Health Law and Policy Commons^™

Is Medicare For All The Answer? Assessing The Health Reform Gestalt As The Aca Turns 10, Nicole Huberfeld

Faculty Scholarship

As presidential candidates debate health reform, the expression “Medicare for All” (“M4A”) is on repeat, yet few appear to understand precisely what Medicare is or what M4A would mean. Even more striking is that Americans are vigorously debating health reform when the ACA – President Obama’s signature legislation and a health reform effort on a scale not seen in decades – turns 10 on March 23.

The ACA pioneered universal coverage, but it also ratcheted up health care complexity by building new scaffolding around an old foundation. This fragmented landscape has been exacerbated by a crazy quilt of implementation crafted …

Pedagogy And Policy: A Tribute To Karen Rothenberg’S Contributions To Health Law, Michael Ulrich

Faculty Scholarship

Professor Karen Rothenberg has had a significant influence on my life, impacting my education, my career, and the way I think. Professor Rothenberg has been a pillar in the health law community, but perhaps her most lasting impact for myself was creating the health law program at the University of Maryland, Francis King Carey School of Law. This nationally recognized program grew from her passion, expertise, and recognition of the importance of health, and is the reason I chose to attend the University of Maryland. The curriculum, faculty, and experience made it one of the best decisions of my life …

Antibiotic Development — Economic, Regulatory And Societal Challenges, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David Mcadams, Kevin Outterson, John H. Rex, Nithima Sumpradit

Faculty Scholarship

Antibiotic resistance is undoubtedly one of the greatest challenges to global health, and the emergence of resistance has outpaced the development of new antibiotics. However, investments by the pharmaceutical industry and biotechnology companies for research into and development of new antibiotics are diminishing. The public health implications of a drying antibiotic pipeline are recognized by policymakers, regulators and many companies. In this Viewpoint article, seven experts discuss the challenges that are contributing to the decline in antibiotic drug discovery and development, and the national and international initiatives aimed at incentivizing research and the development of new antibiotics to improve the …

Tensions And Exclusions: The Knotty Policy Encounter Between Sexual And Reproductive Health And Rights And Hiv, Susana T. Fried, Aziza Ahmed, Luisa Cabal

Faculty Scholarship

The International Conference on Population and Development or ICPD (Cairo, 1994) provided a global policy framework centred on reproductive rights instead of population control. Global standards on sexual and reproductive health and rights (SRHR) and on HIV rapidly expanded throughout the 1990s.1 Considerable activist mobilisation in both arenas advanced health issues as politically salient decision-making venues where human rights and health advocacy were urgently needed, rather than scientific and technical showcases.

The ICPD, quickly followed by the Fourth World Conference on Women (1995), stressed that reproductive rights are anchored in governments’ human rights obligations and development commitments, including to …

Digital Health Privacy In Active-Aging Settings: Will The Law Let You Age Well?, Tara Sklar, Richard Carmona, Kathie Insel, Christopher Robertson

Faculty Scholarship

What is privacy and how are our interpretations of it changing with advances in technology? This question, and concerns around potentially violating a person’s right to privacy, have been emerging across industries around the world. Senior living providers have increased their exposure to privacy risks with the shift to implementing sensors throughout their communities. Typically located in digital health devices that can be worn on the body or placed in the environment, these sensors are capable of collecting and tracking data relevant to a person’s health and well-being on a continuous monitoring basis.
/="/">
/="/">There are privacy laws and …

Affordability Boards: The States’ New Fix For Drug Pricing, Tara Sklar, Christopher Robertson

Faculty Scholarship

A new Maryland law that creates a prescription-drug affordability board to help the state regulate drug prices may be a harbinger of what’s to come in drug-pricing legislation. The law permits cost reviews when drug prices or price increases exceed specified thresholds. Establishing affordability boards may be a natural next step that more states take to exert a stronger influence over price spikes and still survive legal challenges.

Designing Development Programs For Non-Traditional Antibacterial Agents, John H. Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan J. Darrow, Kevin Outterson

Faculty Scholarship

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits …

A Public Health Approach To Gun Violence, Legally Speaking, Michael Ulrich

Faculty Scholarship

The call for a public health approach to gun violence has largely ignored what role the nascent Second Amendment jurisprudence will play in hindering change. Given the state interest for infringing on Second Amendment rights is nearly always public safety, public health law doctrine provides an apt framework for analysis.

