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

2010 promises to be an industry-changing year for healthcare. It is all but certain that legislation will be passed that lays the groundwork for substantial changes in healthcare insurance and delivery. Physician-hospital relationships will evolve into new structures with groundbreaking implications. Quality and evidence-based medicine protocols will continue to develop, raising numerous due process and legal questions. It is appropriate that all of this change comes in 2010, the beginning of the next decade. Clearly, the healthcare industry in the United States in 2020 will be fundamentally different than it is in 2010.

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Revisions to Supervision Requirements for Hospital Outpatient Therapeutic Incident to Services and Diagnostic Services
By Thomas E. Dowdell, Fulbright & Jaworski L.L.P.,
Washington, DC

The Centers for Medicare and Medicaid Services (“CMS”) revised the supervision requirements for hospital outpatient therapeutic incident to services and diagnostic services in the 2010 hospital outpatient prospective payment system (“OPPS”) final rule effective for outpatient services furnished on and after January 1, 2010. This article will review the supervision requirements for hospital outpatient therapeutic incident to services and diagnostic services effective through 2009 and describe the modifications to these supervision requirements effective for services performed January 1, 2010 and thereafter.

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Health Reform Legislation Promises Significant Limitations On New and Continued Physician Ownership and Investment in Specialty and Other Hospitals
By Michael W. Paddock, Esq., and Matthew T. Fornataro, Esq., Crowell & Moring LLP, Washington, D.C.

The health reform legislation just passed by the Senate, the Patient Protection and Affordable Care Act (“Senate Bill”), as well as the healthcare bill already passed by the House of Representatives, the Affordable Health Care for America Act (“House Bill”), both propose significant changes to the federal law that prohibits physician “self-referrals,” otherwise known as the Stark Law. That law prohibits a physician from referring Medicare patients for “designated health services” to entities with which the physician (or an immediate family member) has a financial relationship. The Stark Law confers strict liability and provides stiff penalties for violations, including denial of payment, refunds of improper payments, and high civil money penalties -- ranging from $15,000 to $100,000 per violation. Though the Stark Law’s prohibitions are triggered by the presence of countless types of financial relationships between physicians and the entities to which they refer patients, the law does permit referrals and claims if any such financial relationship satisfies either a statutory or regulatory “exception.”

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Manipulation of Prescription Drug Research Data: Merely an Ethical Breach or a Fraudulent Claim?
by Alison Morrissey, Georgetown University Law Center, Washington, DC

Pharmaceutical companies are intimately involved in the modern research and development (R&D) world. They conduct clinical trials to satisfy the Food and Drug Administration’s (FDA) regulatory requirements to file new drug applications (NDAs), prove the efficacy of new “uses” for existing products, and often design trials which compare the safety and effectiveness of their product to a competitor. These trials have the dual effect of advancing a body of evidence surrounding a particular therapy and serving as powerful advertising and marketing pieces. According to an insider article, “For a pharmaceutical company, getting research published in a peer-reviewed medical journal is like winning a stamp of approval from its most influential audience. It’s an automatic validation unmatched by any other medium.”

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Free Resources from the Health Law Section

Now that the holiday season is over, the Health Law Section of the ABA would like to share a few of your current member benefit offerings as part of our ongoing effort to keep you apprised of all your Section membership has to offer. Please review the list below for links to materials you may find useful. To access members-only resources, please first login to the ABA website at www.myaba.com using your ABA ID or email address. Note that your password is your last name, unless you've changed it. If you have any issues logging onto the website, please contact the ABA Service Center at 800-285-2221.

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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.

Payment & Reimbursement 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.

The IG is led by Chair Holley Thames Lutz, Sonnenschein Nath & Rosenthal LLP, Washington, DC and Vice-Chairs Gwen Chapman, FULBRIGHT & Jaworski L.L.P., Houston, TX; Joseph Geraci, Brown McCarroll, L.L.P., Austin, TX; Andrew B. Wachler, Wachler & Associates, Royal Oak, MI and Jonell Williamson, Baker Donelson et al, Jackson, MS.

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, Hamel Bowers & Clark 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.