Health Law and Policy Commons^™

The Aca, The Large Group Market, And Content Regulation: What’S A State To Do?, Amy B. Monahan

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Policy Challenges Of The Heterogeneity Of The Value Of Statistical Life, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Economic research has developed estimates of the heterogeneity of the value of statistical life (VSL) on dimensions such as individual age, income, immigrant status, and the nature of the risk exposure. This paper examines the empirical evidence on the heterogeneity of VSL and explores the potential implications for the valuation of regulatory policies. Previously, the U.S. Environmental Protection Agency (EPA) unsuccessfully sought to adopt a simple age discount percentage for VSL based on survey evidence. However, labor market estimates of VSL indicate a pattern that tracks lifetime consumption trajectories, as the VSL rises with age and eventually tapers off but …

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 Food And Drug Administration And The Pharmacy Profession: Partners To Ensure The Safety And Efficacy Of Pharmacogenomic Therapy, Jennifer E. Spreng

Journal of Health Care Law and Policy

No abstract provided.

Who’S Guarding The Henhouse And What Are They Doing With The Eggs (And Sperm)? A Call For Increased Regulation Of Gamete Donation And Long-Term Tracking Of Donor Gametes, Lisa M. Luetkemeyer

Saint Louis University Journal of Health Law & Policy

No abstract provided.

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 …

A Broader Liberty: Js Mill, Paternalism, And The Public’S Health, Lawrence O. Gostin, Kieran G. Gostin

O'Neill Institute Papers

Is the ‘harm principle’, famously propounded by JS Mill and widely adopted in bioethics, an appropriate principle to guide public health regulation? The harm principle limits liberty-limiting interventions to only those instances where the person poses a significant risk of harm to others. However, much of public health regulation is not primarily directed to avert risk to others, but to safeguard the health and safety of the individual him or herself. Think about regulations regarding seatbelts, motorcycle helmets, or the fluoridation of water as illustrations of pervasive public health regulations that are primarily intended to safeguard the individual’s own health …

The Burden Of Knowledge, Christian Turner

Scholarly Works

Sometimes we are better off not knowing things. While we often hear that "ignorance is bliss," there has not been a comprehensive consideration in the legal academy of the virtues of ignorance and its regulation. Though the distribution of knowledge, like the distribution of other goods, is affected both directly and indirectly by law, several characteristics of knowledge distinguish it from other kinds of property. Much has been written about the impact of the nonrival and nonexclusive nature of knowledge on its production and distribution. This Article centers around two other attributes of knowledge that combine to create a special …

Public-Private Partnerships And Insurance Regulation, Alexander A. Boni-Saenz

All Faculty Scholarship

A public-private partnership (PPP) is an institutional arrangement that embodies a collaborative approach to policy and regulation; it is a joint venture between the government and one or more private sector entities. Joint financing partnerships link public financing and private insurance to pay for certain social goods. Where the financing for social goods is fragmented and overlapping, as it is for health and social care, joint financing PPPs may help organize existing financing streams. This piece argues that partnerships of this type also present an opportunity for consumer-protective regulation of the insurance industry if certain conditions are met. Private insurers …

The Basis Of A Comprehensive Regulatory Policy For Reduced Harm Tobacco Products, David Sweanor, Rachel C. Grunberger

Journal of Health Care Law and Policy

No abstract provided.

Tobacco Control And Snus: Time To Take A Stand, Lindsey C. Dastrup, Jacqueline M. Mcnamara

Journal of Health Care Law and Policy

No abstract provided.

The Virtues Of Medicare, Jill R. Horwitz

Reviews

Most of us look forward to a heaven where people don't get sick. But if they do, health care would be traded among fully informed patients and providers in perfectly competitive and frictionless markets. In that perfect world, sick citizens simply shop for doctors the way they shop for other consumer goods. The better doctors, like the most elegant hotel rooms and fanciest cars, would cost more than inferior doctors. Patients would consult their utility meters and, with appropriate attention to discounting over an infinite lifetime, choose accordingly. After each treatment, the patients would know the quality of their outcome …

The Battle Of The Bulge: Evaluating Law As A Weapon Against Obesity, Margaret Sova Mccabe

Journal of Food Law & Policy

"Silly rabbit, Trix are for kids." Since the 1970s, kids have gotten to know the silly rabbit created to promote sugary, fruit-flavored cereal in television ads. Today, "i'm lovin' it" is the McDonald's slogan, but to millions of children the more recognizable symbol is Ronald McDonald. Ronald McDonald is so recognizable that one study pegged recognition of Ronald among American children at 96% and another at 80% by children in nine other countries. Given the "obesity crisis," many question whether these ads should be permitted, with some questioning whether such products are even safe for children's consumption. The Trix Rabbit …

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 …

What Have We Here? The Need For Transparent Pricing And Quality Information In Health Care: Creation Of An Sec For Health Care, Keith T. Peters

Journal of Health Care Law and Policy

No abstract provided.

Pharma On The Hot Seat, Nicole Huberfeld

Law Faculty Scholarly Articles

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act’s statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital …

Void For Vagueness, Carl E. Schneider

Articles

When law regulates a profession, where does it get its standards? Largely from the profession. Members of professions acquire esoteric and abstract knowledge through formal education and the experience of practice. They use professional judgment in applying this knowledge to each case. Because legislatures and courts lack this expertise, they adopt the standards of the experts. Thus in a malpractice suit, juries are instructed to determine whether the doctor met medicine's standard of care. Furthermore, physicians must be called as expert witnesses to guide juries in that work. Even when lawmakers contemplated intensifying their regulation of medicine by creating the …

Creating Balance: Problems Within Dshea And Suggestions For Reform, Jennifer Akre Hill

Journal of Food Law & Policy

The Dietary Supplement Health and Education Act of 1994 (DSHEA) was signed into law on October 25, 1994. At the signing, President Clinton endorsed the "intense efforts" of manufacturers and legislators to change the "treatment of dietary supplements under regulation and law." Further, the bill was signed with the hope that it would benefit consumers by permitting more access to dietary supplements and more choices for consumer directed healthcare. In support, politicians on both sides of the aisle claimed the DSHEA as a victory for consumer freedom, populist protection, and preventative medicine.

