Health Law and Policy Commons^™

Civil Partnership: Your Questions Answered - A Comprehensive Analysis Of The Civil Partnership Bill, Fergus Ryan

Reports

The Civil Partnership Bill 2009 arguably represents the most momentous change in Irish Family Law in a generation. The Bill proposes a substantial new legal status for registered same-sex partners, as well as important changes to the law as it relates to cohabitants. This report addresses the provisions of the Bill as initiated, analysing the potential impact of the Bill in clear and accessible language. The Report also highlights potential difficulties with the Bill, and suggests possible enhancements to the Bill as initiated.

The Medicare Drug Benefit: Update On The Low-Income Subsidy, Mary Ellen Stahlman

National Health Policy Forum

The Medicare drug benefit (Medicare "Part D"), provides federal subsidies to pay premiums and cost sharing for low-income beneficiaries—almost 10 million in 2009. Yet there are several policy issues concerning these low-income beneficiaries under Part D. First, over 2 million individuals who may qualify for the subsidies have not enrolled. Second, in some states, low-income beneficiaries have little choice of plans (while non-low-income beneficiaries have dozens of choices), unless they pay out-of-pocket for premium amounts above what the subsidy covers. And third, millions of those who have enrolled in the benefit face the prospect each year of switching drug plans …

How The American Recovery And Reinvestment Act Of 2009 Changed Hipaa’S Privacy Requirements, Corrine Parver

Newsletters & Other Publications

The 2009 economic stimulus bill, known as the American Recovery and Reinvestment Act (ARRA), significantly affects the health care industry by imposing more stringent and expansive requirements under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy and security provisions, most especially on key players in the the health care industry while simultaneously strengthening the enforcement of such provisions. Title XIII of Division A and Title IV of Division of ARRA collectively are known as the "HITECH Act." Because the majority of ARRA's changes to HIPAA appear in Subtitle D of Title XIII of ARRA, entitled, "Privacy," Subtitle …

Eligibility For Organ Donation: A Medico-Legal Perspective On Defining And Determining Death, Jocelyn Downie, Matthew R. Kutcher, Chantelle Rajotte, Alison Shea

Articles, Book Chapters, & Popular Press

Purpose: In the context of post-mortem organ donation, there is an obvious need for certainty regarding the legal definition and determination of death, as individuals must be legally pronounced dead before organs may be procured for donation. Surprisingly then, the legal situation in Canada with regard to the definition and determination of death is uncertain. The purpose of this review is to provide anesthesiologists and critical care specialists with a medico-legal perspective regarding the definition and determination of death (particularly as it relates to non-heart-beating donor protocols) and to contribute to ongoing improvement in policies, protocols, and practices in this …

Influenza A(H1n1) And Pandemic Preparedness Under The Rule Of International Law, Lawrence O. Gostin

O'Neill Institute Papers

A novel strain of Influenza A (H1N1) spread rapidly through Mexico in April 2009 and now spans the globe. By the time WHO was notified and responded, geographical containment was not feasible, leading the agency to call for mitigation. The international outbreak of SARS in 2003 and the more recent Influenza A (H5N1) among birds with limited transmission to humans helped prepare the world for the current pandemic threat. SARS galvanized the WHO to revise the antiquated International Health Regulations (IHR) in 2005, which took effect June 15, 2007. Governments instituted preparedness plans in response to avian influenza.

Despite increased …

Pandemic Preparedness: A Return To The Rule Of Law, Wendy K. Mariner, George J. Annas, Wendy E. Parmet

Faculty Scholarship

Current discussions of pandemic influenza and emergency preparedness would do well to heed the lessons of US Airways flight 1549, which landed in the Hudson River in January 2009. This article examines what past emergencies teach us about how to prevent or control epidemics and argues that it is time for a return to the rule of law in pandemic preparedness. The most important resource in emergency preparedness is a healthy, resilient population, which depends importantly on sustainable systems of medical care and public health. Preparedness thus requires more money than law. After September 11, 2001, however, federal emergency preparedness …

