“Guilty but mentally ill” legislation responds to the increasing outbreak of violent crimes and to public skepticism concerning the ability of psychiatrists to determine the advisability of a criminal's return to society. Under this alternative to the traditional insanity defense, once the defendant chooses to plead not guilty by reason of insanity, the trier of fact may elect to find him guilty, but mentally ill. This may occur when it is determined that the defendant's mental illness is not severe enough to negate culpability. The court must then sentence the defendant to a term in prison instead of committing him to a psychiatric institution.

This Note discusses the origins of the guilty but mentally ill verdict and outlines the development of commitment standards for civil patients and insanity acquittees. While these standards appeared to be merging for a period of time the more recent trend has been to treat civil patients and insanity acquitees differently. This Note maintains that the guilty but mentally ill verdict involves an unnecessarily severe curtailment of the mentally ill offender's constitutional rights.

The Note delineates a proposal critiquing the misconceptions on which the statute is based and the excessive restraints on liberty it causes. The proposal examines the reasons for the public's misgivings with the insanity defense and suggests that the threat to the public's safety may not be as serious as it appears. Furthermore, it indicates that while problems remain with the existing insanity defense, the solution to those problems provided by the guilty but mentally ill statute outweighs the risk that insanity acquittees pose to the public.

Non-communicable and chronic diseases have overtaken infectious diseases as the major causes of death and disability around the world. Despite recognition that reduction in the chronic disease burden will require governance systems to address the social determinants of health, most public health recommendations emphasize individual behavior as the primary cause of illness and the target of intervention. This Article argues that focusing on lifestyle can backfire, by increasing health inequities and inviting human rights violations. If States fail to take meaningful steps to alter the social and economic structures that create health risks and encourage unhealthy behavior, health at the population level is unlikely to improve significantly. Viewing the global health challenge from the perspective of human rights, however, reveals opportunities for positive change in all sectors of governance. Explicit recognition of human rights can help refocus attention on the fundamental causes of health and protect individuals from unnecessary harm.

Accelerating the development and approval of novel therapeutics has emerged as a key public health priority given the mortality, morbidity, and economic costs associated with infections caused by drug-resistant bacteria. However, there is limited empirical evidence to guide policymaking, such as the factors that may disadvantage antibiotics compared to other classes of drugs. In this Article, we empirically examine characteristics of the key clinical trials underpinning FDA's approval of antibiotics and other drugs over the past decade. Despite perceptions that antibiotic trials are larger and more difficult to conduct, we find that antibiotic trials are no larger than those conducted for drugs approved in other disease areas with high unmet medical needs, suggesting that policymakers may need to target other levers to meaningfully stimulate innovation. We discuss the risks and benefits of harnessing new and existing regulatory pathways to speed the approval of new drugs, particularly those intended to treat patients with serious and life-threatening infections, and we evaluate ways that proposals for new regulatory pathways could be improved to better prioritize and expedite the approval of therapies with the greatest potential for patient health benefits.

During the last year, the proposal of “enterprise” liability for medical malpractice became a major issue in debates about health care and malpractice reform. The idea, however, was not new. In scholarly work over an extended period, we have been developing the systematic case for the concept of enterprise — or, as we originally termed it, “organizational” — liability for medical malpractice. After several years of debating the critics of our proposal to shift the focus of liability for medical injury from individual physicians to the organizations that deliver health care, we were naturally gratified that the idea was now on the national agenda.

In particular, we recommended adoption of enterprise liability to President Clinton's Health Care Task Force. The Task Force did embrace a version of the idea as its own, but then encountered stiff resistance from a number of special interests.

Laws for the protection of public health control either the environment, as in the case of sanitation or air pollution regulations, or human conduct. This Article deals with limitations imposed upon individuals in order to prevent the spread of communicable disease and the harm resulting from mental illness. The restraints discussed include compulsory examination and immunization, and forms of compulsory detention or commitment.

This Article is a revised chapter of the author's Public Health Law Manual, first published by the American Public Health Association in 1965. The Manual is intended to help public health professionals to understand the law relevant to their practice, and to apply it more effectively.

