Health Law and Policy Commons^™

Medical Decision Making By And On Behalf Of Adolescents: Reconsidering First Principles, B. Jessie Hill

Faculty Publications

The school nurse cannot give your teenage daughter an aspirin for her headache without your permission, but that same daughter can get an abortion without even informing you. Or can she? The obligations on medical personnel providing care to adolescents are famously indeterminate.

Two common-law presumptions have long lurked in the background, but, far from elucidating matters, those presumptions have contributed to the state of confusion. The first presumption is that, absent any special rule, children lack the legal authority to consent to medical treatment on their own. A parallel and corresponding presumption is that parents have a legal entitlement …

What Is The Meaning Of Health? Constitutional Implications Of Defining 'Medical Necessity' And 'Essential Health Benefits' Under The Affordable Care Act, B. Jessie Hill

Faculty Publications

One consequence of the Affordable Care Act (ACA) is that government will come to play a more extensive role in healthcare decision-making by individuals and their providers. The ACA does not directly regulate access to health services, but by means of a system of funding, mandates, and penalties, it essentially requires many employers to provide, and most individuals to carry, a certain minimum level of health insurance. Governmental decisions about which medical services qualify as medically necessary and appropriate may take on a new and greater importance, because government officials will be required to decide what sorts of procedures must …

Breaking The Cycle Of ‘Unequal Treatment’ With Health Care Reform: Acknowledging And Addressing The Continuation Of Racial Bias, Ruqaiijah Yearby

Faculty Publications

Since the Civil War access to health care in the United States has been racially unequal. This racially unequal access to health care remains even after the passage of Title VI of the Civil Rights Act of 1964 ("Title VI") and the election of an African-American President. Both of these events held the promise of equality, yet the promise has never been fulfilled. Now, many hail the passage of the Patient Protection and Affordable Health Care Act ("ACA") as the biggest governmental step in equalizing access to health care because it has the potential to increase minority access to health …

The Individual Mandate And The Taxing Power, Erik M. Jensen

Faculty Publications

This article, prepared for a symposium at the Salmon P. Chase College of Law, Northern Kentucky University, considers whether the Taxing Clause provides an alternative constitutional basis, as some have recently argued, for the individual mandate in the Patient Protection and Affordable Care Act of 21 - the requirement, going into effect in 214, that most individuals acquire satisfactory health insurance or pay a penalty. The article concludes that the Taxing Clause arguments are misguided. At best, the Clause can provide authority for the penalty, not for the mandate as a whole. Furthermore, the article questions whether the penalty will …

Obligatory Health, Noa Ben-Asher

Faculty Publications

The Supreme Court will soon rule on the constitutionality of the Patient Protection and Affordable Care Act passed in March 2010. Courts thus far are divided on the question whether Congress had authority under the Commerce Clause to impose the Act's "Individual Mandate" to purchase health insurance. At this moment, the public and legal debate can benefit from a clearer understanding of the underlying rights claims. This Article offers two principal contributions. First, the Article argues that, while the constitutional question technically turns on the interpretation of congressional power under the Commerce Clause, underlying these debates is a tension between …

Mandates, Markets, And Risk: Auto Insurance And The Affordable Care Act, Jennifer Wriggins

Faculty Publications

Now that the Affordable Care Act (ACA) individual health insurance mandate has been upheld by the United States Supreme Court, it is an opportune time to examine precedents for the individual mandate that were not considered in the legislative debate or litigation about the ACA’s constitutionality, particularly auto insurance mandates. Although opponents’ arguments were cast largely as Commerce Clause claims, the arguments have a deeper foundation as claims about liberty and coercion which go far beyond the Commerce Clause. Although auto insurance mandates are obviously different, particularly in that they are state rather than federal, auto insurance mandates can help …

Securing Sovereign State Standing, Katherine Mims Crocker

Faculty Publications

No abstract provided.

