Health Law and Policy Commons^™

Hierarchies Of Discrimination In Baby Making: A Response To Professor Carroll, Radhika Rao

Indiana Law Journal

Roundtable on Regulating Assisted Reproductive Technology 2012

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 …

Selling Art Or Selling Out?: A Response To Selling Art: An Empirical Assessment Of Advertising On Fertility Clinics' Websites, Jody L. Madeira

Indiana Law Journal

Roundtable on Regulating Assisted Reproductive Technology 2012

How Parents Are Made: A Response To Discrimination In Baby Making: The Unconstitutional Treatment Of Prospective Parents Through Surrogacy, Kimberly M. Mutcherson

Indiana Law Journal

Roundtable on Regulating Assisted Reproductive Technology 2012

Reproducing Hierarchy In Commercial Intimacy, Michele Goodwin

Indiana Law Journal

Roundtable on Regulating Assisted Reproductive Technology 2012

Do No Harm: The Dispute Over Access To Health Care Between Israel And The Palestinian Territories, Emma Glazer

Cardozo Journal of International and Comparative Law

The note examines the legal dispute over access to healthcare between Israel and the Palestinian Territories under International Humanitarian Law (IHL). It argues that while IHL obligates Israel to provide medical services to Palestinians injured in conflict, it does not require unrestricted access for routine healthcare. The analysis highlights the need for Israel to balance its security interests with humanitarian obligations, ensuring access to healthcare while maintaining necessary restrictions. The note also suggests that as the Palestinian Territories pursue statehood, they should develop their own advanced healthcare facilities to reduce reliance on Israeli institutions.

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 …

The Federal Medical Loss Ratio: A Permissible Federal Regulation Or An Encroachment On State Power?, Meghan S. Stubblebine

William & Mary Law Review

No abstract provided.

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 …

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 …

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 …

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 …

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 …

Conflicting Federal And State Medical Marijuana Policies: A Threat To Cooperative Federalism, Todd Grabarsky

West Virginia Law Review

The legal status of medical marijuana in the United States is something of a paradox. On one hand, the federal government has placed a ban on the drug with no exceptions. On the other hand, forty percent of states have legal- ized its cultivation, distribution, and consumption for medical purposes. As such, medical marijuana activity is at the same time proscribed (by the federal government) and encouraged (by state governments through their systems of regulation and taxation). This Article seeks to shed light on this unprecedented, nebulous zone of legality in which an activity is both legal and illegal, what …

Not The Power To Destroy: An Effects Theory Of The Tax Power, Robert D. Cooter, Neil S. Siegel

Faculty Scholarship

The Supreme Court’s “new federalism” decisions impose modest limits on the regulatory authority of Congress under the Commerce Clause. According to those decisions, the Commerce Clause empowers Congress to use penalties to regulate interstate commerce, but not to regulate noncommercial conduct. What prevents Congress from penalizing non-commercial conduct by calling a penalty a tax and invoking the Taxing Clause? The only obstacle is the distinction between a penalty and a tax for purposes of Article I, Section 8. In National Federation of Independent Business v. Sebelius (NFIB), the Court considered whether the minimum coverage provision in the Patient Protection and …

Rural Roads To Acos: Inter-Community Collaboration Is Key To Rural Accountable Care Organizations' Success Under Medicare's Shared Savings Program, Justin Kearns

West Virginia Law Review

No abstract provided.

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 …

Seeking Genomic Knowledge: The Case For Clinical Restraint, Ellen Wright Clayton, Wylie Burke, Susan Brown Trinidad

Vanderbilt Law School Faculty Publications

Genome sequencing technology provides new and promising tests for clinical practice, including whole genome sequencing, which measures an individual's complete DNA sequence, and whole exome sequencing, which measures the DNA for all genes coding for proteins. These technologies make it possible to test for multiple genes in a single test, which increases the efficiency of genetic testing. However, they can also produce large amounts of information that cannot be interpreted or is of limited clinical utility. This additional information could be distracting for patients and clinicians, and contribute to unnecessary healthcare costs. The potential for genomic sequencing to improve care …

Recommendations For Returning Genomic Incidental Findings? We Need To Talk!, Ellen Wright Clayton, Wylie Burke, Armand H. Matheny Antommaria, Et Al.

