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Articles 1 - 30 of 139

Full-Text Articles in Health Law and Policy

How Much Of Health Care Antitrust Is Really Antitrust?, Spencer Weber Waller Jul 2019

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

Spencer Weber Waller

No abstract provided.


Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill Jul 2019

Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

Money may not corrupt. But should we worry if it corrodes? Legal scholars in a range of fields have expressed concern about “motivational crowding-out,” a process by which offering financial rewards for good behavior may undermine laudable social motivations, like professionalism or civic duty. Disquiet about the motivational impacts of incentives has now extended to health law, employment law, tax, torts, contracts, criminal law, property, and beyond. In some cases, the fear of crowding-out has inspired concrete opposition to innovative policies that marshal incentives to change individual behavior. But to date, our fears about crowding-out have been unfocused and amorphous ...


The Impact Of H.B. 214: A Critical Analysis Of The Texas "Rape Insurance" Bill, Lucie Arvallo Apr 2019

The Impact Of H.B. 214: A Critical Analysis Of The Texas "Rape Insurance" Bill, Lucie Arvallo

St. Mary's Law Journal

Texas House Bill 214 (H.B. 214) is subject to challenge under the Supreme Court precedent protecting a woman’s right to choose. Passed in 2017, H.B. 214 regulates Texas insurance markets by prohibiting coverage for an elective abortion unless a woman affirmatively opts into such coverage through a separate contract and pays a separate premium. Similar restrictions on insurance coverage for elective abortion in other states have been met with mixed results in the courts. What sets H.B. 214 apart from other regulations of insurance coverage for abortion is that it does not include any exceptions for ...


21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen Apr 2019

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any ...


Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler Jan 2019

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

Faculty Scholarship at Penn Law

Several features of the existing occupational licensing system impede access to health care without providing appreciable protections for patients. Licensing restrictions prevent health care providers from offering services to the full extent of their competency, obstruct the adoption of telehealth, and deter foreign-trained providers from practicing in the United States. Scholars and policymakers have proposed a number of reforms to this system over the years, but these proposals have had a limited impact for political and institutional reasons.

Still, there are grounds for optimism. In recent years, the federal government has taken a range of initial steps to reform licensing ...


Practice-Based Research Networks Ceding To A Single Institutional Review Board, Jeanette M. Daly, Tabria Weiner Harrod, Kate Judge, Leann C. Michaels, Barcey T. Levy, David L. Hahn, Lyle J. Fagnan, Donald E. Nease Jr. Oct 2018

Practice-Based Research Networks Ceding To A Single Institutional Review Board, Jeanette M. Daly, Tabria Weiner Harrod, Kate Judge, Leann C. Michaels, Barcey T. Levy, David L. Hahn, Lyle J. Fagnan, Donald E. Nease Jr.

Journal of Patient-Centered Research and Reviews

Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites’ IRBs and becomes the IRB of record for the ceded sites. In the ...


Renovations Needed: The Fda's Floor/Ceiling Framework, Preemption, And The Opioid Epidemic, Michael R. Abrams Oct 2018

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 ...


הורות משפטית מן הדין ומן הצדק - Legal Parenthood - Law And Justice, Yehezkel Margalit Aug 2018

הורות משפטית מן הדין ומן הצדק - Legal Parenthood - Law And Justice, Yehezkel Margalit

Hezi Margalit

מן המפורסמות שאינן צריכות לראיה היא הקביעה שלפיה הכרה בהורות משפטית בישראל של פרט מסוים אפשרית אך ורק מכוח זיקה ביולוגית, גנטית או פיזיולוגית; מכוח צו אימוץ או לחלופין מכוח קבלת צו הורות בסיומו של הליך לנשיאת עוברים. אולם זעיר פה זעיר שם, הלכה למעשה, מתקבלות החלטות שיפוטיות שאינן עולות בקנה אחד עם תפיסת עולם קוהרנטית ומקיפה לכאורה זו, הסודקות עוד ועוד תובנה זו. ללא כל ספק, דרך המלך בקעקועה של הנחת העבודה המקובלת היא השימוש ההולך וגובר בצו הורות פסיקתי. בהליך בתולי זה במשפט הישראלי החלו בתי המשפט לענייני משפחה להשתמש במחצית הראשונה של שנת 2012 בהקניית אימהות משפטית ...