Good Samaritan laws provide legal immunity to persons who assist in medical emergencies. Because good Samaritan laws eliminate the common law right of victims to secure redress for their injuries, these statutes raise certain constitutional questions. The Article begins by examining the vulnerability of good Samaritan statutes to federal constitutional attack on substantive due process and equal protection grounds. It then considers the susceptibility of such laws to state constitutional attack on the same grounds. The Article concludes that while such statutes are not likely to violate federal substantive due process and equal protection provisions, they may be held unconstitutional on similar state grounds.

This Comment explores issues concerning the control of fraud and abuse in health programs financed with public funds, specifically the Medicare and Medicaid programs. It summarizes the nature, scope, and possible causes of what some regard as a fraud and abuse “crisis,” and points out the difficulties and obstacles facing those who attempt to develop legislative and executive action aimed at controlling fraud and abuse. Recent federal initiatives in fraud and abuse control are examined, and a brief summary of key provisions of H.R. 3 (the Medicare-Medicaid Anti-fraud and Abuse Amendments, which may prove to be a landmark piece of legislation in this area) is provided. The author emphasizes that more effective control of fraud and abuse is necessary if further expansion of government financing of health programs, including national health insurance, is to occur in the near future. At the same time, caution must be taken not to neglect the appropriate use of other mechanisms necessary for reducing the costs of medical care and improving its quality. In addition, it is likely that efforts to stem fraud and abuse will raise important medicolegal and public policy issues that will require careful interdisciplinary consideration.

Scientific studies continue to establish a strong relationship between constituents in foods and dietary supplements and certain diseases. The general population is inundated on a seemingly daily basis by media reports of new studies showing that a food or dietary supplement is useful in treating particular diseases or reducing the likelihood that a consumer will develop particular diseases. With increasing frequency, consumers are looking for foods and supplements to help manage and prevent the onset of disease.

Not surprisingly, the food and dietary supplement industries are responding by developing new products and repositioning old products efforts to help consumers manage their health. For example, yogurt used to be positioned only as a delicious component of a meal but now is also promoted for use in weight loss programs after a study showed that the calcium in dairy products is effective in weight loss.

Employer-provided health insurance is the backbone of the American healthcare system. Approximately four of five workers in the United States rely on health insurance provided in the workplace. Many commentators view access to health insurance as the doorway to the entire health care system. Thus, the benefits covered in employer-provided health insurance plans significantly impact millions of Americans.

While private health insurance usually covers abortion, it traditionally has not covered infertility services. Eventually, courts began interpreting insurance contracts to include infertility treatments, leading insurers to specifically exclude infertility treatments from coverage. In response, a few states have passed mandated benefit laws requiring coverage of some or all infertility services. Nonetheless, current insurance coverage of infertility services is “erratic” at best. These exclusions are significant because abortion and infertility services can be quite expensive for the millions of infertile couples seeking some sort of infertility treatment and the millions of women who have abortions each year.

This Article links the legal evolution of mandatory medical prescription since 1900 to the police-power's prohibition of alcohol and the opiates as well as to the self-interested monopolization of new drugs by physicians. The Article advances a theory of professionalization consistent with the evidence that mandatory prescription is not in the public interest. The Article suggests that the supremacy of self-medication is consistent with competition policy, the medical profession's fiduciary duty to clients, reduced medical costs and improved health. The author analyzes the consequences of regulating drug production, testing, marketing and consumtion by granting decision-making authority to the lowest-cost risk avoider, suggesting this as a plausible basis for legal reform.

Notwithstanding the continuing debate over the future of managed care and the appropriate protections to be included in a Patient's Bill of Rights, the safeguarding of patient privacy and the reduction of medical error have emerged as the dominant health law issues. Displacing even the implications of the advances in genomics from the front and editorial pages of our newspapers, privacy and medical error have left the cozy world of professional journals and political platitudes to demand corrective action.

Despite the U.S. substantially outspending peer high income nations with almost 18% of GDP dedicated to health care, on any number of statistical measurements from life expectancy to birth rates to chronic disease,1 the U.S. achieves inferior health outcomes. In short, Americans receive a very disappointing return on investment on their health care dollars, causing economic and social strain.2 Accordingly, the debates rage on: what is the top driver of health care spending? Among the culprits: poor communication and coordination among disparate providers, paperwork required by payors and regulations, well-intentioned physicians overprescribing treatments, drugs and devices, outright fraud and abuse, and medical malpractice litigation.

