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Articles 1 - 30 of 66
Full-Text Articles in Law
Loopholes In The Affordable Care Act: Regulatory Gaps And Border Crossing Techniques And How To Address Them, Timothy Stoltzfus Jost
Loopholes In The Affordable Care Act: Regulatory Gaps And Border Crossing Techniques And How To Address Them, Timothy Stoltzfus Jost
Timothy S. Jost
Not available.
The Real Constitutional Problem With The Affordable Care Act, Timothy Stoltzfus Jost
The Real Constitutional Problem With The Affordable Care Act, Timothy Stoltzfus Jost
Timothy S. Jost
Not available.
Is Medicaid Constitutional?, Timothy Stoltzfus Jost
The Most Important Health Care Legislation Of The Millennium (So Far): The Medicare Modernization Act, Timothy Stoltzfus Jost
The Most Important Health Care Legislation Of The Millennium (So Far): The Medicare Modernization Act, Timothy Stoltzfus Jost
Timothy S. Jost
Whether or not one believes that the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) in fact improves or modernizes Medicare, the legislation obviously changes the program radically. The extent and nature of these changes make the MMA the most important piece of health care legislation to be adopted by Congress to date in this young millennium. The MMA also contains what are arguably the most important amendments to the Medicare program since its creation. This Essay first describes the identifying characteristics of the current Medicare program, then examines the significant changes that the MMA makes in the program, and …
Medicare And Medicaid False Claims: Prohibitions And Sanctions, Timothy Stoltzfus Jost
Medicare And Medicaid False Claims: Prohibitions And Sanctions, Timothy Stoltzfus Jost
Timothy S. Jost
Both state and federal agencies are cracking down on health care professionals who file false Medicare claims, but physicians who make good faith attempts to comply with the law are fairly secure from prosecution, since both criminal and civil penalties must be based on willful or knowing breaches of the law.
The Supreme Court And The Future Of Medicaid, Timothy Stoltzfus Jost
The Supreme Court And The Future Of Medicaid, Timothy Stoltzfus Jost
Timothy S. Jost
Not available.
The Role Of Competition In Health Care: A Western European Perspective, Timothy Stoltzfus Jost, Diane Dawson, André Den Exter
The Role Of Competition In Health Care: A Western European Perspective, Timothy Stoltzfus Jost, Diane Dawson, André Den Exter
Timothy S. Jost
The Federal Trade Commission and Department of Justice 2004 report Improving Health Care: A Dose of Competition expresses a clear allegiance to competition as the organizing principle for health care. In Europe, by contrast, the key organizing principle of health care systems is solidarity. Solidarity means that all have access to health care based on medical needs, regardless of ability to pay. This is not to say that competition is not important in Europe, but competition must take place within the context of solidarity. This article critiques the report from a European perspective, describes the role of competition in Europe …
Pharmaceutical Research And Manufacturers Of America V. Walsh: The Supreme Court Allows The States To Proceed With Expanding Access To Drugs, Timothy Stoltzfus Jost
Pharmaceutical Research And Manufacturers Of America V. Walsh: The Supreme Court Allows The States To Proceed With Expanding Access To Drugs, Timothy Stoltzfus Jost
Timothy S. Jost
On May 19, 2003, the Supreme Court in Pharmaceutical Research and Manufacturers of America v. Walsh affirmed a court of appeals decision allowing for the implementation of the Maine Act to Establish Fairer Pricing for Prescription Drugs.' The Maine program attempted to leverage the considerable market power of the Medicaid program to force drug companies to offer the state a discount on pharmaceuticals. The state in turn would pass the savings on to its uninsured residents. Manufacturers that refused to negotiate a discount with the state would face the prospect of their products being available to Maine Medicaid recipients only …
The Independent Medicare Advisory Board, Timothy Stoltzfus Jost
The Independent Medicare Advisory Board, Timothy Stoltzfus Jost
Timothy S. Jost
It is a common realization that neither unconstrained markets nor our current political institutions are capable of governing our health care system. The cost of health care is spinning dangerously out of control, yet market forces alone cannot manage these costs because of a host of relatively well-understood market failures. Moreover, our traditional political institutions - Congress and the executive administrative agencies - have also failed us in this respect. These institutions are too driven by special interest politics and too limited in their expertise and vision to control costs. Both Medicare payment formulas and coverage determinations often seem to …
The Uses Of The Social Transformation Of American Medicine: The Case Of Law, Timothy Stoltzfus Jost
The Uses Of The Social Transformation Of American Medicine: The Case Of Law, Timothy Stoltzfus Jost
Timothy S. Jost
Not available.
