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Full-Text Articles in Law

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang Sep 2011

Off-Label Promotion Reform: A Legislative Proposal Addressing Vulnerable Patient Drug Access And Limiting Inappropriate Pharmaceutical Marketing, Tim Mackey, Bryan A. Liang

University of Michigan Journal of Law Reform

Off-label promotion occurs when pharmaceutical manufacturers engage in promotion of unapproved or "off-label" uses of their drugs. These off label uses may lack adequate clinical data to substantiate marketing claims, have led to corporate investigations and penalties, and can endanger public health. However there is adequate evidence to suggest that off-label uses are entirely appropriate for some vulnerable patient populations, and that physicians have accepted such uses as standard. Historically, U.S. law has prohibited direct off-label promotion to physicians and patients. However, failed government guidance, industry-based litigation, and the diminished capacity of regulators to police illegal practices have had dire …


Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn Sep 2011

Litigating Against An Epidemic: Hiv/Aids And The Promise Of Socioeconomic Rights In South Africa, Nathaniel Bruhn

Michigan Journal of Race and Law

With one of the highest incidence rates in the world, the HIV/AIDS epidemic has taken a large toll on South Africa. Despite medical advances that have made the disease more manageable, many South Africans still do not have access to the medicines needed to control the disease. At the same time, the Constitution of South Africa grants individuals far-reaching socioeconomic rights, including the right to access health care. This Comment explores the intersection of the socioeconomic rights and the HIV/AIDS crisis. Although the Constitutional Court has developed a deferential approach to enforcing socioeconomic rights, substantial room remains to litigate on …


The Unaffordable Health Act – A Response To Professors Bagley And Horwitz, Douglas A. Kahn, Jeffrey H. Kahn Aug 2011

The Unaffordable Health Act – A Response To Professors Bagley And Horwitz, Douglas A. Kahn, Jeffrey H. Kahn

Law & Economics Working Papers

The Patient Protection and Affordable Care Act of 2010 has stirred considerable controversy. In the public debate over the program, many of its proponents defended it by focusing on what is sometimes called the “free-rider” problem. In a prior article, we contended that the free-rider problem has been greatly exaggerated and was not likely to have been a significant factor in the congressional decision to adopt the Act. We maintained that the free-rider issue is a red herring that was advanced to trigger an emotional attraction for the Act and distract attention from the actual issues that favor and disfavor …


Why It’S Called The Affordable Care Act, Nicholas Bagley Aug 2011

Why It’S Called The Affordable Care Act, Nicholas Bagley

Law & Economics Working Papers

The Patient Protection and Affordable Care Act of 2010 (“ACA”) raises numerous policy and legal issues, but none have attracted as much attention from lawyers as Section 1501. This provision, titled “Maintenance of Mini-mum Essential Coverage,” but better known as the “individual mandate,” requires most Americans to obtain health insurance for themselves and their dependents by 2014. 1 We are dismayed that the narrow issue of the mandate and the narrower issue of free riding have garnered so much attention when our nation’s health-care system suffers from countless problems. By im-proving quality, controlling costs, and extending coverage to the uninsured, …


Augmenting Advocacy: Giving Voice To The Medical-Legal Partnership Model In Medicaid Proceedings And Beyond, Marybeth Musumeci Jul 2011

Augmenting Advocacy: Giving Voice To The Medical-Legal Partnership Model In Medicaid Proceedings And Beyond, Marybeth Musumeci

University of Michigan Journal of Law Reform

The denial of Medicaid coverage for augmentative communication devices, despite an existing legal framework that mandates the opposite result, raises fundamental questions about what independence means for people with disabilities. This situation, compounded by the barriers in the Medicaid administrative appeal process encountered by such beneficiaries, invites new approaches to the delivery of civil legal services, such as medical-legal partnerships (MLPs). MLPs are formalized arrangements that bring lawyers into a healthcare setting to provide specialist consultations when patients experience legal problems that affect health. While there is an emerging scholarship on MLPs, this Article offers the first in-depth analysis of …


Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang Apr 2011

Transplant Candidates And Substance Use: Adopting Rational Health Policy For Resource Allocation, Erin Minelli, Bryan A. Liang

University of Michigan Journal of Law Reform

Organ transplant candidates are often denied life saving organs on account of their medical marijuana drug use. Individuals who smoke medicinal marijuana are typically classified as substance abusers, and ultimately deemed ineligible for transplantation, despite their receipt of the drug under a physician's supervision and prescription. However, patients who smoke cigarettes or engage in excessive alcohol consumption are routinely considered for placement on the national organ transplant waiting list. Transplant facilities have the freedom to regulate patient selection criteria with minimal oversight. As a result, the current organ allocation system in the United States is rife with inconsistencies and results …


Finding A Cure In The Courts: A Private Right Of Action For Disparate Impact In Health Care, Sarah G. Steege Apr 2011

Finding A Cure In The Courts: A Private Right Of Action For Disparate Impact In Health Care, Sarah G. Steege

