ABA Health eSource - Your link to the ABA's Health Law Section

Special Edition PPACA

 August 2010
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PPACA Special Edition for August

Due to the enormous impact of the Affordable Care Act, the ABA Health Law Section's eSource Editorial Board has decided to create a series of Affordable Care Act Special Editions to keep the ABA Health Law Section members informed on cutting-edge topics important to the health law bar. If you would like to review the past edition from June, please click here. July's edition is available here. If you have interest in contributing an eSource article, please contact Simeon Carson, Associate Director, at Simeon.Carson@americanbar.org.

Significant Changes in Medicare Payment Methodology Made by Health Care Reform Legislation
By Chris E. Rossman, Foley & Lardner LLP, Detroit, MI and
Jeffrey R. Bates, Foley & Lardner LLP, Los Angeles, CA

The federal health reform law will significantly revise the way the Medicare program reimburses providers. The Secretary of Health and Human Services (Secretary) is required to promulgate over 1,000 different regulations to implement the law. In some cases, the provisions will not become effective until 2011 or several years later.

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Reforming Health Care: The Legal, Ethical and Regulatory Challenges in Comparative Effectiveness Research
By Claudia E. Haywood, MBA, JD, J. Craig Venter Institute, Inc., Rockville, Maryland

With the passage of the Patient Protection and Affordable Care Act (PPACA), Congress has boldly taken a second step in its funding and support of a national program for Comparative Effectiveness Research (CER). CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition or to improve the delivery of care. Building on the established paradigms that already exist in evidence-based medicine, CER seeks to provide comparison data and information about the clinical outcomes, effectiveness and appropriateness of drugs, devices, clinical treatments and procedures that are used to prevent, diagnose, or treat disease, disorders and other health conditions effecting the population.

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Hanlester v. Shalala – A Victim of Health Reform?
By Claire E. Castles, Law Offices of Dennis M. Lynch, Visalia, CA

“The reports of my death have been greatly exaggerated.”
- Mark Twain

A key component of the recent health care reform legislation was the implementation of additional measures to strengthen program integrity and accountability in the expanding federal healthcare programs. In establishing elements to effectively buttress the current program integrity processes, Congress sought to clarify the intent standard for criminal violations of health care fraud and expressly included, by statute, that a claim resulting from a federal health care fraud scheme constitutes a false claim. Specifically, the Patient Protection and Affordable Care Act (“PPACA”) amended the federal statute enacting criminal penalties for acts involving federal healthcare programs to include the following two (2) additional subsections that now apply to both false statements and kickbacks:

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Complying with Federal and State “Sunshine Laws”: How Manufacturers Can Avoid Getting Burned
By Ann E. Lewis and David I. Sclar, Ropes & Gray LLP, New York, New York

New “sunshine provisions” in the Patient Protection and Affordable Health Care Act (“PPACA”) add federal obligations to an array of requirements under state laws that regulate drug and device manufacturers’ marketing to healthcare providers. This article presents an overview of the scope of federal and state sunshine laws and related industry guidance.

Sunshine Laws and Industry Guidance. Beginning on March 31, 2013, and by the ninetieth day of each calendar year thereafter, the PPACA’s sunshine provisions require pharmaceutical, medical device, biological, and medical supply manufacturers operating in the United States to report to the Secretary of the United States Department of Health and Human Services (the “Secretary”) the payments or transfers of value that they made to covered recipients during the previous calendar year.

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Fraud, Waste and Abuse Initiatives: Enforcing Like It’s 1993
By Frank Sheeder and Lindsey F. Bartula, Jones Day, Dallas, TX

The government is determined to reduce Medicare and Medicaid fraud by using new tools in the recently enacted Patient Protection and Affordable Care Act (“PPACA”) and other legislation, as well as through various traditional initiatives. The need to crack down on fraud, waste and abuse in the health care system is a common political and policy theme. Such initiatives often go hand-in-hand with reform efforts. In fact, some of the current themes were also articulated in 1993, when the Clinton administration endeavored to reform the health care system.

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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.

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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