Journal of health law最新文献

In today's healthcare industry, many hospitals utilize outside agencies for both business and clinical functions. This Article acknowledges the prevalence of outsourcing contract labor in the healthcare arena and focuses on the restrictive provisions included in these employment contracts, particularly "no-hire" clauses. No-hire clauses are often included in contracts between healthcare providers and professional groups that provide clinical service employees to the provider, such as a medical practice group providing physicians to a hospital or an agency providing nurses to a nursing home. These clauses usually provide that the healthcare provider may not directly hire an employee provided by the professional group, nor may it contract with another professional group that later hires the employee. The purpose of a no-hire clause is two-fold: to protect the professional group's investment of time and moneyfor recruiting, training, and establishing the employee's clinical practice, and to give the professional group leverage to retain its employees. While noncompete clauses in employment contracts have traditionally been the subject of litigation, no-hire clauses raise distinct legal issues. Case law provides conflicting views as to the enforceability of these provisions. Some courts find no-hire clauses to be per se illegal restrictions on trade, while others will permit them when they are reasonable within a specific context. The author proposes that a multifactor test be applied on a case-by-case basis to determine the reasonableness of the no-hire provision in a given employment contract and suggests drafting improvements to facilitate enforcement.

The most relevant question for any joint venture is, when does the relationship become a jointventure and not simply a price-fixing cartel? With respect to this question, this Article juxtaposes Texaco, Inc. v. Dagher, 126 S. Ct. 1276 (2006), against years of contrary precedent. In Dagher, the Court altered the seemingly settled foundation of antitrust law by changing its view on past holdings and abandoning the ancillary effects doctrine. The Article provides an outline of key holdings prior to Dagher, as well as a discussion of the issues that can arise as joint ventures are formed. Additionally, the authors examine how the decision altered the foundation of joint venture law in the United States. In particular, the Article exposes several important antitrust concerns relating to joint ventures that the Supreme Court did not address in Dagher. Perhaps the most perplexing issue of Dagher is whether the venture at issue would have survived analysis under the Federal Trade Commission's "continuum" approach.

The emergence of Consumer-Defined Health Plans with large deductibles means that many people will be financially responsible for all or most of their healthcare during any given year. This increasing exposure to costs will bring important changes in the physician-patient relationship, as patients seek more information about the care their physicians propose. Litigation can be anticipated in two areas. First, in tort law, informed consent claims may allege that providers failed to disclose the likely costs and medical importance of their care. Second, in contract law, patients may challenge the reasonableness of the prices they are charged. This Article explores potential causes of action in both areas. Ultimately, increasing transparency of pricing may lend greater rationality not only to pricing structures but also, it is to be hoped, to healthcare itself, as cost-worthiness of care assumes higher priority in medical decisionmaking.

This Article analyzes the October 2005 Initial Decision of the Federal Trade Commission Administrative Law Judge ordering Evanston Northwestern Healthcare Corporation to divest Highland Park Hospital on the grounds that the January 2000 merger of the entities violated Section 7 of the Clayton Act. In particular, this Article focuses on the ALJ's discussion of the use of patient flow analysis and the Elzinga-Hogarty test in defining relevant markets in hospital merger cases. Despite the ALJ's explicit rejection of the Elzinga-Hogarty Test and patient flow analysis as irrelevant and inappropriate in defining markets in the highly differentiated Hospital market, the author concludes that the ALJ's rejection of patient flow analysis likely was a response to misplaced and over-reliance on patient flow analysis by a number of courts in past prospective government challenges to hospital mergers as evidenced by the fact that the ALJ's analysis of competition and competitive effects relied upon, and thereby implicity endorsed, the use of patient flow analysis for certain purposes. Finally, the author concludes that patient flowanalysis, when used appropriately, should continue to be used as a preliminary step in geographic market definition and competitive effects analysis.