Epilogue: Health Care, Federalism, And Democratic Values, Nicole Huberfeld

Faculty Scholarship

Is the United States experiencing a “crisis of democracy in health care”? This symposium's central question can only begin to be addressed here. The answer depends, in part, on where we look and how we measure democracy.

Democracy is a complex ideal often said to be promoted by federalism. In health care, each level of government exercises power because federalism is a default choice in health reform efforts. This default enables state governments and the federal government to create, enforce, and adjudicate health law and policy - democratic operations at the national and the subnational levels. But on each democratic …

Tax Reform, Mixed‐Entity Markets, And Hospitals: How The 2017 Tax Cuts And Jobs Act Favors The For‐Profit Hospital Model, Elizabeth King

Faculty Scholarship

When the U.S. Congress passed the Tax Cuts and Jobs Act in 2017 (the “TCJA”), it achieved a significant tax cut for corporations. In doing so, however, Congress simultaneously reshaped the landscape for mixed‐entity markets—that is, industries like healthcare and education in which nonprofit, for‐profit, and government entities coexist and compete. This is particularly true for the hospital market in which the TCJA’s provisions have subtly but decidedly tilted market conditions towards a for‐profit hospital model.

While scholars may debate the benefits of a nonprofit versus a for‐ profit entity model, the reality is that the majority of U.S. hospitals, …

Women's Rights, Human Rights And The Criminal Law Or, Feminist Debates And Responses To [De]Criminalization And Sexual And Reproductive Health, Aziza Ahmed

Faculty Scholarship

My comments today seek to highlight how social and economic rights advocates, particularly those concerned with the right to health, engage with ongoing debates about the role of criminal law in human rights. In particular, I emphasize how many “right to health” campaigns fight for the decriminalization of laws that result in the arrest of marginalized communities or health workers. This trend within right to health advocacy complicates what has been called the anti-impunity turn in human rights. In other words, although many scholars have correctly highlighted the rise of a carceral agenda in human rights, there is also ongoing, …

Stewart V Azar And The Purpose Of Medicaid: Work As A Condition Of Enrollment, Nicole Huberfeld

Faculty Scholarship

On June 29, 2018, a federal district court found that the US Department of Health and Human Services (HHS) did not properly approve Kentucky’s application for a controversial Medicaid waiver, the first to require work as a condition of eligibility.¹ Because HHS’s approval was vacated, Kentucky’s Medicaid program was required to continue as if no waiver existed, but 3 other states had already received HHS approval to proceed with work requirements. This article provides context for understanding the relevance of work requirements to implementation of Medicaid expansion under the Patient Protection and Affordable Care Act (hereinafter, Affordable Care Act), …

Big Waiver Under Statutory Sabotage, Elizabeth Mccuskey

Faculty Scholarship

The Affordable Care Act's State Innovation waiver allows federal agencies to suspend the most controversial parts of the statute for states to pursue alternative paths, while keeping the federal funding provided by the statute. This "big waiver" provision has the potential to enable states to pursue transformative health reforms, while preserving the affordability and universal coverage aims of the federal statute. Big waivers like this one carry theoretical promise, which largely depends on the strength of the federal statute's baseline infrastructure. This Essay considers early implementation of the State Innovation waiver as a test for big waiver theory - and …

Law, Technology And Patient Safety, Kathryn Zeiler, Gregory Hardy

Faculty Scholarship

Medical error is the third leading cause of death in the United States, In an effort to increase patient safety, various regulatory agencies require reporting of adverse events, but reported counts tend to be inaccurate. In 2005, in an effort to reduce adverse event rates, Congress proposed a list of “never events,” adverse events, such as wrong-site surgery, that should never occur in hospitals, and authorized CMS to refuse payment for care required following such events. CMS has since pushed for further regulation, “such as putting more payment at risk, increasing transparency, increasing frequency of quality data reviews, and stepping …

Disproportionate Exposure To Antibiotics In Children At Risk For Invasive Pneumococcal Disease: Potential For Emerging Resistance And Opportunity For Antibiotic Stewardship, Tamar F. Barlam, Jake R. Morgan, Warren A. Kaplan, Kevin Outterson, Stephen I. Pelton

Faculty Scholarship

We compared antibiotic prescribing for children with and those without an underlying chronic condition associated with increased risk for invasive pneumococcal disease. Children with a chronic condition had significantly greater cumulative exposure to antibiotics and higher rates of prescriptions per person-year than those without a chronic condition; this population is at increased risk for the emergence of multidrug-resistant pathogens.

