Health Law and Policy Commons^™

Whose Body? Whose Soul? Medical Decision-Making On Behalf Of Children And The Free Exercise Clause Before And After Employment Division V. Smith, B. Jessie Hill

Faculty Publications

Within constitutional law, children’s rights have suffered from severe neglect. The issue of parents’ constitutional rights to deny children medical treatment based on religious belief is one area in desperate need of attention. Although the Supreme Court’s 199 decision in Employment Division v. Smith seemingly set forth a relatively clear rule regarding the availability of exemptions from generally applicable laws - such as those requiring parents to ensure that their children receive appropriate medical care - Smith has changed little in this realm, and if anything, it has only confused matters, highlighting the intractable nature of the issue. While Smith …

Political Factors And Enforcement Of The Nursing Home Regulatory Regime, Philip C. Aka, Lucinda M. Deason, Augustine Hammond

Journal of Law and Health

This study analyzes the influence of political factors, oversight, and nursing home affiliation or ownership status on the enforcement of the nursing home regulatory regime, signified by the Nursing Home Reform Act ("NHRA") and its progeny. Specifically speaking, it measures, using the statistical technique of regression analysis, factors that account for variations across states in the number of deficiencies (or violations of quality standards) cited by nursing home inspectors across the states. This work is a first of its kind, an analysis not government-related, by a set of public administration scholars that systematically studies the influence of political forces on …

Protecting Women's Human Rights: A Case Study In The Philippines, Tamar Ezer

Articles

No abstract provided.

Follow The Leader?: Maryland's Response To The New Federal Stem Cell Guidelines, Michael Ulrich

The Appendix, Journal of Health Care Law & Policy

No abstract provided.

The Federalism Of Climex Lectularius: What Bed-Bugs Tell Us About Fifra Preemption In Pesticide Applicator Cases, David Beugelmans

The Appendix, Journal of Health Care Law & Policy

No abstract provided.

Buyer Beware: An Exploration Of Health Risks And Legal Policies In Favor Of A Labeling Requirement For Genetically Modified Organisms, Rebecca Jesada

The Appendix, Journal of Health Care Law & Policy

No abstract provided.

Improving Health Care Outcomes Through Personalized Comparisons Of Treatment Effectiveness Based On Electronic Health Records, Sharona Hoffman, Andy Podgurski

Faculty Publications

Comparative effectiveness research (CER) is one of the Patient Protection and Affordable Care Act’s significant initiatives that aims to improve treatment outcomes and lower health care costs. This Article takes CER a step further and suggests a novel clinical application for it. The Article proposes the development of a national framework to enable physicians to rapidly perform, through a computerized service, medically sound personalized comparisons of the effectiveness of possible treatments for patients’ conditions. A treatment comparison for a given patient would be based on data from electronic health records of a cohort of clinically similar patients who received the …

Foreword, Joseph Van Leer, Lawrence Singer, Megan Bess, John Blum

Annals of Health Law and Life Sciences

No abstract provided.

The Stark Law In Retrospect, Patrick A. Sutton

Annals of Health Law and Life Sciences

Considering the ultimate goals of preventing the over-utilization of medical services and protecting the Medicare program, are the numerous phases of the Stark Law and their concomitant regulations effective; or, conversely, has the legislation served to impede entrepreneurialism among physicians to the detriment of innovations and better integration in the delivery of medical treatment? This article endeavors to answer the above question through an analysis of the policy goals behind the legislation; the evolution of its regulations; its effect on competitiveness in the field of medicine; and the ethical considerations implicated by the issue of physician self-referral. It further offers …

Table Of Contents , Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

The False Claims Act And The Eroding Scienter In Healthcare Fraud Litigation, Richard Doan

Annals of Health Law and Life Sciences

This article addresses the federal government's expansive methods in tackling healthcare fraud, particularly in misapplying the False Claims Act. Although tasked with the obligation to curtail the fraudulent submission of Medicare & Medicaid claims, the U.S. government must rein in the current trend to utilize the False Claims Act against smaller medical providers. As the Act's original focus has ebbed in significance, the government has increasingly applied the False Claims Act to circumstances that do not evince actual fraud. In doing so, federal courts have effectively eroded the statute's critical scienter requirement. The federal common-law doctrines of "payment by mistake" …

