Health Law and Policy Commons^™

How Medicare Could Get Better Prices On Prescription Drugs, Kevin Outterson

Faculty Scholarship

Congress may reform drug pricing policies under Medicare Part D as part of a larger health reform effort. Currently, the "noninterference" provision prevents the government from negotiating drug prices on behalf of Medicare Part D prescription drug plans. Commonly considered reform proposals borrow ideas from Medicaid, either through returning dual eligibles to Medicaid drug pricing or by imposing mandatory rebates across the Part D population. We examine a menu of other options, including value-based pricing; expansion of generic and therapeutically equivalent substitution; increased formulary diversity; importation; and limited antitrust waivers. These latter options may reduce federal spending without direct government …

Death From The Public Domain?, Kevin Outterson

Faculty Scholarship

In his recent article in the Texas Law Review, Ben Roin advances the claim that pharmaceutical innovation and the public’s health are harmed by the doctrines of non-obviousness and novelty. He does not mince words, labeling the nonobvious requirement as “perversity” with a “pernicious” effect on drug development. In his view, these standards pose an insurmountable barrier for drug companies seeking to commercialize inventions already in the public domain. He claims that valuable, life-saving drug ideas languish in the public domain because the companies face high barriers to entry from the FDA, but potential free riders are encouraged through the …

Federalization Snowballs: The Need For National Action In Medical Malpractice Reform, Abigail Moncrieff

Faculty Scholarship

Because tort law generally and healthcare regulation specifically are traditional state functions and because medical, legal, and insurance practices are highly localized, legal scholars have long believed that medical malpractice falls within the states' exclusive jurisdiction and sovereignty. Indeed, this view is so widely held that modern legal scholarship takes it for granted. Articles on general federalism issues use medical malpractice as an easy example of a policy in which federal intervention lacks functional justification, and articles that focus on federalization of other tort reforms use medical malpractice as an easy foil, pointing out that the uniformity interest that justifies …

Defining Health Law Or The Edgewood Syndrome, Paula Lobato De Faria, Wendy K. Mariner, George J. Annas

Faculty Scholarship

The authors' main purpose is to present ideas on defining Health Law by highlighting the particularities of the field of Health Law as well as of the teaching of this legal branch, hoping to contribute to the maturity and academic recognition of Health Law, not only as a very rich legal field but also as a powerful social instrument in the fulfillment of fundamental human rights. The authors defend that Health Law has several characteristics that distinguish it from traditional branches of law such as its complexity and multidisciplinary nature. The study of Health Law normally covers issues such as …

Protecting Hiv Positive Women’S Human’S Rights: Recommendations For The Obama Administration, Aziza Ahmed, Catherine Hanssens, Brook Kelly

Faculty Scholarship

To bring the United States in line with prevailing human rights standards, its National HIV/AIDS Strategy will need to explicitly commit to a human rights framework when developing programmes and policies that serve the unaddressed needs of women. This paper focuses on two aspects of the institutionalized mistreatment of people with HIV: 1) the criminalization of their consensual sexual conduct; and 2) the elimination of informed and documented consensual participation in their diagnosis through reliance on mandatory and opt-out testing policies. More than half of US states have HIV-specific laws criminalizing the consensual sexual activity of people with HIV, regardless …

End-Of-Life Care: Doctors' Complaints And Legal Restraints, Robert L. Schwartz

Faculty Scholarship

Health lawyers and policymakers cannot always see the same shadows of the laws that are visible to health care providers, and sometimes those shadows have penumbras and emanations that are not visible to those outside of a narrow medical practice. Sometimes those shadows, whether real or imagined, cause doctors to act inconsistently with the intent of the law, and inconsistently with the requirements of good medical practice. Doctors may misread or misunderstand a law. Still, if the law as misread or misunderstood actually affects medical practice, we should not be blind to the fact of the misunderstanding. Listen to doctors' …

Estimating The Effect Of Damages Caps In Medical Malpractice Cases: Evidence From Texas, David A. Hyman, Bernard Black, Charles Silver, William M. Sage

