Health Law and Policy Commons^™

Repairing The Broken Market For Antibiotic Innovation, Kevin Outterson, John H. Powers, Gregory W. Daniel, Mark B. Mcclellan

Faculty Scholarship

Multidrug-resistant bacterial diseases pose serious and growing threats to human health. While innovation is important to all areas of health research, it is uniquely important in antibiotics. Resistance destroys the fruit of prior research, making it necessary to constantly innovate to avoid falling back into a pre-antibiotic era. But investment is declining in antibiotics, driven by competition from older antibiotics, the cost and uncertainty of the development process, and limited reimbursement incentives. Good public health practices curb inappropriate antibiotic use, making return on investment challenging in payment systems based on sales volume. We assess the impact of recent initiatives to …

Contextualizing Gay‐Straight Alliances: Student, Advisor And Structural Factors Related To Positive Youth Development Among Members, Matthew P. Shaw

Vanderbilt Law School Faculty Publications

Gay-straight alliances (GSAs) may promote resilience. Yet, what GSA components predict well-being? Among 146 youth and advisors in 13 GSAs (58% lesbian, gay, bisexual, or questioning; 64% White; 38% received free/reduced-cost lunch), student (demographics, victimization, attendance frequency, leadership, support, control), advisor (years served, training, control), and contextual factors (overall support or advocacy, outside support for the GSA) that predicted purpose, mastery, and self-esteem were tested. In multilevel models, GSA support predicted all outcomes. Racial/ethnic minority youth reported greater well-being, yet lower support. Youth in GSAs whose advisors served longer and perceived more control and were in more supportive school contexts …

Business Model Options For Antibiotics: Learning From Other Industries, Ella Jaczynska, Kevin Outterson, Jorge Mestre-Ferrandiz

Faculty Scholarship

As resistance to antibiotics continues to grow, there is a well-recognized misalignment between the clinical need for new antibiotics and the incentives for their development. The returns from investment in antibiotics research and development (R&D) are perceived as too small. Partly as a result, the number of large multinational companies researching antibiotics has fallen drastically in the past 20 years and few high-quality antibiotics have been developed.

In looking at the antimicrobial resistance (AMR) situation, we were aware that other industries have faced conceptually similar challenges and that they might offer helpful lessons and possible solutions that could be adapted …

The Contraception Mandate, Caroline Mala Corbin

Northwestern University Law Review

Under the new health care regime, health insurance plans must cover contraception. While religious employers are exempt from this requirement, religiously affiliated employers are not. Several have sued, claiming that the “contraception mandate” violates the Free Exercise Clause, the Free Speech Clause, and the Religious Freedom Restoration Act. This Essay explains why the contraception mandate violates none of them.

The Paradox Of The Obamacare Decision: How Can The Federal Government Have Limited Unlimited Power?, Robert J. Pushaw Jr.

Florida Law Review

National Federation of Independent Business v. Sebelius, the Supreme Court’s decision upholding the landmark Patient Protection and Affordable Care Act (ACA or “Obamacare”), sets forth the most important judicial examination of constitutional power since the New Deal era. The political and media frenzy over the Obamacare case has obscured its actual legal analysis and larger constitutional implications, which warrant more reflective study. This Article seeks to provide such a scholarly perspective.

Relative Value Units (Rvus), Sally Coberly

National Health Policy Forum

This publication reviews Medicare's relative value units (RVUs), which are assigned to each physician service to represent the resources required to provide the service relative to all other physician services. Three types of resources are included: physician work, that is, the physician time and effort; practice expenses, such as clinical staff and equipment; and professional liability insurance. Each service's RVUs are multiplied by a common dollar conversion factor to determine the Medicare payment.

Predicting The Fallout From King V. Burwell - Exchanges And The Aca, Nicholas Bagley, David K. Jones, Timothy Stoltzfus Jost

Articles

The U.S. Supreme Court's surprise announcement on November 7 that it would hear King v. Burwell struck fear in the hearts of supporters of the Affordable Cara Act (ACA). At stake is the legality of an Internal Revenue Service (IRS) rule extending tax credits to the 4.5 million people who bought their health plans in the 34 states that declined to establish their own health insurance exchanges under the ACA. The case hinges on enigmatic statutory language that seems to link the amount of tax credits to a health plan purchased "through an Exchange established by the State." According to …

Managing The Multiple Layers Of Physician Oversight, Rick D. Barton

Center for Health Law Policy and Bioethics

No abstract provided.

Retaliation And Healthcare Providers: Navigating Health And Safety Code Section 1278.5, Rick D. Barton, Natalie V. Mueller

Center for Health Law Policy and Bioethics

No abstract provided.

