Health Law and Policy Commons^™

Health Law Outlook - Volume 6, Issue 1 (Fall 2012)

Health Law Outlook (archive)

Inside this issue:

• Multi Drug-Resistant TB and Extensive Drug-Resistant TB: Regulating the Growing Crisis, Phil DeFedele
• From School to the 'Real World': Transition Rights for Students with Special Needs, Kristine Kodytek
• Government Tokophobia: Unjustly Denying Pregnant Women Access to Research, Joel Silver
• Criminalizing Prenatal Substance Abuse: Hurting Women and Their Unborn Children, Sara Smith
• Everyone Wants a Piece of Me: The Evolution of Biospecimen Research and the Regulatory World's Attempt to Keep Up, Isabel Heine
• Complications of Globalization: FDA Cracks Down on Fraud in the Pharmaceutical Industry, Clarissa Gomez
• Medical Malpractice Apology Law: "Don't …

Abandoning Women To Their Rights: What Happens When Feminist Jurisprudence Ignores Birthing Rights, Rebecca A. Spence

Student Articles and Papers

The goals of the Article are twofold. First, this Article will demonstrate that while birthing rights issues have been familiar areas of concern for feminist scholarship on women's rights to privacy and equality, neglecting to integrate this work into the law school classroom fails to promote effective legal advocacy for pregnant women. The violation of women's rights during childbirth is a more common problem than reported legal opinions indicate, and few lawyers are prepared to protect clients prospectively or to vindicate women's rights post-childbirth.

Reducing The Discount Rate, Ben L. Trachtenberg

Faculty Publications

This article presents two arguments against the “discounting” of future human lives as part of cost benefit analysis, or CBA. Our first argument is that because CBA has thus far ignored evidence of rising health care expenditures, it underestimates the “willingness to pay” for health and safety that future citizens will likely exhibit, thereby undervaluing their lives. Our second argument is that until recently CBA has ignored the trend of improved material conditions in developed countries, and most agencies continue to ignore it entirely. As time advances, residents of rich countries tend to live better and spend more, meaning that …

Rethinking Hiv-Exposure Crimes, Margo Kaplan

Indiana Law Journal

This Article challenges the current legislative and scholarly approaches to HIV-exposure crimes and proposes an alternative framework to address their flaws. Twenty-four states criminalize consensual sexual activities of people with HIV. Current statutes and the scholarship that supports them focus on HIV-positive status, sexual activity, and knowledge of HIV-positive status as proxies for risk, mental state, and consent to risk. As a result, they are dramatically over- and underinclusive and stigmatize individuals living with HIV. Criminalization should be limited to circumstances in which a defendant exposed her partner to a substantial degree of unassumed risk and did so with a …

Comparativist-Structural Approaches To Interpretation Of The Post-Obamacare Spending Power, Michelle Biddulph, Dwight G. Newman

Cardozo Journal of International and Comparative Law

The U.S. Supreme Court's decision on the Affordable Care Act (ACA) has significant implications for the federal spending power, a topic that has received limited scholarly attention. The article argues that understanding this aspect of the ACA ruling is crucial for comprehending its impact on future federal programs and legislative approaches. By examining the spending power frameworks in Canada and Australia, the article highlights how different federal systems balance central authority with regional autonomy, offering valuable lessons for the U.S. legal framework.

Party Polarization And Judicial Review: Lessons From The Affordable Care Act, Neal Devins

Faculty Publications

Congress paid nearly no attention to the Constitution when enacting the Affordable Care Act (ACA) in 2010. Legislative hearings and committee reports ignored the Constitution altogether; legislative debates largely did the same. This Essay both highlights Congress’s indifference to the Constitution when enacting the ACA and examines the reasons behind this legislative failure. In particular, this Essay advances three explanations. First, Congress is generally uninterested in “public goods” like constitutional interpretation. Second, the polarization of Democrats and Republicans in Congress further depresses Congress’s interest in thinking about the Constitution; instead, the majority party seeks to limit opportunities for the minority …

