Law Commons^™

From Sex For Pleasure To Sex For Parenthood: How The Law Manufactures Mothers, Beth A. Burkstrand-Reid

Nebraska College of Law: Faculty Publications

As soon as sperm enter a woman, so do law and politics, or so the decades-long disputes surrounding abortion suggest. Now, however, renewed debates surrounding contraceptives show legal and political interference with women’s sexual and reproductive autonomy may actually precede the sperm. This Article argues that, increasingly, women even thinking about having sex are defined socially and legally as “mothers.” Via this broad definition of who is a “mother,” the State extends its reach into women’s decision-making throughout their reproductive lifetime.

This Article argues that the State simultaneously devalues women’s choices to have sex for pleasure, which this Article calls …

Anticompetitive Patent Settlements And The Supreme Court's Actavis Decision, Herbert J. Hovenkamp

All Faculty Scholarship

In FTC v. Actavis the Supreme Court held that settlement of a patent infringement suit in which the patentee of a branded pharmaceutical drug pays a generic infringer to stay out of the market may be illegal under the antitrust laws. Justice Breyer's majority opinion was surprisingly broad, in two critical senses. First, he spoke with a generality that reached far beyond the pharmaceutical generic drug disputes that have provoked numerous pay-for-delay settlements.

Second was the aggressive approach that the Court chose. The obvious alternatives were the rule that prevailed in most Circuits, that any settlement is immune from antitrust …

Medicaid Home- And Community-Based Services Programs Enacted By The Aca: Expanding Opportunities One Step At A Time, Carol O'Shaughnessy

National Health Policy Forum

The Patient Protection and Affordable Care Act of 2010 (ACA) enacted the most significant opportunities for optional state expansion of Medicaid-financed home- and community-based services (HCBS) since 1981, when Congress enacted the section 1915(c) waiver program. Three of the ACA provisions, the Balancing Incentive Program (BIP), the Community First Choice (CFC) state plan option, and the health home state plan option, offer states enhanced federal Medicaid matching funds as long as they meet federal requirements. The ACA also expanded two HCBS programs established under the Deficit Reduction Act of 2005 (DRA) by extending the Money Follows the Person (MFP) Rebalancing …

Medicaid Home- And Community-Based Services Programs Enacted By The Aca: Expanding Opportunities One Step At A Time, Carol O'Shaughnessy

National Health Policy Forum

The Patient Protection and Affordable Care Act of 2010 (ACA) enacted the most significant opportunities for optional state expansion of Medicaid-financed home- and community-based services (HCBS) since 1981, when Congress enacted the section 1915(c) waiver program. Three of the ACA provisions, the Balancing Incentive Program (BIP), the Community First Choice (CFC) state plan option, and the health home state plan option, offer states enhanced federal Medicaid matching funds as long as they meet federal requirements. The ACA also expanded two HCBS programs established under the Deficit Reduction Act of 2005 (DRA) by extending the Money Follows the Person (MFP) Rebalancing …

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Reflections On The Cost Of "Low-Cost" Whole Genome Sequencing: Framing The Health Policy Debate, Timothy Caulfield, Jim Evans, Amy Mcguire, Christopher Mccabe, Tania Bubela, Robert Cook-Deegan, Jennifer Fishman, Stuart Hogarth, Fiona A. Miller, Vardit Ravitsky, Barbara Biesecker, Pascal Borry, Mildred K. Cho, June C. Carroll, Holly Etchegary, Yann Joly, Kazuto Kato, Sandra Soo-Jim Lee, Karen H. Rothenberg, Pamela Sankar, Michael J. Szego, Pilar Ossorio, Daryl Pullman, Francois Rousseau, Wendy J. Ungar, Brenda Wilson

Faculty Scholarship

The cost of whole genome sequencing is dropping rapidly. There has been a great deal of enthusiasm about the potential for this technological advance to transform clinical care. Given the interest and significant investment in genomics, this seems an ideal time to consider what the evidence tells us about potential benefits and harms, particularly in the context of health care policy. The scale and pace of adoption of this powerful new technology should be driven by clinical need, clinical evidence, and a commitment to put patients at the centre of health care policy.

