Administrative Law Commons^™

Give Them A Reason They Can Understand: An Examination Of Rhode Island's Medicaid Ineligibility Notices To The State's Most Vulnerable Populations, Laura Pickering

Roger Williams University Law Review

No abstract provided.

Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M.L. Cummings

Richmond Journal of Law & Technology

Some of the most dynamic areas of robotics research and development today are healthcare applications. Robot-assisted surgery, robotic nurses, in-home rehabilitation, and eldercare robots' are all demonstrating rapidly iterating innovation. Rising healthcare labor costs and an aging population will increase demand for these human surrogates and enhancements. However, like many emerging technologies, robots are difficult to place within existing regulatory frameworks. For example, the federal Food, Drug, and Cosmetic Act (FD&C Act) seeks to ensure that medical devices (few of which are consumer devices) are safe, the HIPAA Privacy and Security Rules apply to data collected by health care providers …

Complying With The Hipaa Privacy Rule: Problems And Perspectives, Stacey A. Tovino

Scholarly Works

Twenty years ago, President Clinton signed the Health Insurance Portability and Accountability Act of 1996 (HIPAA) into law. Over the past two decades, the federal Department of Health and Human Services (HHS) has published several sets of rules implementing the Administrative Simplification provisions within HIPAA as well as the Health Information Technology for Economic and Clinical (HITECH) Act within the American Recovery and Reinvestment Act (ARRA). These rules include a final rule governing the use and disclosure of protected health information by covered entities and their business associates (Privacy Rule).

This Article addresses the question of what it means for …

Is It Time To Adopt A No-Fault Scheme To Compensate Injured Patients?, Elaine Gibson

Articles, Book Chapters, & Popular Press

The tort system is roundly indicted for its inadequacies in providing compensation in response to injury. More egregious is its response to injuries incurred due to negligence in the provision of healthcare services specifically. Despite numerous calls for reform, tort-based compensation has persisted as the norm to date. However, recent developments regarding physician malpractice lead to consideration of the possibility of a move to “no-fault” compensation for healthcare-related injuries. In this paper, I explore these developments, examine programs in various foreign jurisdictions which have adopted no-fault compensation for medical injury, and discuss the wisdom and feasibility of adopting an administratively-based …

Baptists, Bootleggers & Electronic Cigarettes, Jonathan H. Adler, Roger E. Meiners, Andrew P. Morriss, Bruce Yandle

Faculty Publications

Electronic cigarettes pose a competitive threat to the makers of cigarettes and other tobacco products, as well as to nicotine replacement therapies such as nicotine gum and patches. A common response to such a threat is support for government regulation to suppress competition. Predictably, cigarette manufacturers and other threatened producers, as well as the governments that earn revenue from tobacco taxes, are supporting greater regulation of electronic cigarettes that would replicate the cartel-supporting rules of the Master Settlement Agreement. These efforts are aided by anti-smoking organizations that would like to prevent the growth of demand for electronic cigarettes. This episode …

Of Kings To Come: The Future Of Health Care Reform Still Remains In Federal Court, Jonathan H. Adler

Faculty Publications

While King [v. Burwell] may be the last lawsuit potentially threatening a core feature of the ACA [Affordable Care Act] (at least for the time being) - and there will be few constitutional challenges of the sort seen in NFIB v. Sebelius - it was anything-but-the-end of ACA litigation. To the contrary, ACA lawsuits are certain to continue for years on end as the statute, the way it was enacted, and the way it is being implemented, create a perfect storm for continued litigation.

Continuing legal conflict creates uncertainty under the ACA. While health care reform remains in place, the …

Resurrecting Health Care Rate Regulation, Erin C. Fuse Brown

Faculty Publications By Year

Our excess health care spending in the United States is driven largely by our high health care prices. Our prices are so high because they are undisciplined by market forces, in a health care system rife with market failures, which include information asymmetries, noncompetitive levels of provider market concentration, moral hazard created by health insurance, multiple principal-agent relationships with misaligned incentives, and externalities from unwarranted price variation and discrimination. These health care market failures invite a regulatory solution. An array of legal and policy solutions are typically advanced to control our health care prices and spending, including: (1) market solutions …

Regulating Drug Promotion To Promote The Public Health: A Response To Bennett, Et Al., Patricia J. Zettler

Faculty Publications By Year

No abstract provided.

