Health Law and Policy Commons^™

The Bipartisan Patient Protection Act: Greater Liability On Managed Care Plans, Urura W. Mayers

Annals of Health Law and Life Sciences

Mrs. Mayers' article notes the substantial differences that exist between the Senate and the House of Representatives' version of the Bipartisan Patient Protection Act of 2001. While observing the remedies made available to participants, beneficiaries, or enrollees under both bills, she shows that the Senate bill places greater liability on managed care plans because it favors consumer protection, while the House of Representatives' bill does not. In order to develop an understanding of why an act of this nature is needed, Mrs. Mayers provides a brief historical overview of how managed care entities developed. She also examines the Employee Retirement …

Physician Restrictive Covenants: The Neglect Of The Incompetent Patients' Interests, S. Elizabeth Malloy

Faculty Articles and Other Publications

The article examines how courts in different jurisdictions have addressed restrictive employment covenants for physicians and proposes a new approach drawn from the third-party beneficiary analysis in contract law. Physicians hired into existing practices often must sign substantial non-compete agreements. In evaluating the enforceability of any restrictive covenant, courts consider, among other factors, the agreement's effect on the public. Surprisingly, the vast majority of jurisdictions treat the "public interest" analysis vis-a-vis physician restrictive covenants no differently than any other commercial restrictive covenant; this approach neglects the impact that such agreements can have on a physician's existing patients. Although at first …

Message Deleted? Resolving Physician-Patient E-Mail Through Contract Law, Michael Mccann

Law Faculty Scholarship

This article examines the impact of e-mail on the physician-patient relationship, and how contract law can resolve the uncertainties incumbent in this nascent form of communication. Significantly, courts have yet to indicate when the physician-patient relationship begins by e-mail, or to what extent e-mail affects the duties of the relationship. Instead of waiting for judicial guidance, physicians and patients can employ specialized contracts to clarify the role that e-mail plays in their relationship. As a result, more physicians and patients will regard e-mail correspondence as a valuable means of communication, and a tool for improving the quality of health care …

Symposium: Issues In Bioterrorism -Introduction, Jessica Wilen Berg

Faculty Publications

This issue of Health Matrix focuses on the legal issues involving bioterrorism.

How Mfn Clauses Used In The Health Care Industry Unreasonably Restrain Trade Under The Sherman Act, Beth Ann Wright

Journal of Law and Health

When used in the health care industry, an MFN clause is a contractual agreement that guarantees a health insurer the same best price as their market competitors. MFN clauses have the effect of unnecessarily raising consumer costs, reducing choice among providers, constraining access to care and preventing the development of alternative health care delivery models. The purpose of this paper is four-fold. First, to design a four-quadrant matrix to evaluate the pro-competitive and anticompetitive purpose and effects of MFN clauses under Section 1 of the Sherman Act. Second, to defeat the jurisprudential presumption that MFN clauses are pro-competitive in the …

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Foreword, Jeffrey Kee, Larry Singer, John Blum

Annals of Health Law and Life Sciences

No abstract provided.

Changing The Law, Changing The Culture: Rethinking The "Sleepy Resident" Problem, Jennifer F. Whetsell

Annals of Health Law and Life Sciences

Ms. Whetsell examines the Bell Regulations, which limit New York's hospital residents' work hours and require increased supervision from senior doctors, in light of the currently pending federal bill that seeks to do the same. The article argues that the federal government should draw lessons from the New York experience before proceeding with similar guidelines. The article notes that many roadblocks have prevented successful implementation of the New York policy, including a long-standing tradition of "hazing" first-year residents with long, unsupervised hours; medical community resistance to the notion of residents' sleep deprivation and dislike of government interference; and a general …

Bioterrorism Meets Privacy: An Analysis Of The Model State Emergency Health Powers Act And The Hipaa Privacy Rule, Julie Bruce

Annals of Health Law and Life Sciences

Ms. Bruce's paper analyzes the interplay between the Model State Emergency Health Powers Act and the HIPAA Privacy Rule. The article begins by examining specific relevant provisions of the Act and Rule. Next, it traces the history of public health law through the court system and then uses this foundation to discuss how the Model State Emergency Health Powers Act and the HIPAA Privacy Rule could co-exist, protecting Americans in the case of a bioterror attack, while being appropriately sensitive to the confidentiality of private health information.