In approving the Food and Drug Administration's (FDA) Fiscal Year 2007 budget, the House approved an amendment that would prevent the agency from using appropriated funds to waive certain conflicts of interest identified by members of its advisory committees. The amendment, introduced by Representative Hinchey and known as the Hinchey Amendment, provides that no funds may be used to: waive a conflict of interest under Section 505(n)(4) of the Federal Food, Drug, and Cosmetic Act (FDCA) for any voting member of an FDA advisory committee or panel; or make a certification under Section 208(b)(3) of Title 18 of the U.S. Code for any such voting member. This creates a problem, as ties to industry create the very expertise that FDA values in its outside advisors-under the Hinchey Amendment, these very ties would prevent them from serving as advisors to FDA during the drug approval process. The author opposes this change in the law and argues that the Hinchey Amendment would undermine congressional efforts in 1962 and 1989 to carefully balance the goals of attracting qualified experts and protecting agency decisionmaking. Further, the author argues, this change is unnecessary at FDA, because experts on FDA advisory committees divulge their connections to the industry, because the committees offer only advice and do not make agency decisions, and because the agency is under the watchful eye of Congress, the public, and public interest groups. The Article concludes that although FDA's advisory committee conflict-of-interest process can be improved, congressional action is unnecessary, and a change in the law through amendment to an appropriations bill that does not go through the ordinary legislative process (as an amendment to the FDCA or Title 18 would) is inappropriate. Instead, recommendations from organizations studying FDA practice, such as the OIG, GAO, and IOM, should be used to carefully and reflectively amend the process at the agency level, within the existing statutory framework.

The recent splintering of the unions of the Change to Win Coalition from the AFL-CIO has received a great deal of attention in the media. Few have watched these developments with greater interest than employers in a broad variety of employment settings. As union prospects in the manufacturing industries have dwindled, employers in the service industries such as healthcare have become especially sensitive to changes in the labor movement and the opportunities to organize. This Article explores the philosophical differences responsible for the AFL-CIO schism, the likely effect this division will have on union organizing efforts in the healthcare industry, and the negative consequences these organizing efforts could have on employee free choice within the industry. In addition, this Article outlines some of the steps healthcare employers can take to protect their ability to communicate freely and directly with their employees.

Counsel for a manufacturer of medical devices or durable medical equipment must have working knowledge of various legal disciplines to draft contracts with intermediaries (sales representatives and distributors) for the marketing and sale of the manufacturer's products. If the manufacturer wishes to sell its products abroad, counsel must become familiar with the laws and business practices of the target country, and methods of gaining access to the foreign market. This Article gives readers an overview of the applicable legal principles, under U.S. and foreign laws, in the areas of agency, contracts, healthcare regulation, consumer protection, intellectual property protection, and dealer protection. To aid counsel in drafting intermediary agreements, specific contractual terms and issues are explored in depth, including: appointment clauses, performance provisions, provisions concerning pricing and payment, protective clauses (shielding the manufacturer from liability), term and termination provisions, independent contractor clauses, export control clauses, recordkeeping and audit provisions, choice of law clauses, and dispute resolution clauses.

Fraudulent or abusive sales and marketing practices by pharmaceutical companies can result in costly overutilization of products that are increasingly paid for by government healthcare programs and may result in adverse health and safety consequences to the patient-beneficiaries of those programs. Federal enforcement efforts in this area are largely modeled on those used to combat white-collar crime, with cases taking years to reach conclusion. This approach overlooks the impact on patients who receive unnecessary care or are denied access to appropriate care during the course of the investigation. Many states are beginning to regulate certain pharmaceutical sales and marketing practices, but state-by-state regulation ignores the importance of a uniform federal regulatory and enforcement approach in an area already occupied by federal law. This Article explores current federal and state efforts to limit overutilization, fraud, and abuse in the sale and marketing of prescription drugs, and illustrates the merits of an expanded role for the U.S. Food and Drug Administration (FDA) to regulate pharmaceutical sales and marketing practices. This approach borrows lessons learned from the FDA's efficient and effective regulatory and enforcement methods and maintains a careful balance between the interests of patient-beneficiaries, the government and industry.

Dr. Portnoy, a former senior clinical reviewer and manager for the FDA's Center for Devices and Radiological Health, provides guidance for determining acceptable practices for the claims, content, and appearance of advertising and promotional materials for medical devices. In the course of doing so, he discusses important regulatory and legal precedents, and provides examples of successful and problematic advertising and promotion strategies including those that resulted in FDA Warning Letters, enforcement activities, and in some cases, monetary and criminal penalties.

American healthcare needs to be reformed into competing, efficient, comprehensive care systems. To get there from here, we need a health insurance market in which each person or household has a wide, responsible, informed, individual multiple choice of health care financing and delivery plans. The point of this is competing delivery systems, not just competing carriers. To compete, some carriers will create or contract with selective delivery systems or doctors selected for their quality and cost-effectiveness. Others will already be teamed up with large multispecialty group practices. On the other hand, high deductible plans will not help us get to a reformed delivery system.