The 2010 federal health insurance reform act includes an individual mandate that will require Americans to carry health insurance. This article argues that even if the mandate were to catalyze universal health insurance coverage, it will fall short on some of the policy objectives many hope to achieve through a mandate if implemented in a fragmented insurance market. To uncover this problem, this article sets forth a novel framework that disentangles three different policy objectives the individual mandate can serve. Namely, supporters of the mandate might hope for it to: (1) facilitate greater health and financial security for the uninsured (“paternalism”); (2) eliminate inefficiencies in health care delivery and financing (“efficiency”); and/or (3) require the healthy to buy insurance to help fund medical care for the sick (“health redistribution”). Health redistribution — the primary focus of this article — is a shifting of wealth from the healthy to the sick through the mechanism of risk pooling. Many see health redistribution as a means to enable all Americans to more equitably access medical care on the basis of need, rather than on the basis of ability or willingness to pay.

Drawing on evidence from the implementation of an individual mandate in Massachusetts's health reform in 2006, this article reveals that the fragmented American health insurance market will thwart the mandate's ability to achieve these objectives— in particular the goal of health redistribution. Fragmentation is an atomization of the insurance market into numerous risk pools that has been driven by market competition and regulation. It prevents Americans from sharing broadly in the risk of poor health and, in doing so, entrenches a system where access to medical care remains tied to ability to pay and individualized characteristics. The final section of this article examines how various policies, including some in the new law (e.g., insurance regulation and exchanges) and others not (e.g., expanded public insurance), can reduce fragmentation so that the mandate can successfully serve all desired objectives and in the process gain greater legitimacy over time.

For years, commentators have debated how to most appropriately allocate scarce medical resources over large populations. In this paper, I abstract the major rationing schema into three general approaches: rationing by price, quantity, and prioritization. Each has both normative appeal and considerable weakness. After exploring them, I present what some commentators have termed the “moral paradigm” as an alternative to broader philosophies designed to encapsulate the universe of options available to allocators (often termed the market, professional, and political paradigms). While not itself an abstraction of any specific viable rationing scheme, it provides a strong basis for the development of a new scheme that offers considerable moral and political appeal often absent from traditionally employed rationing schema.

As I explain, the moral paradigm, in its strong, absolute, and uncompromising version, is economically untenable. This paper articulates a modified version of the moral paradigm that is pluralist in nature rather than absolute. It appeals to the moral, emotional, and irrational sensibilities of each individual person. The moral paradigm, so articulated, can complement any health care delivery system that policy-makers adopt. It functions by granting individuals the ability to appeal to an administrative adjudicatory board designated for this purpose. The adjudicatory board would have the expertise and power to act in response to the complaints of individual aggrieved patients, including those complaints that stem from the moral, religious, ethical, emotional, irrational, or other subjective positions of the patient, and would have plenary power to affirm the denial of access to medical care or to mandate the provision of such care. The board must be designed to facilitate its intended function while creating structural limitations on abuse of power and other excess. I make some specific suggestions on matters of structure and function in the hope of demonstrating both that this adjudicatory model can function and that it can do so immediately, regardless of the underlying health care delivery system or its theoretical underpinnings.

Individual conflicts of interest are rife in healthcare, and substantial attention has been given to address them. Yet a more substantive concern-institutional conflicts of interest (“ICOIs”) in academic medical centers (“AMCs”) engaged in research and clinical care—have yet to garner sufficient attention, despite their higher stakes for patient safety and welfare. ICOIs are standard in AMCs, are virtually unregulated, and have led to patient deaths. Upon review of ICOIs, we find a clear absence of substantive efforts to confront these conflicts. We also assess the Jesse Gelsinger case, which resulted in the death of a study participant exemplifying a deep-seated culture of institutional indifference and complicity in unmanaged conflicts. Federal policy, particularly the Bayh-Dole Act, also creates and promotes ICOIs. Efforts to address ICOIs are narrow or abstract, and do not provide for a systemic infrastructure with effective enforcement mechanisms. Hence, in this paper, we provide a comprehensive proposal to address ICOIs utilizing a “Centralized System” model that would proactively review, manage, approve, and conduct assessments of conflicts, and would have independent power to evaluate and enforce any violations via sanctions. It would also manage any industry funds and pharmaceutical samples and be a condition of participation in public healthcare reimbursement and federal grant funding.

The ICOI policy itself would provide for disclosure requirements, separate management of commercial enterprise units from academic units, voluntary remediation of conflicts, and education on ICOIs. Finally, we propose a new model of medical education—academic detailing—in place of current marketing-focused “education.” Using such a system, AMCs can wean themselves from industry reliance and promote a culture of accountability and independence from industry influence. By doing so, clinical research and treatment can return to a focus on patient care, not profits.

Critics of the current medical malpractice tort system claim that adjudication of malpractice claims before generalist judges and lay juries contributes to rising costs of medical malpractice insurance premiums and medical care. They claim that properly deciding issues in this realm requires specialized knowledge of medicine and medical technology that juries, and even judges of general jurisdiction, do not possess. One lobbying group alleges there is a continuing medical malpractice litigation crisis in the United States, evidenced by increasing medical costs, deaths from needless medical errors, departure of physicians from the practice of medicine due to increasing medical malpractice insurance premiums, and random medical justice in medical malpractice cases. Whether there is a direct, causal correlation between the increasing cost of medical malpractice insurance premiums and medical malpractice litigation is debatable.

Drug compounding is the long-standing pharmacy practice of mixing, combining, or altering ingredients to create drugs tailored to individual patient needs. Compounding is as old as the practice of pharmacy and close to the heart of the modern profession. Indeed, the mortar and pestle – an iconic emblem of compounding – have long been the prevailing symbol of pharmacy. Prior to the emergence of commercially available drug products, the practice of compounding was the practice of pharmacy – to create medicines, early pharmacists inevitably needed to extract and compound natural vegetable, animal, and mineral substances. In one impressive example of successful early compounding, God commanded Moses to “compoundeth” a holy anointing oil of myrrh, cinnamon, cassia, olive oil, and sweet calamus. Not generally one to shrink from a challenge, Moses followed God’s recipe and used his compounded oil to anoint the vessels of the Tabernacle and High Priest.

In Wyeth v. Levine, the Supreme Court held that an FDA-approved drug label did not preempt state tort law. Although the Supreme Court did not defer to the FDA's position, language in the opinion, and Breyer's concurring opinion, suggest that the FDA may be able to abrogate Wyeth v. Levine using the administrative law doctrine originally announced in Chevron v. Natural Resources Defense Council. That is, the FDA may claim deference to its position in a future case involving the same legal questions. This Note explains how Wyeth impacts the Chevron doctrine and identifies how the FDA assertion that drug labels preempt state law may win in a future case.