Access To Health Care: What A Difference Shades Of Color Make, Gwendolyn Roberts Majette

Annals of Health Law and Life Sciences

Professor Majette's timely article examines an age-old problem: the effect of race and ethnicity on a patient's receipt of health care. Her article analyzes some of the major health care access issues, with a focus on barriers confronting African Americans, Asians, Hispanics, and Native Americans. Some of the barriers include inability to pay, cultural insensitivity, a shortage of health care providers, and discrimination. She also examines some of the unsuccessful legal solutions and remedies designed to eliminate these barriers. Given the complexity of the access barriers encountered by people of color, Professor Majette concludes that only an interdisciplinary approach can …

Time Is Running Out - The Burdens And Challenges Of Hipaa Compliance: A Look At Preemption Analysis, The Minimum Necessary Standard, And The Notice Of Privacy Practices, Jennifer Guthrie

Annals of Health Law and Life Sciences

Ms. Guthrie's paper involves the final Privacy Regulations promulgated by the Department of Health and Human Services pursuant to HIPAA. Her thesis highlights three burdensome requirements which remain significant obstacles to the compliance date of April 14, 2003: (1) the need to undertake thorough preemption analyses, (2) lack of clarity surrounding the "Minimum Necessary Standard," and (3) confusion regarding the "Notice of Privacy Practices." Ms. Guthrie provides a close analysis of these three areas and offers several viable and persuasive alternatives to the associated burdens. She concludes that HHS must make several integral modifications and provide substantial and continuing guidance …

Table Of Contents, Annals Of Health Law

Annals of Health Law and Life Sciences

No abstract provided.

Quality Assurance And Hospital Structure: How The Physician-Hospital Relationship Affects Quality Measures, Ronald G. Spaeth, Kelley C. Pickering, Shannon M. Webb

Annals of Health Law and Life Sciences

Mr. Spaeth writes about the relationship between hospital administration and the physician, and how that relationship affects the quality of medical care delivered to the patient. The article focuses on the differences between the employment structure in an academic teaching hospital, and the open, independent contractor medical staff typical of a traditionally smaller community hospitals. The individual traits and nuances of these structures and how they can be distinguished from one another create dynamic differences in the approach for quality care. Peer review, credentialing, and management of adverse outcomes are just a few of the ways in which hospitals continue …

The Hospital Board At Risk And The Need To Restructure The Relationship With The Medical Staff: Bylaws, Peer Review And Related Solutions, John P. Marren, G. Landon Feazell, Michael W. Paddock

Annals of Health Law and Life Sciences

This article argues that the current structure of the hospital governing board and medical staff relationship does not support and promote quality and patient-centered care. The fundamental flaw in the current structure is the interdependent, yet independent and discordant relationships between hospital governing boards and medical staffs. These relationships are described as cultures and fit into three types of "silos": organizational (the "structural silo"); professional (the "professional silo", including the "culture of blame"); and the fragmented quality information silo (the "informational silo"). While case law, statutory requirements and regulatory expectations clearly state that governing boards are ultimately responsible for quality …

Proposed Changes To The Hospital-Medical Staff Relationship To Improve Quality Of Care, Elizabeth A. Snelson

Annals of Health Law and Life Sciences

Medical staff attorney Snelson answers the Colloquium's charge, "What exactly has to change in the hospital-medical staff relationship for health care quality to be improved?" Her response emphasizes the logic of having clinicians vested with authority to establish policies concerning the clinical decision-making. The article discusses the cases defining the medical staff bylaws as contractual in nature, and the problem of hospital attorneys demanding unilateral amendments to bylaws. Bylaw clauses that would chill medical opinion and communication or denigrate clinical recommendations are discussed. Ms. Snelson advocates for the inclusion of the medical staff organization in exclusive contract and other clinical …

Off-Label Or Out Of Bounds? Prescriber And Marketer Liability For Unapproved Uses Of Fda-Approved Drugs, James O'Reilly, Amy Dalal

Annals of Health Law and Life Sciences

Professor O'Reilly's study of recent drug review legislation applies a historical and holistic view of promotion practices for unapproved uses of prescription drugs. He faults Congress for moving public health protections away from a strictly protective mode and toward assistance to drug marketers. He argues that the adverse health consequences of "off-label" promotion of drugs are not well understood, and that the 1997 amendments disserved the public health interest while expanding pharmaceutical company profits.

Fda's Proposed Rules On Patent Listing Requirements For New Drug And 30-Month Stays On Anda Approval (Proposed Oct. 24, 2002), Yuk Fung Hui

Annals of Health Law and Life Sciences

In order to close the loophole in the generic drug approval process that allows a brand name drug patent holder to delay or defeat generic drug application merely by technicality, the FDA recently proposed to modify its regulations. Those proposals affect the patent listing requirements of a new drug application, and the duration of time that a generic drug application could be put on hold in the event of a patent infringement suit. With the modified rules, the FDA expects to see an increase in the availability of generic drugs, which eventually will lead to lower drug costs. Ms. Hui …

Making The Health Insurance Flexibility And Accountability (Hifa) Waiver Work Through Collaborative Governance, Barbara J. Zabawa

Annals of Health Law and Life Sciences

This paper argues that collaborative governance should be an essential component in any HIFA waiver proposal, due to the fact that the health care system is moving away from a federal and hierarchical program design and implementation towards a more local, collaborative approach. As several current collaborative projects demonstrate, collaboration may overcome barriers to health expansion program success, such as stakeholder buy-in, notice, and state access to private health coverage information. Furthermore, collaboration within the context of the HIFA waiver process may maximize the strengths of current collaborations, such as providing: (a) access to greater and more stable funding sources; …

Comparative And International Health Law, Timothy Stoltzfus Jost

Scholarly Articles

No abstract provided.

