Law Commons^™

The International Response To Climate Change: An Agenda For Global Health, Lindsay F. Wiley, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

As the international community negotiates a successor to the Kyoto Protocol of the United Nations Framework Convention on Climate Change (UNFCCC), there is new reason to hope that meaningful action might be taken to prevent devastating climate change. Even the more ambitious mitigation targets currently under negotiation, however, will not be sufficient to avoid a profound effect on the public's health in coming decades, with the world's poorest, most vulnerable populations bearing the disproportionate burden. The influence of historic and current emissions will be so substantial that it is imperative to reduce global emissions while at the same time preparing …

Healthy Planet, Healthy People: Integrating Global Health Into The International Response To Climate Change, Lindsay F. Wiley

Georgetown Law Faculty Publications and Other Works

The potentially groundbreaking negotiations currently underway on the international response to climate change and national implementation of commitments under the United Nations Framework Convention on Climate Change (UNFCCC) include a number of hotly contested issues: (1) what degree of climate change is acceptable as a basis for emissions targets, (2) to what extent and in what ways climate change mitigation should incorporate emissions reductions or increased sinks for developing countries, (3) whether the legal regime governing mitigation can take advantage of the huge mitigation potential of changed practices in the land use and agricultural sectors, (4) how adaptation should be …

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 …

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 …

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.

The Role Of Erisa Preemption In Health Reform: Opportunities And Limits, Peter D. Jacobson

O'Neill Institute Papers

The Employee Retirement Income Security Act (ERISA) is a federal law regulating the administration of private employer-sponsored benefits including health benefits (i.e., health insurance offered by an employer). In general, since the federal government has exercised its authority to preempt state regulation of the administration of private employer-sponsored health plans, states are blocked from enforcing laws interfering with ERISA.

As many states pursue health care reform experiments, ERISA preemption becomes relevant as a potential limit on the scope and type of reforms states are able to enact. The dominant trend in ERISA litigation has been to preempt state legislation and …

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 …

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 …

The Purchase Of Insurance Across State Lines In The Individual Insurance Market, Stephanie W. Kanwit

O'Neill Institute Papers

Proposals to allow the purchase of insurance across state lines (PASL) have gained some support in recent years. Health insurers have traditionally been allowed to sell a policy only within the state that approved and regulates that particular policy. PASL would allow insurers to sell a policy approved in one state to people residing in any state.

Any federal legislation to enact PASL in an individual insurance market would have to address two main legal considerations: 1) the McCarran-Ferguson Act, which allows the states to retain their regulatory authority over insurance, and 2) a constitutional prohibition against the commandeering of …

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 …

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 …

A Broader Liberty: Js Mill, Paternalism, And The Public’S Health, Lawrence O. Gostin, Kieran G. Gostin

O'Neill Institute Papers

Is the ‘harm principle’, famously propounded by JS Mill and widely adopted in bioethics, an appropriate principle to guide public health regulation? The harm principle limits liberty-limiting interventions to only those instances where the person poses a significant risk of harm to others. However, much of public health regulation is not primarily directed to avert risk to others, but to safeguard the health and safety of the individual him or herself. Think about regulations regarding seatbelts, motorcycle helmets, or the fluoridation of water as illustrations of pervasive public health regulations that are primarily intended to safeguard the individual’s own health …

Science, Politics, And Values: The Politicization Of Professional Practice Guidelines, Lawrence O. Gostin, John D. Kraemer

O'Neill Institute Papers

The Connecticut Attorney General’s recent allegations that the Infectious Disease Society of America violated antitrust law through its treatment guidelines for Lyme disease were neither based in sound science or appropriate legal judgment. Strong scientific evidence favors IDSA’s position that chronic infection with the etiologic agent of Lyme disease does not occur in the absence of objective signs of ongoing infection and that long-term antibiotic use to treat dubious infection, recommended in the quasi-scientific guidelines put forth by the International Lyme and Associated Diseases Society (ILADS), are of no benefit. In siding with ILADS and other chronic Lyme disease advocates, …

Empirical Health Law Scholarship: The State Of The Field, Michelle M. Mello, Kathryn Zeiler

Georgetown Law Faculty Publications and Other Works

The last three decades have seen the blossoming of the fields of health law and empirical legal studies and their intersection--empirical scholarship in health law and policy. Researchers in legal academia and other settings have conducted hundreds of studies using data to estimate the effects of health law on accident rates, health outcomes, health care utilization, and costs, as well as other outcome variables. Yet the emerging field of empirical health law faces significant challenges--practical, methodological, and political.

The purpose of this Article is to survey the current state of the field by describing commonly used methods, analyzing enabling and …

The Emergent Logic Of Health Law, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

The American health care system is on a glide path toward ruin. Health spending has become the fiscal equivalent of global warming, and the number of uninsured Americans is approaching fifty million. Can law help to divert our country from this path? There are reasons for deep skepticism. Law governs the provision and financing of medical care in fragmented and incoherent fashion. Commentators from diverse perspectives bemoan this chaos, casting it as an obstacle to change. I contend in this Article that pessimism about health law’s prospects is unjustified, but that a new understanding of health law’s disarray is urgently …

Assessing Laws And Legal Authorities For Obesity Prevention And Control, Lawrence O. Gostin, Jennifer L. Pomeranz, Peter D. Jacobson, Richard N. Gottfried

Georgetown Law Faculty Publications and Other Works

This is the first paper in a two part series on the laws and legal authorities for obesity prevention and control, which resulted from the National Summit on Legal Preparedness for Obesity Prevention and Control in 2008. In this paper, the authors apply the “laws and legal authorities” component of the Centers for Disease Control and Prevention (CDC) legal framework on public health legal preparedness to demonstrate the essential role that law can play in the fight against obesity. Their analysis identified numerous laws and policies in the three vital domains of healthy lifestyles, healthy places, and healthy societies. For …

Improving Laws And Legal Authorities For Obesity Prevention And Control, Lawrence O. Gostin, Jennifer L. Pomeranz

Georgetown Law Faculty Publications and Other Works

This is the second paper in a two part series on the laws and legal authorities for obesity prevention and control. In this paper, the authors present the applicable laws and legal authorities that public health professionals and lawyers can consider implementing to close the legal gaps identified in the first paper (“Assessing Laws and Legal Authorities for Obesity Prevention and Control”). This set of legal action items encompass the federal, tribal, state, local, and community levels and should be considered when developing, implementing, and evaluating obesity prevention and control strategies and interventions.

The paper organizes the action items within …