Health Law and Policy Commons^™

The Affordable Care Act Individual Coverage Requirement: Ways To Frame The Commerce Clause Issue, Wendy K. Mariner

Faculty Scholarship

No abstract provided.

With Child, Without Rights?: Restoring A Pregnant Woman's Right To Refuse Medical Treatment Through The Hiv Lens, Michael Ulrich

Faculty Scholarship

In Doe v. Division of Youth & Family Services , a hospital employee sought state intervention when an HIV-positive woman refused to comply with treatment recommendations during her pregnancy to drastically reduce the chances of mother-to-child-transmission (MTCT), eventually triggering a lawsuit against the hospital. With an increase in the number of HIV-positive women becoming pregnant and the court avoiding constitutional analysis of the woman’s right to refuse medical treatment, there is a clear void where legal analysis is surely needed. This Article fills this void for the inevitable case where an HIV-positive pregnant woman’s right to refuse medical treatment is …

Regulating Compounding Pharmacies After Necc, Kevin Outterson

Faculty Scholarship

Food and Drug Administration (FDA) rules are often forged in crisis. After the 1937 sulfanilamide disaster that killed more than 100 people, Congress passed the Food, Drug, and Cosmetic Act (FDCA),requiring drugs to be safe and properly labeled. In 1962, a requirement was introduced for proof of drug efficacy through “adequate and well-controlled investigations,” partly in response to the thalidomide tragedy. Rules protecting human-research subjects owe a debt to Tuskegee and Nuremberg.

Deductions For Drug Ads? The Constitution Does Not Require Congress To Subsidize Direct-To-Consumer Prescription Drug Advertisements, Shoshana Speiser, Kevin Outterson

Faculty Scholarship

The First Amendment protects lawful, non-misleading advertising as commercial speech, which constrains Congressional attempts to regulate direct-to-consumer advertising (DTCA) of prescription drugs. But the Constitution does not require the federal government to subsidize advertising through the Tax Code. Congress could revoke the legislative gift of tax deductions for DTCA without running afoul of regulating speech. While DTCA proponents maintain that DTCA increases disease awareness and leads to more doctor-patient conversations, Congress could find that these purported benefits are outweighed by other negative consequences, including excessive prescribing.

All Pain, No Gain: Need For Prudent Antimicrobial Use Provisions To Complement The Gain Act, Kevin Outterson

Faculty Scholarship

Once every five years, Congress re-authorizes funding for the FDA under PDUFA. In the current PDUFA legislation, Congress also addressed issues relating to antimicrobial resistance in the Generating Antibiotic Incentives Now (GAIN) Act. This short article critiques the absence of antimicrobial stewardship incentives in the GAIN Act, which is a serious error in the long-term struggle with pathogenic microbes.

Cost-Benefit Federalism: Reconciling Collective Action Federalism And Libertarian Federalism In The Obamacare Litigation And Beyond, Abigail Moncrieff

Faculty Scholarship

The lawsuits challenging Obamacare's individual mandate have exposed a rift in federalism theory. On one side of the divide is a view that the national government ought to intervene - and ought to be constitutionally permitted to intervene - whenever the states are "separately incompetent" to regulate. This is the view that Robert Cooter and Neil Siegel recently theorized as "collective action federalism." On the other side of the divide is a view that federalism exists for reasons other than efficiency of regulation and particularly that the Founders created the federal structure for the protection of individual liberty. According to …

Bad News For John Marshall, Gary S. Lawson, David Kopel

Faculty Scholarship

In "Bad News for Professor Koppelman: The Incidental Unconstitutionality of the Individual Mandate," we demonstrated that the individual mandate’s forced participation in commercial transactions cannot be justified under the Necessary and Proper Clause as the Clause was interpreted in McCulloch v. Maryland. Professor Andrew Koppelman’s response, "Bad News for Everybody," wrongly conflates that argument with a wide range of interpretative and substantive positions that are not logically entailed by taking seriously the requirement that laws enacted under the Necessary and Proper Clause must be incidental to an enumerated power. His response is thus largely unresponsive to our actual arguments.

