ABA Health eSource April 2013 Volume 9 Number 8
ABA Health eSource - Your link to the ABA's Health Law Section
April 2013 Volume 9 Number 8
Health Law Section NewsApril 12, 2013
April 18, 2013
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Chair's Column: Helping Our Veterans

Over there, over there, send the word, send the word over there. That the Yanks are comin, the Yanks are comin, …And we won’t come back ‘til it’s over, over there.
— George M. Cohan

I write this column on the ten year anniversary of the second Iraq invasion, which of course followed closely on the heels of our intervention in Afghanistan. As in World War II, our young men and women ventured bravely overseas to battle tyranny and defend democracy. I, like many others, did not expect then that this 21st century call to arms would last more than a decade.

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This edition of eSource is brought to you by the Healthcare Fraud & Compliance Interest Group.

What Effect Will United States v. Caronia Have On Civil Off-Label Cases?

By Veronica B. Nannis, Joseph, Greenwald & Laake, P.A., Greenbelt, Maryland

Temporary shock waves shook the healthcare bar on December 3, 2012 when the Court of Appeals for the Second Circuit issued an opinion overturning a conviction for off-label promotion in United States v. Caronia. Alfred Caronia was a pharmaceutical sales representative who was convicted of misdemeanor conspiracy related to the off-label promotion of Xyrem for purposes not approved by the Food and Drug Administration (“FDA”).

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New OIG Special Fraud Alert: Physician-Owned Medical Device Distributors Beware

By John E. Kelly and Danielle M. Sloane, Bass, Berry & Sims PLC, Washington, D.C.

As previously noted in our October 2012 ABA article “Physician-Owned Medical Device Distributors: A Controversial Business Model,” the number of physician-owned medical device distributors (referred to generally as physician-owned distributorships or “PODs”) has increased in recent years despite being shrouded in controversy and intense debate regarding the legal viability of their structure.

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Regulatory Issues in Ambulatory Surgery Center Acquisitions

By Patricia O. Powers and Nora L. Liggett, Waller Lansden Dortch & Davis, LLP, Nashville, TN

The realities of health reform – bundled payments, care coordination and the need for expanded market presence – have spurred hospitals and other providers to acquire additional facilities at a rapid pace. Among the prime acquisition targets are local, physician-owned surgery centers. These acquisitions may seem straightforward, but because the facility is being sold by physicians to an entity that can benefit from referrals by those physicians, there are significant compliance risks that must be addressed.

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House Hearings Focus on Emerging Federal Regulations of Mobile Medical Devices and Apps

By Catherine Barrett, MITRE, Annapolis, MD

The House Energy and Commerce subcommittees on oversight and investigations, health and communications and technology held three hearings over three days beginning on March 19 th to discuss the critical role health information technology (“HIT”) plays in the healthcare industry. Two themes which emerged over the course of the hearings were how federal regulations may impact the growing mobile medical applications (“apps”) industry and the possible levying of federal taxes on smartphones, tablets, mobile apps, and other health information technologies.

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Healthcare Fraud & Compliance Interest Group

The Healthcare Fraud & Compliance Interest Group addresses topical, cutting edge issues which are the focus of fraud and abuse prevention, investigations and prosecutions.

If you would like to join the Interest Group, click the following link: Health Law Section IG Sign-up Form.

The IG is led by Chair Martha Talley, Office of Inspector General, U.S. Department of Health & Human Services, Washington, DC and Vice Chairs Joel M Androphy, Berg & Androphy, Houston, TX; Gwen K Chapman, Arthrocare, Inc., Austin, TX; John E Steiner Jr, Cancer Treatment Centers of America, Schaumburg, IL and Winifred M Weitsen, Venable LLP, Washington, DC.


ABA eSource Editorial Board

The ABA Health eSource Editorial Board is led by Editor, Marla Durben Hirsch, Potomac, MD; Chair Conrad Meyer, Chehardy Sherman, LLP, New Orleans, LA and editorial board members Claire Castles, Jones Day, Los Angeles, CA; Robyn Diaz, St. Jude Children's Research Hospital, Memphis, TN; Robert T. Rhoad, Crowell & Moring LLP, Washington, DC and Jose Vela Jr, Assistant United States Attorney, Southern District of Texas, Houston, TX.


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The opinions expressed are those of the authors and shall not be construed to represent the policies or positions of the ABA or the ABA Health Law Section.
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