Health Law and Policy Commons^™

Hipaa-Cracy, Carl E. Schneider

Articles

The Department of Health and Human Services has recently been exercising its authority under the (wittily named) "administrative simplification" part of the Health Insurance Portability and Accountability Act to regulate the confidentiality of medical records. I love the goal; I loathe the means. The benefits are obscure; the costs are onerous. Putatively, the regulations protect my autonomy; practically, they ensnarl me in red tape and hijack my money for services I dislike. HIPAA (a misnomer-HIPAA is the statute, not the regulations) is too lengthy, labile, complex, confused, unfinished, and unclear to be summarized intelligibly or reliably. (Brevis esse laboro, …

Biotechnology Entrepreneurship And Ethics: Principles, Paradigms, And Products, Patricia C. Kuszler

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Biotechnology, whether in the context of new drugs derived from DNA and genetic technology, genetically modified food, or biologics making use of living cells, raises ethical concerns at a variety of different levels. At the research level, there is concern that the very nature of research is being subverted, rather than enhanced, by entrepreneurship. This area of ethical concern has intensified in the United States as a result of the conflicts of interests resulting from the growing alliance between University academia and private industry in the research enterprise. As we travel down the research path into development of a drug …

Syringes In The Sea: Why Federal Regulation Of Medical Waste Is Long Overdue, Chryssa V. Deliganis, Steve P. Calandrillo

Articles

Medical waste is produced everywhere that people live and by almost everyone at some point in their lives. Its treatment and disposal implicates the environment, public health, the economy, human dignity, and aesthetics. With the many issues involved, the need for federal regulation of medical waste today is manifest.

This Article examines the problem of medical waste disposal and evaluates the current state-based approach to regulation. Although many states have implemented stringent medical waste programs with some success, the absence of direct federal regulation in this area is problematic. The need for national leadership is clear, especially with respect to …

Hard Cases And The Politics Of Righteousness, Carl E. Schneider

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The law of bioethics has been the law of cases. Interpreting the common law and the Constitution, judges have written the law of informed consent, abortion, and assisted suicide. Reacting to causes célèbres, legislatures have written the law of advance directives and end of life decisions. The long, sad death of Terri Schiavo eclipsed even the long, sad deaths of Karen Ann Quinlan and Nancy Beth Cruzan in the duration and strength of the attention and passions it evoked. What are Schiavo’s lessons? Hard cases, lawyers say, make bad law. Why? First, hard cases are atypical cases. They present abnormal …

Saving Federal Sentencing Reform After Apprendi, Blakely And Booker, David Yellen

Articles

No abstract provided.

Reaching Disclosure, Carl E. Schneider

Articles

It is easy to forget but crucial to remember that when lawmakers decide to regulate an activity, they must select a method. The law of bioethics particularly favors one method-requiring disclosure of information. The doctrine of informed consent obliges doctors to tell patients their treatment choices. The administrative law of research ethics insists that researchers warn subjects of the risks of experiments. The Patient Self-Determination Act compels medical institutions to remind patients about advance directives. The federal government's new privacy regulations instruct medical institutions to describe their privacy regime to patients. Not just the law of bioethics, but health law …

The Common Law Power Of The Legislature: Insurer Conversions And Charitable Funds, Jill R. Horwitz, Marion R. Fremont-Smith

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New York's Empire Blue Ccoss and Blue Shield conversion from nonprofic cofor­ profic form has considerable legal significance. Three aspects of the conversion ma.ke checase unique: the role of the scace legislature in directing the disposicion of the conversion assets, che face chac it made itself che primary beneficiary of chose assets, and the actions of che scace attorney general defending the state rather than che public inceresc in che charitable assets. Drawing on several cenruries of common Law rejecting the Legislacive power to direct the disposition of charitable funds, chis article argues chat the legislature lacked power cocontrol che …

Intellectual Property Rights And Stem Cell Research: Who Owns The Medical Breakthroughs?, Sean M. O'Connor

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This article will not address the science and ethics of stem cell research—at least as far as those topics are normally addressed in the existing literature. Instead, this article argues that an even more contentious battle is looming on the horizon, with dire practical consequences: Namely, who will own the revolutionary medical breakthroughs that are supposed to emerge from this research? Along the way, this article will assume that stem cell research will progress in some fashion and that at least some of the purported benefits will materialize.