Cooperation, Commandeering, Or Crowding Out?: Federal Intervention And State Choices In Health Care Policy, Jonathan H. Adler

Faculty Publications

This Article's analysis proceeds in three parts. Part II of this article outlines the policy considerations in determining the proper federal and state balance in health care policy. There are strong arguments for state primacy in health care policy, but also substantial justifications for federal intervention. Part III discusses the concept of "cooperative federalism," under which the federal government encourages state governments to implement policies in accord with federal priorities, and identifies constitutional limitations on the federal government's ability to direct or even influence state policy choices. Even if the constitutional challenges to the individual mandate fails, federalism-based challenges to …

Whose Body? Whose Soul? Medical Decision-Making On Behalf Of Children And The Free Exercise Clause Before And After Employment Division V. Smith, B. Jessie Hill

Faculty Publications

Within constitutional law, children’s rights have suffered from severe neglect. The issue of parents’ constitutional rights to deny children medical treatment based on religious belief is one area in desperate need of attention. Although the Supreme Court’s 199 decision in Employment Division v. Smith seemingly set forth a relatively clear rule regarding the availability of exemptions from generally applicable laws - such as those requiring parents to ensure that their children receive appropriate medical care - Smith has changed little in this realm, and if anything, it has only confused matters, highlighting the intractable nature of the issue. While Smith …

Improving Health Care Outcomes Through Personalized Comparisons Of Treatment Effectiveness Based On Electronic Health Records, Sharona Hoffman, Andy Podgurski

Faculty Publications

Comparative effectiveness research (CER) is one of the Patient Protection and Affordable Care Act’s significant initiatives that aims to improve treatment outcomes and lower health care costs. This Article takes CER a step further and suggests a novel clinical application for it. The Article proposes the development of a national framework to enable physicians to rapidly perform, through a computerized service, medically sound personalized comparisons of the effectiveness of possible treatments for patients’ conditions. A treatment comparison for a given patient would be based on data from electronic health records of a cohort of clinically similar patients who received the …

Cooperation, Commandeering, Or Crowding Out? : Federal Intervention And State Choices In Health Care Policy, Jonathan H. Adler

Faculty Publications

The Patient Protection and Affordable Care Act (ACA) substantially alters the respective roles of the federal and state governments in health care policy. Beyond the individual mandate, the ACA presents many questions of federalism, both constitutional and policy-related. This paper, prepared for a symposium sponsored by the Kansas Journal of Law & Public Policy, addresses some of these federalism issues. After outlining some of the policy considerations for determining the proper federal and state balance in health care policy, it identifies constitutional limitations on the federal government’s ability to direct or even influence state policy choices, before discussing how federal …

Meaningful Use And Certification Of Health Information Technology: What About Safety?, Sharona Hoffman, Andy Podgurski

Faculty Publications

Health information technology (HIT) is becoming increasingly prevalent in medical offices and facilities. Like President George W. Bush before him, President Obama announced a plan to computerize all Americans’ medical records by 214. Computerization is certain to transform American health care, but to ensure that its benefits outweigh its risks, the federal government must provide appropriate oversight.

President Obama’s stimulus legislation, the American Recovery and Reinvestment Act of 29 (ARRA), dedicated $27 billion to the promotion of health information technology. It provides payments of up to $44, per clinician under the Medicare incentive program and $63,75 per clinician under the …

Symposium On Commercial Speech And Public Health, Jonathan H. Adler

Faculty Publications

Does the constitutional protection of commercial speech impair the government's ability to protect and promote public health? Or does the commercial speech doctrine itself enhance consumer education and harness market competition to advance public health? Do First Amendment limitations on regulation of commercial messages unduly retard governmental efforts to safeguard consumers? Or do they properly constrain illiberal paternalism? If the Court has been over-protective of health-related commercial speech, is there a principled place to redraw the line? And how should those governmental agencies entrusted with the power to protect public health and welfare respond to these constitutional constraints?

The editors …

The Patient Protection And Affordable Care Act Of 2010: Rulemaking The Shadow Of Incentive-Based Regulation, Sam F. Halabi

Faculty Publications

While legislators, scholars and mainstream observers are focused on the intense debates surrounding the constitutionality of the Patient Protection and Affordable Care Act’s individual mandate, the Department of Health and Human Services and other agencies are proceeding apace in promulgating rules to implement the law’s other requirements. Congress’s substantial delegation of administrative authority to HHS and other agencies will provide a second key area for constitutional challenges after the U.S. Supreme Court resolves the initial lawsuits based on the individual mandate. Between facial constitutional challenges to the Affordable Care Act and lawsuits based on defects in agency rules or the …

Brave New Eugenics: Regulating Assisted Reproductive Technologies In The Name Of Better Babies, Kerry L. Macintosh

Faculty Publications

Infertile men and women have been using assisted reproductive technologies (ART) to conceive children since the first "test-tube baby" was born in 1978. During the past decade, however, the federal government has begun to clamp down on ART, asserting safety concerns as grounds forbanning novel technologies such as cloning, nuclear transfer, and ooplasm transfer.

