Law Commons^™

Unique Proposals For Limiting Legal Liability And Encouraging Adherence To Ventilator Allocation Guidelines In An Influenza Pandemic, Valerie Gutmann Koch

All Faculty Scholarship

No abstract provided.

Changes In Latitudes, Changes In Attitudes: Fqhcs And Community Clinics In A Reformed Health Care Market, Jessamyn Taylor

National Health Policy Forum

The Patient Protection and Affordable Care Act of 2010 and the Supreme Court’s related decision have significantly shifted the health care landscape for safety net providers. Federally qualified health centers (FQHCs) are a mainstay of primary care for the uninsured and those with limited access to care. This paper focuses on the impact of health reform on FQHCs given the significant federal investment in them through grants, Medicaid, and Medicare reimbursement. Where noteworthy, the effect on non-FQHC community clinics is also discussed. The implications of Medicaid coverage expansions (or lack thereof in states that choose not to expand), Medicaid disproportionate …

Let Fifty Flowers Bloom: Health Care Federalism After National Federation Of Independent Business V. Sebelius, Ann Marie Marciarille

Faculty Works

Conventional wisdom is that the American public does not want to think too long or too hard about Medicaid. Medicaid’s reputation has long been big, complicated, and widely misunderstood. The 2012 presidential election campaign has been much about Medicaid, but Medicaid is a subject we love to talk around. Yet, our next president will be compelled to think and speak explicitly and fluently about Medicaid because Medicaid is the budget-buster of government funded health insurance. Its budget busting propensities are most pronounced at the intersection of Medicaid and the government-funded health insurance program we do love to discuss: Medicare.

This …

How Do The Elderly Fare In Medical Malpractice Litigation, Before And After Tort Reform? Evidence From Texas, Myungho Paik, Bernard S. Black, David A. Hyman, William M. Sage, Charles M. Silver

Faculty Scholarship

The elderly account for a disproportionate share of medical spending, but little is known about how they are treated by the medical malpractice system, or how tort reform affects elderly claimants. We compare paid medical malpractice claims brought by elderly plaintiffs in Texas during 1988–2009 to those brought by adult non-elderly plaintiffs. Controlling for healthcare utilization (based on inpatient days), elderly paid claims rose from about 20% to about 40% of the adult non-elderly rate by the early 2000s. Mean and median payouts per claim also converged, although the elderly were far less likely to receive large payouts. Tort reform …

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 …

Emergency Preparedness And Public Health: The Lessons Of Hurricane Sandy, Tia Powell, Dan Hanfling, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

When Hurricane Sandy hit downtown Manhattan, three neighboring hospitals each made different decisions about when to evacuate. Across the metro region, more than five hospitals and over 20 nursing and assisted living facilities were evacuated, making this the central public health challenge of this calamitous event. It is a familiar story—a super storm comes ashore, infrastructure is overwhelmed, and healthcare facilities evacuate patients, with major delays in returning to normal functioning. Afterwards, policy makers evaluate lessons learned for the next disaster, but similar missteps are often repeated.

Although not identical, it is instructive to compare Hurricane Katrina with the still …

Tuskegee Redux: Evolution Of Legal Mandates For Human Experimentation, Robert S. Levine, Jamila C. Williams, Barbara A. Kilbourne, Paul D. Juarez

Sociology Faculty Research

Human health experiments systematically expose people to conditions beyond the boundaries of medical evidence. Such experiments have included legal-medical collaboration, exemplified in the U.S. by the Public Health Service (PHS) Syphilis Study (Tuskegee). That medical experiment was legal, conforming to segregationist protocols and specific legislative authorization which excluded a selected group of African Americans from any medical protection from syphilis. Subsequent corrective action outlawed unethical medical experiments but did not address other forms of collaboration, including PHS submission to laws which may have placed African American women at increased risk from AIDS and breast cancer. Today, anti-lobbying law makes it …

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 …

What’S Right About The Medical Model In Human Subjects Research Regulation, Heidi Li Feldman

Georgetown Law Faculty Publications and Other Works

Critics of Institutional Review Board (IRB) practices often base their charges on the claim that IRB review began with and is premised upon a "medical model" of research, and hence a "medical model" of risk. Based on this claim, they charge that IRB review, especially in the social and behavioral sciences, has experienced "mission creep". This paper argues that this line of critique is fundamentally misguided. While it remains unclear what critics mean by "medical model", the point of contemporary human research subjects regulation remains the same across all domains of research. That point is to protect the autonomy of …

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.

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 Calculus Of Accommodation: Contraception, Abortion, Same-Sex Marriage, And Other Clashes Between Religion And The State, Robin F. Wilson

Scholarly Articles

This Article considers a burning issue in society today— whether, and under what circumstances, religious groups and individuals should be exempted from the dictates of civil law. The “political maelstrom” over the Obama administration’s sterilization and contraceptive coverage mandate is just one of many clashes between religion and the state. Religious groups and individuals have also sought religious exemptions to the duty to assist with abortions or facilitate samesex marriages. In all these contexts, religious objectors claim a special right of entitlement to follow their religious tenets, in the face of equally compelling claims that religious accommodations threaten access and …

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 …

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 …

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 …

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 …

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 …

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 …

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

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 …

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 …

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.