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Regulating Secrecy, W. Nicholson Price Ii

Articles

Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual property exclusivity in socially problematic ways by encouraging secrecy at the expense of innovation, efficiency, and competition. This Article theorizes how regulation empowers intellectual property generally, explains why this strengthening is problematic for trade secrecy but not for patents, and offers the solution of regulator-enforced disclosure. When a regulator defines a product or a process, it becomes much harder to successfully …

Improving Community Health Through Hospital Community Benefit Spending: Charting A Path To Reform, Sara J. Rosenbaum, Maureen Byrnes, Sara Rothenberg, Rachel Gunsalus

Health Policy and Management Faculty Publications

No abstract provided.

Minding Ps And Qs: The Political And Policy Questions Framing Health Care Spending, William M. Sage

Faculty Scholarship

Tracing the evolution of political conversations about health care spending and their relationship to the formation of policy is a valuable exercise. Health care spending is about science and ethics, markets and government, freedom and community. By the late 1980s the unique upward trajectory of post-Medicare U.S. health care spending had been established, recessions and tax cuts were eroding federal and state budgets, and efforts to harness market forces to serve policy goals were accelerating. From the initial writings on “managed competition,” through the failed Clinton health reform effort in the early 1990s, to the passage of the Affordable Care …

Regulating Off-Label Promotion — A Critical Test, Christopher Robertson, Aaron S. Kesselheim

Faculty Scholarship

In 2012, the U.S. Court of Appeals for the Second Circuit handed down a landmark decision in the case of pharmaceutical sales representative Alfred Caronia. The Food and Drug Administration (FDA) had approved sodium oxybate (Xyrem) for treating narcolepsy, but Caronia promoted it for a wide range of nonapproved (off-label) indications, including insomnia, Parkinson’s disease, and fibromyalgia. Off-label use is common, especially in specialties such as oncology, in which it may even be considered the standard of care. However, surveys have revealed that supporting evidence is lacking for a majority of off-label uses of medical products.1 The uses Caronia …

Trouble On The Exchanges — Does The United Owe Billions To Health Insurers?, Nicholas Bagley

Articles

Yet another bruising fight has erupted over health care reform. On September 9, 2016, the Obama administration offered to open settlement negotiations with health insurers that have sued the United States to recover billions of dollars that they claim they are owed. Congressional Republicans are incensed, believing that any settlement would illegally squander taxpayer dollars in a lastgasp effort to save the Affordable Care Act (ACA).

The Next Who Director-General’S Highest Priority: A Global Treaty On The Human Right To Health, Lawrence O. Gostin, Eric A. Friedman, Paulo Buss, Mushtaque Chowdhury, Anand Grover, Mark Heywood, Churnrurtai Kanchanachitra, Gabriel Leung, Judith Mackay, Precious Matsoso, Sigrun Mogedal, Joia S. Mukherjee, Francis Omaswa, Joy Phumaphi, K. Srinath Reddy, Mirta Roses Periago, Joe Thomas, Oyewale Tomori, Miriam Were, Debrework Zewdie

Georgetown Law Faculty Publications and Other Works

Amidst the many challenges facing the next WHO Director-General, the new WHO head should find WHO’s foremost priority in its most important constitutional pillar: the right to health. The centerpiece of this endeavor should be leadership on the Framework Convention on Global Health (FCGH), the proposed global treaty based in the right to health and aimed at national and global health equity. The treaty would reform global governance for health to enhance accountability, transparency, and civil society participation and protect the right to health in trade, investment, climate change, and other international regimes, while catalyzing governments to institutionalize the right …

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Community Health Centers And Medicaid Payment Reform: Emerging Lessons From Medicaid Expansion States, Peter Shin, Jessica Sharac, Zoe Barber, Sara J. Rosenbaum

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

Community health centers represent a major source of primary health care for the nation’s Medicaid beneficiaries. Because the Federally Qualified Health Center (FQHC) payment system is encounter-based, health centers and Medicaid agencies in ACA expansion states are actively pursuing payment reforms that will enable health centers to adopt strategies that can more effectively respond to the considerable and complex health and social needs of people served by health centers, and more efficiently address the surging volume of patient care. In five expansion states whose alternative payment experiments are underway, health centers and Medicaid agencies are testing payment alternatives, such as …

Mid-Atlantic Ethics Committee Newsletter, Fall 2016

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Law And Health Care Newsletter, Vol. 24, No. 1, Fall 2016

Law & Health Care Newsletter

No abstract provided.