Michigan Journal of Race and Law

There is no comprehensive civil rights statute in health care comparable to the Fair Housing Act, Title VII, and similar laws that have made other aspects of society more equal. After Congress passed the Civil Rights Act of 1964, Title VI served this purpose for suits based on race, color, and national origin for almost four decades. Since the Supreme Court's 2001 ruling in Alexander v. Sandoval, however, there has been no private right of action for disparate impact claims under Title VI, and civil rights enforcement in health care has suffered as a result. Congress has passed new legislation …


Free Rider – A Justification For Mandatory Medical Insurance Under Health Care Reform?, Douglas A. Kahn, Jeffrey H. Kahn Mar 2011

Free Rider – A Justification For Mandatory Medical Insurance Under Health Care Reform?, Douglas A. Kahn, Jeffrey H. Kahn

Law & Economics Working Papers

Section 1501 of the Patient Protection and Affordable Care Act added section 5000A to the Internal Revenue Code to require most individuals in the United States to purchase a minimum level of medical insurance. This requirement, which is enforced by a penalty imposed on those who fail to comply, is sometimes referred to as the “individual mandate.” A frequently stated defense of the individual mandate is that there are a vast number of persons who do not purchase medical insurance and then obtain free medical care when the need arises, and the individual mandate will require those persons (often referred …


Free Rider: A Justification For Mandatory Medical Insurance Under Health Care Reform?, Douglas A. Kahn, Jeffrey H. Kahn Jan 2011

Free Rider: A Justification For Mandatory Medical Insurance Under Health Care Reform?, Douglas A. Kahn, Jeffrey H. Kahn

Articles

Section 1501 of the Patient Protection and Affordable Care Act added section 5000A to the Internal Revenue Code to require most individuals in the United States, beginning in the year 2014, to purchase an established minimum level of medical insurance. This requirement, which is enforced by a penalty imposed on those who fail to comply, is sometimes referred to as the “individual mandate.” The individual mandate is one element of a vast change to the provision of medical care that Congress implemented in 2010. The individual mandate has proved to be controversial and has been the subject of a number …


Malpractice Suits And Physician Apologies In Cancer Care, Eugene Chung, Jill R. Horwitz, John A.E. Pottow, Reshma Jagsi Jan 2011

Malpractice Suits And Physician Apologies In Cancer Care, Eugene Chung, Jill R. Horwitz, John A.E. Pottow, Reshma Jagsi

Articles

Conside the following case: The patient is a 44-year-old woman who presents for radiation treatment of an isolated locoregional recurrence of breat cancer in her chest wall, 3 years after undergoing masectomy. At the time of diagnosis, she had T2N2M0 disease, with four of 15 lymph nodes involved with tumor. She received a masectomy with negative margins and appropriate chemotherapy, but none of her physicians talked to her about postmasectomy radiation therapy, which would clearly have been indicated to reduce her risk of locoregional failure and would have been expected to improve her likelihood of survival. She asks the radiation …


The Unaffordable Health Care Act - A Reponse To Professors Bagley And Horwitz, Douglas A. Kahn, Jeffrey H. Kahn Jan 2011

The Unaffordable Health Care Act - A Reponse To Professors Bagley And Horwitz, Douglas A. Kahn, Jeffrey H. Kahn

Articles

The Patient Protection and Affordable Care Act of 2010 has stirred considerable controversy. In the public debate over the program, many of its proponents have defended it by focusing on what is sometimes called the “free-rider” problem. In a prior article, we contended that the free-rider problem has been greatly exaggerated and was not a significant factor in the congressional decision to adopt the Act. We maintained that the free-rider issue is a red herring advanced to trigger an emotional attraction to the Act and distract attention from the actual issues that favor and disfavor its adoption. In a recently …


Rural Hospital Ownership: Medical Service Provision, Market Mix, And Spillover Effects, Jill R. Horwitz, Austin Nichols Jan 2011

Rural Hospital Ownership: Medical Service Provision, Market Mix, And Spillover Effects, Jill R. Horwitz, Austin Nichols

Articles

Objective. To test whether nonprofit, for-profit, or government hospital ownership affects medical service provision in rural hospital markets, either directly or through the spillover effects of ownership mix. Data Sources/Study Setting. Data are from the American Hospital Association, U.S. Census, CMS Healthcare Cost Report Information System and Prospective Payment System Minimum Data File, and primary data collection for geographic coordinates. The sample includes all nonfederal, general medical, and surgical hospitals located outside of metropolitan statistical areas and within the continental United States from 1988 to 2005. Study Design. We estimate multivariate regression models to examine the effects of (1) hospital …


Why It's Called The Affordable Care Act, Nicholas Bagley, Jill R. Horwitz Jan 2011

Why It's Called The Affordable Care Act, Nicholas Bagley, Jill R. Horwitz

Articles

The Patient Protection and Affordable Care Act of 2010 (“ACA”) raises numerous policy and legal issues, but none have attracted as much attention from lawyers as Section 1501. This provision, titled “Maintenance of Mini-mum Essential Coverage,” but better known as the “individual mandate,” requires most Americans to obtain health insurance for themselves and their dependents by 2014. We are dismayed that the narrow issue of the mandate and the narrower issue of free riding have garnered so much attention when our nation’s health-care system suffers from countless problems. By improving quality, controlling costs, and extending coverage to the uninsured, the …