Health Law and Policy Commons^™

Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah A. Yearby

All Faculty Scholarship

For forty years, the United States government allowed economically disadvantaged African American men to be exploited in the name of research, although the research could not generate any benefit to society. Specifically, from 1932 until 1972, government funded researchers enrolled economically disadvantaged African American men in the Tuskegee Syphilis Study to document the already known course of syphilis, which led to the men suffering sores, fever, hair loss, weight loss, headaches, paralysis, blindness, dementia, and death. In exchange for free meals, medical exams, and burial insurance, the researchers promised the men that they would provide treatment for their “bad blood,” …

The Priority Review Voucher Program At The Fda: From Neglected Tropical Diseases To The 21st Century Cures Act, Ana Santos Rutschman

All Faculty Scholarship

The priority review voucher program at the Food and Drug Administration (FDA) was established in 2007 to incentivize research and development (R&D) in traditionally underfunded diseases.1 While shrouded in controversy and criticism, the program has recently been bolstered by the passage of the 21st Century Cures Act,2 which prevented the vouchers from sunsetting in late 2016 and furthered the overall scope of the program.3 As it reaches the end of its first decade, this Article discusses the impact of the program, with a focus on recent developments. The Article builds on literature suggesting that the voucher program has been ineffective …

Lessons From Ferguson And Beyond: Bias, Health, And Justice, Sidney D. Watson

All Faculty Scholarship

August 9, 2014, Michael Brown, an 18-year-old African American teen, killed by police in Ferguson, Missouri.

November 22, 2014, Tamir Rice, a 12-year-old African American child, killed by police in Cleveland, Ohio.

April 4, 2015, Walter Scott, a 50-year-old African American man, killed by police in Charlotte, North Carolina.

November 15, 2015, Jamar Clark, a 24-year-old African American man, killed by police in Minneapolis, Minnesota.

July 6, 2016, Philando Castile, a 32-year-old African American man, killed by police in Falcon Heights, Minnesota.

The list of Black men and women killed by police goes on and seems to grow by the …

Special Issue "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo, Guest Editor

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

Editor, "Health Care Law And The Rights Of Individuals With Disabilities", Elizabeth Pendo

All Faculty Scholarship

People with disabilities are vulnerable. They carry high risk for poor health and health outcomes. As a group, they experience social disadvantages such as poverty, underemployment and unemployment, isolation, and discrimination at a higher rate than the general population. They also face multiple barriers to quality health care and report poorer health status than people without disabilities. This Special Issue will explore the key health disparities and barriers to health care experienced by people with disabilities, and explore the legal, ethical, and social issues they raise. It will investigate the legal requirements of the Americans with Disabilities and other antidiscrimination …

Preventing Neonatal Abstinence Syndrome Within The Opioid Epidemic: A Uniform Facilitative Policy, Jeremiah A. Ho, Alexander Rovzar

All Faculty Scholarship

The United States is currently in the midst of an opioid epidemic that has hit states in the southern New England regions particularly hard — with Massachusetts as one primary example. One of the many unfortunate results of the epidemic is a dramatic upsurge in cases of opioid dependency by expectant women that result in children born with Neonatal Abstinence Syndrome (NAS). NAS is a clinical syndrome that occurs when a newborn suffers withdrawal symptoms as a consequence of abrupt discontinuation of prenatal substance exposure. The expenses of treating and rehabilitating these drug-dependent newborns, predominantly shouldered by state taxpayers, are …

Table Of Contents

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Masthead

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Key Issues Facing Medicaid After The Affordable Care Act, Marybeth Musumeci

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Medicaid, Managed Care, And The Mission For The Poor, John V. Jacobi

Saint Louis University Journal of Health Law & Policy

Medicaid has financed care for the poor for five decades. During that time it has balanced two important missions: providing for the particular health needs of the poor, and mainstreaming care for the poor. These roles have been consistent as all insurance payors—public and private—have shifted away from passively funding fragmented care to actively supporting patient-centered coordinated care. But the health needs of the poor go beyond medical interventions; the health status of the poor depends on the provision of social services to address social determinants of health, including housing, nutrition, and employment training services. Unlike non-poor insureds, Medicaid beneficiaries …

Pin The Tail On The Donkey: Beneficiary Enforcement Of The Medicaid Act Over Time, Jane Perkins