State (Un)Separated Powers And Commandeering, Aaron P. Brecher

Res Gestae

This Essay argues that the Court’s line between state judges and other state officials is not as clean as the case law suggests. Specifically, early state constitutions, as well as the British constitutional order prevailing before the U.S. Constitution was enacted—which did not separate powers as rigidly as the U.S. Constitution—combine to undermine the distinction. Taking this line of analysis seriously is not to deny that commandeering state executive or legislative officials raises federalism concerns. But paying more careful attention to early state conceptions of the separation of powers furthers federalist goals in another way: it engenders respect for the …

A Private Right Of Action For Informed Consent In Research, Valerie Gutmann Koch

All Faculty Scholarship

No abstract provided.

Kermit Gosnell’S Babies: Abortion, Infanticide And Looking Beyond The Masks Of The Law, Richard F. Duncan

Nebraska College of Law: Faculty Publications

If, as Laurence Tribe has observed, “all law tells a story,” this Article tells two stories occurring forty years apart—the story of Justice Harry Blackmun and the unborn human beings he covered with the legal mask of “potential” lives in Roe v. Wade in 1973, and the story of Doctor Kermit Gosnell and the unmasked babies he was convicted of murdering in his Philadelphia abortion clinic in 2013. As Professor Tribe also observes, these stories amount to “a clash of absolutes, of life against liberty,” and therefore they are stories that must be told time and again, until we get …

The “Voluntary” Inpatient Treatment Of Adults Under Guardianship, Richard C. Boldt

Faculty Scholarship

A number of states have adopted a preference for voluntary hospitalization over involuntary civil commitment for adults with severe mental illness who require inpatient treatment. Frequently, however, the very disabilities that call for inpatient treatment also disrupt an individual patient’s capacity to participate fully in the decision-making process by which hospital admission is elected. When impaired patients have a court-appointed guardian, difficult questions can arise as to the power of the guardian to consent to the ward’s admission for inpatient psychiatric treatment. In some states, the guardian may not consent to the ward’s admission. In others, the guardian’s authority to …

Just Compensation: A No-Fault Proposal For Research-Related Injuries, Leslie Meltzer Henry, Megan E. Larkin, Elizabeth R. Pike

Faculty Scholarship

Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants—an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been …

Respect And Dignity: A Conceptual Model For Patients In The Intensive Care Unit, Leslie Meltzer Henry, Cynda Rushton, Mary Catherine Beach, Ruth Faden

Faculty Scholarship

Although the concept of dignity is commonly invoked in clinical care, there is not widespread agreement—in either the academic literature or in everyday clinical conversations—about what dignity means. Without a framework for understanding dignity, it is difficult to determine what threatens patients’ dignity and, conversely, how to honor commitments to protect and promote it. This article aims to change that by offering the first conceptual model of dignity for patients in the intensive care unit. The conceptual model we present is based on the notion that there are three sources of patients’ dignity—their shared humanity, personal narratives, and autonomy—each of …

Guidelines For Avoiding Pitfalls When Drafting Juvenile Curfew Laws: A Legal Analysis, Elyse R. Grossman, Kathleen S. Hoke

Faculty Scholarship

Curfew laws seek to provide general protection to youth and adults by restricting the times that children of certain ages are allowed to occupy public places or streets. These laws often contain exemptions for youth accompanied by an adult, responding to an emergency, or traveling to or from school, work, or a religious service, among others. However, the actual language used and exemptions included vary by locality. As a result, courts have reached different results—several courts upheld curfew laws as constitutional, while others overturned these laws. Although not the original reason behind juvenile curfew enactment, several studies have found that …

Mid-Atlantic Ethics Committee Newsletter, Winter 2015

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Scalpel Please: Cutting To The Heart Of Medical Records Disputes In Employment Law Cases, Megan I. Brennan

William Mitchell Law Review

No abstract provided.

Corporate Law After Hobby Lobby, Lyman P.Q. Johnson, David K. Millon

Scholarly Articles

We evaluate the U.S. Supreme Court’s controversial decision in the Hobby Lobby case from the perspective of state corporate law. We argue that the Court is correct in holding that corporate law does not mandate that business corporations limit themselves to pursuit of profit. Rather, state law allows incorporation for any lawful purpose. We elaborate on this important point and also explain what it means for a corporation to “exercise religion.” In addition, we address the larger implications of the Court’s analysis for an accurate understanding both of state law’s essentially agnostic stance on the question of corporate purpose and …

Clash Of The Titans: Medicaid Meets Private Health Insurance, Sara J. Rosenbaum

Health Policy and Management Faculty Publications

Throughout its first forty-eight years of life, the federal Medicaid statute lacked a viable insurance pathway for most low-income adults' ineligible for employer-sponsored coverage. In what is arguably the most important public health achievement since the enactment of Medicare and Medicaid fifty years ago, the Patient Protection and Affordable Care Act (ACA) fundamentally alters this picture. Building on earlier breakthroughs for children, the ACA restructures Medicaid to cover poor adults and juxtaposes its new architecture against an affordable and accessible private insurance market for people ineligible for employer-sponsored or government insurance.