Annals of Health Law

Medicaid has been subject to reconsiderations of the proper role of government in providing for the health and welfare of populations over recent decades. Over the last decade in particular, a number of states have transferred many functions that they once performed to private entities, including, in a number of cases, express policymaking functions. The Patient Protection and Affordable Care Act (ACA) takes some crucial steps towards readjusting the equilibrium of Medicaid. Rather than further prioritizing the market in its reforms, it gives the federal government stronger charge of Medicaid policy, refocusing the program more directly on expanding eligibility and providing secure care for beneficiaries in the process...

This paper reviews barriers to clinical and financial integration in services for dual eligibles prior to passage of the ACA, identifies models used by states to integrate care through contract and waiver authorities available to CMS prior to passage of the ACA, describes two new demonstrations proposed by CMS through the Medicare-Medicaid Coordination Office and Innovation Center, and discusses several new models available for consideration by federal and state policymakers. These options draw on experience from existing programs and waivers to provide suggested changes to existing programs, as well as a permanent state plan option for a fully integrated, capitated care model...

This article explores the specific consequences to states as a result of expansion of the Medicaid program under PPACA. Jane McCahill and Joseph Van Leer explain the history of the Medicaid program, comparing and contrasting Medicaid pre-PPACA with Medicaid post-PPACA. The authors examine the use of managed care models by state Medicaid programs, describing the various forms of Medicaid managed care employed by the states. The authors then detail the significant changes resulting to Medicaid under PPACA. Finally, the article reviews the Medicaid managed care program in Illinois specifically, focusing on reform of the Illinois Medicaid program to be effectuated over the next few years...

This essay explores the conflicting positions taken by the United States in its Medicaid-related briefs before the Supreme Court this October 2011 Term. In Douglas v. Independent Living Center, the United States articulated a deferential stance toward the states, a position consistent with longstanding states' rights concerns in the Medicaid program. On the other hand, the federal government has advocated a very broad view of federal authority under the spending power to modify and expand Medicaid in Florida v...

No abstract text is available yet for this article.

Currently, pharmaceutical companies' utilization of foreign clinical trial data is a ubiquitous and indispensable aspect of gaining approval to market drugs in the United States. Cost benefits, a larger pool of ready volunteer subjects, and greater efficiency in clinical testing are some of the reasons for conducting clinical trials overseas. Despite these advantages, lack of proper oversight may have serious public health implications regarding the integrity of clinical research, ethical treatment of human subjects, and drug safety...

In 2011, the United States Supreme Court in Sorrell v. IMS Health Inc. struck down a Vermont law that would restrict the ability of pharmaceutical companies to purchase certain physician-identifiable prescription data without the consent of the prescriber. The law's stated purpose was threefold: to protect the privacy of medical information, to protect the public health and to contain healthcare costs by promoting Vermont's preference in having physicians prescribe more generic drugs. The issue before the Supreme Court was whether the Vermont law represented a legitimate, common sense regulatory program or a bold attempt to suppress commercial speech when the "message" is disfavored by the state...

Most tobacco control laws were written to address the scourge of smoking--particularly smoking cigarettes. As a result, these laws frequently exclude non-cigarette tobacco products, which are becoming more prevalent on the market. These regulatory gaps jeopardize public health by increasing the possibility that these products will be used--particularly by minors and young adults. This article examines gaps in regulation using five products as case studies: dissolvable tobacco products, electronic cigarettes, little cigars, snus, and water pipes...

The idea that genetic information is different from other medical information and therefore needs special protection has led to a regulatory puzzle where genetic testing is currently regulated under three separate schemes. Although genetic tests for over 2,000 diseases are available, less than 10% of these tests have been reviewed for clinical validity or utility. Recent action by some genetic testing companies has prompted the federal government to propose changes to the current regulatory scheme. This article discusses the current framework and the recent developments before examining some of the concerns and challenges that face the implementation of these proposed changes...

Over the past century, medical advancements have resulted in tremendous health gains for Americans. Although the federal government has played a prominent role in ensuring that new treatments are safe and effective, questions about which medical treatments work best under which circumstances have largely remained unanswered. Thus, the federal government's recent major investments in comparative-effectiveness research have potential to play a significant role in helping both patients and health care providers navigate the vast array of available treatment options, as well as in improving the quality, efficiency, and delivery of health care system-wide...

This Article proposes a new direction for addressing financial conflicts of interest, which plague biomedical research and threaten scientific integrity. This Article descriptively states the controversy surrounding financial conflicts of interest by explaining how these conflicts arise and the damage that can be created as a result. By describing the scientific process, the Article explains that changes to the academic environment may allow the public-private interaction to proceed, without creating the problems associated with financial conflicts of interest...