But the central premise is that the pitch of the ownership battle …

Liability For Life, Carl E. Schneider

Articles

Marshall Klavan headed the Obstetrics and Gynecology Department of the Crozer-Chester Medical Center. He deeply feared strokes, perhaps because his father had been savaged by one. In 1993, Dr. Klavan wrote an advance directive which said that (as a court later put it) "he 'absolutely did not want any extraordinary care measures utilized by health care providers.'" On April29, 1997, Dr. Klavan tried to kill himsel£ He left suicide notes and a note refusing resuscitation. The next morning, medical center employees found him unconscious and took him to the emergency room, where he was resuscitated. By May 2, Dr. Klavan …

Making Lawyers Compete, Lester Brickman

Articles

The article argues that the market for contingent-fee-financed tort litigation is not price competitive, primarily due to uniform contingency fees charged by lawyers regardless of case-specific factors such as risk or effort required. This lack of competition leads to excessive costs for claimants and contributes to the expansion of tort liability. The author contends that the legal profession maintains this system through various barriers, including ethical rules and entry restrictions, which prevent competitive market forces from functioning effectively.

Enough: The Failure Of The Living Will, Angela Fagerlin, Carl E. Schneider

Articles

Enough. The living will has failed, and it is time to say so. We should have known it would fail: A notable but neglected psychological literature always provided arresting reasons to expect the policy of living wills to misfire. Given their alluring potential, perhaps they were worth trying. But a crescendoing empirical literature and persistent clinical disappointments reveal that the rewards of the campaign to promote living wills do not justify its costs. Nor can any degree of tinkering ever make the living will an effective instrument of social policy. As the evidence of failure has mounted, living wills have …

Cash For Kidneys? Utilizing Incentives To End America's Organ Shortage, Steve P. Calandrillo

Articles

This article addresses the growing organ shortage in America, analyzes current donation and procurement law, and explores both monetary and nonmonetary incentives aimed at eliminating the worsening crisis.

Part I details the law governing human organ donation. Under both the Uniform Anatomical Gift Act (“UAGA”) and the National Organ Transplant Act (“NOTA”), no donor of a human organ may receive “valuable consideration” for providing it. Congress’ intention was simply that the organ recipient be given the “gift” of life—not one which she had to purchase on the market. In reality, the consequences of the Act bear little resemblance to its …

Vanishing Vaccinations: Why Are So Many Americans Opting Out Of Vaccinating Their Children?, Steve P. Calandrillo

Articles

Part I of this Article details the historical development and medical achievements made possible by vaccines. From Edward Jenner to Jonas Salk to Albert Sabin, immense strides have been made in eradicating or substantially eliminating some of the worst diseases in human history. Smallpox, polio, measles, mumps, rubella, diphtheria, pertussis, tetanus, influenza, hepatitis A and B, and even the chicken pox are all now largely preventable.

Literally hundreds of millions of deaths have been avoided and many more lives markedly improved, to say nothing of the financial ramifications for the American healthcare system. All fifty states have therefore enacted compulsory …

Where Is The "There" In Health Law? Can It Become A Coherent Field?, Mark A. Hall, Carl E. Schneider

Articles

Gerturde Stein complained of Oakland, "There is no there there." Churchill complained of his pudding that "it has no theme." And everybody complains of health law that it lacks an organizing principle. Health law scholars bemoan the "pathologies" of health law and its contradictory and competing "paradigms'. which form a "chaotic, dysfunctional patchwork." But it should not surprise us that any field which grows by accretion lacks a unifying idea or animating concern. And health law certainly grew by accretion. It began in the 1960s, when the Law-Medicine Center was established, concerned with medical proof in litigation, physicians' malpractice, and …

Benumbed, Carl E. Schneider

Articles

I originally intended to write a column on tort liability and research ethics, and I still plan to do so. But this column is a cri de coeur as I finish another semester teaching law and bioethics. This year, I asked with growing frequency, urgency, and exasperation, "Must law's reverence for autonomy squeeze out the impulse to kindness? Where is the beneficence in bioethics?" These questions assail me every term. Why? Consider Steele v. Hamilton County Community Mental Health Board. Mr. Steele was involuntarily "hospitalized after his family reported that he was 'seeing things and trying to fight imaginary …