Faculty Scholarship

Using claim-level data, we estimate the effect of Texas's 2003 cap on non-economic damages on jury verdicts, post-verdict payouts, and settlements in medical malpractice cases closed during 1988–2004. For pro-plaintiff jury verdicts, the cap affects 47-percent of verdicts and reduces mean allowed non-economic damages, mean allowed verdict, and mean total payout by 73-percent, 38-percent, and 27-percent, respectively. In total, the non-econ cap reduces adjusted verdicts by $156M, but predicted payouts by only $60M. The impact on payouts is smaller because a substantial portion of the above-cap damage awards were not being paid to begin with. In cases settled without trial, …

Kairos And Safe Havens: The Timing And Calamity Of Unwanted Birth, Susan Ayres

Faculty Scholarship

It is impossible to know the number of infants killed or illegally abandoned at birth. No official reporting requirements exist, but conservative estimates claim that in the United States, 150-300 infants are killed within twenty-four hours of life and that over 100 infants are illegally abandoned. Beginning in 1999, in an effort to stem the problem of neonaticide and illegal abandonment, states began enacting laws to legalize abandonment. By 2008, all fifty states had enacted safe haven laws, which allow parents to anonymously abandon newborns by delivering them to designated providers, such as hospitals. This article provides a practical and …

Can State Health Reform Initiatives Achieve Universal Coverage: Lessons From California’S Recent Failed Experiment, Susan A. Channick

Faculty Scholarship

This article is about the struggle toward health care reform. It looks at the mandated health care insurance model as well as the experiences of Massachusetts and California.

Why We Should Ignore The “Octomom”, Kimberly D. Krawiec

Faculty Scholarship

No abstract provided.

Theorizing And Generalizing About Risk Assessment And Regulation Through Comparative Nested Analysis Of Representative Cases, Jonathan B. Wiener, Brendon Swedlow, Denise Kall, Zheng Zhou, James K. Hammitt

Faculty Scholarship

This article provides a framework and offers strategies for theorizing and generalizing about risk assessment and regulation developed in the context of an on-going comparative study of regulatory behavior. Construction of a universe of nearly 3,000 risks and study of a random sample of 100 of these risks allowed us to estimate relative U.S. and European regulatory precaution over a thirty-five-year period. Comparative nested analysis of cases selected from this universe of ecological, health, safety, and other risks or its eighteen categories or ninety-two subcategories of risk sources or causes will allow theory-testing and -building and many further descriptive and …

Answering The Millennium Call For The Right To Maternal Health: The Need To Eliminate User Fees, Margaux J. Hall, Aziza Ahmed, Stephanie E. Swanson

Faculty Scholarship

Complications during childbirth and pregnancy are a main source of death and disability among women of reproductive age. Approximately 536,000 women die from pregnancy-related complications each year. Developing countries suffer most profoundly, accounting for 99% of deaths. The world's nations, by endorsing U.N. Millennium Development Goals, recognized that most deaths are preventable; they have pledged to reduce maternal mortality by 75% by 2015. This Article assesses the barriers presented by user fees - formal charges for health services still charged by many countries - to the attainment of MDGs. It shows that user fees hamper healthcare access, particularly in emergency …

Decisional Dignity: Teenage Abortion, Bypass Hearings, And The Misuse Of Law, Carol Sanger

Faculty Scholarship

How might we think about reforming abortion regulation in a world in which the basic legality of abortion may, as a matter of constitutional law, at last be relatively secure? I have in mind the era just upon us in which the overturn of Roe v. Wadeno longer looms so threateningly over the reproductive rights community in the United States and is no longer necessarily its central concern. There is now a general and seemingly well-founded optimism that under the Obama administration, those who support and rely on reproductive rights will not have to pray nightly for the health …

Surrogacy And The Politics Of Commodification, Elizabeth S. Scott

Faculty Scholarship

In 2004, the Illinois legislature passed the Gestational Surrogacy Act, which provides that a child conceived through in vitro fertilization (IVF) and born to a surrogate mother automatically becomes the legal child of the intended parents at birth if certain conditions are met. Under the Act, the woman who bears the child has no parental status. The bill generated modest media attention, but little controversy; it passed unanimously in both houses of the legislature and was signed into law by the governor.

