Health Policy Commons^™

Future Oversight Of Recombinant Dna Research: Recommendations Of An Institute Of Medicine Committee, Lawrence O. Gostin, Bruce M. Altevogt, Andrew M. Pope

Georgetown Law Faculty Publications and Other Works

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. Gene transfer research continues to be subjected to multiple layers of review: the Food and Drug Administration (FDA), institutional review boards, institutional biosafety committees, and the RAC. It is within the context of overlapping …

Towards A Framework Convention On Global Health, Lawrence O. Gostin, Eric A. Friedman, Kent Buse, Attiya Waris, Moses Mulumba, Mayowa Joel, Lola Dare, Ames Dhai, Devi Sridhar

Georgetown Law Faculty Publications and Other Works

A global health treaty, a Framework Convention on Global Health (FCGH)–grounded in the right to health, with the central goal of reducing immense domestic and global health inequities–could serve as a robust global governance instrument to underpin the United Nations post-2015 Millennium Development Goals (MDGs). It would ensure for all people the three essential conditions for a healthy life–public health, health care, and the positive social determinants of health–while advancing good governance, responding to drivers of health disadvantages for marginalized populations, elevating health in other legal regimes, and enhancing people's ability to claim their rights.

The legally binding nature of …

Providing Outreach And Enrollment Assistance: Lessons Learned From Community Health Centers In Massachusetts, Julia Paradise, Sara J. Rosenbaum, Peter Shin, Jessica Sharac, Carmen Alvarez, Julia Zur, Leighton C. Ku

Health Policy and Management Faculty Publications

Six years ago, Massachusetts implemented a broad expansion of health coverage to the uninsured population in the state. Understanding that outreach and enrollment assistance would be essential to the success of the expansion, state policymakers provided for public education campaigns, but also for person-to-person, hands-on assistance, especially in communities with large numbers of uninsured people. Community health centers play a central role in this effort. As states and communities gear up to provide outreach and enrollment assistance under the ACA, the experience of the Massachusetts health centers offers lessons that can help inform current efforts to reach and enroll millions …

Realizing The Right To Health Through A Framework Convention On Global Health?, Eric A. Friedman, Jashodhara Dasgupta, Alicia E. Yamin, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

This article introduces a special issue of Health and Human Rights (volume 15, issue 1) that features articles exploring potential elements of and key questions and issues surrounding the Framework Convention on Global Health (FCGH). The FCGH is a proposed global health treaty that would be grounded in the right to health, with the aim of closing domestic and global health inequities. It would set standards and ensure financing for health care and public health services, while also addressing social determinants of health. The FCGH would raise the priority of health in other sectors, ensure effective private sector regulation, and …

Advancing The Right To Health Through Global Organizations: The Potential Role Of A Framework Convention On Global Health, Eric A. Friedman, Lawrence O. Gostin, Kent Buse

Georgetown Law Faculty Publications and Other Works

Organizations, partnerships, and alliances form the building blocks of global governance. Global health organizations thus have the potential to play a formative role in determining the extent to which people are able to realize their right to health.

This article examines how major global health organizations, such as WHO, the Global Fund to Fight AIDS, TB and Malaria, UNAIDS, and GAVI approach human rights concerns, including equality, accountability, and inclusive participation. We argue that organizational support for the right to health must transition from ad hoc and partial to permanent and comprehensive.

Drawing on the literature and our knowledge of …

The Forgotten Half Of Food System Reform: Using Food And Agricultural Law To Foster Healthy Food Production, Emily Broad Leib

Journal of Food Law & Policy

America is facing widespread problems with its food system, including environmental harms due to externalities from industrial farms; the increasing amount of "food _miles" traveled by the products that make up our daily meals; and the growing size and complexity of recent outbreaks of foodborne illnesses. Indeed, the entire system that covers the life cycle of food, through production, processing, distribution, consumption, and food waste management, is in crisis. One of the most disturbing of these well-documented problems with the industrial food system is the increase in rates of obesity and diet-related illnesses. Obesity rates in the U.S. have more …

The U.S. Department Of Agriculture As A Public Health Agency? A "Health In All Policies" Case Study, Lindsay F. Wiley

Journal of Food Law & Policy

The "war on obesity" is now well into its second decade. What began as an effort to encourage medical doctors to screen and treat patients whose weight put them at risk for health problems has transformed into a much broader public health campaign to address the root causes of obesity. A growing number of state, territorial and local health departments are currently exploring new ways to promote healthy eating and physical activity. At the federal level, the U.S. Centers for Disease Control and Prevention (CDC) has made "nutrition, physical activity and obesity" a top priority.