Images Of Health Insurance In Popular Film: The Dissolving Critique, Elizabeth Pendo

Articles

Several recent films have villainized the health insurance industry as central elements of their plots. This Article examines three of those films: Critical Care, The Rainmaker, and John Q. It analyzes these films through the context of the consumer backlash against managed care that began in the 1990s and shows how these films reflect the consumer sentiment regarding health insurance companies and the cost controlling strategies they employ. In addition, the Article identifies three key premises about health insurance in the films that, although exaggerated and incomplete, have significant factual support. Ultimately, the author argues that, despite their passionately critical …

Border Patrol, Carl E. Schneider

Articles

Recently, the Supreme Court has encountered cases that concern perhaps our weightiest bioethical issue-how medical care is to be rationed. But this does not mean that the Court must therefore assess the justice of rationing, as many people incited by many journalists now fondly and firmly believe. In explaining why, we begin with a story about how Learned Hand remembered saying one day to Justice Holmes, "Well, sir, goodbye. Do justice!" Holmes turned quite sharply and said: "That is not my job. My job is to play the game according to the rules." If the Court doesn't do justice, what …

Against A Federal Patients' Bill Of Rights, Edward A. Zelinsky

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The failure of the 107th Congress to pass a "Patients' Bill of Rights" (PBR) is widely considered a major disappointment, to be remedied in the 108th Congress by the adoption of such legislation. Indeed, federal PBR proposals have achieved the proverbial motherhood-and-apple-pie status; it is virtually impossible to find anyone actively opposing a federal PBR. Many members of the 108th Congress likely feel pressure to pass PBR legislation before returning to the electorate in 2004.

I advance a contrary perspective: A federal PBR is an idea whose time is past or, to be precise, is an idea whose rationales are …

Going To Pot, Carl E. Schneider

Articles

In several earlier columns, I suggested that judges are usually poorly placed to make good biomedical policy, not least because the law so rarely offers them direct and cogent guidance. Recently, the U.S. Court of Appeals for the Ninth Circuit proffered a new example of this old problem. In 1996, California's voters approved Proposition 215. Its "Compassionate Use Act of 1996" provided -that a patient "who possesses or cultivates marijuana for the personal medical purposes of the patient upon the written or oral recommendation or approval of a physician" committed no crime.

Why We Need The Independent Sector: The Behavior, Law, And Ethics Of Not-For-Profit Hospitals, Jill R. Horwitz

Articles

Among the major forms of corporate ownership, the not-for-profit ownership form is distinct in its behavior, legal constraints, and moral obligations. A new empirical analysis of the American hospital industry, using eleven years of data for all urban general hospitals in the country, shows that corporate form accounts for large differences in the provision of specific medical services. Not-for-profit hospitals systematically provide both private and public goods that are in the public interest, and that other forms fail to provide. Two hypotheses are proposed to account for the findings, one legal and one moral. While no causal claims are made, …

The Physician As A Conscientious Objector, J. David Bleich

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No abstract provided.

All My Rights, Carl E. Schneider

Articles

Diane Pretty was an Englishwoman in her early 40s who had been married nearly a quarter of a century. In November 1999, she learned she had amyotrophic lateral sclerosis-in Britain, motor neurone disease. Her condition deteriorated rapidly, and soon she was "essentially paralysed from the neck downwards." She had "virtually no decipherable speech" and was fed by a tube. She was expected to live only a few months or even weeks. AB a court later explained, however, "her intellect and capacity to make decisions are unimpaired. The final stages of the disease are exceedingly distressing and undignified. AB she is …

How Underlying Patient Beliefs Can Affect Physician-Patient Communicaion About Prostate-Specific Antigen Testing, Michael H. Farrell, Margaret Ann Murphy, Carl E. Schneider

