Chair's Column
By Vickie Yates Brown, Frost Brown Todd LLC, Louisville, KY

The Section held its spring Council meeting on April 24-26 th in Louisville, Kentucky and I thoroughly enjoyed hosting the section leaders in my hometown. We worked hard with a full business agenda, but time was also set aside for Council members to enjoy the city during Derby week. Most importantly though, it is essential to highlight a couple of significant business items.

First, the Section approved an important Report and Recommendation concerning the task of managing conflicts of interest in medical research, education and medical practices. The Section recommended the establishment of uniform guidance on conflicts of interest in relationships between physicians, researchers and industry in conducting human subject research. The Section plans to bring this Report and Recommendation before the House of Delegates at the ABA Annual meeting in late July. This is a very timely issue and the Council appreciates the hard work of members the Healthcare Task Force, chaired by David Johnson, in conducting the research and preparing the document.

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New 403(b) Prototype Program Offers Planning Opportunity for Employers
By Philip J. Castrogiovanni, McDermott Will & Emery, Chicago, IL

On April 14, 2009, the Internal Revenue Service (IRS) published Announcement 2009-34 (Announcement) describing its intent to establish a program to allow pre-approval of prototype plans under Internal Revenue Code (Code) Section 403(b). The program will be offered along side existing individually approved 403(b) plans. The Announcement requests comments by June 1, 2009, on a proposed revenue procedure to implement the 403(b) prototype plan regime and it also requests that each vendor which expects to establish a prototype plan notify the IRS of its intent to do so by June 1, 2009.  Once the process for establishing a 403(b) prototype plan is finalized, vendors can establish such arrangements and offer them to adopting employers.  A prototype plan is an attractive option for employers maintaining a simple 403(b) plan design that want to ease their administrative burden while assuring that their plan continues to meet IRS plan qualification requirements.

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COBRA Subsidy in Stimulus Package for Involuntarily Terminated Employees
By Robert B. Fitzpatrick, Robert B. Fitzpatrick PLLC, Washington, DC

On February 17, 2009, President Obama signed into law the American Recovery and Reinvestment Act of 2009 (H.R. 1, S. 1) (the “Act”), which, among other things, amends the Consolidated Omnibus Budget Reconciliation Act of 1985 (“COBRA”) to provide a government subsidy of up to 65 percent of the COBRA premiums (including state and D.C. “mini-COBRA” coverage) to certain eligible individuals, known as “assistance eligible individuals”. These funds will be reimbursed by means of a payroll tax credit to the employer (in the case of a self-funded plan), the plan (in the case of a multi-employer plan), or the insurer (in the case of an insured plan). The “assistance eligible individuals” will only be required to pay 35 percent of the total cost of their former health insurance premium. Prior to the passage of this new subsidy, terminated employees were responsible for 100% of their health insurance premium if they wished to maintain COBRA coverage. The COBRA subsidy applies to individuals, and their spouses and dependents, who are eligible for COBRA due to an involuntary termination from employment from September 1, 2008, through December 31, 2009.

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Colorado Heart Institute, LLC v. Johnson: Revised definition of “entity” under Stark survives court challenge; case may impact other pending litigation on related topic
By Donald H. Romano, Arent Fox LLP, Washington, DC

A challenge to the new definition of “entity” under the Stark Law, brought by physicians and physician-owned entities that furnish cardiac catherization services to hospitals that bill for them “under arrangements,” was dismissed for lack of jurisdiction. Colorado Heart Institute, LLC v. Johnson, No. 08-1626 (RMC) (D.D.C. Apr. 21, 2009). As explained below, the decision also may have some effect on pending litigation challenging the revision to the related Stark rule on “per click” lease arrangements. The Stark law generally prohibits a physician from referring designated health services (DHS), including inpatient and outpatient services to an “entity” with which the physician (or an immediate family member) has a financial relationship (ownership or compensation), and prohibits the entity from billing Medicare for the DHS, unless an exception applies. The law and regulations have numerous exceptions for compensation relationships, but relatively few exceptions for ownership relationships.

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FDA Issues Clarification of U.S. Clinical Trials Registry Requirements
By Carolyne Hathaway, J. Ben Haas and Cassie Scherer, Latham & Watkins LLP, Washington , D.C.

The Food and Drug Administration Modernization Act of 1997 (FDAMA or Act) established a clinical trials registry (found at Clinicaltrials.gov) to provide a convenient source of public information regarding ongoing drug trials in human subjects. FDAMA required drug companies conducting clinical trials subject to the Act to submit information about their trials to the registry within the first 21 days of opening enrollment. The Act required that the information be made available to the public within five days of the sponsor's submission. The database, administered by the National Institutes of Health (NIH), provides transparency in the conduct of clinical trials, and is a resource for patients seeking to identify clinical trials in which they might participate. The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the scope and applicability of the clinical trials registry to include medical device trials. It also required sponsors to report information related to clinical trial results.

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Internships Wanted

The Health Law Section is looking for firms or organizations that offer summer law student internships. If your firm or organization has openings for interns, please send the name of the entity, whether the internship is paid or unpaid and an email contact to Simeon Carson at Simeon.Carson@americanbar.org. The information will be posted on the Health Law Section Law Student web page as an information service for law students.

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Employee Benefits & Executive Compensation Interest Group

The Employee Benefits & Executive Compensation Interest Group focuses on significant compliance issues relating to health and other welfare benefit plans with particular emphasis on HIPAA, COBRA, Medicare Secondary Payor rules, and ERISA Title I rules, as well as executive compensation issues.

The IG is led by Chair Phyllis C. Borzi, George Washington University Medical Center, Washington, DC and Vice-Chairs Eugene M. Holmes, McDermott Will & Emery LLP, Washington, DC; Gregory L. Needles, Morgan, Lewis & Bockius, LLP, Washington, DC and Christopher S. Sears, Ice Miller LLP, Indianapolis, IN.

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.