Health Law and Policy Commons^™

Introduction And Geographic Availability Of New Antibiotics Approved Between 1999 And 2014, Cecilia Kållberg, Christine Årdal, Hege Salvesen Blix, Eili Klein, Elena Martinez, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen, Ramanan Laxminarayan

Faculty Scholarship

Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014.

If You Would Not Criminalize Poverty, Do Not Medicalize It, William M. Sage, Jennifer E. Laurin

Faculty Scholarship

American society tends to medicalize or criminalize social problems. Criminal justice reformers have made arguments for a positive role in the relief of poverty that are similar to those aired in healthcare today. The consequences of criminalizing poverty caution against its continued medicalization.

Will Courts Allow States To Regulate Drug Prices?, Christopher Robertson

Faculty Scholarship

Pharmaceuticals are consuming increasingly large portions of U.S. state budgets, and high prices are preventing patients from getting, and adhering to, essential medicines. In mid-May 2018, President Donald Trump announced a heavily hyped but relatively modest federal plan to bring down drug prices. Meanwhile, several states are moving forward with their own solutions, and Maryland’s approach is particularly ambitious. In 2017, responding to notorious cases such as the 5000% increase in the cost of Daraprim (pyrimethamine) and the 10-fold increase in the cost of EpiPens (epinephrine auto-injectors), Maryland enacted a statute that prohibits manufacturers from “price gouging” on any “essential …

Patient Safety And The Ageing Physician: A Qualitative Study Of Key Stakeholder Attitudes And Experiences, Andrew A. White, William M. Sage, Paulina H. Osinska, Monica J. Salgaonkar, Thomas H. Gallagher

Faculty Scholarship

Background Unprecedented numbers of physicians are practicing past age 65. Unlike other safety-conscious industries, such as aviation, medicine lacks robust systems to ensure late-career physician (LCP) competence while promoting career longevity.

Objective To describe the attitudes of key stakeholders about the oversight of LCPs and principles that might shape policy development.

Design Thematic content analysis of interviews and focus groups.

Participants 40 representatives of stakeholder groups including state medical board leaders, institutional chief medical officers, senior physicians (>65 years old), patient advocates (patients or family members in advocacy roles), nurses and junior physicians. Participants represented a balanced sample from …

Rural Health, Universality, And Legislative Targeting, Nicole Huberfeld

Faculty Scholarship

Health disparities are persistent and worsening for rural communities, which have smaller patient populations with higher rates of uninsurance and greater incidence of the diseases and deaths of despair. Hospital closures and provider shortages are more common than in urban areas, also contributing to worsening population health and crises in maternal and infant health. This paper posits that these disparities are tied to the unique rural features of space and population. Efforts to address persistent problems in health care through universal legislation, such as the ACA, have given rural communities important tools to address some long-standing health problems by improving …

What Is Federalism In Health Care For?, Nicole Huberfeld

Faculty Scholarship

The Affordable Care Act offers a window on modern American federalism—and modern American nationalism—in action. The ACA’s federalism is defined not by separation between state and federal, but rather by a national structure that invites state-led implementation. As it turns out, that structure was only a starting point for a remarkably dynamic and adaptive implementation process that has generated new state-federal arrangements. States move back and forth between different structural models vis-à-vis the federal government; internal state politics produce different state choices; states copy, compete, and cooperate with each other; and negotiation with federal counterparts is a near-constant. These characteristics …

Race And Assisted Reproduction: Implications For Population Health, Aziza Ahmed

Faculty Scholarship

This Article emerges from Fordham Law Review's Symposium on the fiftieth anniversary of Loving v. Virginia,¹ the case that found antimiscegenation laws unconstitutional. ² Inspired by the need to interrogate the regulation of race in the context of family, this Article examines the diffuse regulatory environment around assisted reproductive technology (ART) that shapes procreative decisions and the inequalities that these decisions may engender. ³ ART both centers biology and raises questions about how we imagine our racial futures in the context of family, community, and nation. ⁴ Importantly, ART demonstrates how both the state and private actors shape family …

On Drugs: Preemption, Presumption, And Remedy, Elizabeth Mccuskey

Faculty Scholarship

This essay explores the role of litigation in drug safety regulation and the role of drug safety regulation in litigation, exemplified by the 2017 National Health Law Moot Court Problem. Using the example of failure-to-update claims against generic drug manufacturers, this essay argues that pharmaceutical preemption doctrine would benefit from a tailored application of the presumption against preemption. It proposes a presumption that Congress does not intend to displace historic state remedies for injury without clearly saying so, focusing on the role of remedy to account for the evolving overlap in federal and state police powers over health and to …

Insights Into Early Stage Of Antibiotic Development In Small And Medium-Sized Enterprises: A Survey Of Targets, Costs, And Durations, Kevin Outterson, Christine Ardal, Enrico Baraldi, Ursula Theuretzbacher, Francesco Ciabuschi, Jens Plahte, John-Arne Røttingen

Faculty Scholarship

Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs’ targets, costs, and durations related to discovery and early phase development of antibacterial therapies.

