Law Commons^™

Medical Marijuana: Implications Of Evolving Trends In Regulation, Florence Shu-Acquaye

Faculty Scholarship

No abstract provided.

Telehealth For An Aging Population: How Can Law Influence Adoption Among Providers, Payors, And Patients?, Tara Sklar, Christopher Robertson

Faculty Scholarship

Telehealth continues to experience substantial investment, innovation, and unprecedented growth. However, telehealth has been slow to transform healthcare. Recent developments in telehealth technologies suggest great potential for chronic care management, mental health services, and care delivery in the home—all of which should be particularly impactful for an aging population with physical and cognitive limitations. While this alignment of technological capacity and market demand is promising, legal barriers remain for telehealth operators to scale up across large geographic areas. To better understand how federal and state law can be reformed to enable greater telehealth utilization, we review and extract lessons from …

Fda In The Time Of Covid-19, Elizabeth Mccuskey

Faculty Scholarship

Over the past century, Congress has made the Food & Drug Administration (FDA) responsible for regulating the safety and efficacy of drugs and devices being deployed in the fight against the COVID-19 pandemic. The FDA’s regulatory infrastructure was built for public health threats and to combat manufacturers' misinformation about treatments.

This article spotlights the ways in which FDA has been adapting to a new challenge during the COVID-19 pandemic: combating misinformation emanating from within the executive branch.

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 …

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 …

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 …

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 …

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 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 …

Agency Imprimatur & Health Reform Preemption, Elizabeth Mccuskey

Faculty Scholarship

At this moment, there exists nearly unanimous agreement that the American health care system requires reform, but also vehement disagreements over what form regulation should take and who should be in charge of regulating—state or federal authorities. Preemption doctrine typically referees disputes between federal and state regulatory efforts, but it also exacerbates them. There exists nearly as unanimous opinion that preemption doctrine in health law is a mess. This Article identifies an inventive structure that may help defuse some preemption problems in health reform.

The Affordable Care Act’s (ACA) individual and employer mandates, health insurance exchanges, and insurance coverage standards …

Body Of Preemption: Health Law Traditions And The Presumption Against Preemption, Elizabeth Mccuskey

Faculty Scholarship

Preemption plays a prominent role in health law, establishing the contours of coexistence for federal and state regulatory authorities over health topics as varied as medical malpractice, insurance coverage, drug safety, and privacy. When courts adjudicate crucial preemption questions, they must divine Congress's intent by applying substantive canons of statutory interpretation, including presumptions against preemption.

This Article makes three main contributions to health law and preemption doctrine. First, it identifies a variant of the presumption against preemption that applies to health laws-referred to throughout as the "tradition presumption." Unlike the general presumption against preemption on federalism grounds, courts base this …

Regulating Employment-Based Anything, Brendan S. Maher

Faculty Scholarship

Benefit regulation has been called “the most consequential subject to which no one pays enough attention.” It exhausts judges, intimidates legislators, and scares off theorists. That need not be so. Reality is less complicated than advertised.

Governments often consider intervention if markets fail to make some socially desirable Good X — such as education, health care, home mortgages, or pensions, for example — sufficiently available. One obvious fix is for the government to provide the good itself. A less obvious intervention is for the government to regulate employment-based (EB) arrangements that provide Good X as a benefit to employees and …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

The Drug Quality And Security Act - Mind The Gaps, Kevin Outterson

Faculty Scholarship

After the compounding pharmacy disaster at New England Compounding Center, Congress had an opportunity to assure that all compounded medicines were safe and effective. The Drug Quality and Safety Act, despite its name, fell short of that mark.