Regulating Clinical Research: Informed Consent, Privacy, And Irbs, Sharona Hoffman

Faculty Publications

During the past two decades, the United States has experienced dramatic developments in the area of biomedical research. Expanding budgets, augmented computer capabilities, and the Human Genome Project have all significantly enhanced research capabilities. Consequently, the number of research projects conducted in this country is ever growing, and the enrollment of an adequate number of human subjects is becoming an increasingly challenging task.

Clinical research involving human participants is governed by federal regulations that have been promulgated by the Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA). In light of the proliferation of medical …

Medical Restrictive Covenants In Illinois: At The Crossroads Of Carter-Shields And Prairie Eye Center, Stuart Gimbel, Miles J. Zaremski

Annals of Health Law and Life Sciences

This article examines the history, development and treatment by Illinois courts of medical restrictive covenants. The authors highlight two recent cases from Illinois, one from the Supreme Court and the other authored by an appellate court panel. The article concludes by providing not only a forecast of how such covenants should be treated by Illinois state courts in the future, but also a pathway for the expectations of health care practitioners who wish to use restrictive covenants in their employment relationships with their colleagues.

The Medical Staff Structure - Its Role In The 21st Century, Gerald M. Eisenberg

Annals of Health Law and Life Sciences

Dr. Eisenberg's paper presents a vision of the medical staff from the point of view of a practicing physician and medical staff leader. Dr. Eisenberg focuses on ways the medical staff, as an independent entity, may use the collective clinical knowledge and experience of its physician membership to enhance quality. This paper also presents Dr. Eisenberg's unique insights regarding the interplay and conflict between hospitals and their associated medical staff in today's complex health care delivery system. He provides several suggestions to increase cooperation between these two important components of inpatient care.

No More Kidding Around: Restructuring Non-Medical Childhood Immunization Exemptions To Ensure Public Health Protection, Ross D. Silverman

Annals of Health Law and Life Sciences

Professor Silverman's article examines the complex challenges faced by U.S. policymakers attempting to balance the public health protections of mandatory childhood immunization programs with the legal, religious, philosophical, and practical concerns raised by permitting non-medical exemptions under the programs. The article begins with a discussion of the history of childhood immunization programs, and continues by describing the inconsistency of enforcement of state immunization laws and exemptions. The author analyzes recent cases from New York, Wyoming, and Arkansas, and discusses how these decisions both pose threats to these programs' public health protections, while also offering insight into potential problems for other …

The Impact Of 9/11 And Its Aftermath On Substance Use And Psychological Functioning: An Overview, Patrick B. Johnson, Linda Richter

Fordham Urban Law Journal

This Essay provides a brief summary and evaluation of findings on the mental health and substance abuse consequences of the events of 9/11 throughout the nation and in United States' cities. It also presents new data obtained from clients who entered substance abuse treatment in New York and other cities either before 9/11 or during a six-month period following the events. This Essay discusses how best to interpret these varying research findings. It concludes that crisis produces many responses and most people just coped with 9/11 in their individual ways.

Police Training And Specialized Approaches For Responding To People With Mental Illnesses, Judy Hails, Randy Borum

Mental Health Law & Policy Faculty Publications

Eighty-four medium and large law enforcement agencies reported the amount of training provided on mental-health-related issues and the use of specialized responses for calls involving people with mental illnesses. Departments varied widely in the amount of training provided on mental-health-related topics, with a median of 6.5 hours for basic recruits and 1 hour for in-service training. Approximately one third of the agencies (32%) had some specialized response for dealing with calls involving people with mental illnesses. Twenty-one percent had a special unit or bureau within the department to assist in responding to these calls; 8% had access to a mental …

The Relationship Between Service Utilization And Medicaid Enrollees’ Trust In Health Care Providers, Huey Jen Chen

Mental Health Law & Policy Faculty Publications

Based on findings from 1990 National Co-morbidity Survey, it is estimated that nearly 20% of the U.S. population is affected by mental disorders during a given year. Approximately 5.4% of adults are considered to have a serious mental illness that interferes with their social function, and half of them suffer from severe and persistent mental illness (SMI). Mental illness imposes a high socioeconomic burden that is second only to cardiovascular disease (Kessler, Berglund, Zhao et al., 1996; Kessler, McGonagle, Zhao et al., 1994).

Among individuals with SMI, 40% do not seek any treatment from either general medical or specialty mental …

Triad Girls’ Group Treatment Manual, Michelle Levasseur, Colleen Clark

Mental Health Law & Policy Faculty Publications

No abstract provided.

Public Access Versus Proprietary Rights In Genomic Information: What Is The Proper Role Of Intellectual Property Rights?, Janice M. Mueller

Journal of Health Care Law and Policy

No abstract provided.

Contrary To First Impression, Genes Are Patentable: Should There Be Limitations?, Amanda S. Pitcher

Journal of Health Care Law and Policy

No abstract provided.

Cornering The Market In A Post-9/11 World: The Future Of Horizontal Restraints, 36 J. Marshall L. Rev. 557 (2003), Daniel Goldberg

UIC Law Review

No abstract provided.