The Ppaca In Wonderland, Gary S. Lawson, David B. Kopel

Faculty Scholarship

The question whether the Patient Protection and Affordable Care Act (“PPACA”) is “unconstitutional” is thorny, not simply because it presents intriguing issues of interpretation but also because it starkly illustrates the ambiguity that often accompanies the word “unconstitutional.” The term can be, and often is, used to mean a wide range of things, from inconsistency with the Constitution’s text to inconsistency with a set of policy preferences. In this article, we briefly explore the range of meanings that attach to the term “unconstitutional,” as well as the problem of determining the “constitutionality” of a lengthy statute when only some portions …

Obamacare's (3) Day(S) In Court, Abigail Moncrieff

Faculty Scholarship

Before the oral arguments in late March, the vast majority of legal scholars felt confident that the Supreme Court of the United States would uphold the individual mandate against the constitutional challenge that twenty-six states have levied against it. Since the oral argument, that confidence has been severely shaken. This article asks why legal scholars were so confident before the argument and what has made us so concerned since the argument. The article posits that certain fundamental characteristics of health insurance - particularly its unusual role in steering healthcare consumption decisions, which distinguishes health insurance from standard kinds of indemnity …

Brief Of Amici Curiae Health Law & Policy Scholars And Prescriptions Policy Choices In Support Of Respondents On The Constitutional Validity Of The Medicaid Expansion In State Of Florida V. Department Of Health And Human Services, Kevin Outterson, Nicole Huberfeld

Faculty Scholarship

The Medicaid expansion in Section 2001(a)(1)(C) of the Patient Protection and Affordable Care Act is one part of Congress’s comprehensive effort to expand access to health care coverage. This expansion is not revolutionary, but builds on many prior statutory amendments to Medicaid. Nor does it alter the voluntary nature of the Medicaid program – as before, States remain free to decline federal funding. The Petitioners and their amici have mischaracterized the expansion to obscure these facts, hoping this Court will unravel this hard-fought legislative enactment.

The question presented is whether Congress may offer States generous additional funding for Medicaid, with …

Federalizing Medicaid, Nicole Huberfeld

Faculty Scholarship

Medicaid fosters constant tension between the federal government and the states, and that friction has been exacerbated by its expansion in the Patient Protection and Affordable Care Act of 2010 (PPACA). Medicaid was an under-theorized and underfunded continuation of existing programs that retained two key aspects of welfare medicine as it developed: bias toward limiting government assistance to the “deserving poor,” and delivery of care through the states that resulted in a strong sense of states’ rights. These ideas regarding the deserving poor and federalism have remained constants in the program over the last forty-six years, but PPACA changes one …

Sex And Hiv Disclosure, Aziza Ahmed, Beri Hull

Faculty Scholarship

What do you consent to when you have sex with someone? What if the person is a new sexual partner from a night at a bar? What if the person is your spouse or long-term partner? In these two scenarios, people might understand both HIV risk and HIV disclosure differently. Close reflection demonstrates that a purportedly clear set of criminal laws rarely reflects the complexity of sexual interaction.

This article explores how the dynamics of HIV disclosure prior to sex contribute to an ongoing dialogue about disclosure and consent: Does a person have a right to know his or her …

Women And Children Last — The Predictable Effects Of Proposed Federal Funding Cuts, George J. Annas, Wendy K. Mariner

Faculty Scholarship

"Women and children last” might as well be the refrain of the current U.S. Congress's new health care budget cutters. We have seen similar efforts before. In the mid-1990s, managed care organizations tried to save money by limiting hospitalization benefits for new mothers and their infants to 24 hours after a vaginal delivery and 48 hours after a cesarean section. As with current Congressional proposals, financial savings were seen as more important than the health of women and children. Because only women get pregnant and give birth, restricting access to reproductive health care is discriminatory on its face and undermines …

Can Congress Make You Buy Broccoli? And Why That's A Hard Question, Wendy K. Mariner, George J. Annas, Leonard H. Glantz

Faculty Scholarship

The continuing uncertainty over the constitutionality of the Affordable Care Act (ACA), illustrated by conflicting trial court rulings and scholarly commentaries, raises the question of why this constitutional question is so hard to answer. There are at least four reasons.

