Health Law and Policy Commons^™

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 …

Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar

Articles

In an ambitious effort to slow the growth of health care costs, the Affordable Care Act created the Center for Medicare and Medicaid Innovation (CMMI) and armed it with broad authority to test new approaches to reimbursement for health care (payment models) and delivery-system reforms. CMMI was meant to be the government’s innovation laboratory for health care: an entity with the independence to break with past practices and the power to experiment with bold new approaches. Over the past year, however, the Department of Health and Human Services (HHS) has quietly hobbled CMMI, imperiling its ability to generate meaningful data …

Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox

Michigan Telecommunications & Technology Law Review

Biologic drugs offer major advancements over small-molecule drugs when it comes to treating serious diseases. Biosimilars, which mimic innovative biologic drugs, have the potential to further revolutionize the practice of medicine. States now have decades of experience regulating the substitution of generic, small-molecule drugs for their brand-name equivalents. But the complexities of biologic drugs and biosimilars force states to confront novel scientific and legal issues. Many states have begun tackling those issues by passing laws that regulate when pharmacists may substitute biosimilars for their corresponding biologic drugs. Other states have yet to do so. This Note surveys five provisions common …

Big Food And Soda Versus Public Health: Industry Litigation Against Local Government Regulations To Promote Healthy Diets, Sarah A. Roache, Charles Platkin, Lawrence O. Gostin, Cara Kaplan

Georgetown Law Faculty Publications and Other Works

Diets high in fats, sugars, and sodium are contributing to alarming levels of obesity, cardiovascular disease, type 2 diabetes, and certain cancers throughout the United States. Sugary drinks, which include beverages that contain added caloric sweeteners such as flavored milks, fruit drinks, sports drinks, and sodas, are the largest source of added sugar in the American diet and an important causative factor for obesity and other diet-related diseases.

City and county governments have emerged as key innovators to promote healthier diets, adopting menu labeling laws to facilitate informed choices and soda taxes, warnings labels, and a soda portion cap to …

Localism, Labels, And Animal Welfare, Samuel R. Wiseman

Northwestern Journal of Law & Social Policy

The law does relatively little to improve the welfare of animals raised for food. In the short term, at least, market-based solutions appear to have more promise as a means of promoting farm animal welfare, as consumers increasingly seek out local and humanely-raised meat and eggs. To aid consumers in identifying these products, certification systems of varying degrees of rigor exist, but even these are of little use to consumers in the restaurant context, which accounts for a large percentage of meat consumption. Patrons see only finished meals, making fraud difficult to detect, and a recent newspaper investigation suggests that …

The Burden Of A Good Idea: Examining The Impact Of Unfunded Federal Regulatory Mandates On Medicare Participating Hospitals, Rachel Juhas Suddarth

Law Faculty Publications

Health care costs are on the rise. In 1960, the United States spent $9 billion on hospital care. Since then, hospital related spending has grown exponentially. In 2015, the United States spent over $1 trillion on hospital care, with $359.9 billion of those payments coming from the federal Medicare program for the aged and disabled. Researchers have long tried to understand the exact causes of rising health care costs. While many have closely examined the costs associated with population demographics, medical innovation, prescription drug costs, overutilization of services, and fraud or abuse, there is one driving force that does not …

Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams

Michigan Law Review

The FDA’s regulatory framework for pharmaceuticals uses a “floor/ceiling” model: administrative rules set a “floor” of minimum safety, while state tort liability sets a “ceiling” of maximum protection. This model emphasizes premarket scrutiny but largely relies on the state common law “ceiling” to police the postapproval drug market. As the Supreme Court increasingly holds state tort law preempted by federal administrative standards, the FDA’s framework becomes increasingly imbalanced. In the face of a historic prescription medication overdose crisis, the Opioid Epidemic, this imbalance allows the pharmaceutical industry to avoid internalizing the public health costs of their opioid products. This Note …

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

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 …

Regulating Black-Box Medicine, W. Nicholson Price Ii

Michigan Law Review

Data drive modern medicine. And our tools to analyze those data are growing ever more powerful. As health data are collected in greater and greater amounts, sophisticated algorithms based on those data can drive medical innovation, improve the process of care, and increase efficiency. Those algorithms, however, vary widely in quality. Some are accurate and powerful, while others may be riddled with errors or based on faulty science. When an opaque algorithm recommends an insulin dose to a diabetic patient, how do we know that dose is correct? Patients, providers, and insurers face substantial difficulties in identifying high-quality algorithms; they …

