Health Law and Policy Commons^™

Candor After Kadlec: Why, Despite The Fifth Circuit's Decision, Hospitals Should Anticipate An Expanded Obligation To Disclose Risky Physician Behavior, Sallie Thieme Sanford [email protected]

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An anesthesiologist admitted to having been drug-impaired during a tubal ligation that left the patient with massive, incapacitating brain damage. In granting the anesthesiologist privileges, one of the items Kadlec Medical Center had relied upon was a short credentialing letter from Lakeview Regional Medical Center. That letter stated simply that the doctor had held anesthesia privileges there for several years; it did not disclose concerns about on-duty drug use, or that he could not exercise his privileges after having been terminated from his practice group for "put[ting] our patients at significant risk" by "report[ing] to work in an impaired physical, …

Thou Good And Faithful Servant, Carl E. Schneider

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Lawmakers are stewards of social resources. A current debate-over screening newborns for genetic disorders-illuminates dilemmas of that stewardship that have particularly plagued bioethics. Recently in the Report, Mary Ann Baily and Thomas Murray told the story of little Ben Haygood. He died from MCADD, a genetic disorder that can make long fasting fatal. Screening at birth would have let doctors alert Ben's parents. "After Ben died," Baily and Murray wrote, "his father became a passionate advocate for expanding Mississippi's newborn screening program to add MCADD and other disorders." Soon, the Ben Haygood Comprehensive Newborn Screening Act increased the number …

The Patient Life: Can Consumers Direct Health Care?, Carl E. Schneider, Mark A. Hall

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The ultimate aim of health care policy is good care at good prices. Managed care failed to achieve this goal through influencing providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy now pressure patients to spend their own money when they select health plans, providers, and treatments. Expecting patients to choose what they need at the price they want, consumerists believe that market competition will constrain costs while optimizing quality. This classic form of consumerism is today's health policy watchword. This article evaluates consumerism and the regulatory mechanism …

A Black Robe And Healing Words: Constants In A Changing World, Sallie Thieme Sanford [email protected]

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This narrative article describes a bedside hospital hearing to compel surgery, notes the applicable legal standards, and considers the potential impact of the judge in this type of proceeding. The patient, whose back was badly burned, adamantly and vocally refused skin graft surgery. Her physicians believed she lacked decisional capacity; that belief was borne out during the hearing at which the judge did enter an order for surgery. The judge’s handling of the hearing was central to the patient’s expressed agreement with the decision and subsequent successful treatment.

The Professional Ethics Of Billing And Collections, Mark A. Hall, Carl E. Schneider

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Medicine is a Profession on which physicians rely for their livelihood and patients for their lives. If physicians do not charge for services, they cannot survive. If patients cannot afford those services, they cannot survive. No wonder many physicians have long agreed that fees are “one of the most difficult problems . . . between patient and physician.” For years comprehensive insurance subdued this problem, but currently widespread underinsurance and consumer-directed health care are reviving it. Even as the ranks of the uninsured continue to increase,the latest hope for controlling medical costs requires insured patients to pay for much more …

The Use Of Litigation Screenings In Mass Torts: A Formula For Fraud?, Lester Brickman

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The article critically examines the pervasive abuse of litigation screenings in mass tort cases, revealing a system driven by financial exploitation where medical evaluations are manipulated to generate lawsuits. These screenings, often designed to produce false positives, undermine the integrity of the legal system by creating a flood of specious claims. The analysis highlights how lawyers, doctors, and screening companies exploit legal loopholes and financial incentives, leading to billions of dollars in settlements and eroding public trust in the civil justice system.

Health Privacy In A Techno-Social World: A Cyber-Patient's Bill Of Rights, Patricia S. Abril, Anita Cava

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No abstract provided.

How Not To Do Medical Malpractice Reform: A Florida Case Study, Mary I. Coombs

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No abstract provided.

Disability, Equipment Barriers And Women’S Health: Using The Ada To Provide Meaningful Access, Elizabeth Pendo

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It is well-known that people with disabilities face multiple barriers to adequate health care, including lower average incomes, disproportionate poverty, and issues with insurance coverage. This article focuses on a more fundamental barrier-one that has not been discussed in the legal literature-inaccessible medical equipment and its effect on the delivery of women's health care to millions of women with disabilities .

(Debate) Medicare: Did The Devil Make Us Do It?, D. A. Hyman, Jill R. Horwitz

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In this lively and creative debate, Professors David Hyman and Jill Horwitz argue about the virtues and vices of the federal Medicare program. As some predict a bleak future for the American’s government’s ability (or inability) to continue paying for Medicare as the population ages, this debate shows that there is genuine disagreement about the severity of the problem. In his Opening Statement, Professor Hyman offers a satirical letter to the Devil from one of his demonic servants, describes the Medicare program through the lens of the seven deadly sins. Arguing that Medicare’s faults are represented in each sin, the …

Principal Investigator Views Of The Irb System, Simon N. Whitney, Kirsten Alcser, Carl E. Schneider, Laurence B. Mccullough, Amy L. Mcguire, Robert J. Volk

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We undertook a qualitative e-mail survey of federally-funded principal investigators of their views of the US human subjects protection system, intended to identify the range of investigator attitudes. This was an exploratory study with a 14% response rate. Twenty-eight principal investigators responded; their comments were analyzed to show underlying themes, which are here presented along with supporting quotations. There was consensus that it is important to protect human subjects from research abuse, but disagreement over how well the IRB system is functioning. Some researchers felt that the system is effective and serves its purpose well. Of those who support the …

The New Massachusetts Health Law: Preemption And Experimentation, Edward A. Zelinsky

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The Employee Retirement Income Security Act of 1974 (ERISA) preempts major features of the new Massachusetts health law. Although regrettable, this conclusion is mandated by ERISA's statutory terminology and the controlling case law. Other states, in fashioning their health care policies, are looking at elements of the new Massachusetts law. Just as ERISA preempts the individual and business contribution mandates of the Massachusetts statute, ERISA will preempt any similar provisions adopted by other states.