Procedural Triage, Matthew J.B. Lawrence

Faculty Scholarly Works

Prior scholarship has assumed that the inherent value of a “day in court” is the same for all claimants, so that when procedural resources (like a jury trial or a hearing) are scarce, they should be rationed the same way for all claimants. That is incorrect. This Article shows that the inherent value of a “day in court” can be far greater for some claimants, such as first-time filers, than for others, such as corporate entities and that it can be both desirable and feasible to take this variation into account in doling out scarce procedural protections. In other words, …

The Minty Taste Of Death: State And Local Options To Regulate Menthol In Tobacco Products, Michael Freiberg

Catholic University Law Review

Explaining why the additive menthol in tobacco products creates major public health risks, this article advocates for restricting the addition of menthol in cigarettes as a way to reduce smoking-related disease and death. Author Michael Freiberg describes how the decision to regulate menthol in tobacco products, on a federal level, was historically delegated by Congress to the discretion of the U.S. FDA, outlines the U.S. FDA’s subsequent failure to regulate menthol, and surveys state and local government efforts to regulate menthol in response to the FDA’s inaction. The article proposes additional actions that these state and local governments could take …

Compassionate Use Of Experimental Therapies: Who Should Decide?, Patricia J. Zettler

Faculty Publications By Year

In addition to being an example of unsubstantiated hype about regenerative medicine, the controversy around the Italy-based Stamina Foundation's unproven stem cell therapy represents another chapter in a continuing debate about how to balance patients' requests for early access to experimental medicines with requirements for demonstrating safety and effectiveness. Compassionate use of the Stamina therapy arguably should not have been permitted under Italy's laws, but public pressure was intense and judges ultimately granted access. One lesson from these events is that expert regulatory agencies may be the institutions most competent to make compassionate use decisions and that policies should include …

Redrafting Ohio's Advance Directive Laws, Susan R. Martyn, James E. Reagan, Brendan Minogue, Debra L. Dippel, Maria R. Schimer, Robert Taraszewski

Akron Law Review

The Bioethics Network of Ohio (BENO) held its second annual conference on June 12, 1992 at Ohio Dominican College, Columbus, Ohio. Attendees recommended that a Task Force' review Ohio's Durable Power of Attorney for Health Care (DPAHC) and Modified Uniform Rights for the Terminally Ill (MURTIA) laws and suggest changes that would retain the basic structure of these provisions but also simplify and clarify their meaning. The Task Force completed a draft in six months and circulated it to approximately 450 individual and institutional BENO members. About one hundred members responded and this article incorporates most of their comments.

Staffing National Health Care Reform: A Role For Advanced Practice Nurses, Linda H. Aiken, William M. Sage

Akron Law Review

Expanding access and coverage while containing costs can only be accomplished by getting more health care value for our money. Two facts about our current system make this seem possible. First, the currently uninsured are not costless. Providing stop-gap health care to those who lack health insurance is extremely expensive -- people without formal coverage cannot afford preventive services, delay treatment of illness and face substantial barriers to reaching appropriate providers. When they receive care, it is often degrading, usually complicated and costly, and more than occasionally too late. The cost of this "uncompensated" care is borne by all of …

Desperately Seeking Status: Same-Sex Couples Battle For Employment-Linked Benefits, Sue Nussbaum Averill

Akron Law Review

This Comment will focus on the battles that gay and lesbian workers face in their attempts to attain benefit parity in the workplace and how these battles are linked to the fact that their relationships lack legal status. Part I will discuss recent judicial decisions on the issue of employment-linked benefit availability to the same-sex partners of gay and lesbian employees. Part II will review two recent decisions, which although unrelated to employment, may have set the stage for a legal redefinition of the family, and may provide a means by which same-sex couples could attain the legal status required …