Artificial Intelligence In Health Care: Applications And Legal Implications, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) is rapidly moving to change the healthcare system. Driven by the juxtaposition of big data and powerful machine learning techniques—terms I will explain momentarily—innovators have begun to develop tools to improve the process of clinical care, to advance medical research, and to improve efficiency. These tools rely on algorithms, programs created from healthcare data that can make predictions or recommendations. However, the algorithms themselves are often too complex for their reasoning to be understood or even stated explicitly. Such algorithms may be best described as “black-box.” This article briefly describes the concept of AI in medicine, including …

The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah

Michigan Telecommunications & Technology Law Review

Until the December 2016 passage of the Cures Act, the FDA had regulatory power over clinical decision support (CDS) software; however, the Act removed a large group of CDS software from the FDA’s statutory authority. Congressional intent was to increase innovation by removing regulatory blockades—such as device testing and certification—from the FDA’s purview. This note argues that the enactment of this specific provision of the Act will instead stymie innovation and overlook the unfortunate safety consequences inherent in its deregulation. CDS software is a burgeoning field ripe for innovation; however, rapid innovation can often lead to a slew of mistakes—mistakes …

Small Change, Big Consequences — Partial Medicaid Expansions Under The Aca, Adrianna Mcintyre, Allan M. Joseph, Nicholas Bagley

Articles

Though congressional efforts to repeal and replace the Affordable Care Act (ACA) seem to have stalled, the Trump administration retains broad executive authority to reshape the health care landscape. Perhaps the most consequential choices that the administration will make pertain to Medicaid, which today covers more than 1 in 5 Americans. Much has been made of proposals to introduce work requirements or cost sharing to the program. But another decision of arguably greater long-term significance has been overlooked: whether to allow “partial expansions” pursuant to a state Medicaid waiver. Arkansas has already submitted a waiver request for a partial expansion, …

Rwu First Amendment Blog: Jared A. Goldstein's Blog: Ri's Conversion Therapy Ban Protects Lgbtq Youth And It's Constitutional 08-09-2017, Jared A. Goldstein

Law School Blogs

No abstract provided.

The Eeoc, The Ada, And Workplace Wellness Programs, Samuel R. Bagenstos

Articles

It seems that everybody loves workplace wellness programs. The Chamber of Commerce has firmly endorsed those progarms, as have other business groups. So has President Obama, and even liberal firebrands like former Senator Tom Harkin. And why not? After all, what's not to like about programs that encourage people to adopt healthy habits like exercise, nutritious eating, and quitting smoking? The proponents of these programs speak passionately, and with evident good intentions, about reducing the crushing burden that chronic disease places on individuals, families, communities, and the economy as a whole. What's not to like? Plenty. Workplace wellness programs are …

Federalism And The End Of Obamacare, Nicholas Bagley

Articles

Federalism has become a watchword in the acrimonious debate over a possible replacement for the Affordable Care Act (ACA). Missing from that debate, however, is a theoretically grounded and empirically informed understanding of how best to allocate power between the federal government and the states. For health reform, the conventional arguments in favor of a national solution have little resonance: federal intervention will not avoid a race to the bottom, prevent externalities, or protect minority groups from state discrimination. Instead, federal action is necessary to overcome the states’ fiscal limitations: their inability to deficit-spend and the constraints that federal law …

Should Regulatory Compliance Be A Goal Or A Constraint For Health Care Companies? Finding Effective Methods To Assure Compliance With The Federal Anti-Kickback Statute And The False Claims Act, Roni A. Elias

Florida A & M University Law Review

The stereotypical conception of compliance is reinforced by some of the fundamental assumptions about what the primary objectives of a corporation should be and about how a corporation should accomplish those objectives. According to the prevailing theory of corporate structure, a corporation exists for the sole purpose of earning profits for its shareholders, and all of its actions are to be directed toward that end. If compliance with the law is not an inherently profit making activity, it is to be treated as a constraint on the corporation's efficient operation. According to this view, compliance will generally be considered a …

Working Well(Ness): The Impact Of The Ada Final Rule On Wellness Program Regulation And A Proposal For A Zero-Incentive Rule, Stefanie Brody

