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,

When a provider accepts capitation from a health plan for a pool of patients, it assumes risk from the plan. The risk is that the cost of furnishing health care needed by the patients may exceed the funds paid to the provider by the health plan. There are several levels of risk. The first level is capitation arrangements for services rendered by the provider. The next level is capitation arrangements where the provider assumes risk not only for its own services, but also the services of other providers. As the number of services of other providers for which risk is assumed increases, the risk-taking provider comes closer and closer to assuming risk for the entire benefits package. At some point, it makes sense for the risk-taking provider to become a licensed health plan. As providers become more capable in managing large amounts of risk, they become more interested in organizing health plans.

Imagine that you are lying in a hospital: conscious, partially paralyzed, and terminally ill. Physicians predict that you will die in a couple of weeks. You have heard about the shortage of viable organs in the United States and consider consenting to transplantation of your organs after you die. Trying not to think about your imminent death, you open the New York Times brought by your family and skim the table of contents. You notice an article and slowly start to read. The headline reads “Surgeon Accused of Hurrying Death of Patient to Get Organs.” After you finish reading, you are not willing to donate your organs for transplantation. It does not matter that you are altruistic or that you want your life-sustaining treatment to be removed when your condition worsens. You do not want your death to be hastened. You do not want the physician to play God. You want to die with dignity in a peaceful and friendly environment.

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.

Roe v. Wade is a landmark case for women and for reproductive rights. By permitting abortion, Roe v. Wade gives women some control over the timing of pregnancy and childrearing, and has reinforced the movement of women into the labor force. Nevertheless, it is a hotly contested decision. The most fervent critics decry its substantive position on fetal status, likening it to Dred Scott and Nazi atrocities. Others classify it as an arbitrary infliction of judicial will unfit to be called law.

Roe v. Wade, however, is not as radical a departure from the main currents of constitutional precedent as charged. Its premises about procreative choice stem from the Court's decisions in Griswold v. Connecticut and Eisenstadt v. Baird? Its evaluation of fetal status is not markedly different from common law positions. Nor has Roe v. Wade's recognition of procreative liberty greatly expanded the list of nonprocreative rights, as many persons had hoped or feared.

In this Oration, the retired Chief Justice of the Massachusetts Superior Court offers some personal observations on the American medical malpractice crisis and examines the Massachusetts malpractice tribunal system, which is aimed at reducing the incidence of malpractice litigation that is either frivolous or involves simply an “unfortunate medical result” for which the health care provider should not be held accountable. First, the author relates some of his impressions of the evolution of the malpractice crisis and identifies its salient characteristics. Next, he provides a description and an evaluation of the Massachusetts tribunal system. Under that system, the plaintiff in any malpractice action must argue before a special tribunal—composed of a Superior Court judge, an attorney, and a surgeon—that his case raises a “legitimate question of liability.” If the tribunal finds that such a question exists, the plaintiff may pursue his case in the normal manner. But if the tribunal finds that the case involves “merely an unfortunate medical result,” and if the plaintiff still wishes to press his claim, he must, before proceeding, post a $2,000 bond, which is used to help pay the defendant’s litigation costs if the defendant prevails at the trial. The author offers data to support his contention that this tribunal system already is screening out a significant number of inappropriate malpractice claims. Nevertheless, he suggests that the system has substantial problems. He identifies those problems, and proposes methods for solving them.

Healthcare deficiencies in the United States have long been perpetuated by a shortage of primary care providers. A core purpose of the Patient Protection and Affordable Care Act (PPACA) is to provide health insurance for America's approximately fifty million uninsured. Implementation of universal health insurance, however, does not mean sufficient healthcare access for all, since the supply of physicians does not and will not meet demand. For reasons reviewed in this Article, the current physician shortage mainly impacts primary care providers. This shortage is particularly troubling because increased provision of primary care relative to specialty care has been associated with improvement in health outcomes, disease prevention, cost effectiveness, and coordination of care. This Article highlights provisions in the PPACA that impact primary care physicians. Finally, this Article proposes the creation of a universal primary care loan repayment program and a national residency exchange designed to alleviate the U.S. primary care crisis by facilitating optimal distribution of resident physicians in each medical specialty based on community need.

This Article tackles the critical problem of COVID-19 vaccine hesitancy and provides a normative framework for legal policies to address such hesitancy in the ongoing pandemic. The foundation of this Article rests in decision-making theories that allow policymakers to understand individual misperception of risk as compared to evidence-based assessment of risk. Vaccine-hesitant individuals assign a high risk to the COVID-19 vaccine and a low risk to the disease—a perception that is disconnected from the science. The backbone of this Article is the timeline of the COVID-19 pandemic and the underlying science of the disease and vaccines. The timeline provides a factual background to demonstrate how vaccine hesitancy to the COVID-19 vaccine emerged. The instant pandemic also demonstrates changes in how individuals see themselves in society, receive information, and are persuaded by economic forces. This Article combines the individual’s decision-making process with modern day variables to suggest interventions that can undo anti-vaccine damage. While the novelty of the normative framework provided herein is instructive for current COVID-19 vaccine hesitancy issues, this framework can be applied to other areas in which individual’s perceptions of risk are disconnected from evidence-based assessment of risk.