Dynamic Expansion, Nicole Huberfeld

Faculty Scholarship

Nearly one in four Americans will have medical care and costs covered by the Medicaid program when it has been expanded pursuant to the Patient Protection and Affordable Care Act (the ACA). National media outlets have been reporting that only about half of the states are participating in the Medicaid expansion; if the reports were true, millions of Americans would be left without insurance coverage, and many of the nation’s medically fragile citizens would not have access to consistent healthcare. Contrary to these reports, most states will participate in the Medicaid expansion in the near future. This claim is not …

Seeking Value In Medicare: Performance Measurement For Clinical Professionals, Lisa Sprague

National Health Policy Forum

The Medicare program, despite its reputation of being a bill payer with little regard to the worth of the services it buys, has begun to put in place a range of programs aimed at assessing quality and value, with more to come. Attention to resource use and cost is nascent. The issues are complex, and it is no surprise that there is a level of contention between providers and regulators, even though both profess commitment to improved quality. This paper summarizes the quality and value programs that apply to physicians and other clinical professionals, as well as programs designed to …

Health Workforce Needs: Projections Complicated By Practice And Technology Changes, Rob Cunningham

National Health Policy Forum

As population growth and the aging of the overall population increase demand for health care, policymakers and analysts posit whether sufficient health care providers will be able to meet that demand. Some argue there are too few providers already; others say our current supply-demand problems lie with efficiency. But suppose both are correct? Perhaps the real challenge is to understand how physician practices are changing in response to market forces such as payment changes, provider distributions, and technology innovations. This issue brief reviews what is known about evolving practice organizations, professional mixes, information technology support, and the implications of these …

The Commission On Long-Term Care: Background Behind The Mission, Carol O'Shaughnessy

National Health Policy Forum

The American Taxpayer Relief Act of 2012 (ATRA, P.L. 112-240) created a Commission on Long-Term Care charged with developing a plan for financing of long-term services and supports (LTSS) and issuing a report in September 2013. Significant research and advocacy have been devoted to LTSS financing issues and perceived inadequacies of the delivery system over the past several decades, but the most recent comprehensive review of financing options was in 1990 by the Pepper Commission. This publication presents brief background behind the mission of the Commission, including a time line of selected federal and national activities on LTSS financing and …

Sex Trafficking In Massage Parlors: Working Out The Knots In The San Francisco Health Code, Joanne Badua

GGU Law Review Blog

No abstract provided.

Newsletter Fall 2013

Newsletter

No abstract provided.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Akron Law Faculty Publications

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 …

Mid-Atlantic Ethics Committee Newsletter, Fall 2013

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Law & Health Care Newsletter, V. 21, No. 1, Fall 2013

Law & Health Care Newsletter

No abstract provided.

Let Ivf Take Its Course: Reconceiving Procreative Liberty For The Twenty-First Century, Christine E. White

Student Articles and Papers

No abstract provided.

The Dangers Of Psychotropic Medication For Mentally Ill Children: Where Is The Child’S Voice In Consenting To Medication? An Empirical Study, Donald H. Stone

All Faculty Scholarship

When a child with a mental illness is being prescribed psychotropic medication. who decides whether the child should take the medication — the parent or the child? What if the child is sixteen years of age? What if the child is in foster care: Should the parent or social service agency decide? Prior to administering psychotropic medication, what specific information should be provided to the person authorized to consent on behalf of the child? Should children be permitted to refuse psychotropic medications? If so, at what age should a child he able to refuse such medication What procedures should be …

Health Law Outlook - Volume 7, Issue 1 (Fall 2013)

Health Law Outlook (archive)

Inside this Issue:

• Changing the Landscape of New York Hospitals, Nina Schuman
• The Internet, Privacy, and Public Health: How Social Media and "Big Data" are Changing the Landscape of Public Health Surveillance and Research, Donna Hanrahan
• Ending Philosophical Exemptions for Mandatory Vaccinations, Adino Barbarito
• The Affordable Care Act's Impact on Individuals with Disabilities, Brandon Lee Wolff

Corporations, Taxes, And Religion: The Hobby Lobby And Conestoga Contraceptive Cases, Steven J. Willis

UF Law Faculty Publications

Beginning in 2013, the federal government mandated that general business corporations include contraceptive and early abortion coverage in large employee health plans. Internal Revenue Code Section 4980D imposes a substantial excise tax on health plans violating the mandate. Indeed, for one company – Hobby Lobby – the expected annual tax is nearly one-half billion dollars. Dozens of “for profit” businesses have challenged the mandate on free exercise grounds, asserting claims under the First Amendment as well as under the Religious Freedom Restoration Act.