A Closer Look At The Federalization Snowball, Abigail R. Moncrieff

Law Faculty Articles and Essays

While on the academic job market, I presented Federalization Snowballs to several stellar law faculties.1 My argument, in short, was that: (1) federal healthcare spending allows the states to externalize onto the federal government about 40% of the utilization costs associated with their medical malpractice policies (such as the cost of defensive medicine); (2) such an externality systematically distorts a rational state’s incentive to reform medical malpractice; and (3) federalization of medical malpractice is necessary to correct the distortion. In other words, I argued that federalization of healthcare spending through Medicare, Medicaid, and similar programs has snowballed into a need …

Assessing Legal Competencies For Obesity Prevention And Control, Wendy Collins Perdue

Law Faculty Publications

Obesity is the result of people consistently consuming more calories than they expend. A complex interaction of social and environmental conditions affects both energy consumption and physical activity levels. Health professionals who understand the social and environmental factors related to obesity risk may find it challenging to identify, understand, or develop a strategy to improve the vast array of laws that play a role in shaping our environment and behaviors.

Competency in the use of laws and legal authorities is one of the four core elements of public health legal preparedness. Legal competency" is a particularly important component of a …

Improving Legal Competencies For Obesity Prevention And Control, Wendy Collins Perdue

Law Faculty Publications

Our purpose is to offer action options that will help to improve the legal competencies of public health practitioners and policy decision makers with respect to drafting, interpreting, implementing, and enforcing laws and regulations that are relevant to the effective prevention and control of obesity. The accompanying assessment paper provided a foundation for this agenda by first establishing that legal competence for obesity prevention and control is important for both health professionals, who with proper training can effectively interject health considerations into decision- making processes, and non-health professionals involved with relevant policy and legal work, who with proper training can …

Constitutional Flaw?, Carl E. Schneider

Articles

Do terminally ill patients have a constitutional right "to decide, without FDA interference, whether to assume the risks of using potentially life-saving investigational drugs that the FDA has yet to approve for commercial marketing, but that the FDA has determined, after Phase I clinical human trials, are safe enough for further testing"? In Abigail Alliance for Better Access to Developmental Drugs v. McClellan, the United States District Court for the District of Columbia said "no." In Abigail Alliance for Better Access to Developmental Drugs v. von Eschenbach, a panel (three judges) of the United States Court of Appeals …

Health Law-Informed Consent-Trust Me, I Do This All The Time: Comparative Provider Statistics And Informed Consent In Arkansas, Barrett S. Moore

University of Arkansas at Little Rock Law Review

No abstract provided.

Over Under Or Through: Physicians, Law, And Health Care Reform, William M. Sage

Faculty Scholarship

My purpose in this commentary is twofold. First, I want to offer a few thoughts on why the American medical profession sometimes has a hard time accepting law on its own terms. Second, I want to suggest that even “good law” from the perspective of the medical profession—should it overcome its habits of resistance—may still be bad health policy for the United States.

Managing Incidental Findings In Human Subjects Research: Analysis And Recommendations, Ellen Wright Clayton, Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Et Al.

Vanderbilt Law School Faculty Publications

Researchers, institutional review boards (IRBs), participants in human subjects research, and their families face an important but largely neglected problem - how should incidental find- ings (IFs) be managed in human subjects research. If researchers unexpectedly stumble upon information of potential health or reproductive significance, should they seek expert evaluation, contact the participant's physician, tell the research participant, or respond with some combination? What should consent forms and the entire consent process say about how IFs will be handled in research? What should IRBs require? An IF is a finding concerning an individual research participant that has potential health or …

Harmonizing The Internal Market Or Public Health? Revisiting Case C-491/01 (British American Tobacco) And Case C-380/03 (Tobacco Advertising Ii), Han-Wei Liu

Research Collection Yong Pung How School Of Law

According to settled ECJ case law, including Case C-376/98 (Tobacco Advertising I), Article 95 EC cannot be construed as conferring upon the Community a general power to regulate the internal market. Measures that the Community legislature adopts under this Article must rather have the specific objective of improving conditions for the establishment and functioning of the internal market; that is, they must be designed to remove genuine obstacles to free movement or distortions of competition, rather than purely abstract risk. [2] In some respects, however, Article 95 appears to provide a pretext for the Community legislature to implement other policy …

Book Review Of “Populations, Public Health, And The Law,” Wendy E. Parmet (Georgetown University Press, Washington, D.C., 2009), Elizabeth Weeks Leonard

Scholarly Works

Wendy Parmet's new book, Populations, Public Health, and the Law, is a provocative, milestone contribution to the growing body of public health law scholarship. This article reviews this scholarly work.

