Law Commons^™

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 a growing …

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.

Humanizing Work Requirements For Safety Net Programs, Mary Leto Pareja

Faculty Scholarship

This Article explores the political and policy appeal of work requirements for public benefit programs and concludes that inclusion of such requirements can be a reasonable design choice, but not in their current form. This Article’s proposals attempt to humanize these highly controversial work requirements while acknowledging the equity concerns they are designed to address. Drawing on expansive definitions of “work” found in guidance published by the Centers for Medicare and Medicaid (“CMS”) and in various state waiver applications, this Article proposes that work requirements be approved for Medicaid (as well as other benefit programs) only if they encompass various …

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

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 …

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 …

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, …

Informed Consent: Does “Ok” Really Mean “Ok?”, Michael Flynn

Faculty Scholarship

No abstract provided.

The Shadows Of Life: Medicaid's Failure Of Health Care's Moral Test, Barak D. Richman, Kushal T. Kadakia, Shivani A. Shah

Faculty Scholarship

North Carolina Medicaid covers one-fifth of the state’s population and makes up approximately one-third of the budget. Yet the state has experienced increasing costs and worsening health outcomes over the past decade, while socioeconomic disparities persist among communities. In this article, the authors explore the factors that influence these trends and provide a series of policy lessons to inform the state’s current reform efforts following the recent approval of North Carolina’s Section 1115 waiver by the Centers for Medicare and Medicaid Services. The authors used health, social, and financial data from the state Department of Health and Human Services, the …

Disproportionate Exposure To Antibiotics In Children At Risk For Invasive Pneumococcal Disease: Potential For Emerging Resistance And Opportunity For Antibiotic Stewardship, Kevin Outterson

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, Kevin Outterson

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 …

Federalism In Health Care Reform, Nicole Huberfeld

Faculty Scholarship

Throughout American history, protecting states’ rights within federal health reform laws has served purposes other than the needs of the poor, such as excluding those deemed undeserving of assistance, the “able-bodied.” This chapter explores the role of federalism in health reform, paying particular attention to the importance of universality in programs meant to aid the poor, such as Medicaid. American federalism is dynamic, involving separate state negotiations with the federal government rather than the fixed dual sovereignty imagined by the Supreme Court. Such negotiations lead to variability, which in health care may lower the baseline for reform-resistant states and thus …

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 …

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 …

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 …

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 …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

Legal Considerations In Pediatric And Adolescent Obstetrics And Gynecology, Steven R. Smith

Faculty Scholarship

Providing gynecologic and obstetric care for minors raises important legal issues and it is critical that health-care providers understand those legal issues. State laws are often somewhat complicated and unsettled in the areas minors’ of consent to treatment, privacy and information, and abuse reporting requirements. State statutes commonly give minors the authority to consent to treatment for STIs, pregnancy, and contraception. There are, however, many variations among states in these areas. Most states limit the ability of minors to consent to abortion without some parental (or court) involvement. In some circumstances, a physician may provide information to parents if it …

Purchasing Health? The Promise And Limits Of Public Health Insurance, Kristen Underhill

Faculty Scholarship

The 2010s have been a momentous decade for Medicaid. With enrollment of over seventy-two million people (19% of the country’s population), Medicaid is the nation’s largest public health insurance program, and it is the primary or sole source of health insurance for vulnerable groups such as low-income children and pregnant women, adults with disabilities, and people in need of long-term care. Since 2014, the pendulum of Medicaid policy has swung from an unprecedented expansion of coverage under the Affordable Care Act (ACA), toward more recent federal regulations and state policy innovations that are instead predicted to limit uptake of benefits. …