Susan Carter has not been feeling well for days. She would like to see a doctor about her chest pain and wheezing, but Susan knows that missing work will leave her client without a replacement and, worse, she could be fired. Susan is a home healthcare worker in Illinois. Like many of her fellow workers, Susan has no health insurance and cannot afford to risk losing her job by going to see a doctor.

Often, Susan feels unable to handle the constant stress of her job. She helps her clients bathe and dress, prepares their meals and assists them with their medications and housekeeping. Susan travels by bus daily to care for two to five clients. She carries a pager day and night in case a client needs help with a plugged catheter or another emergency. Susan often has to work seven days a week, and she steps in to care for patients whose caregivers have left for better-paying jobs.

Dennis Lindberg came into his aunt’s care when he was in the 4th grade because his parents struggled with drug addiction and could not provide for him. At thirteen, he was baptized in his aunt’s faith as a Jehovah’s Witness. Just days after he turned fourteen, on November 6, he was diagnosed with acute lymphoblastic leukemia.

The prognosis was that Dennis had a 75% chance of cure with standard oncology treatment. Consistent with the requirements of his new faith, however, Dennis told his doctors, “I do not want to be treated if the requirement is that I would have to take a blood transfusion.” His aunt, whose custodial rights seem not to have included medical decisionmaking, was adamant that “[t]his is Dennis’s decision.”

The hospital social worker assigned to Dennis’s case assured his aunt that “having just turned 14, [he] could be considered mature enough to make his own decisions.” But hospital psychologists declined to evaluate Dennis’s maturity because they did “not have the tools for such an assessment.” Established hospital policy described the failure to provide a minor with necessary, life-saving care as medical neglect. Hospital ethicists advised that Dennis’s autonomy interests were outweighed by the benefits associated with treatment. And, standard oncology practice norms are that doctors should push back against minors’ lifesaving treatment refusals. Still, Dennis’s doctor agreed with his social worker and aunt, saying, “We owe respect to a 14-year-old[.]” In this view, he was supported by colleagues on staff and by hospital counsel.

A county judge got the case only at the eleventh hour, on an emergency motion filed by Dennis’s parents and Child Protective Services for a declaration of dependency and to compel the necessary transfusion. Although Dennis was degrading rapidly, his doctor testified that if a transfusion were ordered that day, Dennis still had a 70% chance of survival. The judge had no background in the applicable law and no time to research the issues; nevertheless, he denied the motion concluding, “It is time to do what Dennis has decided.” “Seven hours later, at 6 p.m., on Nov. 28, Dennis died.”1

The day before the inauguration of his Democratic successor, President George W. Bush oversaw the promulgation of an administrative rule that extended “sweeping” new conscience protections to healthcare providers, one which would allow them to refuse to participate in or refuse to refer for medical services to which they morally or religiously object. Enacted in a funding regulation through the Department of Health and Human Services (“HHS”), the rule – commonly called the Provider Conscience Regulation (“Regulation”) – purported to clarify and implement existing federal law; by its own terms; however, the Regulation pushed the boundaries of those laws, granting protections to a broader class of individuals and across a wider range of services. In so doing, the Regulation sought to resolve an ongoing tension between patient access and provider autonomy, yet it served to reignite a long-standing debate over the proper role of morals in medicine.

Merck’s recently released vaccine, Gardasil, may revolutionize cervical cancer prevention. With the rate of detected cervical cancer cases and associated deaths rising rapidly, cervical cancer is a major public health concern. Infection with the human papillomavirus, a sexually transmitted disease, is a necessary cause of cervical cancer. Gardasil protects against two specific “high risk” strains of HPV, associated with about 70% of cervical cancer cases, and blocks infection by two other strains of HPV, responsible for 90% of genital warts cases. Proponents of Gardasil believe that vaccination of women between the ages of 12 and 26 can slow the spread of cervical cancer by eradicating the two major HPV strands associated with the cancer’s development.

A recent New York Court of Appeals decision seriously impedes the ability of incompetent patients to control their medical care. In the case of Mary O'Connor, the court virtually eliminated an incompetent's rights to bodily integrity and privacy. The court relied on formalistic evidentiary arguments to vitiate the patient's refusal of death-prolonging treatment. This Case Comment examines both the doctrine and policy underlying the O'Connor decision, suggesting that the court erred in its holding and reasoning.

An alternative framework is presented, arguing that courts should honor competently expressed patient decisions concerning medical treatment. New York's highest court, instead, posited an incompetent patient who becomes competent for a moment to render a decision. This legal fiction is nothing more than a thinly masked technique for imposition of the judges’ values on the patient. This Case Comment argues that in the absence of clear direction from the patient, family and loved ones generally should make care decisions for the patient.