The Dangerous Right To Food Choice, Samuel R. Wiseman

Scholarly Publications

Scholars, advocates, and interest groups have grown increasingly concerned with the ways in which government regulations—from agricultural subsidies to food safety regulations to licensing restrictions on food trucks—affect access to local food. One argument emerging from the interest in recent years is that choosing what foods to eat, what I have previously called “liberty of palate,” is a fundamental right.1 The attraction is obvious: infringements of fundamental rights trigger strict scrutiny, which few statutes survive. As argued elsewhere, the doctrinal case for the existence of such a right is very weak. This Essay does not revisit those arguments, but instead …

The 2014 Farm Bill: Farm Subsidies And Food Oppression, Andrea Freeman

Seattle University Law Review

The 2014 Farm Bill ushered in some significant and surprising changes. One of these was that it rendered the identity of all the recipients of farm subsidies secret. Representative Larry Combest, who is now a lobbyist for agribusiness, first introduced a secrecy provision into the bill in 2000. The provision, however, only applied to subsidies made in the form of crop insurance. Until 2014, the majority of subsidies were direct payments and the identity of the people who received them was public information. In fact, the Environmental Working Group’s release of the list of recipients led to a series of …

Fracking And The Rural Poor: Negative Externalities, Failing Remedies, And Federal Legislation, Matthew Castelli

Indiana Journal of Law and Social Equality

This Note examines the relationship between the rural poor and the negative externalities of hydraulic fracturing (“fracking”). It asserts that the rural poor are disproportionately burdened with fracking’s negative externalities and that comprehensive, national regulation is needed because current legal methods are insufficient to internalize these costs. The argument is made in four parts: describing fracking’s externalities; assessing their impact on the rural poor; analyzing current legal regimes; and proposing an equitable regulatory framework based on cooperative federalism.

Fracking produces three main categories of negative externalities: water, air, and land contamination. Water contamination can be caused by migration of fracking …

The Paradox Of The Obamacare Decision: How Can The Federal Government Have Limited Unlimited Power?, Robert J. Pushaw Jr.

Florida Law Review

National Federation of Independent Business v. Sebelius, the Supreme Court’s decision upholding the landmark Patient Protection and Affordable Care Act (ACA or “Obamacare”), sets forth the most important judicial examination of constitutional power since the New Deal era. The political and media frenzy over the Obamacare case has obscured its actual legal analysis and larger constitutional implications, which warrant more reflective study. This Article seeks to provide such a scholarly perspective.

Can You Diagnose Me Now? A Proposal To Modify The Fda’S Regulation Of Smartphone Mobile Health Applications With A Pre-Market Notification And Application Database Program, Stephen Mcinerney

University of Michigan Journal of Law Reform

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to …

The Increasing Weight Of Regulation: Countries Combat The Global Obesity Epidemic, Allyn L. Taylor, Emily Whelan Parento, Laura A. Schmidt

Indiana Law Journal

Obesity is a global epidemic, exacting an enormous human and economic toll. In the absence of a comprehensive global governance strategy, states have increasingly employed a wide array of legal strategies targeting the drivers of obesity. This Article identifies recent global trends in obesity-related legislation and makes the normative case for an updated global governance strategy.

National governments have responded to the epidemic both by strengthening traditional interventions and by developing novel legislative strategies. This response consists of nine important trends: (1) strengthened and tailored tax measures; (2) broadened use of counter-advertising and health campaigns; (3) expanded food labeling; (4) …

Toward Coherent Federal Oversight Of Medicine, Patricia J. Zettler

Faculty Publications By Year

The conventional wisdom in U.S. health law and policy holds that states regulate medical practice – the activities of physicians and other health care professionals – while the federal government regulates medical products. But relying on states as the principal regulators of medical practice has, at times, driven law and policy in directions that are problematic from a public health perspective, as demonstrated by a deadly 2012 outbreak of fungal meningitis that was linked to a state-regulated practice known as drug compounding. This Article argues that the federalism concerns underlying the conventional wisdom are misplaced. It demonstrates that, contrary to …