So far, courts have been reluctant to hold corporations have religious rights of their own; as a …

Legally Blind: The Therapeutic Illusion In The Support Study Of Extremely Premature Infants, George J. Annas, Catherine L. Annas

Faculty Scholarship

Physician-researchers follow a protocol to generate generalizable knowledge; physicians have a duty to treat patients in ways they and their patients think best. In both activities, research and treatment, physicians often see themselves simply as physicians, practicing medicine. Sick people have similar perception difficulties, and prefer to think of their physician-researcher simply as their physician, even when their treatment is ² determined by a protocol or the flip of a coin. Almost 20 years ago, in this Journal, one of us suggested that at least some researchers use language "to obscure; to blur or eliminate the distinctions between research …

Reverse Payments, Perverse Incentives, Murat C. Mungan

Faculty Scholarship

Issuing and enforcing prescription drug patents requires courts and legislatures to strike a delicate balance. A patent gives drug manufacturers a legal, if temporary, monopoly on sales of a drug; this encourages manufacturers to engage in costly research and development of new medicines. But not all patents issued by the Patent Office are ultimately deemed valid – generic drug manufacturers can infringe the patent, and, when sued, attack its validity in court on a variety of grounds, including obviousness. In recent years, patent holders have begun to settle these suits (which they initiated) by paying the alleged infringer. Not surprisingly, …

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 …

Approval And Withdrawal Of New Antibiotics And Other Antiinfectives In The U.S., 1980-2009, Kevin Outterson, John H. Powers, Enrique Seoane, Rosa Rodriguez-Monguio, Aaron S. Kesselheim

Faculty Scholarship

Concerns about a dearth of antibiotic innovation have spurred calls for incentives to speed the development of new antibiotics. Our data demonstrates that many of the new molecular entity (NME) antibioticsintroduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes. Adjusted for these withdrawals, the net introduction of NME antibiotics is not as troubling of a trend. The reduction in NME antibiotics was partially offset by a surge in the introduction of NME antiretrovirals for HIV/AIDS and other drug classes (such as cardiovascular drugs) posted similar declines.

These data …

Section 2: Affordable Care Act, Institute Of Bill Of Rights Law, William & Mary Law School

Supreme Court Preview

No abstract provided.

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 …

North Carolina's Bold Model For Eugenics Compensation, Peter Hardin, Paul Lombardo

Faculty Publications By Year

No abstract provided.

Juxtaposing Nasa’S Aeronet Aod With Carb Pm Data Over The San Joaquin Valley To Facilitate Multi-Angle Imaging Spectroradiometer (Misr) Pm Pollution Research, John Kanemoto

STAR Program Research Presentations

Airborne particulate matter (PM) has been shown to increase the risk for asthma, chronic bronchitis, cardiopulmonary complications, and respiratory cell membrane damage/infection/leakage. PM levels are currently analyzed from two perspectives: stationary land-based monitoring (LBM) sites and total Aerosol Optical Depth (AOD) atmospheric column measurements. Both perspectives often leave miles of space between measuring locations and will have a continually increasing cost from introducing/maintaining sites. The Multi-angle Imaging SpectroRadiometer (MISR) satellite team hopes to begin investigating/archiving PM levels comprehensively via inputting MISR AOD measurements into a function/model which predicts the amount of ground level PM.

In the future, multivariable spatial correlations …

Finding A Positive Right To Healthcare, Nicole Huberfeld

Law Faculty Popular Media

In this blog post, Professor Nicole Huberfeld provides a review of Edward Rubin's article The Affordable Care Act, The Constitutional Meaning of Statutes, and the Emerging Doctrine of Positive Constitutional Rights, 53 Wm. & Mary L. Rev. 1639 (2012).

Medicare Advantage Update: Benefits, Enrollment, And Payments After The Aca, Kathryn Linehan

National Health Policy Forum

In 2012, the Medicare program paid private health plans $136 billion to cover about 13 million beneficiaries who received Part A and B benefits through the Medicare Advantage (MA) program rather than traditional fee-for-service (FFS) Medicare. Private plans have been a part of the program since the 1970s. Debate about the policy goals—Should they cost less per beneficiary than FFS Medicare? Should they be available to all beneficiaries? Should they be able to offer additional benefits?—has long accompanied Medicare's private plan option. This debate is reflected in the history of Medicare payment policy, and policy decisions over the …

Can Consumers Make Affordable Care Affordable? The Value Of Choice Architecture, Eric J. Johnson, Ran Hassin, Tom Baker, Allison T. Bajger, Galen Treuer

All Faculty Scholarship

Starting this October, tens of millions will be choosing health coverage on a state or federal health insurance exchange as part of the Patient Protection and Affordable Care Act. We examine how well people make these choices, how well they think they do, and what can be done to improve these choices. We conducted 6 experiments asking people to choose the most cost-effective policy using websites modeled on current exchanges. Our results suggest there is significant room for improvement. Without interventions, respondents perform at near chance levels and show a significant bias, overweighting out-of-pocket expenses and deductibles. Financial incentives do …