Alienage Classifications And The Denial Of Health Care To Dreamers, Fatma E. Marouf

Faculty Scholarship

In the Affordable Care Act (“ACA”), passed in 2010, Congress provided that only “lawfully present” individuals could obtain insurance through the Marketplaces established under the Act. Congress left it to the Department of Health and Human Services (“HHS”) to define who is “lawfully present.” Initially, HHS included all individuals with deferred action status, which is an authorized period of stay but not a legal status. After President Obama announced a new policy of Deferred Action for Childhood Arrivals (“DACA”) in June 2012, however, HHS amended its regulation specifically to exclude DACA recipients from the definition of “lawfully present.” The revised …

Emergency Medical Services And Public Policy In Durban, Kwazulu-Natal, John Buyske

Independent Study Project (ISP) Collection

This project seeks to explore the realities of the emergency medical system in the Durban area, particularly relative to government policy. It contextualizes its findings within the literature on public policy. Data for the project was collected via nine in-depth interviews with various professionals working in the field of emergency medical services, as well as a survey of fourteen citizens conducted in the peri-urban township of Cato Manor. This data was analyzed using qualitative methods. While every participant had different views and a different perspective on emergency services, some recurring themes and trends became evident, allowing for conclusions to be …

Financial Hardship From Purchasing Medications For Senior Citizens Before And After The Medicare Modernization Act Of 2003 And The Patient Protection And Affordable Care Act Of 2010: Findings From 1998, 2001, And 2015, Anthony W. Olson, Jon C. Schommer, David A. Mott, Lawrence M. Brown

Pharmacy Faculty Articles and Research

BACKGROUND: The Medicare Modernization Act of 2003 (Medicare Part D) added prescription drug coverage for senior citizens aged 65 years and older and applied managed care approaches to contain costs. The Patient Protection and Affordable Care Act of 2010 (ACA) had the goals of expanding health care insurance coverage and slowing growth in health care expenditures.

OBJECTIVES: To (a) describe the proportion of senior citizens who had prescription drug insurance coverage and the proportion who experienced financial hardship from purchasing medications in 2015, and (b) compare the findings with those collected in 1998 and 2001.

METHODS: Data were obtained in …

Zika Virus And Global Health Security, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

Americans are largely apathetic about the risks of Zika virus and Congress cannot agree on preparedness funding. Strategies to counter the spread of Zika by the World Health Organisation (WHO) grossly underestimate the disease’s impact. WHO and member countries lack sufficient resources to respond. Consequences of fiscal apathy can be measured in lives lost and long-term disabilities. Zika prevention is a matter of global health security.

The epidemiologic brunt of Zika in South America falls largely on vulnerable women at heightened risk of exposure through mosquitoes and sexual transmission. Resulting transmission to fetuses and infants will have generational impacts in …

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

Preventing Neonatal Abstinence Syndrome Within The Opioid Epidemic: A Uniform Facilitative Policy, Jeremiah A. Ho

Faculty Publications

The United States is currently in the midst of an opioid epidemic that has hit states in the southern New England regions particularly hard — with Massachusetts as one primary example. One of the many unfortunate results of the epidemic is a dramatic upsurge in cases of opioid dependency by expectant women that result in children born with Neonatal Abstinence Syndrome (NAS). NAS is a clinical syndrome that occurs when a newborn suffers withdrawal symptoms as a consequence of abrupt discontinuation of prenatal substance exposure. The expenses of treating and rehabilitating these drug-dependent newborns, predominantly shouldered by state taxpayers, are …

Marine Law Symposium: Legal And Policy Approaches To Reduce Marine Debris In New England 11/04/2016, Roger Wiliams University School Of Law

School of Law Conferences, Lectures & Events

No abstract provided.