The developmentally disabled, specifically those mentally incompetent from birth, are entitled to a full panoply of constitutional rights and protections. These rights include the right to terminate life-sustaining treatment, the right of procreative integrity and the right not to be involuntarily institutionalized. However, the mentally incompetent developmentally disabled are generally unable to exercise these rights. This Note asserts first that proper procedural safeguards are necessary to guarantee the exercise of these constitutional rights by the incompetent disabled individual. Second, the Note focuses upon how best to preserve the disabled person's autonomy. The Note subsequently rejects the substituted judgment standard as a legal fiction, and endorses the best interest test which necessarily comports with the evidence, and properly accounts for the disabled person's incompetency.

Because the health care industry comprises over thirteen percent of the American economy, law enforcers increasingly apply antitrust law to all aspects of health care delivery and financing. Through antitrust enforcement, consumers receive the benefits of lower health care costs and improved health care services. To achieve further cost savings, health care providers are forming, as well as joining, many different types of provider network joint ventures. Providers form networks, expect ing “them to generate efficiencies, reduce excess capacity, improve utilization, permit greater specialization and enhance quality.” However, because they organize competing physicians and enable them to collaborate on prices and set fee schedules, provider networks raise serious antitrust concerns. Consequently, the federal government and courts are increasingly focusing their antitrust enforcement efforts on the formation and anticompetitive activities of provider networks.

In Part I, this Note addresses the degree to which network providers must be economically and financially integrated to legally collaborate and set prices. Part II briefly explains the procedures one may use to enforce the federal antitrust laws. Following this explanation of antitrust enforcement procedures, Part III discusses the relevant statutory and case law applicable to health care provider networks.

This article marks the 30th anniversary of the Supreme Court of New Jersey's Baby M decision by offering a critical analysis of surrogacy policy in the United States. Despite fundamental changes in both science and society since the case was decided, state courts and legislatures remain bitterly divided on the legality of surrogacy. In arguing for a more uniform, permissive legal posture toward surrogacy, the article addresses five central debates in the surrogacy literature.

First, should the legal system accommodate those seeking conception through surrogacy, or should it prohibit such arrangements? Second, if surrogacy is permitted, what steps can be taken to minimize the potential exploitation of women who are willing to rent their wombs for income? Third, what criteria should govern the eligibility to serve as a surrogate mother and an intended parent? Fourth, what principle(s) should serve as the basis for determining the parentage of children born through surrogacy? Fifth, is regulatory uniformity in the surrogacy realm desirable? Is it achievable?

The article concludes that courts and legislatures should accept the validity of surrogacy contracts, determine parentage according to intent, and identify transparent criteria for the eligibility of both surrogates and intended parents.

An announcement in July 1990 concerning the possible transmission of the Human Immunodeficiency Virus from an HIV-positive health care professional to a patient launched a public outcry for patient protection from acquiring HIV from health care professionals. As a result of numerous debates, Congress issued a mandate requiring the states to adopt the Centers for Disease Control and Prevention's guidelines concerning HIV-positive health care professionals or an equivalent policy. This Note explores the regulations and guidelines established by various states in response to this mandate. The author concludes that policies requiring adherence to universal precautions within the health care setting, and not mandatory testing of health care professionals or mandatory disclosure of their HIV status, are best for protecting public health.

Having argued in Part One against extensive judicial or regulatory interference with private personnel credentialing in the health care field, this Article now shifts its focus to emphasize the anticompetitive hazards inherent in credentialing as practiced by professional interests. Competitor-sponsored credentialing is shown to be a vital part of a larger cartel strategy to curb competition by standardizing personnel and services and controlling the flow of information to health care consumers. Instead of altering the conclusions reached in Part One, however, Part Two sets forth a new and hitherto unexplored agenda for antitrust enforcement, one that the authors believe will increase the quantity and quality of information available to consumers and offer a fairer competitive environment to individuals and groups disadvantaged by the denial of desirable credentials. The specific targets singled out for antitrust scrutiny are (1) the practice of "grandfathering," by which new candidates for credentials are required to meet tougher requirements than were met by existing credential holders; (2) agreements to standardize educational programs if they go beyond setting and applying accrediting standards and impair the freedom of institutions to decide independently whether to offer unaccredited training; (3) agreements by which independent certifying or accrediting bodies limit the nature or scope of competition among themselves; and (4) mergers and joint ventures in credentialing and accrediting. The legal theory supporting antitrust attacks in the latter two categories is strengthened by the apparently original insight that commercial information and opinion are themselves articles of commerce such that agreements and combinations restricting their nature and output can be characterized as restraints of trade. Among the many self-regulatory institutions in the health care field whose operation or sponsorship is called into question by the analysis herein are the leading medical specialty boards, the Liaison Committee on Medical Education, various accrediting and certifying bodies in the allied health occupations, and the Joint Commission on Accreditation of Hospitals.