Because state experimentation with health care is particularly desirable today, Congress should, at a minimum, amend ERISA to validate the new Massachusetts health law. More comprehensively, …

The Cash Nexus, Carl E. Schneider

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Courts and legislatures have labored for decades to protect patients' choice of medical treatments, even though patients seize that gift less eagerly than lawmakers expect. Yet while courts have rushed to build the whited sepulchre of informed consent, they have fled from a related problem that patients actually yearn to solve and that actually can be ameliorated the plight of patients who perforce agree to a treatment before they know its costs and who receive a bill both unrelated to the treatment's value and several times what an insured patient would pay. Increasingly, patients must be consumers in the medical …

The Health Care Choice Act: The Individual Insurance Market And The Politics Of "Choice", Elizabeth Pendo

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The Health Care Choice Act of 2005 (HCCA) aims to reform perceived problems in the individual market, and is touted as part of the solution to the problem of the uninsured. It purports to allow individuals who are not eligible for or cannot afford group coverage to purchase an individual policy in and from any state. If passed, the HCCA would allow health insurers to offer individual policies of insurance from any state without being required to comply with the laws of the insured's own state. Its proponents claim that it would lower the cost of individual health insurance by …

Does Nonprofit Ownership Matter?, Jill R. Horwitz

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In recent years, policymakers have increasingly questioned whether nonprofit institutions, particularly hospitals, merit tax exemption. They argue that nonprofit hospitals differ little from their for-profit counterparts in the provision of charity care and, therefore, should either lose their tax-exempt status or adhere to new, strict, and specific requirements to provide free services for the poor. In this Article, I present evidence that hospital ownership-whether it is for-profit, nonprofit, or government owned-has a significant effect on the mix of medical services it offers. Despite notoriously weak enforcement mechanisms, nonprofit hospitals act in the public interest by providing services that are unlikely …

Void For Vagueness, Carl E. Schneider

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When law regulates a profession, where does it get its standards? Largely from the profession. Members of professions acquire esoteric and abstract knowledge through formal education and the experience of practice. They use professional judgment in applying this knowledge to each case. Because legislatures and courts lack this expertise, they adopt the standards of the experts. Thus in a malpractice suit, juries are instructed to determine whether the doctor met medicine's standard of care. Furthermore, physicians must be called as expert witnesses to guide juries in that work. Even when lawmakers contemplated intensifying their regulation of medicine by creating the …

Global Health And Human Rights Imperative, Patricia C. Kuszler

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Open any magazine, click on a television news channel, or surf the net and you are likely to find global health highlighted as one of the foremost challenges of new millennium. First, this article will consider the meaning and measures of global health and detail the path to improved health and development prescribed by the United Nations Millennium Development Goals. Second, it will trace the development of international human rights law as it relates to health. Third, it demonstrate how human rights and health, long traversing parallel routes, are in fact converging in the 21st Century quest for global health–a …

The Social Security Administration's New Disability Adjudication Rules: A Significant And Promising Reform, Frank S. Bloch, Jeffrey S. Lubbers, Paul R. Verkuil

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The article evaluates the Social Security Administration's (SSA) new Disability Service Improvement (DSI) process, introduced in 2006, which aims to address inefficiencies and inconsistencies in disability adjudication. The reforms include key innovations such as Quick Disability Determinations (QDDs), the Medical and Vocational Expert System (MVES), and the replacement of the Appeals Council with the Decision Review Board (DRB). While the reforms represent a significant and promising step toward improving the disability determination process, the article identifies remaining concerns, particularly regarding the role of the Federal Reviewing Official (FRO) and rules for submitting evidence at administrative hearings.

Drugged, Carl E. Schneider

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The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …

After Autonomy, Carl E. Schneider

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Bioethicists today are like Bolsheviks on the death of Lenin. They have, rather to their surprise, won the day. Their principle of autonomy is dogma. Their era of charismatic leadership is over. Their work of Weberian rationalization, of institutionalizing principle and party, has begun. The liturgy is reverently recited, but the vitality of Lenin's "What Is To Be Done?" has yielded to the vacuity of Stalin's "The Foundations of Leninism." Effort once lavished on expounding ideology is now devoted to establishing associations, organizing degree programs, installing bioethicist commissars in every hospital, and staffing IRB soviets. Not-so-secret police prowl the libraries …

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

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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 …

Hipaa-Cracy, Carl E. Schneider

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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 …

Liability, Regulation And Policy In Surgical Innovation: The Cutting Edge Of Research And Therapy, Anna C. Mastroianni

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This article examines the implications of the foregoing competing claims from a U.S. legal perspective, focusing particularly on how the legal system addresses patient safety concerns and autonomous decision-making of surgeons in the context of surgical innovation. The lack of oversight and the risks borne by patients during surgeons' development and subsequent refinement of a novel procedure must be balanced with the need to encourage medical progress through the development of improved techniques designed to benefit the health of current and future patients. This article argues that current reliance on the medical malpractice system and the federal regulatory system of …

The (Legal) Pains Of Vioxx: Why Product Liability Can Make Products More Dangerous, Omri Ben-Shahar

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Comparing the experience of Vioxx and Celebrex leads Omri Ben-Shahar to think that stiff product liability has the perverse effect of inducing manufacturers of defective products to leave these products on the market, rather than withdraw them.

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

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No abstract provided.

Reaching Disclosure, Carl E. Schneider

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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 …