The Global Preclinical Antibacterial Pipeline, Ursula Theuretzbacher, Kevin Outterson, Aleks Engel, Anders Karlén

Faculty Scholarship

Antibacterial resistance is a great concern and requires global action. A critical question is whether enough new antibacterial drugs are being discovered and developed. A review of the clinical antibacterial drug pipeline was recently published, but comprehensive information about the global preclinical pipeline is unavailable. This Review focuses on discovery and preclinical development projects and has found, as of 1 May 2019, 407 antibacterial projects from 314 institutions. The focus is on Gram-negative pathogens, particularly bacteria on the WHO priority bacteria list. The preclinical pipeline is characterized by high levels of diversity and interesting scientific concepts, with 135 projects on …

Manufactured Emergencies, Robert L. Tsai

Faculty Scholarship

Emergencies are presumed to be unusual affairs, but the United States has been in one state of emergency or another for the last forty years. That is a problem. The erosion of democratic norms has led to not simply the collapse of the traditional conceptual boundary between ordinary rule and emergency governance, but also the emergence of an even graver problem: the manufactured crisis. In an age characterized by extreme partisanship, institutional gridlock, and technological manipulation of information, it has become exceedingly easy and far more tempting for a President to invoke extraordinary power by ginning up exigencies. To reduce …

Revisionist History? Responding To Gun Violence Under Historical Limitations, Michael Ulrich

Faculty Scholarship

In the D.C. Circuit case Heller v. District of Columbia (Heller II), Judge Kavanaugh wrote that “Heller and McDonald leave little doubt that courts are to assess gun bans and regulations based on text, history, and tradition, not by a balancing test such as strict or intermediate scrutiny.” Now Justice Kavanaugh, will he find support on the highest court for what was then a dissenting view? Chief Justice Roberts, during oral arguments for Heller I, asked “Isn’t it enough to…look at the various regulations that were available at the time…and determine how these—how this restriction and the scope of this …

Us Military Medical Ethics In The War On Terror, George J. Annas, Sondra S. Crosby

Faculty Scholarship

Military medical ethics has been challenged by the post-11 September 2001 ‘War on Terror’. Two recurrent questions are whether military physicians are officers first or physicians first, and whether military physicians need a separate code of ethics. In this article, we focus on how the War on Terror has affected the way we have addressed these questions since 2001. Two examples frame this discussion: the use of military physicians to force-feed hunger strikers held in Guantanamo Bay prison camp, and the uncertain fate of the Department of Defense’s report on ‘Ethical Guidelines and Practices for US Military …

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.

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 …

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 …

Insights Into Early Stage Of Antibiotic Development In Small And Medium-Sized Enterprises: A Survey Of Targets, Costs, And Durations, Christine Årdal, Enrico Baraldi, Ursula Theuretzbacher, Kevin Outterson, Jens Plahte, Francesco Ciabuschi, 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, Michael R. Ulrich, Wendy K. Mariner

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 …

Can Work Be Required In The Medicaid Program, Nicole Huberfeld

Faculty Scholarship

On January 11, 2018, a new policy encouraging states to develop work requirements in their Medicaid programs was issued by the Centers for Medicare and Medicaid Services (CMS).1 Under this policy, states can require nonelderly, nondisabled adults to work or engage in community service to qualify for Medicaid coverage, unless they are deemed medically frail or have a substance use disorder. States will be permitted to require detailed reporting on work status, decide who will be exempt from these requirements, and impose lockout periods for those who do not comply. For example, Kentucky’s newly approved program requires at least …

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, Taimur Bhatti, Ka Lum, Silas Holland, Stephanie Sassman, David Findlay, 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.

Practice-Based Research Networks And The Mandate For Real-World Evidence, Elizabeth Hall-Lipsy, Leila Barraza, 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”), …