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

A Tough Pill To Swallow: Does The First Amendment Prohibit Wv From Regulating Pharmaceutical Companies' Advertising Expenses To Lower The Cost Of Prescription Drugs?, Brienne Taylor Greiner

West Virginia Law Review

No abstract provided.

“Just Scanning Around” With Diagnostic Medical Ultrasound: Should States Regulate The Non-Diagnostic Uses Of This Technology?, Archie A. Alexander

ExpressO

Recent advances in medical imaging have provided physicians with more accurate diagnostic information, which has allowed them to tailor their therapies to reduce health care costs. These recent advances have caused the New England Journal of Medicine to hail diagnostic medical imaging as one of the greatest contributions to medicine in last thousand years. Yes, modern diagnostic imaging plays a major role in medicine, especially in the case of diagnostic imaging technology. One reason this technology has assumed such a prominent position worldwide is the usage of higher sound intensities by its manufacturers for better image quality. A recent survey …

Drugged, Carl E. Schneider

Articles

The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …

Zoning And Eminent Domain Under The New Minimum Scrutiny, John H. Ryskamp

ExpressO

Recently the Supreme Court has made it clearer that minimum scrutiny is a factual analysis. Whether in any government action there is a rational relation to a legitimate interest is a matter of determining whether there is a policy maintaining important facts. This has come about in the Court’s emerging emphasis on developing fact-based criteria for determining government purpose. Thus, those who want to affect zoning and eminent domain outcomes should look to what the Court sees as important facts, and whether government action is maintaining those facts with its proposed land use or eminent domain action.

The Food And Drug Administration's Evolving Regulation Of Press Releases: Limits And Challenges, William W. Vodra, Nathan Cortez, David E. Korn

Faculty Journal Articles and Book Chapters

The Food and Drug Administration (FDA) has developed an informal framework for regulating press releases by drug and medical device companies. FDA asserted jurisdiction over press releases based on its authority over labeling and advertising, and over the past 20 years, the agency has both broadened and scaled back its claims to authority over press statements.

Despite a somewhat predictable framework for anticipating how FDA regulates press materials, the agency's approach appears to be in flux. FDA will not tolerate false or misleading statements in press materials, but there are legal and practical limits to its regulation in this area. …

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.

Hipaa-Cracy, Carl E. Schneider

Articles

The Department of Health and Human Services has recently been exercising its authority under the (wittily named) "administrative simplification" part of the Health Insurance Portability and Accountability Act to regulate the confidentiality of medical records. I love the goal; I loathe the means. The benefits are obscure; the costs are onerous. Putatively, the regulations protect my autonomy; practically, they ensnarl me in red tape and hijack my money for services I dislike. HIPAA (a misnomer-HIPAA is the statute, not the regulations) is too lengthy, labile, complex, confused, unfinished, and unclear to be summarized intelligibly or reliably. (Brevis esse laboro, …

Preparing The Groundwork For A Responsible Debate On Stem Cell Research And Human Cloning, O. Carter Snead

Journal Articles

The debate over both cloning and stem cell research has been intense and polarizing. It played a significant role in the recently completed presidential campaign, mentioned by both candidates on the stump, at both parties' conventions, and was even taken up directly during one of the presidential debates. The topic has been discussed and debated almost continuously by the members of the legal, scientific, medical, and public policy commentariat. I believe that it is a heartening tribute to our national polity that such a complex moral, ethical, and scientific issue has become a central focus of our political discourse. But, …

A Legal Framework For Preventing Cardiovascular Diseases, Wendy Collins Perdue

Law Faculty Publications

Cardiovascular diseases are major contributors to death, disability, disparities, and reduced quality of life in the United States. Successful prevention and control of these diseases requires a comprehensive approach applied across multiple public health settings and in all life stages. Individual lifestyle and behavior change, as well as the broader social, environmental, and policy changes that enable healthy lifestyles, are necessary. Legal strategies can be powerful tools in this endeavor. This review presents seven such strategies applicable at the federal, state, and local levels that can be employed by healthcare providers, public health practitioners, legislators, and other policymakers. They include …

Internet Pharmacies: Why State Regulatory Solutions Are Not Enough, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

Internet pharmacies are an economic and communications miracle--and a regulatory nightmare. It is estimated that Americans spent some $3.2 billion in 2003 on medications from the Internet, but Internet pharmacies permit consumers to evade long-standing regulatory protections, particularly those that rely on the oversight of drug prescribing and dispensing by licensed physicians and pharmacists.

Legal Frameworks For Chronic Disease Prevention, Wendy Collins Perdue

Law Faculty Publications

Law is a tool that can be used to shape both private and government conduct so as to impact public health. There are at least seven different techniques of legal intervention, each of which has advantages and disadvantages. These techniques are: direct regulation through command and coercion; economic incentives to encourage private parties to behave in a particular way; indirect regulation through private enforcement such as tort law; altering the informational environment; directly providing services or infrastructure to the public; government acting as a "model citizen" with respect to its employees and facilities; and, inducing other levels of government to …