Fundamentally, what is the best way to reduce U.S. health care spending, while improving the patient experience of care in terms of quality and satisfaction, and driving better patient health outcomes? Mergers, partnerships, and consolidation in the health care industry, new care delivery models like Accountable Care Organizations and integrated care systems, bundled payments, information technology, innovation through new drugs and new medical devices, or some combination of the foregoing? More importantly, recent ambitious reform efforts fall short of a cohesive approach, leaving fundamental internal inconsistencies across divergent arms of the federal government, raising the issue of whether the U.S. health care system can drive sufficient efficiencies within the current health care and antitrust regulatory environments.

While debate rages on Capitol Hill over “repeal and replace,” only limited attention has been directed toward reforming the current “fee-for-service” model pursuant to which providers are paid for volume of care rather than quality or outcomes. Indeed, both the Patient Protection and Affordable Care Act (“ACA”)3 and proposals for its replacement focus primarily on the reach and cost of providing coverage for health care, rather than specifics for the delivery of health care.4 With the U.S. expenditures on health care producing inferior results, experts see consolidation and alternatives to fee-for-service as fundamental to reducing costs.5 Integrating care coordination and delivery and increasing scale to drive efficiencies allows organizations to benefit from shared savings and relationships with payors and vendors.6 Deloitte forecasts that, by 2024, the current health system landscape—which includes roughly 80 national health systems, 275 regional systems, 130 academic medical centers, and 1,300 small community systems—will morph into just over 900 multi-hospital systems.7

Even though health care market and payment reforms encourage organizations to consolidate and integrate, innovators must proceed with extreme caution. Health care organizations attempting to drive efficiencies and bring down costs through mergers may run afoul of numerous federal and state laws and regulations.8 Calls for updates or leniency in these laws are growing, including the possible recognition of an “Obamacare defense” to antitrust restrictions9 and speculation that laws restricting physicians from having financial relationships will be repealed, ostensibly to allow sharing of the rewards reaped from coordinated care.10 In the meantime, however, absent specific waivers or exemptions, all the usual rules and regulations apply, including antitrust constraints,11 physician self-referral12 and anti-kickback laws and regulations,13 state fraud and abuse restrictions,14 and more. In short, a maelstrom of conflicting political prescriptions, health care regulations, and antitrust restrictions undermine the ability of innovators to achieve efficiencies through joint ventures, transactions, innovative models, and other structures.

This article first considers the conflicting positions taken by the United States government with respect to achieving efficiencies in health care under the ACA and alternative delivery models, on the one hand, and health care regulatory enforcement and antitrust enforcement, on the other. At almost a fifth of the U.S. economy,15 health care arguably has grown ungovernable, exceeding the ability of any one law or branch of government to create or implement coherent reform. Indeed, the article posits that although the ACA reformed and expanded access to health care, it failed to transform the way health care is delivered beyond limited “demonstration projects”, leaving fee-for-service intact. Nonetheless, even with limited rather than revolutionary goals, the ACA still lacks sufficient authority across disparate branches of government to achieve its stated goals. The article then examines the conflicting positions of the various United States regulatory schemes and enforcement agencies governing health care, and whether they can be reconciled with the stated goal of the government, often referred to as the “Triple Aim”:16 improving quality of care, improving population health, and lowering health care costs. It examines fundamental, systemic challenges to achieving the “Triple Aim”: longstanding health care regulatory laws that impede adoption of innovative delivery systems beyond their current “demonstration project” status, and antitrust enforcement that promotes waste and duplication in densely populated areas, while preventing necessary consolidation to more efficiently reach rural areas. The article concludes with recommendations for promoting efficiency through modest reconciliation of the conflicting goals and regulations in health care.

The dramatic growth of medical malpractice litigation in recent decades has contributed significantly to an overall increase in health care costs in this country. Although lawmakers, physicians, and other responsible citizens have proposed numerous solutions in an effort to curb die crisis, diese proposals have generally been ineffective.

In this Article the Audior endorses countersuits as die most appropriate response to frivolous medical malpractice actions. The Author also suggests that contingent fee systems, coupled with the economic motivation of private insurers to settle claims quickly, provide incentive for plaintiffs to initiate frivolous claims.

This Article analyzes the general legal approaches available for countersuits, emphasizing recent successful actions based on malicious prosecution and abuse of process, and proposes more widespread use of diese approaches.