Professional Sovereignty In A Changing Health Care System: Reflections On Paul Starr's The Social Transformation Of American Medicine, Timothy Stoltzfus Jost, Keith Wailoo, Mark Schlesinger
Professional Sovereignty In A Changing Health Care System: Reflections On Paul Starr's The Social Transformation Of American Medicine, Timothy Stoltzfus Jost, Keith Wailoo, Mark Schlesinger
Timothy S. Jost
Not available.
The American Right-Wing Policy Agenda, Timothy Stoltzfus Jost
The American Right-Wing Policy Agenda, Timothy Stoltzfus Jost
Timothy S. Jost
Right-wing health policy is alive and well in the United States. Pro-business and libertarian health policy advocacy groups, generously funded by right-wing foundations (and, in some instances, by the health care industry), produce a continuous stream of press releases, policy-statements, books, articles, and symposia, as well as testimony before legislative and administrative bodies. Their positions are taken very seriously by the American media, who make certain that right-wing policy experts are represented in any discussion of current health policy issues.
Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski
Doctors, Patients, And Pills--A System Popping Under Too Much Physician Discretion? A Law-Policy Prescription To Make Drug Approval More Meaningful In The Delivery Of Health Care, Michael J. Malinowski
Michael J. Malinowski
This article challenges the scope of physician discretion to engage in off-label use of prescription drugs. The discretion to prescribe dimensions beyond the clinical research that puts new drugs on pharmacy shelves has been shaped by two historic influences: a legacy of physician paternalism, solidarity, autonomy, and self-determination that predates the contemporary commercialization of medicine by more than half a century, and regulatory necessity due to the limits of science and innate crudeness of pharmaceuticals prior to the genomics revolution (drug development and delivery based upon genetic expression). Although both factors have changed immensely, the standard for drug approval has …
Public Assistance, Drug Testing And The Law: The Limits Of Population-Based Legal Analysis, Candice Player
Public Assistance, Drug Testing And The Law: The Limits Of Population-Based Legal Analysis, Candice Player
Candice T Player
In Populations, Public Health and the Law, legal scholar Wendy Parmet urges courts to embrace population-based legal analysis, a public health inspired approach to legal reasoning. Parmet contends that population-based legal analysis offers a way to analyze legal issues—not unlike law and economics—as well as a set of values from which to critique contemporary legal discourse. Population-based analysis has been warmly embraced by the health law community as a bold new way of analyzing legal issues. Still population-based analysis is not without its problems. At times Parmet claims too much territory for the population-perspective. Moreover Parmet urges courts to recognize …
The Aca’S Tobacco Use Rating: Implementation, Inconsistencies And Ironies, Mary Ann Chirba, Alice Noble
The Aca’S Tobacco Use Rating: Implementation, Inconsistencies And Ironies, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display. As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems. The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements.
Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba
Erisa Preemption Of State “Play Or Pay” Mandates: How Ppaca Clouds An Already Confusing Picture, Mary Ann Chirba
Mary Ann Chirba
From the introduction: Although ERISA preemption was ranked among the top "eight pertinent issues" that needed to be addressed in order to achieve comprehensive health care reform, Congress opted to avoid it when it passed the Patient Protection and Affordable Health Care Act on March 23, 2010, and the Health Care and Education Reconciliation Act just one week later ("PPACA" or the "Act", collectively). Currently 180 million Americans receive employer-sponsored health benefits, and millions more will do so once PPACA takes full effect over the next few years. This expansion of employer based coverage, coupled with what the Act does …
Medical Malpractice, The Affordable Care Act And State Provider Shield Laws: More Myth Than Necessity?, Mary Ann Chirba, Alice Noble
Medical Malpractice, The Affordable Care Act And State Provider Shield Laws: More Myth Than Necessity?, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, …
The Supreme Court On The Affordable Care Act: What We Are Waiting For, Mary Ann Chirba, Alice Noble
The Supreme Court On The Affordable Care Act: What We Are Waiting For, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
From the introduction: With the U.S. Supreme Court poised to rule on the Affordable Care Act (ACA) it is worth reminding ourselves of what, exactly, we have been waiting for. We await a judicial opinion that could deliver a decisive blow to all or part of a massive piece of legislation and the hard-fought battles that led to its enactment, or salvage the near-century-old quest for health care reform. At the same time we await an opinion that may reshape our fundamental understanding of the Court, the power of Congress, and long-standing principles of federalism.
The Supreme Court Upholds The Individual Mandate: But Who Are We Talking About?, Mary Ann Chirba, Alice Noble
The Supreme Court Upholds The Individual Mandate: But Who Are We Talking About?, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
From the introduction: While the Affordable Care Act’s individual mandate survived constitutional scrutiny in NFIB v. Sebelius, a Republican president and/or changes in the House or Senate this fall could lead to its demise. As campaigns shift into high gear, the law’s opponents will undoubtedly draw on the strident and jointly authored dissent of Justices Scalia, Kennedy, Thomas, and Alito. Despite the value of robust debate, relying on the dissent may be problematic due to its misperceptions about the ACA and the realities of health care. Thus, while we considered what we were waiting for in the weeks before the …
Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble
Our Bodies, Our Cells: Fda Regulation Of Autologous Adult Stem Cell Therapies, Mary Ann Chirba, Alice Noble
Mary Ann Chirba
Stem cells have been an endless source of fascination and controversy since Dolly the sheep was cloned in 1996. This month’s announcement of a cloned human embryo from a single skin cell came on the heels of Sir John B. Gurdon and Dr. Shinya Yamanaka’s receipt of the 2012 Nobel for Physiology and Medicine for their work with induced pluripotent stem cells. Pluripotent stem cells can be embryonic or induced. Embryonic stem cells (ESCs) can generally be obtained from human embryos or by cloning embryos through somatic cell nuclear transfer (SCNT), as was done for Dolly. Gurdon and Yamanaka demonstrated …
Life And Death Decision-Making: Judges V. Legislators As Sources Of Law In Bioethics, Charles Baron
Life And Death Decision-Making: Judges V. Legislators As Sources Of Law In Bioethics, Charles Baron
Charles H. Baron
In some situations, courts may be better sources of new law than legislatures. Some support for this proposition is provided by the performance of American courts in the development of law regarding the “right to die.” When confronted with the problems presented by mid-Twentieth Century technological advances in prolonging human life, American legislators were slow to act. It was the state common law courts, beginning with Quinlan in 1976, that took primary responsibility for gradually crafting new legal principles that excepted withdrawal of life-prolonging treatment from the application of general laws dealing with homicide and suicide. These courts, like the …
Licensure Of Health Care Professionals: The Consumer's Case For Abolition, Charles H. Baron
Licensure Of Health Care Professionals: The Consumer's Case For Abolition, Charles H. Baron
Charles H. Baron
While state medical licensure laws ostensibly are intended to promote worthwhile goals, such as the maintenance of high standards in health care delivery, this Article argues that these laws in practice are detrimental to consumers. The Article takes the position that licensure contributes to high medical care costs and stifles competition, innovation and consumer autonomy. It concludes that delicensure would expand the range of health services available to consumers and reduce patient dependency, and that these developments would tend to make medical practice more satisfying to consumers and providers of health care services.
