The author of this Article, an internationally recognized coroner perhaps best known among laymen for his incisive and tenacious criticism of the Warren Commission report on the Kennedy assassination, turns his attention to the federal government's 1976-1977 Swine Flu Immunization Program. Dr. Wecht contends that although this program may have been viewed by its key proponents as having great public health importance, or perhaps even political value, its creation and continuation nevertheless were scientifically unjustified. Furthermore, he contends, the federal government failed to inform the public adequately of important facts about the program's origins and progress, and it mismanaged the program in several important respects. Among the topics he discusses are swine flu's epidemiological history (including the 1976 Fort Dix outbreak that propelled swine flu into the national consciousness); the key elements leading to the government's decision to immunize; the government's failure to reevaluate the program seriously as problems arose; the shortcomings of the federal swine flu statute; the inadequacy of the government's investigation of the deaths of three persons in Pittsburgh within a few hours after being vaccinated (a matter that was of immediate concern to the author in his role as Coroner of Allegheny County, Pennsylvania); the long-delayed termination of the program following the emergence of a possible statistical link between the immunizations and an increase in the incidence of the Guillain-Barré Syndrome; the financial and human costs of the program; and the need for calmer, more objective decision making in future situations where immunization of the general populace is being considered.

Internal policy decisions of private nonprofit hospitals can have a powerful impact. For example, the denial of medical staff privileges to a physician can limit his income and perhaps damage his reputation. The rejection of a prospective father’s request to assist his wife in the hospital’s delivery room during childbirth deprives the couple of the opportunity to share one of life’s most profound experiences.

Plaintiffs aggrieved by, and seeking to challenge, a policy decision of a private nonprofit hospital often turn instinctively to the fourteenth amendment to the U.S. Constitution for a remedy, hoping to prove (1) “state action” by the hospital and (2) violation of the constitutional rights of the plaintiff. Currently, suggests the author, such an approach is likely to be of limited usefulness. As an alternative, the plaintiff may be able to marshall a common law challenge based on the argument that the hospital, although privately owned, is “affected with a public interest”—that is, it is sufficiently “public” in nature and function that it has a common law duty to serve the public fairly and reasonably, a duty enforceable in a state court. Courts that characterize private nonprofit hospitals as enterprises affected with a public interest (as many courts currently do) will review the challenged hospital policy decision and will decide whether or not, on balance, it was “procedurally fair” and “substantively rational.” This common law approach to judicial review, whose roots are deep in medieval English law, will have a bright future if state courts are willing to heed their common law heritage.

Currently, there is a serious shortage of human organs, such as kidneys and corneas, available for transplant to patients who need them. State laws—through the adoption of the Uniform Anatomical Gift Act— support an “altruistic” system of organ donation, in which the supply of transplantable organs depends upon the willingness of individuals to relinquish organs without financial compensation. The author of this Comment, an economist, proposes that state laws should instead support a combined altruistic-market system of organ procurement and distribution. In such a system, not only could individuals give their organs, but those who so desired could sell their organs—to be removed and transplanted upon their death, or possibly even during their life in appropriate cases—with the proceeds going to the donor or his estate. The author contends that statutory authorization of a combined altruistic-market system of organ transfer—for which the current mixed voluntary-commercial blood system provides a precedent—would foster the growth of a new incentive (the receipt of money) to relinquish one’s organs for transplantation. The sale of organs could (1) alleviate the organ shortage, (2) decrease the incidence of organ rejection by the host, and (3) lessen the need to remove organs from living donors. The author confronts various practical and ethical objections to the introduction of a commercial market in human organs, and concludes that the objections are unjustified, or can be addressed effectively through appropriate statutory provisions, or are outweighed by the benefits of a vastly increased supply. He calls for support for his proposal from organized medicine, and suggests that the new system be introduced on an experimental basis in a single state prior to nationwide implementation.

