Week in Review, March 18, 2013

The PharmaCertify™ Team

So, was your weekend full of excitement? Were your wearing that special color as you waited anxiously for the excitement to begin? Then suddenly, like a pot of gold at the end of the rainbow, it happened…the NCAA Tournament teams were announced! Release the brackets, it’s March Madness! If you’re team didn’t make it to the tourney, you can at least seek redemption with the office pool, right? As we wait for the madness to begin, and the games to get underway, let’s catch up on week’s compliance news with the News in Review.

Taking the jump ball in this week’s Review is a story that raises the question of whether the Sunshine Act could have the unintended consequence of stifling research. At an event sponsored by the Healthcare Leadership Council, Dr. David Caraway announce that his colleagues who receive no more than $250 in transfers of value in a year have told him they will no longer participate in industry-sponsored education or collaborations. They simply do not want their name appearing in newspapers. The Health Leadership Council said its members were satisfied with the way the rules were presented in general, but they had concerns about the public database. Panelists at the event agreed that the context around the data will be the key to the public understanding the details.

Stakeholders representing a wide range of healthcare industry concerns have released a statement of principles to guide collaborations between physicians, researchers and pharmaceutical and medical device companies. The principles include an acknowledgment that; physicians and researchers must have autonomy; all involved in healthcare must be responsible for their own actions; and collaborations at any level should ultimately be for the benefit of patients. The groups participating in the development of the principles include the Association of American Medical Colleges, AdvaMed, Cleveland Clinic, Eli Lily and PhRMA.

As the industry waits for the FDA to release guidance on social media, the Federal Trade Commission has released its own guidance on the subject. The folks at Pharmalot raised the question of whether the FDA steal from the FTC guidance as the agency develops its own policy. Of particular interest to those in the life sciences industry may be the FTC’s take on what is known as the “one-click rule.” The FTC insists that information regarding the safety of the product should be on the original page or message, and not relegated to a page available through a hyperlink.

Slipping in at the final buzzer is a story that points out the success states are having in the pursuit of Medicaid fraud. A report from Health and Human Services (HHS) shows that states recovered $2.9 billion in Medicaid fraud in fiscal year 2012. Part of the total is the result of joint federal and state investigations. The states collectively engaged in over 15,000 investigations, with over 11,000 of those being for Medicaid fraud.

That brings us to the end of the Review for this week. Good luck cheering on your favorite team or alma mater this week and remember, PharmaCertify offers the eLearning modules and mobile apps needed to keep your sales and marketing team up-to-date on the latest in good promotional practices and compliance regulations.

Have a great week everyone!

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