Mining, Uranium, Bert Chapman

Libraries Faculty and Staff Scholarship and Research

Provides an overview of uranium mining's role and influence in the American West with comparative information on uranium mining in foreign countries.

Tackling The Global Ncd Crisis: Innovations In Law And Governance, Bryan P. Thomas, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

35 million people die annually of non-communicable diseases (NCDs), 80% of them in low- and middle-income countries—representing a marked epidemiological transition from infectious to chronic diseases and from richer to poorer countries. The total number of NCDs is projected to rise by 17% over the coming decade, absent significant interventions. The NCD epidemic poses unique governance challenges: the causes are multifactorial, the affected populations diffuse, and effective responses require sustained multi-sectorial cooperation. The authors propose a range of regulatory options available at the domestic level, including stricter food labeling laws, regulation of food advertisements, tax incentives for healthy lifestyle choices, …

Community Health Centers In An Era Of Health Reform: An Overview And Key Challenges To Health Center Growth, Susan F. Wood, Debora Goetz Goldberg, Brian K. Bruen, Kay Johnson, Holly Mead, Peter Shin, Tishra Beeson, Julie Lewis, Shavon Artis, Katherine J. Hayes, Merle Cunningham, Xiaoxiao Lu, Trent White, Sara Rosenbaum

Health Policy and Management Faculty Publications

No abstract provided.

Implications Of Rhode Island’S Global Consumer Choice Compact Medicaid Waiver For Rebalancing Long-Term Care Under The Affordable Care Act, Edward Alan Miller, Divya Samuel, Susan Allen, Amal Trivedi, Vincent Mor

Gerontology Institute Publications

Federal approval of Rhode Island’s Global Consumer Choice Compact Global Waiver in 2009 provided Rhode Island with greater flexibility to modify its Medicaid program. Because 96% of long-term care expenditures in Rhode Island were directed toward institutional settings, a primary goal was to facilitate the state’s efforts to shift the locus of long-term care to non-institutional settings. This study draws lessons from Rhode Island’s experience with the Global Waiver for the long-term care rebalancing provisions of the Patient Protection and Affordable Care Act of 2010. Data derive from 325 archival sources and 26 semi-structured interviews. Results suggest that prospectively documenting …

Implications Of Rhode Island’S Global Consumer Choice Compact Medicaid Waiver For Designing And Implementing State Health Reform, Edward Alan Miller, Divya Samuel, Susan Allen, Amal Trivedi, Vincent Mor

Gerontology Institute Publications

Provisions in the Medicaid statute permit states to apply for waivers from traditional program requirements. On January 16, 2009, the federal government approved Rhode Island's Global Consumer Choice Compact Waiver. In exchange for a cap on combined federal and state spending of $12.075 billion through 2013, Rhode Island received greater flexibility to adopt certain Medicaid program changes. This study analyzes the design and implementation of the Global Waiver to draw general lessons for health reform at the state-level, a key concern given ongoing state discretion to improve their health care systems under the Patient Protection and Affordable Care Act. Data …

Implications Of Rhode Island’S Global Consumer Choice Compact Medicaid Waiver For Block Granting Medicaid And Other Retrenchment, Edward Alan Miller, Divya Samuel, Susan Allen, Amal Trivedi, Vincent Mor

Gerontology Institute Publications

On January 16, 2009, the Federal government approved Rhode Island’s application for a Global Consumer Choice Compact Medicaid Waiver whereby the state became the first granted permission to operate its entire Medicaid program under the state plan and a single 1115 “research and demonstration” waiver. The Global Waiver has been implemented in the context of Republican proposals to turn Medicaid into a block grant which would give states substantially more flexibility administering the program in exchange for receiving an upfront allotment from the Federal government. Proponents have held up the Global Waiver as a successful example of what might be …

Commentary: Hospital Tax-Exempt Policy: A Comparison Of Schedule H And State Community Benefit Reporting Systems, Laura L. Hitchcock

Frontiers in Public Health Services and Systems Research

In Hospital Tax-Exempt Policy: A Comparison of Schedule H and State Community Benefit Reporting Systems, Rosenbaum et aldescribe the numerous variations between current state law in 24 states and federal requirements regarding nonprofit hospitals’ community benefit activities. The potential for nonprofit hospitals to help shape community health is great, and how states choose to address requirements regarding community benefit, and potentially reinforce the new federal requirements to incentivize hospital participation in addressing root causes of poor health, should be of significant interest to the public, policy makers and public and population health experts, given the large percentage of …

Readiness For Meaningful Use Of Health Information Technology And Patient Centered Medical Home Recognition Survey Results, Peter Shin, Jessica Sharac

Health Policy and Management Faculty Publications

Objective. Determine the factors that impact HIT use and MU readiness for community health centers (CHCs).

