountability, the Synthes executive whose sentencing was delayed when his lawyer collapsed in the courtroom received an eight month prison sentence.

With that, we kick off the Airing of Grievances portion of the program with news of the government’s grievances against Medtronic leading to a $23.5 million settlement for kickback allegations.

Meanwhile, Allergan and Los Angeles county health officials aired their grievances about billboards that tout Lap-Band surgery but do not disclose any of the risks associated with surgery. The FDA issued a warning letter to a company known as 1-800-GET-THIN and several surgery centers associated with the marketer.

Some French politicians have grievances with the country’s regulatory system, and are calling for widespread changes to assure patient safety and rid the system of conflict of interests.

And back in the U.S., federal authorities are set to air grievances against a group of New Jersey doctors who they say accepted illegal kickbacks for referrals to a specific MRI center. Perhaps these doctors should share this OIG video intended to educate providers about the Anti-kickback Statute as they gather around the Festivus aluminum pole.

If a video from the OIG isn’t exactly the kind of tale you’d like to share with your family and friends around the pole, then perhaps this summary of the top stories of the year about the medical device industry is more to your liking.

2011 is quickly coming to an end. With new regulations for Sunshine and the increased enforcement of anti-corruption laws both here and abroad, training early and often is an important consideration for 2012. PharmaCertify helps you address  training on topics likes the FCPA, anti-bribery, state and federal disclosure promotion and on-label promotion. Our solutions range from off-the-shelf and customizable eLearning modules, to iPad apps and reinforcement tools. Check us out at www.pharmacertify.com/compliance.

That’s the News for this week. We hope you have a lovely weekend, and a Merry (is that right word?) Festivus. And if you’ve been wondering all along, “what is this Festivus craziness,” here’s a link to the Seinfeld episode that started it all.


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