Health Law and Policy Commons^™

When Patients Say No (To Save Money): An Essay On The Tectonics Of Health Law., Mark A. Hall, Carl E. Schneider

Articles

The ultimate aim of health care public policy is good care at good prices. Managed care stalled at achieving this goal by trying to influence providers, so health policy has turned to the only market-based option left: treating patients like consumers. Health insurance and tax policy are now pressuring 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 watchword. This Article evaluates this ideal type …

Out Of The Box: The Future Of Retail Medical Clinics, William M. Sage

Faculty Scholarship

The 2000s was mostly a lost decade for reform of the health care delivery system. Among the few significant innovations was the retail medical clinic, where individuals could receive basic health care at posted prices without appointments, typically from nurse practitioners or physician assistants. Most retail clinics were associated with chain drugstores, supermarkets, or other "big box" retailers. This short article describes the implications of the retail clinic model for US health policy and health care reform. It is no longer available from the online journal in which it originally appeared.

The Life Science Lawyer, Erin Albert

Butler University Books

Health care and life sciences are increasingly complex. There are many global players in life sciences and healthcare-patients, governments, hospitals, managed care companies, pharmaceutical, biotechnology, and medical device companies and pharmacies are only a few. With this increasing complexity comes a higher demand for hybrid professionals who can translate both the science as well as the legal issues surrounding this complicated environment. In the US, there are thousands of life science lawyers--people who have both a scientific/healthcare background and also who have gone on to law school (or in one case, vice versa). This book explores the following through interviews: …

Reauthorizing Schip: A Summary Of Selected Issues, Jennifer Ryan, Cynthia Shirk

National Health Policy Forum

This document provides a brief overview of some of the policy and programmatic issues that were addressed in legislation to reau¬thorize the State Children’s Health Insurance Program (Title XXI of the Social Security Act) during the summer and fall of 2007. This overview provides a background for understanding the elements for a second round of reauthorization that will likely be debated in the early days of the 111th Congress. The paper reviews several of the key issues under discussion and summarizes some of the related provisions in the reauthorization bills that were considered in 2007.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Changing Expectations For Board Oversight Of Healthcare Quality: The Emerging Paradigm, Valerie Gutmann Koch

All Faculty Scholarship

Within healthcare institutions, leadership is an essential driver of expectations, performance, and culture. Yet boards of directors traditionally played a limited role in overseeing healthcare quality, providing final approval of credentialing decisions but deferring to the medical staff to set standards for the institution. Case law and standards provide little guidance for board performance in verseeing quality of care. Recent developments — the availability of comparative quality data, public reporting, and financial incentives for higher quality — have transformed expectations for board oversight. Enforcement of fraud and abuse laws based on poor quality of care, as well as federal standards …

Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch

All Faculty Scholarship

This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.

Unintended Consequences: The Primacy Of Public Trust In Vaccination, Jason L. Schwartz

Michigan Law Review First Impressions

The increasing availability of personal belief exemptions from state vaccination requirements is a growing concern among proponents of vaccination. Holding parents of non-vaccinated children liable to those they infect is among the responses proposed to maintain high vaccination rates. Even if motivated by a sincere desire to maximize the benefits of vaccination throughout society, such a step would be inadvisable, further entrenching opponents of vaccination and adding to the atmosphere of confusion and unnecessary alarm that has become increasingly common among parents of children for whom vaccination is recommended.

Challenging Personal Belief Immunization Exemptions: Considering Legal Responses, Alexandra Stewart

Michigan Law Review First Impressions

Public health agencies and citizens should employ legal approaches to hold parents accountable for refusing to vaccinate their children. The judiciary would craft an effective response to defeat the threat posed by these parents. Public-nuisance law may offer a legal mechanism to hold vaccine objectors liable for their actions.

Prosecuting Doctors For Trusting Patients, Deborah Hellman

Faculty Scholarship

In an escalating phase of our country’s war on drugs, doctors treating patients in pain are being prosecuted for drug trafficking under the Controlled Substances Act. While doctors surely can be guilty of drug trafficking when they sell drugs for money, lately some doctors have been prosecuted for violations of a statute that requires knowingly distributing or dispensing controlled substances in an unauthorized manner for simply being willfully blind to the fact that their patients were reselling the drugs. While willful blindness may be an apt substitute for knowledge in the traditional drug courier scenario, doctors in these cases are …

Physicians Who Break The Law, Diane E. Hoffmann

Faculty Scholarship

This paper takes as its starting point a recent article by Prof. Sandra Johnson, Regulating Physician Behavior: Taking Doctors “Bad Law” Claims Seriously. In the article, Johnson focuses on doctors who comply with the law despite their belief that the law is “bad”, i.e., causes them to behave in ways that are harmful to their patients. In Physicians Who Break the Law, I explore cases where physicians break the law claiming that it is “bad”. In this exploration, I focus on two areas of physicians’ lawbreaking: (1) violations of business-related laws, in particular, insurance fraud; and (2) violations of laws …

A Circumspect Look At Problem-Solving Courts, Richard C. Boldt

Faculty Scholarship

No abstract provided.

Violence On The Brain: A Critique Of Neuroscience In Criminal Law, Amanda C. Pustilnik

Faculty Scholarship

Is there such a thing as a criminally "violent brain"? Does it make sense to speak of "the neurobiology of violence" or the "psychopathology of crime"? Is it possible to answer on a physiological level what makes one person engage in criminal violence and another not, under similar circumstances?