Virginia's "War On Women": How Forcing Women To Have An Ultrasound Before Abortion Is Unconstitutional, Alison B. Linas

Law Student Publications

This comment will discuss how the ultrasound bill, like similar ones in other states, is unconstitutional for two reasons....Part II of this comment will focus on the Supreme Court's role in shaping abortion policy....Part III will describe Virginia’s new ultrasound requirement and how the above-mentioned Supreme Court decisions affect the new bill’s legality. Part III(A) will lay out the relevant portions of the bill and discuss its legislative history. Part III(B) will analyze the bill through Casey’s undue burden lens....Part III(C) will argue that requiring a woman to have a mandatory medical procedure effectively prevents her from refusing medical care, …

Dispatch From The Culture War: Virginia's Failed Hpv Vaccination Mandate, Rachel Reynolds

Law Student Publications

This paper will inquire into what makes Gardasil different from other vaccines, and how that impacts its administration. Part I will describe the specifics of the HPV vaccine: how it works and how Virginia decided to promote its usage. Part II will examine the ways in which jurisdictions have traditionally understood vaccination policy, and contrast it with the ways in which they have handled the HPV vaccine. Part III will examine the disadvantages of continuing the mandate’s ineffective political war of attrition, and suggest a coalition-building strategy to effect policy that honors communal values and meaningfully increases access to the …

The Past And Future Of Deinstitutionalization Litigation, Samuel R. Bagenstos

Cardozo Law Review

Two conflicting stories have consumed the academic debate regarding the impact of deinstitutionalization litigation. The first, which has risen almost to the level of conventional wisdom, is that deinstitutionalization was a disaster. The second story challenges the suggestion that deinstitutionalization has uniformly been unsuccessful, as well as the causal link critics seek to draw with the growth of the homeless population. This Article, which embraces the second story, assesses the current wave of deinstitutionalization litigation. It contends that things will be different this time. The particular outcomes of the first wave of deinstitutionalization litigation, this Article contends, resulted from the …

Family Law—Egg Donation And Stem Cell Research—Eggs For Sale: The Scrambled State Of Legislation In The Human Egg Market, Kitty L. Cone

University of Arkansas at Little Rock Law Review

Rapid expansion of technology in medicine over the last few decades has both enhanced our lives and complicated our laws. For example, thanks to advances in science and medicine, couples who were previously unable to reproduce are now able to do so with the help of donors, medical personnel, and a host of other middlemen facilitating the process. The growth of medical technology has also lead to the advent of using human eggs for medical research. However, despite competing for eggs from a small pool of willing donors, there is a disparity in the law between the treatment of human …

Health Insurance And Federalism-In-Fact, Radha A. Pathak, Brendan S. Maher

Faculty Scholarship

The constitutional legitimacy of the Patient Protection and Affordable Care Act (“ACA”) received substantial attention. Less examined has been the legislation’s sub-constitutional effect on the regulatory power that states can and might exercise. Regarding a state's ability to promulgate "sickness rules," (those legal rules pertaining to the conditions or treatment an insurance policy covers) and "non-sickness" rules (those legal rules pertaining to insurance other than sickness rules), we scrutinize the ACA itself and contrast it with the other most significant statute governing private health insurance, the Employee Retirement Income Security Act of 1974 (“ERISA”). The authors would like to thank …

Verify, Then Trust: How To Legalize Off-Label Drug Marketing, Fazal Khan, Justin Holloway

Scholarly Works

This article will discuss the current state of off-label medicine, relevant legislation in the area, and a proposal designed to capture the benefits of off-label medicine while limiting its dangers when practiced perniciously. Part II will discuss the regulations in place governing off-label promotion and will detail the practice of ghostwriting and its associated concerns. Part III will analyze the costs and benefits of off-label marketing and practice of medicine, and will utilize a case study to demonstrate the predicament of drug manufacturers. Part IV will set forth a proposal to use the newly created Patient-Centered Outcomes Research Institute to …

