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Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Foreword, Daniel Marino, Lawrence Singer, Megan Bess, John Blum

Annals of Health Law and Life Sciences

No abstract provided.

Beyond Safe And Effective: The Role Of The Federal Government In Supporting And Disseminating Comparative-Effectiveness Research, Maggie H. Francis

Annals of Health Law and Life Sciences

Over the past century, medical advancements have resulted in tremendous health gains for Americans. Although the federal government has played a prominent role in ensuring that new treatments are safe and effective, questions about which medical treatments work best under which circumstances have largely remained unanswered. Thus, the federal government's recent major investments in comparative-effectiveness research have potential to play a significant role in helping both patients and health care providers navigate the vast array of available treatment options, as well as in improving the quality, efficiency, and delivery of health care system-wide. Yet, the controversial nature of the government's …

Can The Fda Improve Oversight Of Foreign Clinical Trials: Closing The Information Gap And Moving Towards A Globalized Regulatory Scheme, Andre Ourso

Annals of Health Law and Life Sciences

Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety. Due to the expansive global nature of foreign clinical trials, there are concerns with the FDA's ability to monitor and regulate these trials. …

Prescription Data Mining, Medical Privacy And The First Amendment: The U.S. Supreme Court In Sorrell V. Ims Health Inc., Marcia M. Boumil, Kaitlyn Dunn, Nancy Ryan, Katrina Clearwater

Annals of Health Law and Life Sciences

In 2011, the United States Supreme Court in Sorrell v. IMS Health Inc. struck down a Vermont law that would restrict the ability of pharmaceutical companies to purchase certain physician-identifiable prescription data without the consent of the prescriber. The law's stated purpose was threefold: to protect the privacy of medical information, to protect the public health and to contain healthcare costs by promoting Vermont's preference in having physicians prescribe more generic drugs. The issue before the Supreme Court was whether the Vermont law represented a legitimate, common sense regulatory program or a bold attempt to suppress commercial speech when the …

Foreword, Christopher Carlson, Daniel Marino, Lawrence Singer, Megan Bess, John Blum

Annals of Health Law and Life Sciences

No abstract provided.

Informed Consent Beyond The Physician-Patient Encounter: Tort Law Implications Of Extra-Clinical Decision Support Tools, Nadia N. Sawicki

Annals of Health Law and Life Sciences

No abstract provided.

Financial Conflicts Of Interest In Science, Joanna K. Sax

Annals of Health Law and Life Sciences

This Article proposes a new direction for addressing financial conflicts of interest, which plague biomedical research and threaten scientific integrity. This Article descriptively states the controversy surrounding financial conflicts of interest by explaining how these conflicts arise and the damage that can be created as a result. By describing the scientific process, the Article explains that changes to the academic environment may allow the public-private interaction to proceed, without creating the problems associated with financial conflicts of interest.

Financial conflicts of interest are created when the profit-seeking motive of a private funding source unduly influences an academic scientist's primary responsibilities. …

The Schizophrenia Of Physician Extender Utilization, Thomas R. Mclean

Annals of Health Law and Life Sciences

The Patient Protection and Affordable Care Act of 2010 provides incentives for healthcare to be delivered by Affordable Care Organizations (ACOs). The public face of many, if not most, ACOs is likely to be the Patient Centered Medical Home (PCMHs), a business structure that evolved from Retail Medical Clinics, which made greater use of physician extenders (PAs). Accordingly, this paper examines the evolution and structure of PCMHs as well as how the PCMH is regulated. As neither legal or market regulatory mechanisms are ideal for policing business structures that employ PAs, this paper concludes that the tort reform most appropriate …

Using Law To Fight A Silent Epidemic: The Role Of Healthy Literacy In Health Care Access, Quality & Cost, Brietta Clark

Annals of Health Law and Life Sciences

The dominant rhetoric in the health care policy debate about cost has assumed an inherent tension between access and quality on the one hand, and cost effectiveness on the other; but an emerging discourse has challenged this narrative by presenting a more nuanced relationship between access, quality, and cost. This is reflected in the discourse surrounding health literacy, which is viewed as an important tool for achieving all three goals. Health literacy refers to one's ability to obtain, understand and use health information to make appropriate health decisions. Research shows that improving patients' health literacy can help overcome access barriers …

Lebron V. Gottlieb Memorial Hospital: Capping Medical Practice Reform In Illinois, Leonard Nelson, Amanda Swanson, Marianne Buckley

Annals of Health Law and Life Sciences

On February 4, 2010 the Illinois Supreme Court struck down Illinois' medical practice reform bill, P.A. 94-677, when it decided Lebron v. Gottlieb Memorial Hospital. Although the court only considered the unconstitutionality of the cap on non-economic damages contained in that bill, an inseverability provision resulted in the invalidation of all of its provisions. The end result of the Lebron decision extends much further than the striking of the cap on non-economic damages. It affects such areas as medical liability insurance law, physician discipline, public disclosure of information, the admissibility of physician statements into evidence, and expert witness standards. …

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.

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 …

Perceiving Others As Different: A Discussion On The Stigmatization Of The Mentally Ill, Marchell Goins, Kyneitres Good, Cori Harley

Annals of Health Law and Life Sciences

This commentary on the stigmatization of people with mental illness explores social perceptions of them as dangerous and uncivilized. The authors discuss how the legal system suggests that these are people who should be ousted from the community while mental health professionals attempt to reiterate the fact that these individuals are simply human. The authors describe ways people with mental illness have been subjected to discrimination, ridicule, and humiliation. This commentary discusses multiple perspectives of mental illness, from past to present, and how those perspectives influenced social, legal, and psychological frameworks.

Charter Rights & Health Care Funding: A Typology Of Canadian Health Rights Litigation, Colleen M. Flood, Y.Y. Brandon Chen

Annals of Health Law and Life Sciences

Canadian health consumers have increasingly relied on the Charter of Rights and Freedoms to demand certain therapies and reasonably timely access to care. Organizing these cases into a 5-part typology, we examine how a rights-based discourse affects allocation of health care resources. First, successful Charter challenges can, in theory, lead to courts granting and enforcing positive rights to therapies or to timely care. Second, courts may grant a right to certain health services; however, subsequently government fails to deliver on this right. Third, successful litigation may create negative rights, i.e. rights to access care or private health insurance without government …

Mental Health Courts: Serving Justice And Promoting Recovery, Ginger Lerner Wren

Annals of Health Law and Life Sciences

This article begins and ends with a call for more empirical research to understand the connection between societal views of mental illness and the legal system. The author asserts that changing social perceptions of mental illness certainly affect legal outcomes and commitment levels, but the degree remains unknown. This article explores the above two topics through the framework of the Circuit Court 'split' regarding the Constitutional rights of persons committed to state mental health institutions. A main facet of the 'split' is centered on the Circuits' disagreement about whether or not all mentally ill patients committed to institutions deserve the …

The Aftermath Of Federal Health Care Reform: The Challenge For States And The Private Sector, Lawrence E. Singer

Annals of Health Law and Life Sciences

No abstract provided.

Medicare: It's Time To Talk About Changing It, Cynthia E. Boyd

Annals of Health Law and Life Sciences

No abstract provided.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

What I Talk About When I Talk About Health Law, Elizabeth Weeks Leonard

Annals of Health Law and Life Sciences

No abstract provided.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Health Care Law: A Field Of Gaps, David Orentlicher

Annals of Health Law and Life Sciences

No abstract provided.