Surviving The Storm 2016: Employee Benefit Compliance & Employment Law Update, George Thompson, Brooks R. Magratten, Mark A. Pogue, Kelli Viera, Cecily Banks, Roger Williams University School Of Law

School of Law Conferences, Lectures & Events

No abstract provided.

Comments Submitted To The Department Of Health And Human Services Regarding Religious Exemptions To Contraceptive Coverage, Public Rights/Private Conscience Project

Center for Gender & Sexuality Law

Following the Supreme Court's decision to vacate and remand the cases in Zubik v. Burwell, the Department of Health and Human Services (HHS) issued a request for information on alternative ways to accommodate religious nonprofits from compliance with the contraceptive mandate of the Affordable Care Act (ACA), CMS-9931-NC. The following comment, from the Law, Rights, and Religion Project, explains that the ACA's existing religious accommodation complies with federal law, and that expanding the accommodation in a way that harms employees and their families would risk violating the Establishment Clause of the First Amendment. Further, this comment highlights the effects an …

Resource Guide For Addiction And Mental Health Care Consumers: Answering Questions About Insurance Coverage And Parity For Addiction And Mental Health Care Services, Lucy C. Hodder, Michele D. Merritt, Margaret H. Schmidt, Jacqueline Botchman, Caitlyn Ebert, Marguerite Corvini, Kate Crary, Bridget Drake

Law Faculty Scholarship

Navigating the maze of health insurance coverage can be difficult. For individuals with addiction or mental illness, the process of getting treatment approved and paid for by health insurance can be overwhelming. As a result, many people give up when their health insurance company denies coverage for needed services. This Guide can help people learn how to access health insurance and use their coverage to pay for treatment. This Guide also provides a basic explanation of consumers’ rights under the federal Mental Health Parity and Addiction Equity Act.

Smoking On The Margins: A Comprehensive Analysis Of A Municipal Outdoor Smoke-Free Policy, Ann Pederson, Chizimuzo T. C. Okoli, Natalie Hemsing, Renée O'Leary, Amanda T. Wiggins, Wendy Rice, Joan L. Bottorff, Lorraine Greaves

Nursing Faculty Publications

Background: This study examined the formulation, adoption, and implementation of a ban on smoking in the parks and beaches in Vancouver, Canada.

Methods: Informed by Critical Multiplism, we explored the policy adoption process, support for and compliance with a local bylaw prohibiting smoking in parks and on beaches, experiences with enforcement, and potential health equity issues through a series of qualitative and quantitative studies.

Results: Findings suggest that there was unanimous support for the introduction of the bylaw among policy makers, as well as a high degree of positive public support. We observed that smoking initially declined following the ban’s …

Implementation Of The Affordable Care Act In Physical Therapy, Greg Austin

Mahurin Honors College Capstone Experience/Thesis Projects

Introduction: With the implementation of the Affordable Care Act (ACA) in 2010, many medical specialties prepared to see reimbursement rates altered. Not impervious to this trend was the field of physical therapy (PT). This change in reimbursement structure could impact the effectiveness of PT treatment. Under this model, a patient may not be able to receive the appropriate number of visits to a physical therapist, resulting in a loss of utilization in the injured area and, possibly, a loss of independence. Methods: A literature review was performed to determine reimbursement rate impact on PT. A seven-item open-ended survey regarding various …

The Lautenberg Act: Chemical Safety Overhaul Of The Toxic Substances Control Act, Alyssa S. Rosen

Elisabeth Haub School of Law Faculty Publications

On June 22, 2016, President Obama signed the Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), a landmark bipartisan compromise legislation designed to overhaul the Toxic Substances Control Act (TSCA). The Lautenberg Act makes it easier for the U.S. Environmental Protection Agency (EPA) to regulate toxic substances while providing the chemical industry with regulatory clarity and certainty. Law Librarians, practicing lawyers, and academics have taken note of this groundbreaking law that most likely will set the template for the next generation of environmental reform by tackling issues such as preemption of state law, protection of vulnerable populations, …