Quarantine And The Federal Role In Epidemics, Wendy K. Mariner, Michael Ulrich

Faculty Scholarship

Every recent presidential administration has faced an infectious disease threat, and this trend is certain to continue. The states have primary responsibility for protecting the public’s health under their police powers, but modern travel makes diseases almost impossible to contain intrastate. How should the federal government respond in the future? The Ebola scare in the U.S. repeated a typical response—demands for quarantine. In January 2017, the Department of Health and Human Services and the Centers for Disease Control and Prevention issued final regulations on its authority to issue Federal Quarantine Orders. These regulations rely heavily on confining persons who may …

The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck

Faculty Scholarship

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …

The Drug Debate: Data Exclusivity Is The New Way To Delay Generics, Srividhya Ragavan

Faculty Scholarship

The article discusses the protection regime for clinical trial data internationally and outlines the applicable protection regime. In doing so, this article outlines how the data exclusivity regime can operate in parallel with the patent regime to add a layer of protection for the data. Such protection operates at a regulatory level to delay the entry of generic medications. Internationally, the data exclusivity regime, which has become an important contemporary tool in trade negotiations with poorer nations, works to detrimentally affect access to medication

What To Expect When You’Re Expecting…Tanf-Style Medicaid Waivers, Laura D. Hermer

Faculty Scholarship

Many health policy scholars believe that Medicaid, the federal-state coverage program for lower-income Americans, should remain free from welfare reform trappings such as work requirements that are extraneous to the program. It would seem such requirements would be both inappropriate and counterproductive to the goals of Medicaid. Given the high probability that such requirements will, at least at some level, go into effect during the Trump administration, it bears considering what to expect. What evidence, if any, suggests that imposing welfare reform-style requirements on certain Medicaid beneficiaries will yield harmful results to those beneficiaries, or harmful to Medicaid’s programmatic goal …

Independence Is The New Health, Laura D. Hermer

Faculty Scholarship

Medicaid plays key roles in supporting our nation’s health. Under the Affordable Care Act, Medicaid took an even more central position in public health endeavors by extending coverage in all interested states to millions of adults who typically fell through the health care cracks. Nevertheless, the Trump administration is now undoing these gains by actively encouraging states to curtail access to Medicaid in key respects while using the rhetoric of health.

This article examines Trump administration efforts in two contexts: (1) state § 1115 waiver applications seeking to better align their Medicaid programs with cash welfare and food stamp programs, …

Removing Obstacles To A Peaceful Death, Kathy L. Cerminara, Barbara A. Noah

Faculty Scholarship

We all will die, but the American health care system often impedes a peaceful death. Instead of a quiet death at home surrounded by loved ones, many of us suffer through overutilization of sometimes-toxic therapeutic interventions long past the time when those interventions do more good than harm. This article proposes revisions to health professional training and payment policy to eliminate as much as possible physical and existential suffering while progressing through the terminal phase of illness. The solution lies in seamless progression from treatment with integrated palliative care to hospice before death, but provider attitudes and payor practices must …

Removing Obstacles To A Peaceful Death, Kathy Cerminara, Barbara Noah

Faculty Scholarship

No abstract provided.

Structured Settlement Sales And Lead-Poisoned Sellers: Just Say No, Karen Czapanskiy

Faculty Scholarship

No abstract provided.

When Popular Culture And The Nfl Collide: Fan Responsibility In Ending The Concussion Crisis, Taylor Simpson-Wood

Faculty Scholarship

No abstract provided.

Women’S Human Rights And Migration: Sex Selective Abortion Laws In The United States And India, Aziza Ahmed

Faculty Scholarship

In her compelling new book, Women's Human Rights and Migration, Sital Kalantry challenges the idea that a women's human rights framework offers a consistent and universal way to address complicated gender issues across countries. She is primarily concerned with the lives of migrant women in countries that respond to their social and cultural practices with harsh regulations designed to bring them in line with dominant ideas about gender equality. Kalantry focuses in on two issues in particular: sex-selective abortion and the veil as worn by Muslim women. Kalantry insightfully identifies a primary problem with these types of laws and …

The New Health Care Federalism On The Ground, Nicole Huberfeld, Abbe Gluck

Faculty Scholarship

This essay, part of a symposium investigating methods of empirically evaluating health policy, focuses on American health care federalism, the relationship between the federal and state governments in the realm of health care policy and regulation. We describe the results of a five year study of the implementation of the Patient Protection and Affordable Care Act (ACA) from 2012-2017. Our study focused on two key pillars of the ACA, which happen to be its most state-centered — expansion of Medicaid and the implementation of health insurance exchanges — and sheds light on federalism in the modern era of nationally-enacted health …

Practice-Based Research Networks And The Mandate For Real-World Evidence, Christopher Robertson

Faculty Scholarship

The 21^st Century Cures Act encourages the Food and Drug Administration to consider “real-world evidence” in its regulation of the safety and efficacy of drugs and devices. Many have interpreted this mandate to focus on non-randomized observational research. However, we suggest that regulatory science must also move from rarefied academic hospitals to community-based settings, where the vast majority of patients in fact receive care in the fragmented U.S. healthcare system. This move is especially important if innovations are to reach, and be validated in, more diverse populations. A solution can be found in the 183 Practiced-Based Research Networks (“PBRN”), …

Brief Of Professor Ernest A. Young As Amicus Curiae In Support Of Plaintiff Appellant Urging Reversal, Ernest A. Young

Faculty Scholarship

No abstract provided.

