Seton Hall law review
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Patients with serious or life-threatening illness are frequently asked to make complex, high-stakes medical decisions. The impact of anxiety, low health literacy, asymmetric information and inadequate communication between patients and health care providers, family pressures, rational apathy by health care providers, cognitive biases of both patients and health care providers, and other factors make it quite difficult for patients in these circumstances to process and comprehend the strategic uncertainty and resultant risks and benefits of, and alternatives to, whatever therapeutic or life-prolonging treatment physicians are offering. All of these factors render the classic goal of "informed consent" unachievable in all but the rarest of circumstances: The effort to discuss and evaluate strategic uncertainty, its rational reduction into risks and benefits, and alternatives of treatment for purposes of optimizing decisional outcomes will have genuine intrinsic value only for ultra-rational patients (and physicians). ⋯ In the context of this persistent patient avoidance of substantive decision-making, empirical evidence demonstrates frequent reversion to a quantity-over-quality approach, allowing health care providers to "do everything" until continued medical intervention reaches the point of obvious medical or economic futility. As a result—and as a largely discounted trade-off of choosing to avoid decisional burdens through non-careful consideration or no consideration at all—the overwhelming result of rational patient apathy in end-of-life decision-making is an irrational calculation and decision unto itself. Not only does rational patient apathy negate the classic (and utopian) goal of informed consent, it also exerts tremendous costs--on patients, on loved ones, on health care providers and on society at-large--in terms of adverse effects, avoidable suffering, constantly recurring decisional commitment costs, and the wasting of scarce economic resources.
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For the better part of a decade, Americans have had a front-row seat to a fervent and turbulent debate over the future of their health care system. The passage of the Patient Protection and Affordable Care Act of 2010 (ACA), the most comprehensive health reform effort since the mid-1960s, ushered in a new era in health law and policy, granting millions of Americans access to health care. After multiple legal challenges and congressional efforts that ultimately failed to slay the law, the ACA had become entrenched by the end of the Obama administration, even though pieces of the law had failed to work exactly as planned. ⋯ Just because reimbursement policy has shifted to shoulder some of the regulatory burden of overtreatment does not mean that health care fraud--like fee-for-service medicine--should be confined to the past. In the end--and regardless of whatever legislation the national debate surrounding American health care produces--American medicine must adequately address its susceptibility to overtreatment, its incentives toward financial excess and waste, and its inability to push providers and entities into adopting more efficient practices. Medicare is finally moving quickly to bring about effective changes, and the program is seeking clarity in the midst of a period of tremendous uncertainty for American health care.
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Seton Hall law review · Jan 2011
Foreword: Follow-on Biologics: Implementation Challenges and Opportunities.
This Book of the Seton Hall Law Review presents the contributions to Follow-On Biologics: Implementation Challenges and Opportunities, a one-day roundtable event hosted by Seton Hall University School of Law in the fall of 2010. The roundtable fostered an international dialogue regarding the future of follow-on biologics in the United States resulting from the Patient Protection and Affordable Care Act of March 2010. THE BIOLOGIC PRICE COMPETITION AND INNOVATION ACT OF 2010. ⋯ A subtitle within PPACA, the Biologics Price Competition and Innovation Act (BPCIA), bestows upon FDA broad authority to implement an abbreviated approval route to market for biological products (also known as biologics) that are "biosimilar" to an existing marketed product. The brief introduction will provide a basic comparison of biologics and conventional pharmaceutical drugs that will prove central to the FDA's development of this follow-on biologic pathway as well as specifically examine the content and scope of the BPCIA provisions and identify future challenges for the FDA. It will conclude by highlighting details of presentations during the roundtable held at the Seton Hall University School of Law and introduce the two resulting articles contained with this Book of the Seton Hall Law Review.