Managing Our Microbial Mark: What We Can Learn About Pay For Performance From Ebola's Arrival At Our Shores, Ann Marie Marciarille

Faculty Works

The narrative of Ebola’s arrival in the United States has been overwhelmed by our fear of a West African-style epidemic. The real story of Ebola’s arrival is about our healthcare system’s failure to identify, treat, and contain healthcare associated infections. Having long been willfully ignorant of the path of fatal infectious diseases through our healthcare facilities, this paper considers why our reimbursement and quality reporting systems made it easy for this to be so. West Africa’s challenges in controlling Ebola resonate with our own struggles to standardize, centralize, and enforce infection control procedures in American healthcare facilities.

Women's Health And Abortion Rights: Whole Woman's Health V Hellerstedt, Lawrence O. Gostin, Rebecca B. Reingold

Georgetown Law Faculty Publications and Other Works

Nearly a quarter century ago, the Supreme Court asked pro-choice and right-to-life advocates “to end their national division by accepting a common mandate rooted in the Constitution.” Nothing of the sort materialized. If anything, the social and political battles intensified, with states enacting 1074 abortion restrictions. The Court has not considered various appeals in the face of an avalanche of legislation, but on June 27, 2016, it struck down 2 onerous restrictions on physicians and clinics offering abortion services.

In Whole Woman’s Health v Hellerstedt, the Court found Texas’s requirements that physicians conducting abortions obtain admitting privileges at local …

Newsroom: Horwitz On Marijuana Legalization 7/15/2016, John S. Kiernan, Roger Williams University School Of Law

Life of the Law School (1993- )

No abstract provided.

Rubbing The Rabbit's Foot: Gallows Superstitions And Public Healthcare In England During The Eighteenth And Nineteenth Centuries, Roberta M. Harding

Law Faculty Scholarly Articles

Superstitions possess an ancient pedigree. With the passage of time thematic superstitions developed; for example, some solely addressed the public’s health care needs. In fact, as far back as the fifth century many English subjects believed magical spells and jewels had curative properties. Law was another context that generated a body of superstitions. Capital punishment was one area that generated many superstitions. In fact, so many that a specific category was established: gallows superstitions. With hanging as the primary method of execution in England for centuries, this group of superstitions became a relatively large one. By merging the health care …

How To Think About Religious Freedom In An Egalitarian Age, Nelson Tebbe

Cornell Law Faculty Publications

No abstract provided.

Newsletter, Summer/Fall 2016

Newsletter

No abstract provided.

Posthumous Organ Donation As Prisoner Agency And Rehabilitation, Amanda Seals Bersinger, Lisa Milot

Scholarly Works

Unlike U.S. citizens generally, who are encouraged to become organ donors through drivers' license designations, advance directives, and state registries, in most instances inmates are barred from donating their organs until release.

To date, the scholarship in favor of allowing inmates to donate their organs has largely focused on the benefit these donations could offer patients languishing on organ transplant lists, while objections center on the vulnerability of the imprisoned potential donors and their inability to make decisions freely. A donor-focused case for donation, however, is missing in this debate. This Article fills that gap by setting out the philosophical …

Delinking Investment In Antibiotic Research And Development From Sales Revenues: The Challenges Of Transforming A Promising Idea Into Reality, Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel, John-Arne Røttingen

Faculty Scholarship

1. The current business model for antibiotics is plagued by market failures and perverse incentives that both work against conservation efforts and provide insufficient rewards to drive the development of much-needed new treatments for resistant infection.

2. Many new incentive mechanisms have been proposed to realign incentives and support innovation and conservation over the long term. The most promising of these are based on the idea of delinking rewards from sales volume of the antibiotic — the notion of “delinkage.”

3. Some critical design issues for delinkage remain, such as how to secure access to badly needed new products when …