The Concept Of Person In The Law, Charles Baron
The Concept Of Person In The Law, Charles Baron
Charles H. Baron
The focus of the abortion debate in the United States tends to be on whether and at what stage a fetus is a person. I believe this tendency has been unfortunate and counterproductive. Instead of advancing dialogue between opposing sides, such a focus seems to have stunted it, leaving advocates in the sort of “I did not!” – “You did too!” impasse we remember from childhood. Also reminiscent of that childhood scene has been the vain attempt to break the impasse by appeal to a higher authority. Thus, the pro-choice forces hoped they had proved the pro-life forces “wrong” by …
Medical Paternalism And The Rule Of Law: A Reply To Dr. Relman, Charles Baron
Medical Paternalism And The Rule Of Law: A Reply To Dr. Relman, Charles Baron
Charles H. Baron
In this Article, Professor Baron challenges the position taken recently by Dr. Arnold Relman in this journal that the 1977 Saikewicz decision of the Supreme Judicial Court of Massachusetts was incorrect in calling for routine judicial resolution of decisions whether to provide life-prolonging treatment to terminally ill incompetent patients. First, Professor Baron argues that Dr. Relman's position that doctors should make such decisions is based upon an outmoded, paternalistic view of the doctor-patient relationship. Second, he points out the importance of guaranteeing to such decisions the special qualities of process which characterize decision making by courts and which are not …
Assuring "Detached But Passionate Investigation And Decision": The Role Of Guardians Ad Litem In Saikewicz-Type Cases, Charles Baron
Assuring "Detached But Passionate Investigation And Decision": The Role Of Guardians Ad Litem In Saikewicz-Type Cases, Charles Baron
Charles H. Baron
The author focuses this Article upon the aspect of the Saikewicz decision which determines that the kind of "proxy consent" question involved in that case required for its decision "the process of detached but passionate investigation and decision that forms the ideal on which the judicial branch of government was created." This aspect of the decision has drawn much criticism from the medical community on the ground that it embroils what doctors believe to be a medical question in the adversarial processes of the court system. The author criticizes the decision from an entirely opposite perspective, arguing that the court's …
Addressing Early Marriage: Culturally Competent Practices And Romanian Roma (“Gypsy”) Communities, Judith Hale Reed
Addressing Early Marriage: Culturally Competent Practices And Romanian Roma (“Gypsy”) Communities, Judith Hale Reed
Judith A Hale Reed
Early marriage affects many communities around the world. Examples of commonly practiced early marriage can be found today in the U.S., India, Syria, and many other places. Although most countries have instituted minimum age laws for marriage, so that legal marriage can only occur after an age set by law, early marriage is still practiced for tradition, control, security, and other reasons. This article explores the harms of early marriage and the international instruments meant to defend against these harms in Part II. Part III reviews theoretical perspectives from legal anthropology and presents a case study of early marriage in …
Health Claim Regulation Of Probiotics In The Usa And The Eu: Is There A Middle Way?, Diane Hoffmann
Health Claim Regulation Of Probiotics In The Usa And The Eu: Is There A Middle Way?, Diane Hoffmann
Diane Hoffmann
In both the USA and Europe, supermarkets and pharmacies are brimming with probiotics—products containing live micro-organisms claiming they improve health. The availability of these products corresponds to a growing consumer demand for foods that improve or maintain health and wellness. The most persuasive include claims that consumption may confer health benefits. While some of these claims may have merit, others have not been substantiated. For a number of products, claims are based on insufficient research, underpowered studies, or mixed research results, yet individual consumers find that the product is of benefit to them. In attempting to regulate health claims, as …
Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel
Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel
Diane Hoffmann
This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.
Moral Gridlock: Conceptual Barriers To No-Fault Compensation For Injured Research Subjects, Leslie Henry
Moral Gridlock: Conceptual Barriers To No-Fault Compensation For Injured Research Subjects, Leslie Henry
Leslie Meltzer Henry
The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the …
Revising The Common Rule: Prospects And Challenges, Leslie Henry
Revising The Common Rule: Prospects And Challenges, Leslie Henry
Leslie Meltzer Henry
The annual Bioethics and Law Roundtable, jointly sponsored by the Law & Health Care Program at the University of Maryland Francis King Carey School of Law and the Johns Hopkins Berman Institute of Bioethics, convened in April 2012 to address "Human Subjects Research Regulations: Proposals for Reform." This paper serves as the introduction to the seven papers presented at the symposium that discuss the prospects and challenges of revising the Common Rule.