A Health Insurance Exchange: Prototypes And Design Issues, Mark Merlis

National Health Policy Forum

Many reform proposals call for the creation of one or more health insurance exchanges, intermediaries that can help individuals or small employers navigate the insurance market. An exchange might be public or private, national, or local. It might serve simply as a clearinghouse for plan information or could play an active role in setting benefit packages, choosing high-quality plans, and negotiating premium rates. This paper begins with a summary of recent experience with insurance exchanges and similar systems. It then reviews basic issues in the design of an exchange.

Underwriting In The Non-Group Health Insurance Market: The Fundamentals, Kathryn Linehan

National Health Policy Forum

Non-group health insurance is coverage that individuals purchase on their own rather than as part of a group. Most states currently permit non-group insurers to underwrite, a process whereby an insurer assesses the health and other characteristics of individuals to determine their likely utilization of health services or risk; insurers then use this assessment to determine whether they will offer coverage and the premium they will charge. Policymakers have identified underwriting and related practices in non-group markets as a target for reform to enable broader access for the currently uninsured. This publication reviews the characteristics of non-group markets and insurers' …

Self-Assessment/Planning Tool For Implementing Recovery-Oriented Mental Health Services (Sapt), James Winarski, Michael G. Dow, Patrick Hendry, Patricia Robison, Roger H. Peters

Mental Health Law & Policy Faculty Publications

No abstract provided.

Utilization Of The Most Costly And Intense Mental Health Services Among Children In Out-Of-Home Care, Svetlana Yampolskaya, Paul E. Greenbaum, Colleen Clark, Richard Briscoe

Mental Health Law & Policy Faculty Publications

No abstract provided.

Finding The Middle Ground: Acuna V. Turkish And The New Jersey Supreme Court's Reaffirmation Of A Doctor's Role Under The Doctrine Of Informed Consent In The Digital Age, Allyson M. Rucinski

Pace Law Review

No abstract provided.

Creating A Paternalistic Market For Legal Rules Affecting The Benefit Promise, Brendan S. Maher

Faculty Scholarship

Notwithstanding the fact that ERISA was enacted to protect employee benefits, courts have narrowly construed the relief available when benefits are denied, out of concern that a stronger remedy would be too costly for the system to bear. Judges, I argue, are ill-equipped to make this policy judgment. Instead, a regulated, subsidized, paternalistic market should be created to permit the benefit players themselves to choose and price the strength of the remedy they desire. This is a superior means to reach the right level of remedial strength for the most players. To protect against undesirably weak remedial options being selected, …

Resilience And Renaissance: Efforts To Rebuild A Healthier New Orleans, Michele J. Orza, Jessamyn Taylor

National Health Policy Forum

The National Health Policy Forum sponsored a site visit to New Orleans, Louisiana, in May 2009 to explore the city's health challenges, which are similar to those faced by other cities but were all greatly exacerbated by Hurricane Katrina and its aftermath. The agenda focused on three themes: primary care and behavioral health services availability and access, public health preparedness, and rebuilding healthier communities. It examined how these themes and others intersect in two distinct communities within New Orleans: the Holy Cross community surrounding the Lower Ninth Ward Center for Sustainable Engagement and Development and the community surrounding the Mary …

Medical Device Safety Act Of 2009: Hearing Before The Subcomm. On Health Of The H. Comm. On Energy And Commerce, 111th Cong., May 12, 2009 (Statement Of David C. Vladeck, Prof. Of Law, Geo. U. L. Center), David C. Vladeck

Testimony Before Congress

I start with a brief history of the Medical Device Amendments of 1976 and explain why that history demonstrates that Congress quite clearly intended to preserve state liability law, not wipe it away. I will then turn to the Court's ruling in Riegel and address why the Court's wooden, textual approach to the Amendments -- which ignores their purpose -- led the Court to conclude, wrongly, that Congress intended the Amendments to preempt state liability claims for devices approved by FDA under the pre-market approval process. Next, I discuss the impact Riegel has had in the courts, resulting in the …