Can Rationing Through Inconvenience Be Ethical?, Nir Eyal, Paul Romain, Christopher Robertson

Faculty Scholarship

In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By “rationing through inconvenience” in the health sphere, we refer to a non-financial burden (the inconvenience) that is either intended to cause or has the effect of causing patients or clinicians to choose an option for health‐related consumption that is preferred by the health system for its fairness, efficiency, or other distributive desiderata beyond assisting the immediate patient. We argue that under certain conditions, rationing through inconvenience may turn out to serve as a legitimate and, compared to direct …

If We Pay Football Players, Why Not Kidney Donors, Philip J. Cook, Kimberly D. Krawiec

Faculty Scholarship

Ethicists who oppose compensating kidney donors claim they do so because kidney donation is risky for the donor’s health, donors may not appreciate the risks and may be cognitively biased in other ways, and donors may come from disadvantaged groups and thus could be exploited. However, few ethical qualms are raised about professional football players, who face much greater health risks than kidney donors, have much less counseling and screening concerning that risk, and who often come from racial and economic groups deemed disadvantaged. It thus seems that either ethicists—and the law—should ban both professional football and compensated organ donation, …

Ideology Meets Reality: What Works And What Doesn't In Patient Exposure To Health Care Costs, Christopher Robertson, Victor Laurion

Faculty Scholarship

U.S. policymakers, scholars, and advocates have long displayed an ideological commitment to exposing insured patients to substantial out-of-pocket expenses. These commitments derive from both overt political ideologies, which favor individual responsibility and oppose redistribution of wealth and risks, as well as more-subtle ideological commitments of academic economists, which link observed patterns of consumption to value-claims about welfare. In this symposium contribution, we document those ideological commitments and juxtapose them with a review of the scientific evidence about the actual effects of patient cost-sharing. We find, as economic theory predicts, that patients exposed to healthcare costs consume less healthcare. However, a …

The Body Politic: Federalism As Feminism In Health Reform, Elizabeth Mccuskey

Faculty Scholarship

This essay illuminates how modern health law has been mainstreaming feminism under the auspices of health equity and social determinants research. Feminism shares with public health and health policy both the empirical impulse to identify inequality and the normative value of pursing equity in treatment. Using the Affordable Care Act's federal health insurance reforms as a case study of health equity in action, the essay exposes the feminist undercurrents of health insurance reform and the impulse toward mutuality in a body politic. The essay concludes by revisiting-from a feminist perspective-scholars' arguments that equity in health insurance is essential for human …

A Perspective On Incentives For Novel Inpatient Antibiotics: No One-Size-Fits-All, Kevin Outterson

Faculty Scholarship

The need for new “pull” incentives to stimulate antibiotic R&D is widely recognized. Due to the global diversity of health systems, combined with different challenges faced by antibiotics used in different types of healthcare settings, there is no one-size-fits-all solution. Instead, different “pull” incentives should be tailored to local contexts, priorities, and antibiotic types. Policymakers and industry should collaborate to identify appropriate solutions at the local, regional, and global levels.

Bearing Faith: The Limits Of Catholic Health Care For Women Of Color, Kira Shepherd, Elizabeth Reiner Platt, Katherine M. Franke, Elizabeth Boylan

Faculty Scholarship

This study finds that in nineteen out of the thirty-four states/territories that we studied, women of color are more likely than white women to give birth at hospitals bound by the ERDs. Women of color’s disproportionate reliance on Catholic hospitals in these states increases their exposure to restrictions that place religious ideology over best medical practices.

To determine whether women of color disproportionately give birth at hospitals operating under the ERDs, we compared the percentage of births to women of color at Catholic and non-Catholic hospitals. In over half of the states we studied (19 out of 33 states plus …

Women Of Color And Health: Issues And Solutions, June Cross, Nia Weeks, Kristen Underhill, Chloe Bootstaylor

Faculty Scholarship

Chloe Bootstaylor: Welcome to our second panel. This panel focuses on women of color in health, issues, and solutions. The session is inspired by Professor June Cross of the Columbia School of Journalism and her recent film, Wilhemina’s War, which follows the story of Wilhemina Dixon and depicts the obstacles that Americans with HIV/AIDS face in accessing not only adequate healthcare but also financial, infrastructural, and social support in their communities.

This panel will consist of Professor Underhill and Nia Weeks. June Cross will join us a little later on. We will start with a clip from her film, …