Health Law and Policy Commons^™

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. …

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 …

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 …

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 …

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 …

Open Science Precision Medicine In Canada: Points To Consider, Palmira Granados Moreno, Sarah E. Ali-Khan, Benjamin Capps, Timothy Caulfield, Damien Chalaud, Aled Edwards, E. Richard Gold, Vasiliki Rahimzadeh, Adrian Thorogood, Daniel Auld, Gabrielle Bertier, Felix Breden, Roxanne Caron, Priscilla M.D.G. César, Robert Cook-Deegan, Megan Doerr, Ros Duncan, Amalia M. Issa, Jerome Reichman, Jacques Simard, Derek So, Sandeep Vanamala, Yann Joly

Faculty Scholarship

Open science can significantly influence the development and translational process of precision medicine in Canada. Precision medicine presents a unique opportunity to improve disease prevention and healthcare, as well as to reduce health-related expenditures. However, the development of precision medicine also brings about economic challenges, such as costly development, high failure rates, and reduced market size in comparison with the traditional blockbuster drug development model. Open science, characterized by principles of open data sharing, fast dissemination of knowledge, cumulative research, and cooperation, presents a unique opportunity to address these economic challenges while also promoting the public good.

The Centre of …

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 …

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.

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 …

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 …

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 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

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.

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

Faculty Scholarship

No abstract provided.

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 …

Improving Outcomes In Child Poverty And Wellness In Appalachia In The "New Normal" Era: Infusing Empathy Into Law, Jill C. Engle

Faculty Scholarship

No abstract provided.