Background. The HITECH Act allocates funds to Medicaid and Medicare providers to encourage the adoption of electronic health records (EHR), in an effort to improve health care quality and patient outcomes, and to reduce health care costs.

Methods. We surveyed CHCs on their Readiness for Meaningful Use (MU) of Health Information Technology (HIT) and Patient Centered Medical Home (PCMH) Recognition, then we combined responses with 2009 Uniform Data System data to determine which factors impact use of HIT and MU readiness.

Results. Nearly 70% …

Enhancing Communication Between Scientists, Government Officials, And The Lay Public: Advancing Science And Protecting The Public's Welfare Through Better Multi-Stakeholder Interfacing, Clark J. Lee, Patrick P. Rose, Earl Stoddard Iii

Homeland Security Publications

No abstract provided.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, James Ming Chen, Jay Dratler Jr., Thomas Folsom, Timothy S. Hall, Yaniv Heled, Frank A. Pasquale Iii, Elizabeth A. Reilly, Jeffrey Samuels, Katherine J. Strandburg, Kara W. Swanson, Andrew W. Torrance, Katharine A. Van Tassel

Law Faculty Scholarship

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions. Led by the moderator, participants at the Forum focused generally on three broad …

Not For Bathing: Bath Salts And The New Menace Of Synthetic Drugs, Jake Shaller

Journal of Health Care Law and Policy

No abstract provided.

Is More Information Always Better? Mandatory Disclosure Regulations In The Prescription Drug Market, Joanna Shepherd

Faculty Articles

This Article proceeds as follows. In Section I, I describe the structure of the PBM industry. I also describe the business model PBMs employ to administer prescription drug coverage and the methods they use to reduce prescription drug spending. In Section II, I discuss mandatory disclosure regulations enacted in several states and at the federal level under the Affordable Care Act. In Section III, I explain why mandatory disclosure regulations are not needed to ensure that health plan sponsors pay a competitive price for PBM services. In Section IV, I discuss the various costs that mandatory disclosure regulations will impose …

Better Health, But Less Justice: Widening Health Disparities After National Federation Of Independent Business V. Sebelius, Emily W. Parento, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

At the time it was enacted in 2010, the Patient Protection and Affordable Care Act (ACA) was widely applauded by health activists, as it meant that the United States would at last join the overwhelming majority of industrialized countries in providing its population with guaranteed access to affordable health care. Roughly half of the increase in access to health insurance was to come from the expansion of Medicaid eligibility to all U.S. citizens and legal residents with income below 138% of the Federal Poverty Level. However, the Supreme Court’s 2012 ruling in National Federation of Independent Business v. Sebelius ( …

Towards A Framework Convention On Global Health: A Transformative Agenda For Global Health Justice, Lawrence O. Gostin, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

International law has responded weakly to the inequities in health care, public health, and the broader determinates of health that collectively cause the greatest loss of lives and human potential every year. Approximately one-third of global deaths can be attributed to enduring and unconscionable inequities. Despite significant progress in improving global health over the past several decades, these inequities persist. Current global governance for health is inadequate to the task of resolving these inequities, from lack of accountability and enforcement to inadequate funding and the absence of leadership required to respond to the threats to health that arise from other …

Bloomberg’S Health Legacy: Urban Innovator Or Meddling Nanny?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Michael Bloomberg leaves the mayoralty of New York City, with his health legacy is bitterly contested. The public health community views him as an urban innovator—a rare political and business leader willing to fight for a built environment conducive to healthier, safer lifestyles. To his distractors, however, Bloomberg epitomizes a meddling nanny—an elitist dictating to largely poor and working class people about how they ought to lead their lives. His policies have sparked intense public, corporate, and political ire—critical of sweeping mayoral power to socially engineer the city and its inhabitants.