This Article first demonstrates parallels between certain current claims about the neurobiology of criminal violence and past movements that were concerned with the law and neuroscience of violence: phrenology, Lombrosian biological criminology, and lobotomy. It then engages in a substantive review and critique of several current claims about the neurological bases …

Law & Health Care Newsletter, V. 16, No. 2, Spring 2009

Law & Health Care Newsletter

No abstract provided.

Prizes For Innovation Of New Medicines And Vaccines, James Love, Tim Hubbard

Annals of Health Law and Life Sciences

This article argues that prizes can help stimulate medical innovation, control costs and ensure greater access to new medicines and vaccines. The authors explore four increasingly ambitious prize options to reward medical innovation, each addressing flaws in the current patent system. The first option promotes innovation through a large prize fund linked to the impact on health outcomes; the second option rewards the sharing of knowledge, data, and technology with open source dividends; the third option awards prizes for interim benchmarks and discrete technical problems; and the final option removes the exclusive right to use patented inventions in upstream research …

Health Insurance Exchanges: Legal Issues, Timothy Stoltzfus Jost

Scholarly Articles

No abstract provided.

George Smith, Edmund D. Pellegrino, John Carroll

Journal of Contemporary Health Law & Policy (1985-2015)

No abstract provided.

The Costs Of Multiple Gestation Pregnancies In Assisted Reproduction, Urska Velikonja

Faculty Scholarship

The United States, unlike most developed countries, does not regulate its fertility industry. Rather, it vests control over the industry to professional organizations and to market forces. While lack of regulation has produced a vibrant market for fertility services, it has also produced an undesirable consequence: a high rate of multiple gestation pregnancies, including twin pregnancies. This Article summarizes the data on the medical, psychological, and financial costs associated with multiple pregnancies to the parents, the children, and American society. It suggests that the current U.S. regulatory regime has not only failed to address these costs as they surfaced but …

Patents & (And) The Progress Of Personalized Medicine: Biomarkers Research As Lens, Matthew Herder

Annals of Health Law and Life Sciences

This article addresses the barriers to personalized medicine, focusing on the burgeoning field of biomarkers research. The author begins by framing intellectual property issues as more than a product of industry incentives and suggests that these issues are deeply entangled with other barriers facing personalized medicine such as regulatory framework deficiencies. The author proposes a set of future research questions to more fully define the barriers to biomarkers research and to uncover which corrective measures may be effective. The author concludes by recommending an integration of regulatory and patent reforms, with a call to action by scholars, scientists, representatives of …

An Introduction - Patents Versus Patients: Must We Choose, Cynthia M. Ho, Ann Weilbaecher

Annals of Health Law and Life Sciences

No abstract provided.

Diseases Endemic In Developing Countries: How To Incentive Innovation, Ann Weilbaecher

Annals of Health Law and Life Sciences

This comment addresses the inadequacies of research and development for diseases endemic in developing countries and explores how the patent system can inhibit innovation for new drugs for neglected diseases. The author analyzes four strategies to encourage innovation, including open source initiatives, patent pools, prizes, and wild card patent extensions, and examines how these alternative systems may spur innovation while balancing cost concerns held by drug manufacturers and purchasers. The author concludes that a combination of solutions may provide the best framework for the creation of essential medicines for neglected diseases.

Patents With An "I" = Patients, Alice O. Martin, Sendil K. Devadas

Annals of Health Law and Life Sciences

The authors address how patent protection in the United States is often quite narrow in scope, difficult to obtain, and insufficient in duration, thus stifling research and development of potential breakthrough pharmaceuticals. The authors further posit that countries that have enacted stronger intellectual property rights and research incentives have seen tremendous increases in foreign direct investment. In addressing critics of the current patent system, the authors show that alternatives to biotechnology patents would not demonstrably improve innovation and development of beneficial medicines. The authors conclude that given the substantial evidence of the patent system's benefits, and the mere speculation that …

Legal, Ethical, And Conceptual Bottlenecks To The Development Of Useful Genomic Tests, Michael Tomasson

Annals of Health Law and Life Sciences

This article discusses advances in genomic research in the context of the debate surrounding gene patent rights and the limited rights of patient-participants in translational research. In addition, the author explores statutory and regulatory hurdles to advances in disease diagnosis, such the Bayh-Dole Act, Medicare Legislation, and the Health Insurance Portability and Accountability Act. The author questions the effectiveness of increasingly commercialized academic research and the limited success of the private sector in genomic research. The author concludes that future genomic research will require significantly increased patient participation, which may necessitate a reshaping of the pharmaceutical approach to medicine and …

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' …

The Emergence Of Mandatory Wellness Programs In The United States: Welcoming, Or Worrisome?, Daniel Charles Rubenstein

Journal of Health Care Law and Policy

No abstract provided.

The Law And Policy Of Health Care Quality Reporting, Kristin Madison

Campbell Law Review

Part I of this Essay provides an overview of hospital and physician quality reporting in the United States today. It compiles examples of quality report cards, examines empirical evidence of report cards' impact, and discusses report cards' problems, including barriers to consumer use and deficiencies in content and quality. Part II reviews legal issues that have arisen with respect to quality reporting, focusing on controversies surrounding health insurers' use and publication of physician performance measures. It traces the roles of various stakeholders in responding to these controversies and shows how the resolutions reached address broader policy concerns about quality measures. …

Multi-Institutional Healthcare Ethics Committees: The Procedurally Fair Internal Dispute Resolution Mechanism, Thaddeus Mason Pope

Campbell Law Review

No abstract provided.

Cutt Ing Funds For Oral Contracept Ives: Violation Of Equal Protection Rights And The Disparate Impact On Women’S Healt Hcare, Rachel V. Rose

The Modern American

No abstract provided.

Legislative Updates , Guadalupe A. Lopez

The Modern American

No abstract provided.