The dominant rhetoric in the health care policy debate about cost has assumed an inherent tension between access and quality on the one hand, and cost effectiveness on the other; but an emerging discourse has challenged this narrative by presenting a more nuanced relationship between access, quality, and cost. This is reflected in the discourse surrounding health literacy, which is viewed as an important tool for achieving all three goals. Health literacy refers to one's ability to obtain, understand and use health information to make appropriate health decisions...

The Patient Protection and Affordable Care Act of 2010 provides incentives for healthcare to be delivered by Affordable Care Organizations (ACOs). The public face of many, if not most, ACOs is likely to be the Patient Centered Medical Home (PCMHs), a business structure that evolved from Retail Medical Clinics, which made greater use of physician extenders (PAs). Accordingly, this paper examines the evolution and structure of PCMHs as well as how the PCMH is regulated. As neither legal or market regulatory mechanisms are ideal for policing business structures that employ PAs, this paper concludes that the tort reform most appropriate for PCMHs is the introduction of either no-fault or enterprise liability coverage...

This article seeks to examine the conflict between non-cost-conscious medical malpractice liability standards and health care cost cutting measures within the context of Accountable Care Organizations ("ACOs") under the new health care reform law. This article begins by providing an overview of the high level of health care spending within the United States health care system in order to provide a context for better understanding policymakers' push for cost cutting measures, including ACOs. This article then examines the tension between cost containment efforts and medical liability standards through an examination of the "stuck in the middle" mentality that physicians face when they are forced to meet both liability standards that do not take into account cost concerns and cost cutting standards imposed by or through managed care organizations, pay-for-performance programs and consumer-driven healthcare...

Four key challenges to reforming health care organizations can be addressed by a clinical integration model patterned after Advocate Physician Partners (APP). These challenges are: predominance of small group practices, dominant fee-for-service reimbursement methods, weaknesses of the traditional hospital medical staff structure and a need to partner with commercial insurance companies. APP has demonstrated teamwork between 3800 physicians and hospitals to improve quality, patient safety and cost-effectiveness...

Public health laws may mandate drastic limitations on individual liberty, such as forced medication and quarantine. This results in a tension between public health laws and guarantees of liberty such as the Due Process Clauses of the Fifth and Fourteenth Amendments to the United States Constitution. The Supreme Court has resolved this tension in favor of one or the other of these legal principles, depending on the facts and issues involved. Nevertheless, Supreme Court jurisprudence is internally consistent...

Pharmacy benefit management (PBM) companies are the middlemen of the pharmaceutical industry, designing plans for sponsors and insurers and pushing the products of manufacturers. Their unique position can often create conflicts of interest, which has been the basis of much litigation. This article reviews the structure of the PBM industry and analyzes concerns arising from its handling of prescription drug pricing, manufacturer rebates and discounts, and mail order pharmacies. After surveying several legislative proposals, it concludes with a comprehensive outline for legislation to eliminate underhanded dealing in the industry and lower the cost of prescription drugs...

This article addresses the federal government's expansive methods in tackling healthcare fraud, particularly in misapplying the False Claims Act. Although tasked with the obligation to curtail the fraudulent submission of Medicare & Medicaid claims, the U.S. government must rein in the current trend to utilize the False Claims Act against smaller medical providers. As the Act's original focus has ebbed in significance, the government has increasingly applied the False Claims Act to circumstances that do not evince actual fraud...

Considering the ultimate goals of preventing the over-utilization of medical services and protecting the Medicare program, are the numerous phases of the Stark Law and their concomitant regulations effective; or, conversely, has the legislation served to impede entrepreneurialism among physicians to the detriment of innovations and better integration in the delivery of medical treatment? This article endeavors to answer the above question through an analysis of the policy goals behind the legislation; the evolution of its regulations; its effect on competitiveness in the field of medicine; and the ethical considerations implicated by the issue of physician self-referral...

On February 4, 2010 the Illinois Supreme Court struck down Illinois' medical practice reform bill, P.A. 94-677, when it decided Lebron v. Gottlieb Memorial Hospital. Although the court only considered the unconstitutionality of the cap on non-economic damages contained in that bill, an inseverability provision resulted in the invalidation of all of its provisions. The end result of the Lebron decision extends much further than the striking of the cap on non-economic damages. It affects such areas as medical liability insurance law, physician discipline, public disclosure of information, the admissibility of physician statements into evidence, and expert witness standards...