Here, I seek to show how Bloomberg has fundamentally …

Funding Health-Related Vr Services: The Potential Impact Of The Affordable Care Act On The Use Of Private Health Insurance And Medicaid To Pay For Health-Related Vr Services, Robert Silverstein

All Institute for Community Inclusion Publications

One of the myriad of issues affecting the administration of the vocational rehabilitation (VR) program by State VR agencies under Title I of the Rehabilitation Act is how to maximize access to and use of all available funding sources to pay for VR services and supports for VR applicants and clients. In March 2010, Congress passed and the President signed into law the "Affordable Care Act" (ACA). 1 On June 28, 2012, the United States Supreme Court upheld all of the provisions of the ACA, with the exception of provisions mandating Medicaid expansion. The Supreme Court held that if a …

The Power To Block The Affordable Care Act: What Are The Limits?, John D. Kraemer, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Though Supreme Court upheld most parts of the Affordable Care Act (ACA), Congress’ goals in enacting it could still be frustrated by non-implementation. During his campaign for president, Governor Romney promised “to issue Obamacare waivers to all fifty states.” While such blanket waivers would likely violate the Constitution’s Take Care Clause, the ACA does permit other waivers. To be lawful, however, they must meet certain requirements designed to enhance access and lower cost. A president who opposes the ACA might be able to limit its implementation by refusing to issue premium subsidies in federally operated insurance exchanges, and this might …

Reducing Unlawful Prescription Drug Promotion: Is The Public Health Being Served By An Enforcement Approach That Focuses On Punishment?, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

Despite the imposition of increasingly substantial fines and recently successful efforts to impose individual liability on corporate executives under the Park doctrine, punishing pharmaceutical companies and their executives for unlawful promotional activities has not been as successful in achieving compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) as the protection of the public health demands. Over the past decade, the Food and Drug Administration (FDA) and the Department of Justice (DOJ) have shifted their focus from correction and compliance to a more punitive model when it comes to allegedly unlawful promotion of pharmaceuticals. The shift initially focused …

The Patient Protection And Affordable Care Act: Why It Is Important For Women’S Health, Mary Fanning

Journal of Interdisciplinary Feminist Thought

President Barack Obama signed into law the Patient Protection and Affordable Care Act (ACA) on March 23, 2010 ending the long history of disparity in access to health care services between insured and uninsured persons. Disparity between women and men in obtaining health insurance coverage is also corrected in the act. Women’s organizations that have focused attention on women’s distinctive health needs over the past century and a half laid the foundation for provisions in the legislation that address women’s health. This article addresses health insurance coverage, its impact on health, the particular challenges women have confronted in seeking coverage, …

Justice Roberts’ America, Robin West

Georgetown Law Faculty Publications and Other Works

Less than a week after the Roberts Court issued its decision in National Federation of Independent Business v Sebelius, Jeffrey Toobin, writing in The New Yorker, compared the first part of Chief Justice John Roberts's opinion, in which he found that the Commerce Clause did not authorize Congress to enact the "individual mandate" section of the Affordable Care Act (ACA) that requires all individuals to buy health insurance, with an Ayn Rand screed, noting that the pivotal sections of the argument were long on libertarian rhetoric but short on citations of authority. Roberts held (although "held" might be …

An O’Neill Institute Briefing Paper: The Supreme Court’S Landmark Decision On The Affordable Care Act: Healthcare Reform’S Ultimate Fate Remains Uncertain, Emily W. Parento, Lawrence O. Gostin

O'Neill Institute Papers

The Supreme Court’s decision on the constitutionality of the Patient Protection and Affordable Care Act (ACA) is a landmark on the path toward ensuring universal access to health care in the United States. In a 5-4 decision written by Chief Justice Roberts, the Court upheld the law in its entirety with the sole exception that Congress may not revoke existing state Medicaid funding to penalize states that decline to participate in the Medicaid expansion under the ACA. In this O’Neill Institute Briefing, we explain and analyze the Court’s decision, focusing on the individual purchase mandate and the Medicaid expansion, while …

Off Premises Sunday Sales In Georgia Localities: Will It Affect Traffic Accidents?, Forrest Rose, Nathan Dunkel

Georgia Journal of Public Policy

Discussions about public policy relating to alcohol cause a polarizing reaction to many people in this country, particularly in the South. The state of Georgia, for example, has a long history of policies regulating alcohol which reflects its membership as part of the “Bible Belt” where Sunday is regarded as a holy day and therefore alcohol cannot and should not be purchased on this day. Given that the impetus of alcohol control policy has generally widened the availability of alcohol since the Prohibition, the moral concerns of voters regarding alcohol regulation have been superseded in the public debate with safety …

Pillars For Progress On The Right To Health: Harnessing The Potential Of Human Rights Through A Framework Convention On Global Health, Eric A. Friedman, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Ever more constitutions incorporate the right to health, courts continue to expand their right to health jurisprudence, and communities and civil society increasingly turn to the right to health in their advocacy. Yet the right remains far from being realized. Even with steady progress on numerous fronts of global health, vast inequities at the global and national levels persist, and are responsible for millions of deaths annually. We propose a four-part approach to accelerating progress towards fulfilling the right to health: 1) national legal and policy reform, incorporating right to health obligations and principles including equity, participation, and accountability in …