Saint Louis University Journal of Health Law & Policy

During the twentieth century, Congress enacted legislation designed to improve the lives of low-income Americans. A number of these laws were enacted by Congress pursuant to the Constitution’s Spending Clause, including the Medicaid Act, which entitles certain low-income individuals to publicly funded health insurance coverage. As enacted in 1965, the Medicaid Act did not include a provision authorizing the statute’s beneficiaries to bring private enforcement actions in court. Since the early 1970s, however, program beneficiaries relied upon the Constitution’s Supremacy Clause or, more frequently, 42 U.S.C. § 1983 for the cause of action allowing them to obtain relief in court. …

On The Expansion Of “Welfare” And “Health” Under Medicaid, Laura D. Hermer

Saint Louis University Journal of Health Law & Policy

Medicaid was intended from its inception to provide financial access to health care for certain categories of impoverished Americans. While rooted in historical welfare programs, it was meant to afford the “deserving” poor access to the same sort of health care that other, wealthier Americans received. Yet despite this seemingly innocuous and laudable purpose, it has become a front in the political and social battles waged over the last several decades on the issues of welfare and the safety net. The latest battleground pits competing visions of Medicaid. One vision seeks to transform Medicaid from a health care program into …

Premiums And Section 1115 Waivers: What Cost Medicaid Expansion?, Sidney D. Watson

Saint Louis University Journal of Health Law & Policy

States reluctant to adopt the Affordable Care Act’s Medicaid expansion are demanding that the U.S. Department of Health and Human Services grant them Section 1115 demonstration waivers that allow them to charge poor people premiums.

The U.S. Department of Health and Human Services has yielded to these demands, granting five states waivers of long standing federal statutory protections that limit state discretion to impose premiums for Medicaid. These premium waivers present a fundamental problem of law because the Secretary of the U.S. Department of Health and Human Services has no statutory authority to grant Section 1115 waivers that allow states …

Mergers And Monopolies: An Examination Of The Cyclical Effect Of Anti-Competition And A Lack Of Rate Regulation In Health Care, Madeline J. Bainer

Saint Louis University Journal of Health Law & Policy

Health care costs continue to rise, forcing consumers to make difficult choices between seeking expensive treatment and risking the consequences without. To combat the inflation of health care costs, the Affordable Care Act implemented a number of policies aimed at improving the quality of care while lowering the cost of that care. In order to accomplish the goals of the Affordable Care Act, health care systems began merging with one another and acquiring smaller groups to incorporate into a vast network of providers. However, many of these mergers offer little value to consumers. Instead, they ultimately drive up the cost …

A False Sense Of Safety: How The Drug Quality And Security Act Fails To Protect Patients From Harm, Tyler Dinkelaker

Saint Louis University Journal of Health Law & Policy

For many years, the art of pharmaceutical compounding in the United States has been largely an overlooked and under regulated industry providing millions of patients each year with customized medications. Only after piecemeal enforcement resulted in hundreds of injuries and deaths in an event known as the New England Compounding Center Tragedy, did legislators and regulatory agencies refocus attention on current regulations in pharmaceutical compounding. Congress passed the Drug Quality and Security Act providing clarification for state and federal agencies as to their specific regulatory authority and responsibility to ensure patient safety in pharmaceutical compounding. However, the Drug Quality and …

Table Of Contents

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Masthead

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Foreword, Kelly Dineen

Saint Louis University Journal of Health Law & Policy

No abstract provided.

The Medicalization Of End-Of-Life Care: The Role Of Health Professions Education, Philip Fung, Miguel Paniagua

Saint Louis University Journal of Health Law & Policy

In the past 100 years, the advances in medical science and technology have shaped the health care delivery system in remarkable ways. The side effect of these advances has been a tendency to dehumanize the dying process, and consequently it has led to the rise of a specialty focused merely on bridging this gap in care. The public’s expectations of our legal, licensing, and medical education systems have also reflected this evolution in health care.

Making Sense Of Family Communication About And At The End Of Life: Family Communication Around End-Of-Life Planning And Decision Making, April R. Trees, Jennifer E. Ohs

Saint Louis University Journal of Health Law & Policy

Families faced with end-of-life (EOL) decisions on behalf of a family member are charged with honoring a care recipient’s wishes, which may or may not be clear to them. The process of decision making is challenging for surrogate decision makers and their families, and it often results in suboptimal decisions that fail to meet the best interests of the patients, cause stress for family members, and burden the legal and medical systems. Effective family communication, something that legal representatives, medical professionals, and social workers are often in positions to influence, can enhance the quality of EOL care planning and decisions. …

Is There A Moral Obligation For Health Care Organizations To Develop Robust Advance Care Planning Programs?, Thomas D. Harter

