The Journal of Health and Life Sciences Law is published four times a year in coordination with LexisNexis, and will contain in-depth, professionally reviewed articles of interest to healthcare attorney -- including those who represent researchers, board members, institutions, practitioners, employers, and multi-state entities. The Journal will also contain "Notes and Comments" focused on new ideas as well as current developments, as well as "Practice Resources" which will help the reader excel in their practice-checklists, glossaries, reference tools and other useful items.
Articles featured in Volume I, Issue #4 (July 2008):
Today's Conflict of Interest Compliance Challenge: How Do We Balance the Commitment to Integrity with the Demand for Innovation? -- Bernadette M. Broccolo and Jennifer S. Geetter Limited Provider Panels: Their Promise and Problems in an Individual Health Insurance Market -- William H. Pitsenberger FTC v. Evanston: Antitrust Enforcement of Hospital Mergers Receives a Shot in the Arm -- Chul Pak and Kashana Cauley Medical Devices: The Obvious, the Readily-Accepted, and the Surprising -- Deborah E. Tolomeo and Laurie A. Clarke Having Your Cake and Eating It Too? The (Un)Enforceability of Releases on Future Qui Tam Claims -- Todd P. Photopulos and Graham W. Askew Practice Resource
Union Organizing in Assisted Living -- Allison M. Woodall
Today's Conflict of Interest Compliance Challenge: How Do We Balance the Commitment to Integrity with the Demand for Innovation?
Bernadette M. Broccolo and Jennifer S. Geetter
ABSTRACT: Beginning in the 1980s, the federal government encouraged institutional providers to collaborate with pharmaceutical companies, medical device manufacturers, and biotechnology ventures. The rationale underlying this public policy was that collaboration would accelerate the pace of innovation. More recently, the focus is on whether these collaborations create conflicts of interest that jeopardize the safety of subjects and the integrity of data. Various constituencies are calling for conflict of interest reform, while the demand for new diagnostic and therapeutic tools has never been greater. These competing messages have stakeholders questioning what to do. This article reviews recent developments in conflicts of interest reform and provides recommendations that institutions and industry can consider as they undertake to develop a scalable and flexible approach to enhancing their conflicts of interest infrastructure.
FTC v. Evanston: Antitrust Enforcement of Hospital Mergers Receives a Shot in the Arm
Chul Pak and Kashana Cauley
ABSTRACT: This article examines the Federal Trade Commission?s Evanston decision and assesses its future impact on hospital merger analysis. In finding that a consummated merger of two Chicago-area hospitals violated the antitrust laws, the FTC analyzed the merger using a unilateral effects theory of anticompetitive harm. This theory entails examining the competitive impact on third-party payors as a result of the loss of competition between the merging hospitals, rather than the traditional market share and market structure data relied upon in earlier court decisions. After a detailed discussion of the Evanston decision and the history of hospital merger litigation leading up to it, the authors argue that while the Evanston decision indicates that the government will use unilateral effects analysis in challenging future hospital mergers, this analysis is fraught with litigation challenges. The government?s next case will not have the benefit of a strong evidentiary record as in Evanston, thereby making it more difficult for the government to prove its unilateral effects theory.
Having Your Cake and Eating It Too? The (Un)Enforceability of Releases on Future Qui Tam Claims
Todd P. Photopulos and Graham W. Askew
ABSTRACT: The Department of Justice reports that the United States has recovered over twenty billion dollars in settlements and judgments since Congress substantially strengthened the False Claims Act in 1986. These recoveries have come disproportionately at the expense of the healthcare industry. This article will provide a working knowledge of the significant cases addressing the issue of the enforceability of releases on future qui tam claims, then proceed to provide strategies for protecting members of the healthcare industry from future whistleblower claims.
Limited Provider Panels: Their Promise and Problems in an Individual Health Insurance Market
William H. Pitsenberger
ABSTRACT: The cost of healthcare, and consequently of health insurance, continues to increase dramatically. A growing chorus calls for replacing the fundamental method by which people purchase insurance today -- through their employers -- with a system of individually acquired insurance. This article argues that changing how Americans purchase health insurance could change the dynamics between insurers and healthcare providers in a way that could favorably impact costs, primarily through reliance on highly limited provider networks. It examines the bases of legal obstacles to limited provider networks embedded in both statutory and case law and urges re-examination of those bases in light of changes in the distribution system of health insurance.
Medical Devices: The Obvious, the Readily-Accepted, and the Surprising
Deborah E. Tolomeo and Laurie A. Clarke
ABSTRACT: The Food and Drug Administration's (FDA or the Agency) interpretation of the definition of a medical device in the Federal Food, Drug, and Cosmetic Act is very broad. Thus, the Agency has authority to regulate most products that have a health purpose or affect a person?s body as medical devices unless they are clearly drugs or biologics. The primary purposes of this article are to help executives, managers, attorneys, regulatory professionals, healthcare providers, and consumers: (1) identify products that are potentially medical devices; (2) determine whether FDA is likely to regulate them as medical devices; and (3) if so, determine the applicable premarket requirements, if any. This article discusses the statutory criteria of a product?s intended use, technological characteristics, and mode of action, and shows how FDA applies these criteria to determine whether a product is a medical device. This article provides examples of the Agency?s interpretation of the statutory definition of a medical device and shows how to analyze whether a product is an FDA regulated medical device.
Practice Resource
Union Organizing in Assisted Living
Allison M. Woodall
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