The Presumption Against Expensive Health Care Consumption, Christopher Robertson

Faculty Scholarship

This essay, as part of a symposium in honor of Professor Einer Elhauge, starts with his recognition that, for both epistemic and normative reasons, it remains profoundly difficult to regulate particular uses of medical technologies on the basis of their cost-benefit ratios. Nonetheless, this essay argues in favor of a general regulatory presumption against consumption for the most expensive medical technology usages, which drive most of aggregate healthcare spending. This essay synthesizes twelve facts about the ways in which medical technologies are produced, regulated, studied, and consumed to suggest that it is quite unlikely that the most expensive usages of …

The Tobacco Diaries: Lessons Learned And Applied To Regulation Of Dietary Supplements, Joanna K. Sax

Faculty Scholarship

This Article examines the future role of the FDA in the regulation of the dietary supplement industry. To address the role of the FDA in the twenty-first century with respect to the dietary supplement industry, Part I of this Article begins by describing the dietary supplement industry and the role of the FDA in this industry. In Part II, this Article provides a brief exposé of the tactics used by the tobacco industry to evade regulation. The purpose of Part II is to provide insight into the tobacco industry’s ability to manipulate consumers and discount scientific proof of the harmful …

Enough About The Constitution: How States Can Regulate Health Insurance Under The Aca, Brendan S. Maher, Radha A. Pathak

Faculty Scholarship

Last term, the United States Supreme Court upheld the constitutionality of the Affordable Care Act in a landmark decision. It is a forceful reminder that America’s oldest question — how power should be shared between federal and state sovereigns — retains powerful political salience. Critics have reflexively attacked the decision as an assault on states’ rights, while supporters have celebrated the result. Regrettably, insufficient attention has been paid to how, in actuality, health care regulatory authority has been and will be divided between federal and state governments. In this Article, we fill that gap. To do so, we apply “federalism-in-fact,” …

Combating Antimicrobial Resistance: Regulatory Strategies And Institutional Capacity, William M. Sage, David A. Hyman

Faculty Scholarship

Amnesia is a common, important, but rarely noted side effect of antibiotics. Apart from medical historians, few recall the severe morbidity and mortality once associated with acute bacterial infection. However, decades of antibiotic overuse and misuse have compromised the long-term availability and efficacy of these life-saving therapies. If designed and implemented appropriately, regulation can reduce the risk of bacterial infection, reserve antibiotics for circumstances where they are necessary, and rationalize the use of the most powerful agents. Regulation of antibiotic resistance can be justified, and should be guided, by both efficiency and fairness. A range of regulatory options are available--some …

The Supreme Court's Assault On Litigation: Why (And How) It Could Be Good For Health Law, Abigail Moncrieff

Faculty Scholarship

In recent years, the Supreme Court has narrowed or eliminated private rights of action in many legal regimes, much to the chagrin of the legal academy. That trend has had a significant impact on health law; the Court’s decisions have eliminated the private enforcement mechanism for at least four important healthcare regimes: Medicaid, employer-sponsored insurance, and medical devices. In a similar trend outside the courts, state legislatures have capped noneconomic and punitive damages for medical malpractice litigation, weakening the tort system’s deterrent capacity in those states. This Article points out that the trend of eliminating private rights of action in …

The Three Faces Of Retainer Care: Crafting A Tailored Regulatory Response, Frank Pasquale

Faculty Scholarship

Retainer care arrangements allow patients to pay a fee directly to a physician's office in order to obtain special access to care. Practices usually convert to retainer status by concentrating their attention on a small panel and dropping the majority of their patients. Proponents call retainer care a triumph of consumer-directed health care; opponents deride it as boutique medicine. Both sides are deploying a variety of legal tactics in order to attain their goals.

After surveying these conflicts, this article clarifies what is at stake by analyzing the three key features of retainer care: preventive care, queue-jumping, and amenity-bundling. Most …

A Drug By Any Other Name ... ? Paradoxes In Dietary Supplement Risk Regulation, Lars Noah, Barbara A. Noah

Faculty Scholarship

Dietary supplements present vexing regulatory challenges for the Food and Drug Administration (FDA). Although several observers have called for reform or repeal of Dietary Supplement Health and Education Act (DSHEA), and the FDA often has lamented its lack of meaningful authority over dietary supplements, this Author suggests that the agency actually possesses the regulatory muscle to adopt a more aggressive risk identification and risk management strategy within the confines of DSHEA, and that it need not ask Congress to amend the statute.