Community Health Workers: A Front Line For Primary Care?, Lisa Sprague

National Health Policy Forum

Among the potential changes invoked in discussions on health system transformation, a need to revitalize primary care remains paramount. One way of doing this, most agree, is to move more in the direction of team-based care. Professionals such as physician assistants and nurse practitioners may be able to ease some of the physician’s clinical care load, but some populations also need help accessing services and basic health education in a familiar setting. Enter the community health worker (CHW), known by many titles and playing a variety of roles, who comes from the community he or she is serving and therefore …

The Supreme Court And The Future Of Medicaid, Timothy Stoltzfus Jost, Sara Rosenbaum

Scholarly Articles

Not available.

Can Consumers Control Health-Care Costs?, Mark A. Hall, Carl E. Schneider

Articles

The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today’s health policy watchword. This article evaluates consumerism and the regulatory mechanism …

Satmed: Legal Aspects Of The Physical Layer Of Satellite Telemedicine, Stephen Rooke

Michigan Journal of International Law

In 2003, Paul Hunt, the U.N. Commission on Human Rights' Special Rapporteur on the Right to Health, presented a report on the global availability of health care. Special Rapporteur Hunt argued that states are obligated to implement a right to health. Included in this right is the obligation "to ensure that no international agreement or policy adversely impacts upon the right to health, and that .. . international organizations take due account of the right to health, as well as the obligation of international assistance and cooperation, in all policy-making matters." One area Hunt left unexplored in his report was …

Reframing Federalism — The Affordable Care Act (And Broccoli) In The Supreme Court, Wendy K. Mariner, Leonard H. Glantz, George J. Annas

Faculty Scholarship

The U.S. Supreme Court decision to uphold most of the Affordable Care Act (ACA), including the insurance-coverage requirement, allows historic reforms in the health care system to move forward. Because the justices were split four to four on whether the ACA was constitutional, Chief Justice John Roberts was able to write the lead opinion that commanded five votes for whatever outcome he determined was constitutional. The chief justice's leadership in upholding almost all of the ACA was unanticipated, as was much of his legal reasoning. It was widely assumed that the interpretation of the Commerce Clause by the Court would …

Defensive Medicine And Obstetric Practices, Michael Frakes

Cornell Law Faculty Publications

Using data on physician behavior from the 1979–2005 National Hospital Discharge Surveys (NHDS), I estimate the relationship between malpractice pressure, as identified by the adoption of noneconomic damage caps and related tort reforms, and certain decisions faced by obstetricians during the delivery of a child. The NHDS data, supplemented with restricted geographic identifiers, provides inpatient discharge records from a broad enough span of states and covering a long enough period of time to allow for a defensive medicine analysis that draws on an extensive set of variations in relevant tort laws. Contrary to the conventional wisdom, I find no evidence …

Science On Law's Terms: Implications Of Procedural Legitimacy On Scientific Evidence, Nayha Acharya

LLM Theses

Scientific evidence is relied on more and more in litigation. Discussions and debates aimed at enabling courts to make the best use scientific evidence are increasingly critical. This thesis adds the perspective of procedural legitimacy to the science and law discussion. Procedural Legitimacy is the concept that consistent adherence to legal procedure maintains the overall legitimacy of the legal system, and the validity of its outcomes. I argue that the integrity of legal procedures must be maintained where scientific evidence is presented, so that judicial decisions that rely on scientific evidence are legitimate.

