Law Commons^™

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

Timothy S. Jost

Not available.

Is Medicaid Constitutional?, Timothy Stoltzfus Jost

Timothy S. Jost

Not available.

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

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

Timothy S. Jost

Not available.

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

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

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

Timothy S. Jost

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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

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

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 …

Where Babies And Death-Row Inmates Intersect: Is Arbitrary Agency Decision-Making Supported Under Existing Law?, Lisa C. Blanton Bs., Mj.

Lisa C. Blanton BS., MJ.

The Food and Drug Administration (FDA) is the executive branch regulatory agency primarily responsible for protecting the nation’s drug products.^[1] The FDA recently made highly inconsistent decisions surrounding a new drug for the prevention of pre-term birth, Makena™ (hydroxyprogesterone caproate). During a lengthy approval process, FDA made laudatory public announcements and demonstrated high programmatic preference to expedite approval of Makena by assigning orphan status^[2] and granting accelerated “fast-track” approval time-frames.^[3] Despite these actions, within weeks of the approval, the FDA issued aggressive public statements against the product’s efficacy and safety and made supportive comments about a non-FDA …

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

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

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

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

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

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

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 …

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.

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 …

Privacy As A Tool For Antidiscrimination, Jessica Roberts

Jessica L. Roberts

Traditionally, laws that protect privacy and laws that prohibit discrimination have been considered distinct kinds of legal protections. This Essay challenges that binary on both practical and theoretical grounds. Using the Genetic Information Nondiscrimination Act (GINA) as a case study, it argues that lawmakers can use privacy law to further antidiscrimination goals. GINA, which prohibits genetic-information discrimination in health insurance and employment, does more than simply outlaw discriminatory conduct. It also prohibits employers from requiring—or even requesting—their employees’ genetic information. While GINA’s privacy and antidiscrimination protections have previously been viewed as discrete, this Essay reads them in concert, arguing that …

Synaptic Plasticity In Neurological Deficit As A Form Of Indemnification: The Utility Of Analogical Thinking, Madeleine Schachter, Madeleine Schachter

Madeleine Schachter

The need for creative problem-solving is as infinite as are the ways in which to engage in it. This article posits that one useful, albeit not flawless, mechanism in which to seek scientific advancements is through the use of analogical thinking. The technique has been invoked in virtually all disciplines, sometimes successfully and sometimes not. The utility of thinking by analogy lies, paradoxically, in its capacity to conceptualize a solution or a viable avenue of further inquiry as much as in its capacity to expose flaws in the analogical concept hypothesized. As such, it is an important means of stimulating …

"Introduction" (Chapter 1) Of Stories About Science In Law: Literary And Historical Images Of Acquired Expertise (Ashgate 2011), David S. Caudill

David S Caudill

This is the introductory chapter of Stories About Science in Law: Literary and Historical Images of Acquired Expertise (Ashgate, 2011), explaining that the book presents examples of how literary accounts can provide a supplement to our understanding of science in law. Challenging the view that law and science are completely different, I focus on stories that explore the relationship between law and science, and identify cultural images of science that prevail in legal contexts. In contrast to other studies on the transfer and construction of expertise in legal settings, the book considers the intersection of three interdisciplinary projects-- law and …

Gauging The Heartbeat Of E-Prescriptions? - A Retrospective Analysis, Samuel D. Hodge Jr., Alison Kilcourse

Samuel D. Hodge Jr.

Medication can treat infectious diseases, alleviate pain, and prevent complications from chronic illnesses. But they can also be harmful if not used properly. Medication errors injure at least 1.5 million people each year and studies demonstrate that these errors are due to illegible handwriting, improper prescribing, order miscommunication, product labeling, compounding, and misuse.

Conversion to an e-prescription system is the most prevalent recommendation to make this process safer. This technology generates medical prescriptions by using an automated data-entry system. Compared to paper or faxed prescriptions, e-prescribing is said to increase medication safety, provide better control of expenses, improve prescribing accuracy …

The Path Between Sebastian's Hospitals: Fostering Reconciliation After A Tragedy, Jonathan R. Cohen

Jonathan R. Cohen

On October 8, 2007, Horst and Luisa Ferrero brought their healthy but short, three-year-old son Sebastian to a university hospital for a “routine” test to determine whether he lacked human growth hormone. Two days later, following a tragic string of errors, Sebastian was pronounced brain dead. Approximately two weeks later, the hospital offered a detailed public apology to the parents for Sebastian’s death. Several months after the apology, the parents began working collaboratively with the hospital to improve patient safety at the hospital and to advocate for a new children’s hospital in their community. This paper is a case study …

Community Health Centers As A Model For Health Care Reform, Timothy Li

Timothy Li

This Note evaluates Community Health Centers (“CHCs”) as a model for health care reform by considering access, cost, and effectiveness of health care delivered through CHCs, as well as their system of corporate governance. This Note proposes that every medically underserved community adopt a CHC-based model to function as a health care safety net. Not only should the federal government increase support for CHCs, but CHCs should also continue to raise funds from government sources, private foundations, and community supporters. Even though alternative proposals for health care reform may exist, those proposals do not provide an adequate remedy to increase …

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.