This mundane story of the legislative process in action stands in sharp contrast to the political tale of …

Virginity Testing And South Africa's Hiv/Aids Crisis: Beyond Rights Universalism And Cultural Relativism Toward Health Capabilities, Erika George

Faculty Scholarship

In this Article, I explore the tension between the politics of culture and the rights of women and girls to equality, privacy, and sexual autonomy in the context of epidemic disease. Specifically, this Article examines the political debate surrounding the resurgence of virginity testing, its widespread popular support in certain communities, and the South African government's recent efforts to prohibit the practice. This Article argues that the current debate over virginity testing, which focuses on abolition or accommodation of the practice, is misguided and polarizing. It argues that these perspectives on the debate increase the likelihood that the problem causing …

Defense Costs And Insurer Reserves In Medical Malpractice And Other Personal Injury Cases: Evidence From Texas, 1988-2004, Bernard Black, David A. Hyman, Charles Silver, William M. Sage

Faculty Scholarship

We study defense costs for commercially insured personal injury tort claims in Texas over 1988–2004, and insurer reserves for those costs. We rely on detailed case-level data on defense legal fees and expenses, and Texas state bar data on lawyers’ hourly rates. We study medical malpractice (“med mal”) cases in detail, and other types of cases in less detail. Controlling for payouts, real defense costs in med mal cases rise by 4.6 percent per year, roughly doubling over this period. The rate of increase is similar for legal fees and for other expenses. Real hourly rates for personal injury defense …

The Changing Face Of Family Law: Global Consequences Of Embedding Physicians And Biotechnology In The Parent-Child Relationship, George J. Annas

Faculty Scholarship

Sexual reproduction, also known as making babies the old-fashioned way, has always brought with it significant challenges for family law, especially regarding protecting the best interests of children, and the identification of parents with the right and responsibility to rear them. But these challenges often seem mundane in the face of what has evolved since physicians have been injected into baby making and thus into novel parent-child relationships. The addition of physicians and their "new" medical technologies, sometimes called Assisted Reproductive Technology (ART), have forced the law to reconsider the very definition of motherhood and have radically altered society's view …

Dances With Elephants: Administrative Resolution Of Medical Injury Claims By Medicare Beneficiaries, Eleanor D. Kinney, William M. Sage

Faculty Scholarship

In our judgment, Hoffmann and Rowthorn's research clearly demonstrates that the QIO-based complaint review process does not provide genuine relief to beneficiaries. People who complain typically want an explanation of their bad experience, compensation for harm they may have suffered, and assurance that future experiences will be better for themselves and for others. Medicare beneficiaries, however, receive minimal information about the resolution of their complaints and no substantive relief whatsoever.

As Hoffmann and Rowthorn point out, several reform proposals are now before Congress, including moving the beneficiary complaint function from QIOs to new "Medicare Provider Review Organizations." It is not …

Social Solidarity And Personal Responsibility In Health Reform, Wendy K. Mariner

Faculty Scholarship

In the United States, calls to expand access to health care, when not simply ignored, typically result in bills or legislation to reform health insurance. We are in the midst of just such a cycle today. Several states have adopted reform laws to make insurance available to most of their residents. Presidential candidates are offering their own proposals for the nation's health care system. Former Treasury Secretary Paul O'Neill even declared that health care should be a right, adding that wealthier people should help pay for those who will never be able to afford their own care. Most Americans cannot …

Erisa, Agency Costs, And The Future Of Health Care In The United States, John Bronsteen, Brendan S. Maher, Peter K. Stris

Faculty Scholarship

Because so many Americans receive health insurance through their employers, the Employee Retirement Income Security Act of 1974 (ERISA) plays a dominant role in the delivery of healthcare in the United States. The ERISA system enables employers and insurers to save money by providing inadequate healthcare to employees, thereby creating incentives for these agents to act contrary to the interests of their principals. Such agency costs play a significant role in the current healthcare crisis and require attention when considering reform. We evaluate the two major healthcare reform movements by exploring the extent to which each reduces agency costs. We …

The Role And Legal Status Of Health Care Ethics Committees In The United States, Diane E. Hoffmann, Anita J. Tarzian

