ABA Health eSource January 2012 Volume 8 Number 5
ABA Health eSource - Your link to the ABA's Health Law Section
January 2012 Volume 8 Number 5
Health Law Section NewsJanuary 18, 2012

January 26 , 2012
The Fundamentals of a Healthcare Transaction: An Interactive Look at the Anatomy of a Deal
(CLE Webinar & Teleconference)

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The ACOs Are Coming: What You Must Know About the Accountable Care Organizations Final Rules

Online Course!
The Final ACO Regulations: Is Participation Worth a Second Look?
Part 1: Quality of Care, Antifraud, and Antitrust

Part 2: Assignment of Beneficiaries, Risk, Structure and Governance, and Tax Issues

Health Law Highlights

Health Law News

ACO Resources & News

HHS Office of Inspector General (OIG)

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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: A Bridge Over Troubled Water
By David H. Johnson, Bannerman & Johnson, P.A.,
Albuquerque, NM

Not long ago, I had dinner with my friend Beth Schermer, who related her experiences in being recruited by then-Arizona governor Janet Napolitano to assist in bringing divergent forces together to establish a new four-year medical school in Phoenix.  The interested parties included the two major state universities, numerous hospitals and medical groups, research organizations, and foundations - all with their own vision, priorities and needs.  Multiple obstacles were encountered en route to a resolution.  To Beth the project was both challenging and exhilarating.  It led her to rethink the role of leaders and lawyers in navigating conflict and bringing many parties to a single goal, and ultimately led to her refocusing her efforts from the traditional practice of law to business consulting. 

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This edition of eSource is brought to you by the Public Health and Policy Interest Group.

Drug Shortages in the United States
By Rina Shah, U.S. Office of Personnel Management on National Healthcare Operations, Washington, DC

According to the American Society of Health System Pharmacists (“ASHP”), there are currently about 200 drug shortages, ranging from the Acetazolamide Injection to the Zoster Vaccine Live. A recent study claimed that these numerous drug shortages are not as bad as they seem because they are limited to a few disease areas and generic injectables. Despite the purportedly limited scope, drugs that are vital to treating major diseases such as childhood leukemia and breast cancer are part of the current shortages. Due to concerns about delays in treatment, increased morbidity and mortality, and higher healthcare costs, manufacturers and the government have been attempting to remedy the issue. As government legislation is still pending and other responses are fairly recent, there has not been any reliable information to indicate whether these strategies are working.

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CMS Launches New Demonstration Programs
By Andrew B. Wachler and Jessica C. Lange,
Wachler & Associates, P.C., Royal Oak, MI

On November 15, 2011, the Centers for Medicare & Medicaid Services (“CMS”) announced three demonstration programs, directed to “…strengthen Medicare by aiming at eliminating fraud and abuse.” The three demonstration programs are the Part A to Part B Rebilling Demonstration Program (“AB Rebilling Demonstration”), the Recovery Audit Pre-Payment Review Demonstration Program and the Prior Authorization and Pre-Payment Review of Power Mobility Devices (“PMD”s). The demonstration programs stem from Executive Orders announced by President Obama. The first order was announced on November 23, 2009 with the purpose of reducing improper payments and waste in federal programs.

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Food and Drug Administration (“FDA”) Regulation of Mobile Health
By Catherine Barrett, Federal Working Group, Washington, DC

The consumer electronics, IT and telecommunications industries are carefully monitoring the Food and Drug Administration’s (“FDA”) interest in creating a new body of regulations designed to govern the use and marketability of certain hardware, software applications, mobile medical apps, mobile phones and accessories. On July 21, 2011 the FDA released draft guidance entitled “Mobile Medical Applications.” The purpose of the draft guidance is to “inform manufacturers, distributors, and other entities about how the FDA intends to apply its regulatory authorities to select software applications intended for use on mobile platforms (“mobile applications” or ‘‘mobile apps’’).”

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Risk-Bearing under the MSSP ACO Final Rule
By Gregory W. Bee, Taft Stettinius & Hollister LLP, Cincinnati, OH
and Catherine T. Dunlay, Taft Stettinius & Hollister LLP, Columbus, OH

On October 20, 2011, The Centers for Medicare & Medicaid Services (“CMS”) released a final rule (the “Final Rule”) for accountable care organizations (“ACOs”) under the Medicare Shared Savings Program (the “MSSP”). The Final Rule was promulgated pursuant to the 2010 Patient Protection and Affordable Care Act. The Final Rule contains a number of changes from the proposed rule (the “Proposed Rule”) that, taken together, lessen downside financial risks to participants and, therefore, lower some of the barriers to entry for smaller and less experienced providers. This article provides an overview of the changes affecting risk-bearing by participating ACOs.

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Supreme Court to Decide the Fate of the Obama Administration’s Landmark Healthcare Reform Act
By Michelle Browning Coughlin, Holland N. (“Quint”) McTyeire, V, and Peter L. Thurman, Jr., Bingham Greenebaum Doll LLP, Louisville, KY

On Monday, November 14, 2011, the United States Supreme Court granted certiorari to hear arguments regarding the constitutionality of the Patient Protection and Affordable Care Act (“PPACA”). Cases challenging PPACA have been moving through courts across the United States. In general, the cases filed have examined whether a mandate requiring individuals to purchase health insurance exceeds Congress’s power under the Commerce Clause of the United States Constitution.

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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 and Policy Interest Group

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

The IG is led by Chair Rakel M. Meir, Tufts Health Plan, Watertown, MA and Vice Chairs Deirdre Golden, University of Michigan; Dan Stier, Public Health Law Center at William Mitchell College of Law, St. Paul, MN; Major Joseph B. Topinka, US Army Medical Command, Fort Sam Houston, TX and Kyle McConnell, Wiggins, Baker, Donelson, Memphis, TN.

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 Adrienne Dresevic, The Health Law Partners, PC, Southfield, MI and editorial board members Claire Castles, Jones Day, Los Angeles, CA; Michael E. Clark, Duane Morris LLP, Houston, TX; Marla Durben Hirsch, Potomac, MD; Conrad Meyer, Chaffe McCall, LLP, New Orleans, LA; Robert T. Rhoad, Crowell & Moring LLP, Washington, DC and Jennifer Tsao, Hernandez Schaedel & Associates LLP, Pasadena, CA.

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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