Too Little Too Late: The Infeasibility Of Osha's Silica Standards In The Oil Industry, Cali M. Franks Aug 2018

Too Little Too Late: The Infeasibility Of Osha's Silica Standards In The Oil Industry, Cali M. Franks

St. Mary's Law Journal

Abstract forthcoming


Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman Jun 2018

Environmental Health Regulation In The Trump Era: How President Trump’S Two-For-One Regulatory Plan Impacts Environmental Regulation, Elizabeth Ann Glass Geltman

University of Michigan Journal of Law Reform

This Article explores the Trump regulatory reform agenda and its potential impact on environmental determinants of health. The Article begins with a discussion of the Department of Commerce’s (DOC or Commerce) initial fact-finding investigation to evaluate the impact of federal regulations on domestic manufacturing. The Article next presents an overview of the Trump administration’s regulatory reform formula as announced in E.O. 13771 and the interim guidance explaining E.O. 13771 and E.O. 13777 (the executive order announcing the Trump administration’s plans to enforce the regulatory reform plan announced in E.O. 13771). The Article then ...


Reform At Risk — Mandating Participation In Alternative Payment Plans, Scott Levy, Nicholas Bagley, Rahul Rajkumar May 2018

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 ...


Suggestions For State Laws On Biosimilar Substitution, Gary M. Fox May 2018

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 May 2018

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 ...


Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa Mar 2018

Marijuana Agriculture Law: Regulation At The Root Of An Industry, Ryan Stoa

Ryan B. Stoa

Marijuana legalization is sweeping the nation. Recreational marijuana use is legal in eight states. Medical marijuana use is legal in thirteen states. Only three states maintain an absolute criminal prohibition on marijuana use. Many of these legalization initiatives propose to regulate marijuana in a manner similar to alcohol, and many titles are variations of the "Regulate Marijuana Like Alcohol Act." For political and public health reasons the analogy makes sense, but it also reveals a regulatory blind spot. States may be using alcohol as a model for regulating the distribution, retail, and consumption of marijuana, but marijuana is much more ...


Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa Mar 2018

Comparative Cannabis: Approaches To Marijuana Agriculture Regulation In The United States And Canada, Ryan Stoa

Ryan B. Stoa

The United States and Canada may be friends and allies, but the two countries' approaches to the regulation of marijuana agriculture have not evolved in tandem. On the contrary, their respective paths toward legalization and regulation of marijuana agriculture are remarkably divergent. In the United States, where marijuana remains a federally prohibited and tightly-controlled substance, legalization and regulation have remained the province of state legislatures and their administrative agencies for decades. In Canada, a succession of court cases paving the way toward medicinal marijuana use has prompted the federal government to develop a national framework committed to "legalize, regulate, and ...


The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel Mar 2018

The Growing Consumer Exposure To Nanotechnology In Everyday Products: Regulating Innovative Technologies In Light Of Lessons From The Past, Katharine Van Tassel

Katharine Van Tassel

This Article discusses the public health, regulatory, legal, and ethical issues raised by the developing appreciation of the negative physical effects and potential health risks associated with nanotech products, and is arranged as follows. After this Introduction, this Article describes the present scientific understanding of the health risks associated with the consumption of nanoparticles. Next, a summary of the existing FDA regulatory structure that governs food, dietary supplements, cosmetics, and sunscreens is provided along with an explanation of why these regulations fail to protect public health when applied to regulate the nanotech versions of these products. The Article goes on ...


Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel Mar 2018

Genetically Modified Plants Used For Food, Risk Assessment And Uncertainty Principles: Does The Transition From Ignorance To Indeterminacy Trigger The Need For Post-Market Surveillance?, Katharine Van Tassel

Katharine Van Tassel

In the context of GM foods, a genetic modification changes the biochemical cross-talk between genes, creating genetic material that has never existed before in nature. This novel genetic material can create unintended health risks, as seen with the case of the GM peas that contained a novel and unexpected allergenic protein and primed test mice to react to other allergens.6 The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a ...


Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel Mar 2018

Regulating In Uncertainty: Animating The Public Health Product Safety Net To Capture Consumer Products Regulated By The Fda That Use Innovative Technologies, Including Nanotechnologies, Genetic Modification, Cloning, And Lab Grown Meat, Katharine A. Van Tassel

Katharine Van Tassel

This Article will use nanotechnology as an example that highlights how regulation based on novelty rather than hazard achieves the proper balance between protecting public health while encouraging innovation through the animation of the public health product safety net. In Part II, this Article starts by explaining what nanotechnology is and the remarkable growth of its use in everyday consumer products. It then summarizes the steadily increasing number of studies that suggest that there are likely to be serious health risks associated with the use of nanotech consumer products. Next, it explains how the FDA [Food and Drug Administration] is ...


The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel Mar 2018

The Introduction Of Biotech Foods To The Tort System: Creating A New Duty To Identify, Katharine Van Tassel

Katharine Van Tassel

This Article examines the question of whether an unsuspecting consumer who dies from an allergic or toxic reaction to an undisclosed biotech ingredient in food can recover damages through the tort system. The surprising answer is that recovery is very unlikely. This Article outlines why this is the case, then evaluates the merits of several potential solutions to this problem including the possible creation of a common law 'duty to identify' biotech ingredients in food.

This Article is arranged as follows. First, a brief primer on the nature of biotech foods is provided. For the reader unfamiliar with the regulatory ...


Too Clever By Half: Commanding The Nonuse Of State Authority To Regulate Health Benefits In The Aca, Michael F. Ryan Feb 2018

Too Clever By Half: Commanding The Nonuse Of State Authority To Regulate Health Benefits In The Aca, Michael F. Ryan

University of Massachusetts Law Review

Prior to the enactment of the Patient Protection and Affordable Care Act (ACA), state legislatures routinely passed laws requiring health insurance carriers to cover certain health care services or providers. At the behest of the insurance industry, Congress attempted to use the health reform law as a vehicle to reign in state-specific “mandated benefit” laws. That being said, the ACA does not prevent states from enacting mandated benefit laws; in fact, the statute expressly permits states to enact such laws. Instead, Congress created a significant barrier to continued state-specific regulation of health insurance benefits. Specifically, 42 U.S.C. § 18031 ...


Localism, Labels, And Animal Welfare, Samuel R. Wiseman Jan 2018

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 Jan 2018

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 ...


What Congress's Repeal Efforts Can Teach Us About Regulatory Reform, Cary Coglianese, Gabriel Scheffler Dec 2017

What Congress's Repeal Efforts Can Teach Us About Regulatory Reform, Cary Coglianese, Gabriel Scheffler

Faculty Scholarship at Penn Law

Major legislative actions during the early part of the 115th Congress have undermined the central argument for regulatory reform measures such as the REINS Act, a bill that would require congressional approval of all new major regulations. Proponents of the REINS Act argue that it would make the federal regulatory system more democratic by shifting responsibility for regulatory decisions away from unelected bureaucrats and toward the people’s representatives in Congress. But separate legislative actions in the opening of the 115th Congress only call this argument into question. Congress’s most significant initiatives during this period — its derailed attempts to ...


Regulating Black-Box Medicine, W. Nicholson Price Ii Dec 2017

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 Nov 2017

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 ...


The Oversimplification Of Deregulation: A Case Study On Clinical Decision Support Software, Deeva V. Shah Nov 2017

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 ...


Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro Oct 2017

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply ...


Small Change, Big Consequences — Partial Medicaid Expansions Under The Aca, Adrianna Mcintyre, Allan M. Joseph, Nicholas Bagley Sep 2017

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 Aug 2017

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 May 2017

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 ...