Some scholars and policymakers now want to extend governmental regulation to include conventional ART such as in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). They claim children conceived through ART face an increased risk of birth defects and other health problems.

This Article examines the …

Dangers In Prescription Drugs: Filling A Private Law Gap In The Healthcare Debate, David G. Owen

Faculty Publications

No abstract provided.

Employing E-Health: The Impact Of Electronic Health Records On The Workplace, Sharona Hoffman

Faculty Publications

Electronic Health Record (HER) systems may soon become a fixture in most medical settings. President Obama’s 29 stimulus legislation includes $19 billion to promote their implementation. The sophisticated features and efficiencies of HER systems have the potential to improve health outcomes and enhance patient welfare considerably. However, this emerging technology also poses significant challenges and risks, not the least of which are its workplace impacts. This article provides a first of its kind analysis of the ramifications of HER systems for workers and employers.

The potential effects of health information computerization on the workplace are numerous. Employers may obtain and …

Litigation, Integration, And Transformation: Using Medicaid To Address Racial Inequities In Health Care, Ruqaiijah Yearby

Faculty Publications

Using a public health policy perspective, this article examines the persistence of racial inequities in nursing homes and prescribes a solution to address these inequities. I use empirical data to prove the persistence of racial inequities in health care, analyze the government policies that allow racial inequities to continue, and provide a solution of regulatory integration. Specifically, I propose that civil rights enforcement be integrated with the nursing home enforcement system, which has been aggressively enforced and monitored. There are many strategies that may lead to the adoption of this system. One such strategy is using the Medicaid Act to …

Pregnant Man?: A Conversation, Darren Rosenblum, Noa Ben-Asher, Mary Anne Case, Elizabeth Emens, Berta E. Hernández-Truyol, Vivian M. Gutierrez, Lisa C. Ikemoto, Angela Onwuachi-Willig, Jacob Willig-Onwuachi, Kimberly Mutcherson, Peter Siegelman, Beth Jones

Faculty Publications

(Excerpt)

I'm a law professor who works on gender, sexuality, and culture in the international and comparative context. That's my head working. In "real" life, my partner, Howard, and I have been engaged in having a baby together for several years, a project that came to fruition with the birth of our daughter Melina. Of course, such a project evokes intensely complex feelings and thoughts. Beyond a simple transposition of the personal onto the political, I feel so fortunate to have engaged in myriad conversations with a variety of friends and colleagues who think much more carefully about the family …

Nil: The Value Of Patents In A Major Crisis Such As An Influenza Pandemic, Dennis D. Crouch

Faculty Publications

This essay focuses on the role of patents in relation to a potential global crisis such as an influenza pandemic or other public health crisis. I argue that patent rights will be largely ignored during an epidemic and that any post-crisis compensation would likely be low when compared to traditional patent rewards or settlements entered under threat of injunctive relief. In some situations, such as use of a patented invention by a state or local government, a patentee may have no recourse. Part III of the essay raises a separate issue that stems from the relatively long time frame for …

E-Health Hazards: Provider Liability And Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski

Faculty Publications

In the foreseeable future, electronic health record (EHR) systems are likely to become a fixture in medical settings. The potential benefits of computerization could be substantial, but EHR systems also give rise to new liability risks for health care providers that have received little attention in the legal literature. This Article features a first of its kind, comprehensive analysis of the liability risks associated with use of this complex and important technology. In addition, it develops recommendations to address these liability concerns. Appropriate measures include federal regulations designed to ensure the quality and safety of EHR systems along with agency …

Making All The Children Above Average: Ethical And Regulatory Concerns For Pediatricians In Pediatric Enhancement Research, Jessica W. Berg, Maxwell J. Mehlman, Daniel B. Rubin, Eric Kodish

Faculty Publications

Building on the knowledge generated by the long history of disease-oriented research, the next few decades will witness an explosion of biomedical enhancements to make people faster, stronger, smarter, less forgetful, happier, prettier, and live longer. Growing interest in pediatric enhancements is likely to stimulate the conduct of enhancement research involving children. However, guidelines for the protection of human subjects were developed for investigations of therapeutic modalities. To date, virtually no attention has been paid to whether these rules would be appropriate for investigations to establish the safety and efficacy of technologies intended for enhancement rather than therapeutic uses and, …

Introduction To Proceedings From A Conference On Newborn Screening For Nontreatable Disorders, Maxwell J. Mehlman

Faculty Publications

No abstract provided.