Federalization Snowballs: The Need For National Action In Medical Malpractice Reform, Abigail R. Moncrieff

Law Faculty Articles and Essays

Because tort law and healthcare regulation are traditional state functions and because medical, legal, and insurance practices are localized, legal scholars have long believed that medical malpractice falls within the states' exclusive jurisdiction and sovereignty. This conventional view fails to consider the impact that federal healthcare programs have on the states' incentives to regulate. As a result of federal financing, each state externalizes some of the costs of its malpractice policy onto the federal government. The federal government therefore needs to take charge of medical malpractice in order to fix the spillover problem created by existing federal healthcare programs.

Importantly, …

Solidarity: Unfashionable, But Still American, William M. Sage

Faculty Scholarship

Illness, we are often told, is a private matter. Accordingly, none must interfere in the medical decisions that emerge from the confidential relationship be- tween physician and patient. Yet evidence of interdependence is ubiquitous in health care. One person’s malady can harm families, workplaces, clubs, churches, and sometimes entire communities. Similarly, a suffering pa- tient must rely on many individuals, associational groups, corporate entities, and government agencies for support and assistance. It is, therefore, unsurprising that various social units claim an interest and a voice in maintaining health and treating disease.

However, explicit solidarity has long been out of vogue …

The Constitutionality Of Mandates To Purchase Health Insurance, Mark A. Hall

O'Neill Institute Papers

Health insurance mandates have been a component of many recent health care reform proposals. Because a federal requirement that individuals transfer money to a private party is unprecedented, a number of legal issues must be examined.

This paper analyzes whether Congress can legislate a health insurance mandate and the potential legal challenges that might arise, given such a mandate. The analysis of legal challenges to health insurance mandates applies to federal individual mandates, but can also apply to a federal mandate requiring employers to purchase health insurance for their employees. There are no Constitutional barriers for Congress to legislate a …

Insurance Discrimination On The Basis Of Health Status: An Overview Of Discrimination Practices, Federal Law And Federal Reform Options, Sara Rosenbaum

O'Neill Institute Papers

Actuarial underwriting, or discrimination based on an individual’s health status, is a business feature of the voluntary private insurance market. The term “discrimination” in this paper is not intended to convey the concept of unfair treatment, but rather how the insurance industry differentiates among individuals in designing and administering health insurance and employee health benefit products.

Discrimination can occur at the point of enrollment, coverage design, or decisions regarding scope of coverage. Several major federal laws aimed at regulating insurance discrimination based on health status focus at the point of enrollment. However, because of multiple exceptions and loopholes, these laws …

Privacy And Health Information Technology, Deven Mcgraw

O'Neill Institute Papers

The increased use of health information technology (health IT) is a common element of nearly every health reform proposal because it has the potential to decrease costs, improve health outcomes, coordinate care, and improve public health. However, it raises concerns about security and privacy of medical information.

This paper examines some of the “gaps” in privacy protections that arise out of the current federal health privacy standard, the Health Insurance Portability and Accountability (HIPAA) Privacy Rule, the main federal law which governs the use and disclosure of health information.

Additionally, it puts forth a range of possible solutions, accompanied by …

Executive Authority To Reform Health: Options And Limitations, Madhu Chugh

O'Neill Institute Papers

Presidential power has provoked increasingly vigorous debate since the turn of this century. In recent years, scholars and lawyers have been grappling with how Congress's dictates may limit the President's Commander-in-Chief power to detain enemy combatants at Guantanamo Bay, to fight wars abroad, and to conduct intelligence activities at home. But policymakers have not yet explored the many possibilities for invoking the President's "Take Care" power to change health care policy.

This paper explores the scope and limits of President Barack Obama's ability to invoke his executive authority to reform health care. Specifically, it identifies ways the Obama Administration can …

Health Insurance Exchanges: Legal Issues, Timothy S. Jost

O'Neill Institute Papers

Health insurance exchanges (HIE) are entities that organize the market for health insurance by connecting small businesses and individuals into larger pools that spread the risk for insurance companies, while facilitating the availability, choice and purchase of private health insurance for the uninsured. While there are legal issues that warrant consideration under a federal, state, or private exchange framework, those issues are not insurmountable barriers to implementation.