Privacy Rights And Public Families, Khiara Bridges

Faculty Scholarship

This Article is based on eighteen months of anthropological fieldwork conducted among poor, pregnant women receiving prenatal care provided by the Prenatal Care Assistance Program (“PCAP”) at a large public hospital in New York City. The Prenatal Care Assistance Program (“PCAP”) is a special program within the New York State Medicaid program that provides comprehensive prenatal care services to otherwise uninsured or underinsured women. This Article attempts to accomplish two goals. The first goal is to argue that PCAP’s compelled consultations – with social workers, health educators, nutritionists, and financial officers – function as a gross and substantial intrusion by …

The Freedom Of Health, Abigail Moncrieff

Faculty Scholarship

What would have happened if the Patient Protection and Affordable Care Act (PPACA) really had authorized government “death panels” that would decide whether an elderly patient could get treatment? Leaving aside commerce clause and other constraints particular to Congress, would that kind of direct healthcare rationing be a constitutional exercise of governmental power in the United States? I think not. I argue here that an emergent substantive due process constraint would invalidate such an exercise; direct rationing of that kind would violate a constitutional “freedom of health” that is nascent in Supreme Court jurisprudence. Based on that logic, I argue …

Follow The Leader?: Maryland's Response To The New Federal Stem Cell Guidelines, Michael Ulrich

Faculty Scholarship

Billions of dollars have been spent in search of cures for diseases such as cancer, muscular dystrophy, heart disease, diabetes, Alzheimer’s, and Parkinson’s. Medical research has consistently pushed the envelope to find new ways to tackle old problems, yet, the field of embryonic stem cell research, a field that many believe could be the key to providing new and effective treatments, remains relatively underfunded due to concerns over ethical considerations. This is largely because the biggest financial backer of scientific research is the federal government, and its desire to finance embryonic stem cell research has waxed and waned over the …

Higher First Amendment Hurdles For Public Health Regulation, Kevin Outterson

Faculty Scholarship

In 2007, Vermont enacted the Prescription Confidentiality Law, prohibiting pharmacies from selling “prescriber-identifiable” prescription information to data-mining companies such as IMS Health and Verispan. These companies aggregate such data and sell them to many groups, including drug companies, so when drug sales representatives visit a physician, they can know exactly what prescriptions the physician has written.

Smoking And The First Amendment, Kevin Outterson

Faculty Scholarship

On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act into law. For the first time, Congress had given the Food and Drug Administration (FDA) authority to directly regulate tobacco products, with the aim of improving public health. And indeed, effective tobacco control would be a remarkable public health achievement — and might be possible if the law is allowed to stand. But on November 7, 2011, a federal judge in Washington, D.C., issued a preliminary injunction blocking some of its key provisions as unconstitutional restrictions on commercial speech, and the battle seems likely …

Improving Antibiotic Markets For Long Term Sustainability, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. We review a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics. However, such strategies directly conflict with the clear need to reduce unnecessary antibiotic prescriptions and could actually increase prescription use. As an alternative, we recommend a two-prong, “integrated” strategy based on prizes administered through the insurance …

Hiv And Women: Incongruent Policies, Criminal Consequences, Aziza Ahmed

Faculty Scholarship

UN Women must take an aggressive role in the standardization of laws and policies at the global and national level where their incongruence has negative and often criminal consequences for the health and lives of women and girls. This article focuses in on three such examples: opt-out testing for HIV, criminalization of vertical transmission, and the new World Health Organization guidelines on breastfeeding.

Feminism, Power, And Sex Work In The Context Of Hiv/Aids: Consequences For Women's Health, Aziza Ahmed

Faculty Scholarship

This paper examines the involvement of feminists in approaches to sex work in the context of HIV/AIDS. The paper focuses on two moments where feminist disagreement produced results in favor of an "anti-trafficking" approach to addressing the vulnerability of sex workers in the context of HIV. The first is the UNAIDS Guidance Note on Sex Work and the second is the "anti-prostitution pledge" found in the Presidents Emergency Plan for AIDS Relief. This article also examines the anti-sex work position articulated by abolitionist feminists and demonstrates the unintended consequences of the abolitionist position on women's health. By examining the actual …

Germ Shed Management In The United States, Kevin Outterson

Faculty Scholarship

The U.S. Medicare program reimburses only for discrete treatments of individuals with infections, but fails to pay for infection control or antibiotic stewardship more generally. By focusing solely on discrete hospitals and patients, Medicare ignores the larger epidemiological reality - that hospitals, nursing homes and other institutions operate within a germ shed. Under current Medicare rules, institutions that invest in infection control or antibiotic stewardship, may actually lose money and benefit rival firms in the market. In effect, current Medicare rules subsidize MRSA pollution. Worse yet, Medicare rules block potentially efficient Coasian contracts to promote private coordination within germ sheds.

