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Attorney Spotlight

How did an interest in healthcare policy lead Robert Platt to a career in the law? Find out more>

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Experience Spotlight

Primary Care Providers Win Challenge of CMS Interpretation of Enhanced Payment Law

With the help and support of the Tennessee Medical Association, 21 Tennessee physicians of underserved communities joined together and retained Bass, Berry & Sims to file suit against the Centers for Medicare & Medicaid Services to stop improper collection efforts. Our team, led by David King, was successful in halting efforts to recoup TennCare payments that were used legitimately to expand services in communities that needed them. Read more

Tennessee Medical Association & Bass, Berry & Sims

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Thought Leadership

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Thought Leadership Spotlight

GDPR Top 5 Actions You Should Take Now

The EU's General Data Protection Regulation (GDPR) went into effect on May 25th. As most organizations are aware, the GDPR applies not only to EU businesses but also many companies in the U.S. While the deadline is quickly approaching, most organizations are still grappling with the implications of the regulation on their business. Even if your readiness efforts are behind the curve, the GDPR Top 5 Actions You Should Take NOW will help you begin your efforts towards compliance and help mitigate your organization's risk in the short-term.

Click here to download the checklist.

John Kelly and Rob Platt Author Article on FCA Liability for Pharmaceutical and Device Manufacturers

Life Science Compliance Update

Publications

July 12, 2017

Bass, Berry & Sims attorneys John Kelly and Rob Platt authored an article in Life Science Compliance Update outlining risk areas faced by pharmaceutical and medical device manufacturers related to False Claims Act (FCA) violations. According to Department of Justice data, these manufacturers accounted for nearly half of FCA recoveries within the healthcare industry in 2016. As John and Rob discuss, last year's enforcement targeted several key risk areas, including speaker programs and off-label promotions, discount pricing programs, and violations of current good manufacturing practices (cGMP). 

As the authors point out in conclusion, "the breadth of conduct that can expose manufacturers to unwanted liability is likely to expand as agencies and whistleblowers seek new ways to hold companies accountable for alleged misconduct. With that in mind, it is critical that pharmaceutical and medical device manufacturers develop adequate compliance programs that both help them prevent inappropriate conduct and allow them to address concerns if they arise rapidly."

The full article, "Pharmaceutical and Device Manufacturers: Buyer Seller Beware," was published in the July 2017 issue of Life Science Compliance Update and is available online to subscribers.


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