In 1965 Congress, through amendments to the Social Security Act, established the Medicare and Medicaid programs and mandated that hospitals participating in those programs be reimbursed for the “reasonable cost” of providing inpatient services to Medicare and Medicaid patients. In this Article, the Chairman of the Massachusetts Rate Setting Commission contends that HEW—which, like Congress, was anxious to stimulate the voluntary participation of hospitals in the Medicare and Medicaid programs—interpreted “reasonable cost” with excessive liberality toward participating hospitals and created a fiscally burdensome and inflationary reimbursement system lacking principles of efficiency and planning. The author then describes a series of attempts—varying in scope and success—to reformulate “reasonable cost,” as applied to Medicare and Medicaid reimbursement, in a manner more consistent with the author's concept of sound public policy. The culmination of these attempts to date, he states, was Public Law 92-603 (Social Security Amendments of 1972), which introduced to the reimbursement system the concepts of (1) tough evaluation of the reasonableness of hospital costs, with emphasis on efficiency, utilization, and planning; (2) shifting de facto power over reimbursement rates away from the hospitals and into the hands of the agencies that purchase their services; and (3) increased public scrutiny of hospital operations. The author contends that this law, and the philosophy which underlies it, represents a healthy balancing of the needs of hospitals and the needs of the public; that the trend toward cost control and public control which the law embodies has been substantially furthered in those states which have statutorily established hospital budget or charge review programs; and that such trend will continue and profoundly affect any national health insurance plan enacted in the future.

In this Comment, Dr. Altschule contends that in a variety of ways the American legal system currently is endangering the existence of positive physician-patient relationships, which are essential io the effective practice of medicine. First, he contends, physicians are exposed to an excessively high risk of liability for malpractice, and as a result must substitute the use of “defensive,” often unnecessary laboratory tests for reliance on their own sound medical judgment. Second, the confidentiality of communications between physicians and patients is receiving inadequate legal protection; therefore, patients often are hesitant to reveal aspects of their medical history that may be critical to their case. Third, the federal government, by its medically inappropriate attempts to ban drugs that do not meet certain federal “safe and effective” standards, and to ban food additives that fail to pass certain federally controlled tests aimed at determining whether the additive causes cancer, is making it increasingly difficult for physicians to prescribe substances that may be of great value to their patients. The author warns that our society's failure to substantially alleviate such problems is likely to lead to an inferior brand of medical practice.

The authors of this Comment note recent trends rigidifying the enforcement of building and safety codes for health care facilities and compare the estimated costs (in terms of dollars spent) of those trends with their anticipated benefits (in terms of potential years of human life saved). They estimate that for each potential year of life saved, strict enforcement of the Life Safety Code of the National Fire Protection Association would cost $12.7 to $63.5 million for hospitals and $1.1 to $2.6 million for nursing homes, the latter figure based on Massachusetts's experience. These figures are contrasted to the cost of routine kidney dialysis, which is generally acknowledged to be an extremely expensive technology, costing approximately $20,000 per potential year of life saved. The authors suggest that even if strict enforcement of the Code were fully effective (which, given the current structure of the Code, seems doubtful), a portion of the substantial financial resources expended from our limited national health care budget in hewing to the letter of the Code might be better spent on other activities with greater potential yield in improving the quality of life for patients in hospitals and nursing homes.

The authors of this Comment—a lawyer and a physician—suggest that most physicians who are called upon to testify concerning medical issues in personal injury litigation do not understand that judges and attorneys view “causation” quite differently than do members of the medical community. For example, medical practitioners tend to be concerned with all possible causes of the patient's current medical condition, whereas legal practitioners in personal injury cases generally focus on a particular event as possibly precipitating, hastening, or aggravating a particular aspect of the patient's condition to the extent that the event in question is, in legal language, the “proximate cause” of an injurious result. The authors summarize and analyze the differences—and the occasional similarities—between the medical and the legal approaches to causation, in the hope that they will thereby (1) contribute to greater understanding by the two professions of each other's theory and practice, and (2) help the expert medical witness to be more comfortable and more effective in his courtroom role.

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.