Procedural Triage, Matthew B. Lawrence

Faculty Articles

Prior scholarship has assumed that the inherent value of a “day in court” is the same for all claimants, so that when procedural resources (like a jury trial or a hearing) are scarce, they should be rationed the same way for all claimants. That is incorrect. This Article shows that the inherent value of a “day in court” can be far greater for some claimants, such as first-time filers, than for others, such as corporate entities and that it can be both desirable and feasible to take this variation into account in doling out scarce procedural protections. In other words, …

Agencies, Polarization, And The States, Gillian E. Metzger

Faculty Scholarship

Political polarization is all the rage. Yet administrative agencies are strikingly absent from leading accounts of contemporary polarization. To the extent they appear, it is largely as acted-upon entities that bear the fallout from the congressional-presidential confrontations that polarization fuels, or as the tools of presidential unilateralism. This failure to incorporate administrative agencies into polarization accounts is a major omission. Agencies possess broad grants of preexisting authority that they can use to reshape governing policy and law, often at presidential instigation, thereby putting pressure on Congress to respond. In the process, they can construct new alliances and arrangements that have …

"Do No Harm": A Comparative Analysis Of Legal Barriers To Corporate Clinical Telemedicine Providers In The United States, Australia, And Canada, Ian R. Landgreen

Georgia Journal of International & Comparative Law

No abstract provided.

The Legality Of Delaying Key Elements Of The Aca., Nicholas Bagley

Articles

Under the Affordable Care Act (ACA), the employer mandate — the requirement that most employers offer health insurance to their workers or pay a tax penalty — was scheduled to go into effect on January 1, 2014. Last summer, however, the Obama administration announced that it was delaying the mandate for a year. The administration has now extended the delay for midsize firms until 2016.

Throwing Dirt On Doctor Frankenstein’S Grave: Access To Experimental Treatments At The End Of Life, Michael J. Malinowski

Journal Articles

All U.S. federal research funding triggers regulations to protect human subjects known as the Common Rule, a collaborative government effort that spans seventeen federal agencies. The Department of Health and Human Services has been in the process of re-evaluating the Common Rule comprehensively after decades of application and in response to the jolting advancement of biopharmaceutical science. The Common Rule designates specific groups as “vulnerable populations”—pregnant women, fetuses, children, prisoners, and those with serious mental comprehension challenges—and imposes heightened protections of them. This article addresses a question at the cornerstone of regulations to protect human subjects as biopharmaceutical research and …

Dissecting The Heart Of Organ Allocation Policy: Evaluating The Eastern District Of Pennsylvania's Grant Of Life In Murnaghan V. U.S. Department Of Health And Human Services, Jocelyn Cooper

Villanova Law Review (1956 - )

No abstract provided.

Making Do In Making Drugs: Innovation Policy And Pharmaceutical Manufacturing, W. Nicholson Price Ii

Law Faculty Scholarship

Despite increasing recalls, contamination events, and shortages, drug companies continue to rely on outdated manufacturing plants and processes. Drug manufacturing’s inefficiency and lack of innovation stand in stark contrast to drug discovery, which is the focus of a calibrated innovation policy that combines patents and FDA regulation. Pharmaceutical manufacturing lags far behind the innovative techniques found in other industries due to high regulatory barriers and ineffective intellectual property incentives. Among other challenges, although manufacturers tend to rely on trade secrecy because of the difficulty in enforcing patents on manufacturing processes, trade secrecy provides limited incentives for innovation. To increase those …

Re-Negotiating A Theory Of Social Contract For Universal Health Care In America Or, Securing The Regulatory State?, George P. Smith Ii

Scholarly Articles

Political ideologies and evolving notions of social justice have shaped public health policies throughout American history in a quest to find a point of balance between the collective good and economic realities. In pursuit of this balance, Congress enacted the Affordable Care Act in 2010. This Article first examines the new law through the lens of the social contract as envisioned by Rousseau and adopted by the Framers of the Constitution. Using economic data, public opinion, and information from the medical community, Smith and Gallena proceed to offer a frank appraisal of the state of health care in America and …

The Hang-Up With Hamburg: How Center For Food Safety V. Hamburg Will Alter The Food Industry, Joella Roland

Journal of Business & Technology Law

No abstract provided.