Squeezing The Middleman: Ending Underhanded Dealing In The Pharmacy Benefit Management Industry Through Regulation, Mark Meador

Annals of Health Law and Life Sciences

Pharmacy benefit management (PBM) companies are the middlemen of the pharmaceutical industry, designing plans for sponsors and insurers and pushing the products of manufacturers. Their unique position can often create conflicts of interest, which has been the basis of much litigation. This article reviews the structure of the PBM industry and analyzes concerns arising from its handling of prescription drug pricing, manufacturer rebates and discounts, and mail order pharmacies. After surveying several legislative proposals, it concludes with a comprehensive outline for legislation to eliminate underhanded dealing in the industry and lower the cost of prescription drugs.

Is State Power To Protect Health Compatible With Substantive Due Process Rights?, Allan J. Jacobs

Annals of Health Law and Life Sciences

Public health laws may mandate drastic limitations on individual liberty, such as forced medication and quarantine. This results in a tension between public health laws and guarantees of liberty such as the Due Process Clauses of the Fifth and Fourteenth Amendments to the United States Constitution. The Supreme Court has resolved this tension in favor of one or the other of these legal principles, depending on the facts and issues involved. Nevertheless, Supreme Court jurisprudence is internally consistent. The Court has applied a level of scrutiny that, while rigorous, is more flexible than strict scrutiny. I denote this as "enhanced …

Between The Scylla And Charybdis: Physicians And The Clash Of Liability Standards And Cost Cutting Goals Within Accountable Care Organizations, Christopher Smith

Annals of Health Law and Life Sciences

This article seeks to examine the conflict between non-cost-conscious medical malpractice liability standards and health care cost cutting measures within the context of Accountable Care Organizations ("ACOs") under the new health care reform law. This article begins by providing an overview of the high level of health care spending within the United States health care system in order to provide a context for better understanding policymakers' push for cost cutting measures, including ACOs. This article then examines the tension between cost containment efforts and medical liability standards through an examination of the "stuck in the middle" mentality that physicians face …

Foreword, Joseph Van Leer, Lawrence Singer, Megan Bess, John Blum

Annals of Health Law and Life Sciences

No abstract provided.

Sunshine And Accountability: The Pursuit Of Information On Quality In Medicaid Managed Care, Sarah Somers, Jane Perkins, Nhelp .

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Cooperation, Commandeering, Or Crowding Out? : Federal Intervention And State Choices In Health Care Policy, Jonathan H. Adler

Faculty Publications

The Patient Protection and Affordable Care Act (ACA) substantially alters the respective roles of the federal and state governments in health care policy. Beyond the individual mandate, the ACA presents many questions of federalism, both constitutional and policy-related. This paper, prepared for a symposium sponsored by the Kansas Journal of Law & Public Policy, addresses some of these federalism issues. After outlining some of the policy considerations for determining the proper federal and state balance in health care policy, it identifies constitutional limitations on the federal government’s ability to direct or even influence state policy choices, before discussing how federal …

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

From Clinical Integration To Accountable Care, Mark Shields

Annals of Health Law and Life Sciences

Four key challenges to reforming health care organizations can be addressed by a clinical integration model patterned after Advocate Physician Partners (APP). These challenges are: predominance of small group practices, dominant fee-for-service reimbursement methods, weaknesses of the traditional hospital medical staff structure and a need to partner with commercial insurance companies. APP has demonstrated teamwork between 3800 physicians and hospitals to improve quality, patient safety and cost-effectiveness. Building on this model, an innovative contract with Blue Cross Blue Shield of Illinois serves as a prototype for a commercial Accountable Care Organization. For this contract to succeed, APP must outperform the …

The Experiential Future Of The Law, Adam Kolber

Faculty Scholarship

No abstract provided.