The author of this Comment describes how recent federal legislation (P.L. 93-641, signed into law in January, 1975)—and improved scientific techniques for integrating (1) community medical needs assessment, (2) institutional budgeting linked to regional/state health plans, and (3) budget ceilings—have given the public new authority and technology to shape the nation's institutional health services. He urges administrators and trustees of health institutions—both proprietary and charitable—to become aware of recent developments in this area, and says that active consumer and provider participation in Health Systems Agencies and Statewide Coordinating Councils is necessary if the new federal expectations concerning health planning and regulation are to be met. Given the rising costs of medical care, stronger federal control might be forthcoming if the purposes of P.L. 93-641 are not achieved.

The rapid growth of medical technology gives rise to difficult dilemmas concerning the appropriateness of, and access to, new equipment and devices capable of maintaining life or improving its quality. Such a dilemma already exists, for example, with regard to kidney dialysis machines. In 1972, Congress amended the Social Security Act to make such machines available under Medicare to all who needed them. But almost immediately the overwhelming cost of such equipment—in the billions of dollars—made the original appropriations totally inadequate, and prompted serious questions of whether access to kidney dialysis should be made available at public expense—and, if so, to whom.

This Comment takes the reader 25 years into the future through the medium of a hypothetical U.S. Supreme Court decision** regarding a federal health agency's regulations that establish a system for allocating artificial hearts to those whose lives can be lengthened by implantation. The author assumes that a national health insurance system has been enacted and implemented, that all physicians are employees of the federal government, and that the enabling legislation has placed broad powers in the hands of the federal government to regulate the development and allocation of scarce and expensive medical resources. The opinions of the various Supreme Court Justices reflect a broad range of legal and ethical viewpoints, and—in keeping with the difficult, indeed frightening, life-or-death issues involved—are often intensely personal in nature.

Regulation of the health care system to achieve appropriate containment of overall costs is characterized by Professor Havighurst as requiring public officials to engage, directly or indirectly, in the rationing of medical services. This rationing function is seen by the author as peculiarly difficult for political institutions to perform, given the public's expectations and the symbolic importance of health care. An effort on the part of regulators to shift the rationing burden to providers is detected, as is a trend toward increasingly arbitrary regulation, designed to minimize regulators’ confrontations with sensitive issues. Irrationality and ignorance are found to plague regulatory decision making on health-related issues, even though it is the consumer who is usually thought to suffer most from these disabilities. The author argues that consumer choice under some cost constraints is a preferable mechanism for allocating resources because it better reflects individuals’ subjective preferences, has a greater capacity for facing trade-offs realistically, and can better contend with professional dominance of the resource allocation process.

In view of the unlikelihood of regulation that is both sensitive and effective in containing costs, the author proposes that we rely primarily on consumer incentives to reform the system. A simple change in the tax treatment of health insurance or other health plan premiums, to strengthen consumers’ interest in cost containment while also subsidizing needy consumers, is advocated. Steps to improve opportunities for innovation in cost containment by health insurers, HMOs, and other actors are outlined briefly.

In January of every odd-numbered year, a new Congress convenes, made up of new or re-elected Members of the House of Representatives and of the Senate, along with Senators who are entering the second or third Congress of their six-year term. In both its first year (“first session“) and its second year (“second session“) the new Congress stays at work until adjournment in late autumn or early winter.

Any Member of Congress may introduce a legislative proposal when Congress is in session. Ideas for bills and resolutions may emanate directly from a Member (or a group of Members) either in the House of Representatives or in the Senate. Often the proposals are a response to the appeals of constituents, such as trade or professional associations or consumer groups, who may participate in their preparation.

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.

The struggle for control of this nation's life-giving blood resources was, up until five years ago, largely a private affair between representative organizations of the blood collectors. The system that emerged from that struggle was declared unhealthy by several experts who complained that blood was too often unsafe or unavailable. Then in 1972 the government, predominantly the federal government, responded to public pressure and joined the fray. This Comment examines some legal, political, and policy aspects of the battle over blood collection—a battle from which no stable guiding force has yet evolved.