Saint Louis University Journal of Health Law & Policy

The Equal Employment Opportunity Commission (EEOC) recently amended wellness program regulation under 29 C.F.R. § 1630.14 of the Americans with Disabilities Act (ADA). Amidst criticism of the new rule, this article proposes the EEOC return to a zero-incentive policy for voluntary wellness programs that include disability-related inquiries or medical examinations. First, it reviews existing literature on wellness programs and the ADA, highlighting the legal and ethical challenges facing American workers with disabilities. Then, it explores the latest case law, illustrating the effects of the new rule compared to the proposal. By eliminating the thirty percent incentive limit and redefining “voluntary” …

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Journal Articles and Book Chapters

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …

How Much Of Health Care Antitrust Is Really Antitrust?, Spencer Weber Waller

Faculty Publications & Other Works

No abstract provided.

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

Teaching Health Law From A Social-Ecological Perspective, Lindsay Wiley

Scholarly Articles in Law Reviews & Journals

I started teaching health law relatively recently-in the fall of 2010, just after the Affordable Care Act ("ACA") was enacted, but before much of it had been implemented. This timing has been a blessing because I started with a fresh slate rather than adding the ACA on top of a previously developed course. It has also been a curse, but ultimately I appreciate that I started teaching the course at a time when the ACA was under constant threat. The ever-evolving nature of health law means that health law teachers must always bear in mind a goal that applies to …

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 …

Regulating Secrecy, W. Nicholson Price Ii

Articles

Inventors face a stark choice between two intellectual property systems of protecting innovative ideas: patents and trade secrecy. But accounts of this choice underexplore the role of the regulators that dominate some areas of innovation. Regulation interacts with intellectual property exclusivity in socially problematic ways by encouraging secrecy at the expense of innovation, efficiency, and competition. This Article theorizes how regulation empowers intellectual property generally, explains why this strengthening is problematic for trade secrecy but not for patents, and offers the solution of regulator-enforced disclosure. When a regulator defines a product or a process, it becomes much harder to successfully …

A Consumer Protection Perspective On Regulation For Healthier Eating, Barbara Von Tigerstrom

Dalhousie Law Journal

This article explores the potential for a consumer protection perspective to complement public health approaches in designing and justifying laws that aim to promote healthier eating, such as food labelling regulations or restrictions on marketing and advertising. Consumer protection and public health are distinct perspectives, but they share the goal of protecting health and both accept the need for regulation to protect important interests. Consumer protection objectives could be used to defend public health measures that are challenged as infringing rights or restricting trade. Insights from consumer law and scholarship could also contribute to discussions about when regulatory intervention to …

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 …

Testing For Regulatory Penalties: Insuring The Health Of Fedrealism In The Age Of Obamacare, Steven Z. Hodaszy

West Virginia Law Review

No abstract provided.

Paternalism, Self-Governance, And Public Health: The Case Of E-Cigarettes, Wendy E. Parmet

University of Miami Law Review

This article develops a normative framework for assessing public health laws, using the regulation of e-cigarettes as a case study. Although e-cigarettes are likely far less dangerous to individual users than traditional cigarettes, it remains uncertain whether their proliferation will lead to a reduction of smoking-related disease and deaths or to increased morbidity and mortality. This scientific uncertainty, whether and how to regulate e-cigarettes. This article presents a normative framework for analyzing such questions by offering three justifications for public health laws: impaired agency, harm to others, and self-governance. Each justification responds to the common charge that public health laws …

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.

When Fantasy Becomes Reality: Attempts To Regulate The Highly Unregulated Daily Fantasy Sports Industry., Garrett Greene

St. Mary's Law Journal

Legislation is beginning to creep into the once safeguard-devoid sphere of the daily fantasy sports industry. Daily fantasy sports are a subset of traditional season-long fantasy sports and are immensely lucrative, yet there are hardly any standard regulations. Ironically, the Unlawful Internet Gambling Enforcement Act (UIGEA) of 2006, which was used to outlaw online poker gambling, paved the way for daily fantasy sports, because it federally exempted fantasy sports from being classified as illegal sports gambling. The UIGEA further protects daily fantasy sports from the Professional and Amateur Sports Prohibition Act (PASPA) of 1992 which prohibits states from sponsoring sports …