The Disappearing Provision: Medical Liability Reform Vanishes From The Patient Protection And Affordable Care Act Despite State Court Split, Rafael Andre Roberti

Legislation and Policy Brief

The legal and medical communities have debated the impact and necessity of medical liability reform for over twenty years. At the heart of the debate is the question of how to strike a balance between compensating patients and their families for the thousands of deaths and injuries resulting from medical errors that occur annually, and encouraging physicians to continue to care for patients across America. While several states have passed medical liability reform laws previously, on March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (ACA)—colloquially known as the “health care bill”—that contains provisions on medical …

Ethical Challenges Of Preexposure Prophylaxis For Hiv, Jonathan S. Jay, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On July 16, 2012, emtricitabine/tenofovir (Truvada) became the first drug approved by the US Food and Drug Administration for preexposure prophylaxis (PrEP) of human immunodeficiency virus (HIV) for adults at high risk. While PrEP appears highly effective with consistent adherence, effective implementation poses ethical challenges for the medical and public health community. For PrEP users, it is necessary to maintain adherence, safe sex practices, and routine HIV testing and medical monitoring, to maximize benefits and reduce risks. On a population level, comparative cost-effectiveness should guide priority-setting, while safety measures must address drug resistance concerns without burdening patients' access. Equitable distribution …

Condoms: The New Medium Of Expression Protected By The First Amendment- People V. Andujar, Leodyne Calixte

Touro Law Review

No abstract provided.

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 …

'How's My Doctoring?' Patient Feedback's Role In Assessing Physician Quality, Ann Marie Marciarille

Faculty Works

A society-wide consumer revolution is underway with the rise of online user-generated review websites such as Yelp, Angie’s List, and Zagat. Service provider reviews are now available with an intensity and scope that attracts increasing numbers of reviewers and readers. Health care providers are not exempt from this new consumer generated scrutiny though they have arrived relatively late to the party and as somewhat unwilling guests.

The thesis of this article is that online patient feedback on physicians is relevant and valuable even though it is also uncomfortable for health care providers. This is because the modern physician-patient relationship is …

Minority Over-Representation In The Criminal Justice System―The Impact On African American Women, Families And Their Communities And Important Emerging Interventions, Brenda V. Smith

Presentations

sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA) in partnership with Mental Health Systems, Inc.

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 …

Newsletter Summer 2012

Newsletter

No abstract provided.

Post-Reform Medicaid Before The Court: Discordant Advocacy Reflects Conflicting Attitudes, Nicole Huberfeld

Faculty Scholarship

The Supreme Court will decide two major Medicaid cases this term that raise major questions about the program and the tensions it creates between the federal government and the states. The Court heard oral arguments on October 3d in Douglas v. Independent Living Center, a dispute between California and its Medicaid providers regarding reimbursement cuts due to California’s budget crisis. The Medicaid providers argue that these proposed cuts are so extreme as to violate federal law and thus the Supremacy Clause. Their contention hinges on the Equal Access Provision of the Medicaid Act, which commands states to pay healthcare providers …

Common Law Constitutionalism, The Constitutional Common Law, And The Validity Of The Individual Mandate, Abigail R. Moncrieff

Law Faculty Articles and Essays

The paper proceeds as follows. Part I describes the constitutional common law and its interactions with common-law constitutionalism. Part II uses the fight over the constitutionality of the Patient Protection and Affordable Care Act (ACA) and its so-called "individual mandate" as a case study to flesh out the core differences between common-law constitutionalism and constitutional common law. Part III argues that a viable justification for a living constitution needs to embrace and defend the courts' essentially political nature, confronting head-on the (skyscraper) originalists' sense that courts should never do politics.

Transcript: The Case For National Political (Rather Than State Or Judicial) Regulation Of Healthcare, Abigail R. Moncrieff

Law Faculty Articles and Essays

One place where judges are becoming increasingly involved is in dormant Commerce Clause cases, and it would have been possible to issue the exact same holding in Sorrell by using dormant commerce analysis. To make the exact same challenge (it would have been up to the litigants, but) it would have been possible to present a similar challenge on dormant Commerce Clause grounds and to have said that this creates uneven regulation for pharmaceutical companies that need to craft different marketing approaches for different states according to different rules about what kinds of data they're allowed to use and not …