Journal of health law
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Journal of health law · Jan 2007
Doctors, apologies, and the law: an analysis and critique of apology laws.
This Article analyzes and critiques apology laws, their potential use, and effectiveness, both legally and ethically, in light of the strong professional norms that shape physicians' reaction to medical errors. Physicians are largely reluctant to disclose medical errors to patients, patients' families, and even other physicians. ⋯ This Article examines potential barriers to physicians' disclosure of medical mistakes and demonstrates how the underlying problem may actually be rooted in professional norms-norms that will remain outside the scope of law's influence. The Article also considers other legal and policy changes that could help to encourage disclosure.
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Journal of health law · Jan 2007
Beyond the anti-kickback statute: new entities, new theories in healthcare fraud prosecutions.
The authors analyze existing and developing trends in healthcare fraud litigation. They first review the traditional use of the Medicare-Medicaid Anti-Kickback Statute to prosecute such fraudulent activity. ⋯ The Article then turns to a discussion and warning of attorneys' potential liability for a client's kickback arrangements. Finally, the Article takes a very brief look at relationships under Medicare Part D that may well prove to be a fertile area of problematic conduct, public and congressional scrutiny, and prosecutions utilizing some of these theories.
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As medicine's technical limits have become increasingly clear, Americans seem more willing to address end-of-life decisionmaking. A major development during the 1990s was physician assistance in dying: physician-assisted suicide in Michigan, Oregon's Death with Dignity Act, and developments in Europe, most notably The Netherlands. ⋯ These issues include the effects on providers' values systems, the trust between patient and provider, and the "slippery slope" that voluntary, active assistance in dying will become involuntary, active assistance. This Article addresses the policy issues that institutions must confront in a changing environment.
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Journal of health law · Jan 2006
Reining in agency action: the rejected proposal rule and Section 1011 of the 2003 Medicare Act.
Section 1011 of the 2003 Medicare Act authorized the disbursement of over one billion dollars to healthcare providers that provide uncompensated emergency medical care to undocumented immigrants. In 2005, the Centers for Medicare and Medicaid Services (CMS) issued its final interpretation of the statute. Despite previous statementsto the contrary, CMS conditioned eligibilityfor Section 1011 funds on the collection of certain immigration status-related information from patients seeking emergency care. ⋯ A. Inc. v. National Resources Defense Council, Inc.
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Journal of health law · Jan 2006
Advisory committees at FDA: the Hinchey Amendment and "conflict of interest" waivers.
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. ⋯ 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.