American Vertigo: Dual Use, Prison Physicians, Research, And Guantanamo, George J. Annas

Faculty Scholarship

Physicians can be used by governments for nonmedical purposes, and physician acceptance of their nonmedical use is usually denoted as "dual loyalty, " although it is more analytically helpful to frame it "dual use. " Dual use of physicians has been on display at Guantanamo where physicians have consistently been used to break hunger strikes as part of the military security mission in ways that directly violate medical ethics. Guantanamo itself has also been seen worldwide as a uniquely horrible prison, which can tell us little about other American prisons. The contrary seems to be true: Guantanamo, and the use …

The Human Right To Health And Hiv/Aids: South Africa And South-South Cooperation To Reframe Global Intellectual Property Principles And Promote Access To Essential Medicines, Erika George

Faculty Scholarship

The HIV/AIDS pandemic has had a devastating and disproportionate impact in countries of the Global South. The experience of an individual infected with HIV in Africa is very different than that of an individual infected with HIV in America. Life expectancy varies sharply. The ability or inability to access medicines essential for treatment accounts for much of the variance. This article examines how the rhetoric of human rights used in the context of South Africa's AIDS crisis resonated across the Global South, resulted in a powerful social movement for access to medicines, and contributed to important changes in international intellectual …

Health Insurance Politics In Federal Court, Wendy K. Mariner, George J. Annas

Faculty Scholarship

Having been outmaneuvered in Congress with the passage of the Patient Protection and Affordable Care Act (“Affordable Care Act,” or ACA), Republicans have taken their case to federal court, arguing that the law's key provision, the individual mandate to purchase health insurance, is unconstitutional. This argument has been made most prominently by attorneys general from 20 states in a Florida federal court and by the Commonwealth of Virginia in a Virginia federal court. In early August, federal district court judge Henry Hudson decided that the Virginia challenge deserves a hearing,1 thereby giving the constitutional argument an aura of respectability …

Gift Giving To Biobanks, Leonard H. Glantz, Patricia Roche, George J. Annas

Faculty Scholarship

We agree with Mark Rothstein's goal of giving tissue donors control over their donated tissues. But we think using the research model as the basis for attaining this goal, while widely employed and accepted, should be abandoned.

The research regulations were originally adopted to deal with interventions on living human beings, not on the tissue of human beings. The Nuremberg Code (a reaction to concentration camp experiments), the Willowbrook experiment, the Tuskegee syphilis experiment, and the other examples of the abuse of research subjects that provided the rationale for regulating research on human subjects clearly had nothing to do with …

Health Reform: What's Insurance Got To Do With It? Recognizing Health Insurance As A Separate Species Of Insurance, Wendy K. Mariner

Faculty Scholarship

Health insurance can be, and to a large extent already is, a separate species of insurance. This article describes the different views of insurance that made health reform contentious. It argues that the goals of health reform are incompatible with conventional views of insurance. Nonetheless, reforming health insurance to achieve those goals does not require as dramatic shift as some might think, because health insurance has already become primarily a means of paying for health care, rather than a simple risk spreading device for specified losses.

Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals, Aaron S. Kesselheim, Kevin Outterson

Faculty Scholarship

The world faces a worsening public health crisis: A growing number of bacteria are resistant to available antibiotics. Yet there are few new antibiotics in the development pipeline to take the place of these increasingly ineffective drugs. We review a number of proposals intended to bolster drug development, including such financial incentives for pharmaceutical manufacturers as extending the effective patent life for new antibiotics. However, such strategies directly conflict with the clear need to reduce unnecessary antibiotic prescriptions and could actually increase prescription use. As an alternative, we recommend a two-prong, "integrated" strategy. This would increase reimbursement for the appropriate, …

The Supreme Court's Assault On Litigation: Why (And How) It Could Be Good For Health Law, Abigail Moncrieff

Faculty Scholarship

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend has had a significant impact on health law; the Court’s decisions have eliminated the private enforcement mechanism for at least four important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend of eliminating private rights of action in …