ABA Health eSource - Your link to the ABA's Health Law Section
June 2010 Volume 6 Number 10
Health Law Section News  June 3, 2010

June 10, 2010
Healthcare Reform and Tax-Exempt Status for Hospitals
(CLE Teleconference)

June 17, 2010
Fundamentals of Health Insurance and Managed Care
(CLE Teleconference)

June 22, 2010
Meaningful Use: What is It? Who Should Obtain It? How to Get Incentive Payments
(CLE Teleconference)
June 24, 2010
Physicians and Healthcare Reform: For Better or Worse
(CLE Teleconference)
June 29, 2010
Tax Exempt Bonds: Schedule K, Private Use, and Other Compliance Issues
(CLE Teleconference)

Health Law Highlights

PPACA Resources

Latest Resources & News

HHS Office of Inspector General (OIG)

For more Resources
and News
click here.


New BNA Products
New Reference Manual
Civil Mental Disability Law, Evidence and Testimony: A Comprehensive Reference Manual for Lawyers, Judges and Mental Disability Professionals
(Pre-Order Now)
CDC Public Health Law News

CDC Newsletter is a free electronic newsletter published monthly by the Centers for Disease Control and Prevention, Public Health Law Program


Chair's Column
By David W. Hilgers, Brown McCarroll, L.L.P., Austin, TX

I was recently invited by our healthcare colleagues in the military to speak to a 2010 Health Law Conference of the Joint Department of Defense and MedCom in San Antonio. Major Joseph Topinka in the Office of the Staff Judge Advocate, who is a member of the Health Law Section, asked me to come and speak on the top issues facing health lawyers in 2010. It was a very enlightening experience.

First, I will have to say that our military counterparts are extraordinarily polite and hospitable. On arrival I was greeted, offered water, bags, pens, and materials of all sorts about the military. I was very generously introduced and amazingly, the audience was extremely attentive (which is unusual for my talks). No one got up to leave, no one was reading their BlackBerries, and the audience gave me a generous round of applause (which is also not my normal expectation). Finally, at the end of the talk I was given a commemorative medal reflecting my participation in the conference. It was a very nice experience.

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Food and Drug Administration Regulation of Tobacco: New Opportunities and Challenges
By Matthew R. Herington, Montana Department of Public Health & Human Services, Helena, MT

On June 22, 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). By amending the Federal Food, Drug, and Cosmetic Act, the Tobacco Control Act, for the first time, expressly gives jurisdiction over tobacco products to the Food and Drug Administration (FDA). As part of this delegation of jurisdiction, the Tobacco Control Act requires that FDA reissue its 1996 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, with certain limited modifications. The Tobacco Control Act notes that the regulations are “deemed to be in compliance with all applicable provisions” of the Administrative Procedure Act.

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Fraud and Abuse in Clinical Research:
Three Case Studies

By Julie M. Rusczek, Drinker Biddle & Reath LLP, Milwaukee, WI and Andrew P. Rusczek, Ropes & Gray LLP, Boston, MA

The federal government is renewing its focus on fraud and abuse in clinical research activities at a time when pharmaceutical, device, and biotech companies are sponsoring an increasing number of clinical trials. In light of these trends, industry sponsors and institutions that conduct research studies must be increasingly vigilant in their compliance efforts. This article presents three common clinical research scenarios that pose fraud and abuse concerns and offers suggestions for mitigating risk of fraud and abuse violations.

Research Involving Non-Employed Physician Investigators

A hospital enters into an agreement with a pharmaceutical company to conduct a drug study. The physician who will serve as the principal investigator is not a hospital employee. The principal investigator asks the hospital to pass along to him half of the funds that the hospital will receive from the sponsor pharmaceutical company for conducting the study, figuring that a 50/50 split would be fair.

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The Myriad decision: Judicial criticism of the Bayh-Dole Act and its progeny?
By Kathryn R. James, Chapman University School of Law,
Orange, CA

Recently, a federal court in New York ruled against the Utah-based biopharmaceutical research and development company, Myriad Inc.The issue in the case was whether or not patents held by Myriad over specific genes related to susceptibility to breast and ovarian cancer were valid under the Patent Act and the Constitution. The court’s rejection of the patents’ validity was unexpected by many, as the courts have typically upheld genetic patents as valid since 1980. Hence, while Myriad will almost certainly appeal, the decision potentially represents the beginning of a judiciary rejection – or, at the least, criticism - of the last 30 years of judicial and legislative encouragement of the commercialization of medicinal research and development.

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Test your knowledge of ABA Member Advantage

AuthorABA Member Advantage has been adding value to ABA membership for nearly 25 years with discounts on products and services that benefit our members and their firms. How well do you know the program? Take this quiz to find out. Answers are below.

1. How many companies participate in the ABA Member Advantage program today?

a.) 10
b.) 17
c.) 20
d.) 23

2. Which of the following is NOT a Member Advantage company?

a.) FTD
c.) Canon
d.) Brooks Brothers

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Did you know membership in an interest group is FREE with your Health Law Section membership?

Did you know your membership in the ABA Health Law Section qualifies you for free membership in up to three interest groups of your choice? Interest groups, which are comprised of twelve practices areas within health law, make significant contributions to the Section's programming, publications and legislative initiatives. The interest groups also provide an excellent opportunity for you to interact with and have access to some of the most outstanding lawyers in the legal community. You can enroll on our webpage by clicking here. If you have any questions or need more information, please contact Simeon Carson at Simeon.Carson@americanbar.org.

Public Health & Policy Interest Group

The Public Health & Policy Interest Group provides leadership to the ABA Health Law Section, and the ABA at large, in the area of public health and policy matters..

The IG is led by Chair Almeta Cooper, Ohio State Univ Medical Center, Columbus, OH and Vice-Chairs Michael DeLucia, Agnes Lindsay Trust, Manchester, NH; James G. Hodge, Jr., Sandra Day O'Connor College of Law, Arizona State University, Tempe, AZ; Howard Kaufman, University of Miami School of Medicine, Boca Raton, FL and Melisa Laura Thombley, Centers for Disease Control and Prevention, Atlanta, GA.

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

ABA eSource Editorial Board

The ABA Health eSource Editorial Board is led by Chair Lisa Genecov, Locke Lord Bissell and Liddell LLP, Dallas, TX and editorial board members Michael E. Clark, Duane Morris LLP, Houston, TX; Adrienne Dresevic, The Health Law Partners, PC, Southfield, MI; Marla Durben Hirsch, Potomac, MD and Conrad Meyer, Chaffe McCall, LLP, New Orleans, LA.

Do you want to communicate your ideas to thousands of other members? To contribute a newsletter article on a health law topic, send us your ideas to Simeon.Carson@americanbar.org
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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