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Back Issues and Articles
Back Issues and Articles

Table of Contents
Table Of Contents
AJLM - [PDF] (Free Download)
American Journal of Law & Medicine Volume 37, Number 1 * 2011 Articles: 7 Clinical Practice Guidelines: The Warped Incentives in the U.S. Healthcare System Ronen Avraham 41 Healing Medicare Hospital Recidivism: Causes and Cures Ann Marie Marciarille 81 Modernizing Medicaid Eligibility Criteria for Children with Significant Disabilities: Moving from a Disabling to an Enabling Paradigm MaryBeth Musumeci 128 Planning for Pandemic: A New Model for Governing Public Health Emergencies Leslie E. Gerwin Notes and Comments: 172 Cheaper Clinical Trials: The Real Solution to the Biologic Industry's Gordian Knot Alana Montas 194 Recent Case Developments
Articles
Clinical Practice Guidelines: The Warped Incentives in the U.S. Healthcare System
Ronen Avraham - [PDF]

The healthcare system is sick. The players are incentivized to maximize their own benefit and externalize their costs onto the other parties. This paper examines the warped incentives that underlie the system. The tort system, lacking expertise and slow to adapt, is unable to overcome cognitive biases to adequately solve the problems. Clinical practice guidelines could pose a solution, but not as they are currently developed. Guidelines promulgated by healthcare associations are infected by a web of conflicts of interest with every player in the industry. Government agencies, and their revolving doors, are underfunded and also subject to the industry's web of conflicts. Even if adequate guidelines could consistently be produced, state legislatures and courts have been unwilling and unable to substantially incorporate guidelines into the legal landscape. Lastly, this article proposes a private regulation regime that could be a solution which would align all of the players' incentives to society's interests.
Healing Medicare Hospital Recidivism: Causes and Cures
Ann Marie Marciarille - [PDF]

The role of Medicare in our national market for acute care hospital services is that of a power buyer. Medicare beneficiaries in 2008 included some 45.2 million people. Total benefits paid in 2008 were $462 billion, including 29% of all hospital spending. Medicare's dominance in the buyer's market for acute care hospital beds renders the program particularly well suited to scrutinize the role of acute care hospital services in producing effective and efficient outcomes for Medicare beneficiaries. "If there are to be far-reaching changes in the way medicine is practiced in this country, Medicare will have to drive them." It is a historical irony that a program, a scaled down version of national health insurance, could have grown to this power buyer status; but the history of Medicare is full of ironies--the greatest of which may prove to be that Medicare reforms now sit at the very center of the funding mechanisms for the 2010 Patient Protection and Affordable Care Act (PPACA).
Modernizing Medicaid Eligibility Criteria for Children with Significant Disabilities: Moving from a Disabling to an Enabling Paradigm
MaryBeth Musumeci - [PDF]

Children with significant disabilities may qualify for Medicaid benefits, regardless of household income, if their state elects to offer the Tax Equity Fiscal Responsibility Act (TEFRA) option. However, a significant number of children with serious medical problems presently are being denied eligibility for, or terminated from, this Medicaid program. This Article describes the ways in which the existing health insurance system inadequately meets the needs of children with significant disabilities, recounts the history and development of the TEFRA Medicaid coverage option, and analyzes the eligibility criteria used by the various states. It proceeds to consider how disability should be legally defined in the health care context and proposes reforms to modernize the eligibility standards so that these benefits can be more effectively, efficiently, and fairly allocated. To accomplish this goal, the federal statute and regulation that define disability, as well as corresponding state laws, must be reformed so that the law can keep pace with advances in modern medical science, and people with disabilities are not, in effect, penalized for receiving currently accepted preventative care that maintains health but will never cure the underlying disease.
Planning for Pandemic: A New Model for Governing Public Health Emergencies
Leslie E. Gerwin - [PDF]

Imagine the following scenario: The Centers for Disease Control confirms the appearance of a heretoforeunknown virus. It appears highly contagious since it is spreading easily between human beings. At this initial stage, the largest cohort of victims is youth in their late teens. There is no geographic locus of the disease or single identifiable index case from which the virus's origin can be determined. The disease is independently prevalent in many geographic areas, particularly among those living in the inner cities of major metropolitan areas in the United States and in some of the densely populated immigrant enclaves in European cities. At this point, the mortality is uncertain although in its early phase it is at least as deadly as a seasonal flu. It is the end of May: young people are dreading final exams, anticipating their high school and college graduations, and looking forward to the many end of the year celebrations. The weather is getting warmer, and the public pools are about to open. Despite the hot weather, the prevalence of the disease is not significantly waning. Americans are nervous. They want answers. They expect their government to protect them.
Cheaper Clinical Trials: The Real Solution to the Biologic Industry's Gordian Knot
Alana Montas - [PDF]

Biologics include a wide range of products, such as vaccines, allergenics, gene therapies, and tissues, among others. Biologics are complex combinations of sugars, proteins, or nucleic acids that are produced by biotechnology methods or other advanced technology. Biologics often represent the only medical treatment for complex medical conditions such as: Hepatitis B; Measles, Mumps, Rubella and Varicella; and Tetravalent meningococcal conjugate among others. As a result, biologic sales are growing at twice the rate of chemical pharmaceuticals and are expected to exceed $158 billion by 2015. Various interest groups, including patients, insurers, and regulatory agencies, raised concerns about the financial impact that biologics may have on health care costs. Congress and the Food and Drug Administration (FDA) faced pressure to provide a solution to the soaring biologic costs, namely through a regulatory pathway for generic biologics ("follow-on biologics") to manufacture cheaper products. Although a regulatory pathway for generic chemical pharmaceuticals ("generic") exists under the Hatch-Waxman Act, a similar regulatory pathway for follow-on biologics did not exist prior to 2010.
Recent Court Decisions
Recent Case Developments (E-cigarettes)
Laura Kirshner - [PDF]

D.C. Circuit Rules FDA Cannot Block E-cigarette Imports - Sottera, Inc. v. FDA - The United States Court of Appeals for the District of Columbia Circuit held that the Food and Drug Administration's (FDA) authority to regulate electronic cigarettes (e-cigarettes) derives from the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Act), rather than from the Federal Food, Drug, and Cosmetic Act (FDCA); thus the FDA lacks the authority to ban the importation of e-cigarettes into the United States. E-cigarettes are smokeless, flameless, battery-powered devices that vaporize liquid nicotine for the user to inhale. While the nicotine in ecigarettes is derived from tobacco, the e-cigarette itself contains no tobacco. E-cigarettes thus allow the user to satisfy a nicotine craving without ingesting the harmful chemicals contained in traditional tobacco products such as cigarettes, cigars, and smokeless tobacco.
Recent Case Developments ( Alzheimer's Disease)
Julia Tebor - [PDF]

New Federal Law Calls for Government, Public Attention to Alzheimer's Crisis - The National Alzheimer's Project Act - The National Alzheimer's Project Act (NAPA) strives to combat Alzheimer's disease by accelerating development of Alzheimer's treatments and cures, bettering methods for early diagnosis, and broadening research diversity through federally coordinated cost-efficiency planning. Alzheimer's disease is a brain disease that is both irreversible and progressive, which makes it increasingly difficult for patients to live independently once they lose cognitive function. Much about Alzheimer's disease, including the disease's causes, remains a mystery, but researchers have found that damage, in the form of tangles or plaque in the brain, starts to appear as early as ten to twenty years before symptoms become evident. Scientists believe that genetic, environmental, and lifestyle factors are all likely contributors to the disease.