In 2009, health care expenditures in the United States totaled $2.5 trillion and accounted for almost eighteen percent of the national Gross Domestic Product (GDP). Rising health care costs are an increasing concern in the national health care industry and in government policy reform. When estimates show that thirty percent of health care is unnecessary, improving quality and efficiency of health care could eliminate a significant amount of excessive spending.

Prescription drugs contributed to ten percent of national health expenditures in 2009, comprising about $250 billion. And while the rate of growth for overall health care spending declined as a result of the recent recession, “the number of prescription drugs dispensed rebounded to prerecession rate of growth.” Estimates show that off-label drug use comprises between twenty and sixty percent of U.S. prescriptions. This could be a troubling percentage considering that off-label use carries an increased risk of harm or ineffectiveness.

Antibiotic resistance menaces the population as a dire public health threat and costly social problem. Recent proposals to combat antibiotic resistance focus to a large degree on supply side approaches. Suggestions include tinkering with patent rights so that pharmaceutical companies have greater incentives to discover novel antibiotics as well as to resist overselling their newer drugs already on market. This Article argues that a primarily supply side emphasis unfortunately detracts attention from physicians' important demand side influences. Physicians have a vital and unavoidably necessary role to play in ensuring socially optimal access to antibiotics. Dismayingly, physicians' management of the antibiotic supply has been poor and their defense of population health tepid at best. Acting as a prudent steward of the antibiotic supply often seems to be at odds with a physician's commonly understood fiduciary duties, ethical obligations, and professional norms, all of which traditionally emphasize the individual health paradigm as opposed to population health responsibilities. Meanwhile, physicians face limited incentives for antibiotic conservation from other sources, such as malpractice liability, regulatory standards, and reimbursement systems. While multi-faceted efforts are needed to combat antibiotic resistance effectively, physician gatekeeping behavior should become a priority area of focus. This Article considers how health law and policy tools could favorably change the incentives physicians face for antibiotic conservation. A clear lesson from the managed care reform battles of the recent past is that interventions, to have the best chance of success, need to respect physician interest in clinical autonomy and individualized medicine even if, somewhat paradoxically, vigorously promoting population health perspectives. Also, physicians' legal and ethical obligations need to be reconceptualized in the antibiotic context in order to better support gatekeeping in defense of population health. The principal recommendation is for increased use of financial incentives to reward physicians for compliance with recommended guidelines on antibiotic prescribing. Although not a panacea, greater experimentation with financial incentives can provide a much needed jump-start to physician interest in antibiotic conservation and likely best address physicians' legitimate clinical autonomy concerns.

Hospitals in the United States rely on peer review committees to make credentialing decisions and to conduct ongoing evaluations of all medical care, thereby ensuring the quality of the physicians they employ. Physicians, however, may be reluctant to serve on peer review committees for fear of retaliatory litigation. In response, and in an effort to improve the quality of healthcare in the United States, Congress passed the Health Care Quality Improvement Act of 1986 (“HCQIA”).

Congress designed the HCQIA to improve the quality of healthcare in two ways. First, it increased the effectiveness of peer review by providing review committees with immunity from lawsuits filed in response to professional review actions. Second, it authorized the Secretary of Health and Human Services (“HHS”) to create the National Practitioner's Data Bank (“NPDB”). Any disciplinary action taken by a review committee must, as a condition to immunity, be reported for listing in the NPDB.

With respect to addressing food safety—and food system issues in a more general sense—coordination in regulatory approaches can be critical. As a recent Washington Post article stated,

Financing health care for perons with HIV infection is an increasing burden on states and their taxpayers. The major problems of state policy in the 1990s are how to organize and finance both early detection of infection and preventive drug treatment for persons without symptoms and how to provide a full range of health and social services for infected persons whose life expectancy is unknown. This article first describes the shift in the perceptions of HIV infection from a plague to a chronic disease and the implications of this shift for state government. Then it places the history of financing for health care in the context of general health care financing policy during the past decade. Next it describes the history of state action to finance care for HIV infection, especially the use of of Medicaid Waivers, problems of state financing for expensive prescription drugs, and state initiatives, especially in California, Michigan, New Jersey and New York. Finally, the article presents seven policy questions that states should consider in deciding what, if any, legislation or regulations to enact in order to organize treatment and pay some or all of the costs of care for persons with HIV infection.