Vanderbilt Law School Faculty Publications

The American College of Medical Genetics and Genomics recently issued recommendations for reporting incidental findings from clinical whole-genome sequencing and whole-exome sequencing. The recommendations call for evaluating a specific set of genes as part of all whole-genome sequencing/whole-exome sequencing and reporting all pathogenic variants irrespective of patient age. The genes are associated with highly penetrant disorders for which treatment or prevention is available. The effort to generate a list of genes with actionable findings is commendable, but the recommendations raise several concerns. They constitute a call for opportunistic screening, through intentional effort to identify pathogenic variants in specified genes unrelated …

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).

An Analysis Of New York State’S Flawed Recovery Scheme In Prenatal Malpractice Actions: Why A Claim Of Nied Should Be Available To Plaintiffs, Amanda Campo

Pace Law Review

Prior to 2006 mothers could not bring a wrongful death action on behalf of their stillborn child, nor could they bring any personal cause of action, absent a physical injury independent from the unsuccessful birth itself. In 2006, the New York Court of Appeals attempted to fill this gap in the case of Broadnax v. Gonzalez. This Note will analyze whether Broadnax successfully filled this recovery gap. Parts II, III, and IV will discuss the history of a mother’s failed attempts to gain recovery for the death of her stillborn child. Part V will discuss Broadnax. I will argue that …

Adjudicating Sex Crimes As Mental Disease, Melissa Hamilton

Pace Law Review

The psychiatric diseases of the paraphilias are now entrenched in the law in decisions concerning culpability, desert, and risk. Though, as the foregoing cases suggest, it is a tough balancing act, considering the existence of psychiatric illness suggests less responsibility, while at the same time implying a greater risk of future dangerousness. To better navigate this conundrum, the law has drawn on the psychiatric sciences. Part II of this Article outlines a basic need for law and science to serve each other even though they may not share objectives. With respect to the advent of new laws to control sex …

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 …

“Religious Freedom,” The Individual Mandate, And Gifts: On Why The Church Is Not A Bomb Shelter, Patrick Mckinley Brennan

Working Paper Series

The Health and Human Services' regulatory requirement that all but a narrow set of "religious" employers provide contraceptives to employees is an example of what Robert Post and Nancy Rosenblum refer to as a growing "congruence" between civil society's values and the state's legally enacted policy. Catholics and many others have resisted the HHS requirement on the ground that it violates "religious freedom." They ask (in the words of Cardinal Dolan) to be "left alone" by the state. But the argument to be "left alone" overlooks or suppresses the fact that the Catholic Church understands that it is its role …

Repairing The Antibiotic Pipeline: Can The Gain Act Do It?, Caitlin Forsyth

Washington Journal of Law, Technology & Arts

Antibiotic resistance, according to the World Health Organization, is one of the greatest threats to public health. To combat the problem, new antibiotics need to be developed. However, antibiotic research and development is fraught with scientific and economic problems. Recognizing these problems and the public health threat posed by antibiotic resistance, Congress passed the GAIN Act, which President Obama signed into law in June 2012. The GAIN Act (Act) incentivizes pharmaceutical companies to invest in antibiotic research and development. This Article will outline the incentives in the Act and suggest why the Act may not solve the growing antibiotic resistance …

Medical Advances, Criminal Disadvantages: The Tension Between Contemporary Antiretroviral Therapy And Criminal Hiv Exposure Laws In The Workplace, Chelsey Heindel

Washington Journal of Law, Technology & Arts

In 1988, the Washington Legislature classified intentionally exposing individuals to the human immunodeficiency virus (HIV) as criminal assault in the first degree. Lawmakers intended to penalize infected individuals without conditioning criminal liability on actual HIV transmission. Since 1988, however, medical technologies and effective HIV treatment have rapidly advanced. Recent studies indicate that effective antiretroviral therapy (ART) can reduce HIV transmission risks to a virtual impossibility during moments of intentional exposure. Despite these medical advances, the 1988 exposure law remains unchanged. Consequently, individuals undergoing effective ART risk felony liability within the course of commonplace work conduct by intentionally exposing others to …

The Affordable Care Act And International Recruitment And Migration Of Nursing Professionals, Helen D. Arnold

Indiana Journal of Global Legal Studies

Through its various provisions, the Affordable Care Act will insure more than thirty million Americans by January 1, 2014. This dramatic increase in coverage will have significant effects on both the U.S. economy and its healthcare system. Nursing professionals make up a large portion of the U.S. healthcare system and with a dramatic nursing shortage already in place, employers increasingly look abroad to fill nursing vacancies. Due to the increasing effects of globalization, foreign nurses have become an integral part of the U.S. healthcare system. This note argues that the increased coverage created by the Affordable Care Act will increase …