Finding A Cure: The Case For Regulation And Oversight Of Electronic Health Record Systems, Sharona Hoffman, Andy Podgurski

Faculty Publications

In the foreseeable future, it is likely that the familiar, paper-based patient medical files will become a thing of the past. On April 26, 24, President George W. Bush announced a plan to ensure that all Americans' health records are computerized within ten years and to establish a National Health Information Network. Many advocates are enthusiastically promoting the adoption of health information technology (HIT) and electronic health record (HER) systems as a means to improve U.S. health care.

HER systems often not only serve as record-keeping systems, but also have multiple capabilities, including drug ordering, decision support, alerts concerning patient …

Preparing For Disaster: Protecting The Most Vulnerable In Emergencies, Sharona Hoffman

Faculty Publications

Many federal, state, local and private entities are investing significant resources in disaster readiness initiatives. Often disregarded, however, are the special needs of vulnerable populations during disasters. In the context of emergencies, vulnerable groups may include individuals with disabilities, pregnant women, children, the elderly, prisoners, members of ethnic minorities, people with language barriers, and the impoverished. The fate of the disadvantaged during disasters has received little attention in the legal literature, and this article begins to fill that gap. It examines ethical theories of distributive justice and existing federal and state civil rights and emergency response laws and argues that …

Participation And The Right To Health: Lessons From Indonesia, Sam F. Halabi

Faculty Publications

The right to participation is the “the right of rights” — the basic right of people to have a say in how decisions that affect their lives are made. All legally binding international human rights treaties explicitly recognize the essential role of participation in realizing fundamental human rights. While the substance of the human right to health has been extensively developed, the right to participation as one of its components has remained largely unexplored. Should rights-based health advocacy focus on participation because there is a relationship between an individual’s or a community’s active involvement in health care decision-making and the …

Reproductive Rights As Health Care Rights, B. Jessie Hill

Faculty Publications

U.S. legal scholarship concerning reproductive rights has largely revolved around the poles of decisional autonomy, privacy, and equality, with a concomitant a tendency to de-emphasize the medical aspect of abortion rights. The medical approach has been particularly disfavored by feminist scholars, largely due to concerns about undermining the equality rationale for reproductive rights and placing too much power in the hands of physicians. In addition, American constitutional law has tended to treat reproductive-rights cases differently from other cases raising challenges to government restrictions on individuals’ rights to access certain forms of medical treatment, granting heightened judicial scrutiny to the former …

How Planned Parenthood V. Casey (Pretty Much) Settled The Abortion Wars, Neal Devins

Faculty Publications

More than twenty-one years after Robert Bork's failed Supreme Court nomination and seventeen years after Planned Parenthood of Southeastern Pennsylvania v. Casey, the rhetoric of abortion politics remains unchanged. Pro-choice interests, for example, argue that states are poised to outlaw abortion and that Roe v. Wade is vulnerable to overruling. In this Essay, I will debunk those claims. First, I will explain how Casey's approval of limited abortion rights reflected an emerging national consensus in 1992. Second, I will explain why the Supreme Court is unlikely to risk political backlash by formally modifying Casey- either by restoring the trimester test …

The Patent Lottery: Exploiting Behavioral Economics For The Common Good, Dennis D. Crouch

Faculty Publications

Lotteries are immensely popular. Players are willing to give the organizer a large monetary cut of every ticket purchase in return for a chance at a jackpot. In some ways, our current patent system operates as a lottery as well. Most patents are relatively worthless, while a few are highly valuable. Reaching the major payout of a highly valuable patent takes perseverance in the face of tremendous uncertainty. Like lottery players, small entrepreneurial companies and individuals have shows signs of bounded rationality. In particular, what I call the patent lottery effect is associated with the phenomena of potential innovators overweighting …

What Is Urban Health Policy And What's Law Got To Do With It?, Larry I. Palmer

Faculty Publications

No abstract provided.