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Routine cancer screening with prostate-specific antigen (PSA) is controversial, and practice guidelines recommend that men be counseled about its risks and benefits. OBJECTIVE. To evaluate the process of decision making as men react to and use information after PSA counseling. DESIGN. Written surveys and semistructured qualitative interviews before and after a neutral PSA counseling intervention. PARTICIPANTS. Men 40 to 65 years of age in southeastern Michigan were recruited until thematic saturation—that is, the point at which no new themes emerged in interviews (n = 40). RESULTS. In a paper survey, 37 of 40 participants (93%) said that they interpreted the …

The Bill For Rights, Carl E. Schneider

Articles

Where today is legislative ingenuity lavished more bountiully than on the titles of statutes? And where has that ingenuity been better exercised than in the name "patients' bill of rights"? Do not our dearest liberties flow from the Bill of Rights? And who more deserves similar protection than patients in the hands of an angry Managed Care Organization? And behold, both Democrats and Republicans, both President Clinton and President Bush, have summoned us to arms. The patients' bill of rights is an idea whose time has seemed to have come for several years, and only conflicts among the numerous proposals …

Responsible Regulation: A Sensible Cost-Benefit, Risk Versus Risk Approach To Federal Health And Safety Regulation, Steve Calandrillo

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Federal health and safety regulations have saved or improved the lives of thousands of Americans, but protecting our citizens from risk entails significant costs. In a world of limited resources, we must spend our regulatory dollars responsibly in order to do the most we can with the money we have. Given the infeasibility of creating a risk-free society, this paper argues that a sensible cost-benefit, risk versus risk approach be taken in the design of U.S. regulatory oversight policy. The goal should always be to further the best interests of the nation, rather than to satisfy the narrow agenda of …

Curing Conflicts Of Interest In Clinical Research: Impossible Dreams And Harsh Realities, Patricia C. Kuszler

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This article will explore conflicts of interest in the context of clinical research, focusing on the incentives and practices that foster such conflicts. Part I will briefly define and categorize the revenue streams at play in clinical research—both contemporaneous with the clinical trial, and the downstream, long-term gains available to the researcher and research university. Part II will discuss how these entangled revenue streams result in financial and non-financial conflicts of interest that affect the nature and balance of the research enterprise and potentially endanger patients and human subjects. Part III will summarize current conflicts of interest regulations and policies, …

Gang Aft Agley, Carl E. Schneider

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In my last contribution to this column (HCR, July-August 2000), I argued that the law of bioethics has repeatedly failed to achieve the hopes cherished for it. I presented evidence, for example, that most doctors breach the duty of informed consent, that advance directives do not direct patients' care, and that repeated legal attempts to increase organ donation have failed to find the success predicted for them. I closed that column by promising to try to explain this chastening experience. It would, of course, take a lifetime of columns to capture all the reasons the law of bioethics …

The Best-Laid Plans, Carl E. Schneider

Articles

It is natural to suppose law is like the centurion and can do as it will: "I say to this man, Go, and he goeth; and to another, Come, and he cometh; and to my servant, Do this, and he doeth it." But a thousand years ago, King Canute tried to disillusion his courtiers about his efficacy by commanding the waves to stop beating. And fifty years ago, Harry Truman predicted of Dwight Eisenhower, "He'll sit here, and he'll say, 'Do this! Do that!' And nothing will happen. Poor Ike-it won't be a bit like the Army. He'll find it …

Financing Clinical Research And Experimental Therapies: Payment Due, But From Whom?, Patricia C. Kuszler

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This article will explore the realm of clinical research and the question of who should finance such research. The first part will define the various types and levels of clinical research in terms of the regulatory controls and oversight applied to such research. Then the article will summarize how the costs of clinical research and experimental therapies have been covered in the past. Finally, the article will evaluate the risks and benefits derived by the various stakeholders and propose a financing rationale for therapies that places the burden of cost squarely on the stakeholders most likely to benefit.

Regulating Doctors, Carl E. Schneider

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Alawyer today can hardly speak to a doctor--or even be treated by one-without being assailed by lawyer jokes. These jokes go well beyond good-humored badinage and pass the line into venom and gall. They reflect, I think, the sense many doctors today have that they are embattled and endangered, cruelly subject to pervasive and perverse controls. This is puzzling, almost to the point of mystery. Doctors have long been the American profession with the greatest social prestige, the greatest wealth, and the greatest control over its work. Indeed, what other profession has been as all-conquering? One may need to go …