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

The December 2011 issue of Public Health (the Journal of the Royal Society for Public Health) contains a symposium entitled: Legislate, Regulate, Litigate? Legal approaches to the prevention and treatment of cancer. This symposium explores the possibilities for using law and regulation – both internationally and at the national level – as the policy instrument for preventing and improving the treatment of cancer and other leading non-communicable diseases (NCDs). In this editorial, we argue that there is an urgent need for more legal scholarship on cancer and other leading NCDs, as well as greater dialogue between lawyers, public health practitioners …

The Impact Of The Biosimilars Provision Of The Health Care Reform Bill On Innovation Investments, 10 J. Marshall Rev. Intell. Prop. L. 553 (2011), Katherine N. Addison

UIC Review of Intellectual Property Law

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of highly specialized …

Schiavo Revisited? The Struggle For Autonomy At The End Of Life In Italy, Kathy L. Cerminara

Faculty Scholarship

Kathy Cerminara, Schiavo Revisited? The Struggle for Autonomy at the End of Life in Italy, 12 Marquette University Elder's Advisor 295 (2011). Politically strident debates surrounding end-of-life decisionmaking have surfaced once again, this time across the Atlantic in Italy. Eluana Englaro died early this year after a prolonged court fight, causing the international press to compare her case to that of Theresa Marie Schiavo, who passed away in 2005 in Florida after nearly sparking constitutional crises on both state and federal levels. In many respects, the facts of Ms. Englaro’s case are similar to Schiavo, but a close analysis …

Seven Pillars Of Small War Power, Randy Borum

Mental Health Law & Policy Faculty Publications

No abstract provided.

It's In Our Blood: A Critique Of The Fda's Reluctance To Regulate The Use Of Bisphenol A In The Food Supply, Ryan J. Carra

Journal of Health Care Law and Policy

No abstract provided.

Outsourcing Human Reproduction: Embryos & Surrogacy Services In The Cyberprocreation Era, J. Brad Reich, Dawn Swink

Journal of Health Care Law and Policy

No abstract provided.

Consumer Direction In Medicaid Long Term Care: Autonomy, Commodification Of Family Labor, And Community Resilience, Daniela Kraiem

American University Journal of Gender, Social Policy & the Law

No abstract provided.

Health Care Reform In Virginia: Lessons Learned Before, During, And After The 2011 Virginia General Assembly, Hunter W. Jamerson

Richmond Journal of Law and the Public Interest

This article surveys Virginia's initial foray into health care reform. This process began with the Virginia Health Reform Initiative, which had a significant presence in the Virginia 2011 General Assembly session. While the nascent health care reform efforts this session reflect only incremental steps, they are indicative of Virginia's direction and commitment to change. Such change, however, will carry great political and professional strife. This article highlights some examples of the challenges faced on the road to health care reform and discusses possible directions of future legislation in the Virginia General Assembly.

Bounty Hunters And Whistleblowers: Constitutional Concerns For False Claims Actions After Passage Of The Patient Protection And Affordable Care Act Of 2010, A.G. Harmon

Scholarly Articles

Recently, the False Claims Act (FCA) was amended by the Patient Protection and Affordable Care Act of 2010 (PPACA). In a five-word alteration, the PPACA has greatly expanded the reach of the statute, in terms of how a case must be proven, who has to prove it, and what circumstances, if any, will bar the proceeding from going forward." Additionally, new constitutional and policy concerns stem from the increased governmental discretion in deciding which suits can and cannot proceed.6 The problems resulting from the government's expanded discretion go to the very nature of qui tam actions themselves.

This article will …

The Skeleton Key: Will The Federal Health Care Reform Legislation Unlock The Solutions To Diverse Dilemmas Arising From The State Health Care Reform Laboratories , Christopher R. Smith

Journal of Law and Health

Given that the Reform Law is not operating on a blank slate, this article examines its impact on the health care reform efforts of three states: Hawaii, Maine, and Vermont. More specifically, this article examines each state’s health care reform plan, the outcomes of each plan in terms of achieving universal coverage or near universal coverage, and the likely impact of the federal health care reform legislation on these plans, with a particular focus on how the federal legislation and state laws will or will not work together to achieve near-universal coverage. The article aims to determine whether the Reform …