Faculty Scholarship

Over a quarter of a century has passed since health care ethics committees (HCECs) in the United States received legal recognition as alternatives to the courts in resolving conflicts related to patient end-of-life care. By the mid to late 1980s HCECs had been established in over half of U.S. hospitals and had received a certain legitimacy in the health care system. Given their age and growth one could characterize them developmentally as emerging from adolescence and establishing themselves in young adult-hood. As a result, we might expect that they would have resolved the identify crisis characterizing the adolescent years. Yet, …

Achieving Quality And Responding To Consumers - The Medicare Beneficiary Complaint Process: Who Should Respond?, Diane E. Hoffmann, Virginia Rowthorn

Faculty Scholarship

No abstract provided.

Are Health Care Conflicts All That Different? A Contrarian View, Diane E. Hoffmann

Faculty Scholarship

No abstract provided.

Treating Pain V. Reducing Drug Diversion And Abuse: Recalibrating The Balance In Our Drug Control Laws And Policies, Diane E. Hoffmann

Faculty Scholarship

No abstract provided.

Rules For Donations To Tissue Banks: What Next?, George J. Annas

Faculty Scholarship

Michael Crichton's Next is a fictional creation of multiple catastrophes emanating from the real-life case of John Moore, in which the California Supreme Court ruled in 1990 that Moore did not own his cells after they were removed from his body. As human tissue has become commercially useful, and as tissue banks storing and providing samples for research have flourished, the question of who owns the tissue has become more vital. Next got mixed reviews, but even many scientists, such as Michael Goldman, who reviewed the book in Nature, agree with Crichton that it is imperative that we “establish clear …

Lessons From India In Organizational Innovation: A Tale Of Two Heart Hospitals, Barak D. Richman, Krishna Udayakumar, Will Mitchell, Kevin A. Schulman

Faculty Scholarship

Recent discussions in health reform circles have pinned great hopes on the prospect of innovation as the solution to the high-cost, inadequate-quality U.S. health system. But U.S. health care institutions--insurers, providers and specialists--have ceded leadership in innovation to Indian hospitals such as Care Hospital in Hyderabad and the Fortis Hospitals around New Delhi, which have U.S.-trained doctors and can perform open heart surgery for $6000 (compared to $100,000 in the United States). The Indian success is a window into America's stalemate with inflating costs and stagnant innovation.

Electroconvulsive Therapy Baby Boomers May Be In For The Shock Of Their Lives, Helia Garrido Hull

Faculty Scholarship

No abstract provided.

Book Review: Elizabeth Wicks' Human Rights And Healthcare, Barbara A. Noah

Faculty Scholarship

The Author reviews the book Human Rights and Healthcare, by Elizabeth Wicks and published by Hart Publishing, 2007. Although the book focuses mainly on rights within the United Kingdom, those familiar with healthcare and bioethics issues within the United States or elsewhere will find it an extremely useful comparative resource.

Empirical Health Law Scholarship: The State Of The Field, Michelle M. Mello, Kathryn Zeiler

Faculty Scholarship

The last three decades have seen the blossoming of the fields of health law and empirical legal studies and their intersection - empirical scholarship in health law and policy. Researchers in legal academia and other settings have conducted hundreds of studies using data to estimate the effects of health law on accident rates, health outcomes, health care utilization, and costs, as well as other outcome variables. Yet the emerging field of empirical health law faces significant challenges: practical, methodological, and political. The purpose of this Article is to survey the current state of the field by describing commonly used methods, …

Reviews In Medical Ethics: Stumbling On Options: A Review Of Readings In Comparative Health Law & Ethics, Frances H. Miller

Faculty Scholarship

Thanks to a series of storms sweeping up the eastern seaboard for three days, I found myself with four fivehour flight delays and two completely unrelated books in my briefcase. One of the books was the second edition of Professor Tim Jost's Readings in Comparative Health Law & Ethics,' which I was reviewing for this publication. The second was Daniel Gilbert's Stumbling on Happiness,² which someone - no doubt thinking I could use a little wisdom on the subject - had given me for my birthday. I did not mind the delays, for they gave me time …