Saint Louis University Journal of Health Law & Policy

Advance care planning (ACP) has become an integral part of patient care because of its ability to help guide treatment decision making for individuals in need of medical care but who have lost the ability to communicate—temporarily or permanently—due to illness or injury. Not all persons have the same treatment threshold; some persons value their lives above all else and will accept a high level of physical debility regardless of personal discomfort to stay alive. Others value their individual personal comfort over the length of their lives and will refuse otherwise life-sustaining treatment if they believe the treatment will cause …

Give Me Liberty To Choose (A Better) Death: Respecting Autonomy More Fully In Advance Directive Statutes, Kathy L. Cerminara, Joseph R. Kadis

Saint Louis University Journal of Health Law & Policy

In the name of state interests, advance directive statutes almost universally include language requiring that a patient be in a particular physical state as a condition precedent to operation of a directive. This article urges state legislatures to recognize and rectify the conflict they have created by imposing such triggering conditions. First, it examines states’ efforts to facilitate autonomous end-of-life decision making through advance directive statutes. Then it proposes amending those statutes to align the law with medical ethics by eliminating specified physical triggering conditions burdening the exercise of patients’ rights to refuse life-sustaining treatment. Such amendment will improve end-of-life …

Procedural Due Process And Intramural Hospital Dispute Resolution Mechanisms: The Texas Advance Directives Act, Thaddeus Mason Pope

Saint Louis University Journal of Health Law & Policy

Increasingly, clinicians and commentators have been calling for the establishment of special adjudicatory dispute resolution mechanisms to resolve intractable medical futility disputes. As a leading model to follow, policymakers both around the United States and around the world have been looking to the conflict resolution provisions in the 1999 Texas Advance Directives Act (TADA).

In this article, I provide a complete and thorough review of the purpose, history, and operation of TADA. I conclude that TADA is a commendable attempt to balance the competing goals of efficiency and fairness in the resolution of these time-sensitive, life-and-death conflicts. But TADA is …

Dying Fast: Suicide In Individuals With Gambling Disorder, Stacey A. Tovino

Saint Louis University Journal of Health Law & Policy

These published remarks carefully document the history of health insurance coverage of gambling disorder. They begin by providing examples of gambling disorder insurance benefit disparities in the contexts of public health care programs and private health plans. They proceed by reviewing the effect of three pieces of legislation, including the Mental Health Parity Act of 1996, the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, and the Affordable Care Act of 2010, on public and private insurance coverage of gambling disorder. They highlight the partial victory that will occur in some states beginning in …

Celebrating The Distinguished, Humble, And Joyous Career Of Professor Jesse Goldner, Robert Gatter

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Adding Insult To Injury: How The Aca’S “Fix” For Nursing Home Compare Staffing Data Misses The Mark, Elizabeth J. Tucker

Saint Louis University Journal of Health Law & Policy

The Baby Boomers are aging, and soon many will require more long-term health care services, looking to the Nursing Home Compare Website (Website) to help guide their choices. The staffing rating on the Website, which rates nursing homes on a scale of one to five, uses a biased formula to generate its ratings. It counts registered nurses twice, completely excludes other important care staff, and uses outdated case-mix adjustments left over from the early 1990’s. In light of the pressing need for accurate data but no mechanism to obtain it, the staffing rating must be eliminated from the Website. Some …

Antitrust Enforcement Against Pharmaceutical Product Hopping: Protecting Consumers Or Reaching Too Far?, Tyler J. Klein

Saint Louis University Journal of Health Law & Policy

Pharmaceutical drugs are the backbone of modern medicine, which makes the continued development of new drugs essential and puts many lives in the hands of the brand-name pharmaceutical companies that develop these new treatments. Currently, antitrust litigation is being used to strike a balance between the innovator’s right to earn a profit and the need for generic drug companies to make these drugs available to the masses that need them. Antitrust law stops brand-name companies from taking over the market and excluding generics, but it should not be used to impose harsh remedies that restrict the thing that we all …

Collecting New Data On Disability Health Inequities, Elizabeth Pendo

All Faculty Scholarship

Prior to the Affordable Care Act, disability was marginalized in data collection efforts, limiting our ability to understand and address significant health inequities experienced by millions of Americans. Now, for the first time, we can use these tools to collect valuable new data on the nature and extent of health inequities experienced by people with disabilities across the country.

This article argues that standardized health collection data is critical to health equity, and because of the ACA’s groundbreaking requirements for data collection of disability status and treatment of patients with disabilities, we now have the potential to identify, track, and …

Missing The “Target”: Preventing The Unjust Inclusion Of Vulnerable Children For Medical Research Studies, Ruqaiijah A. Yearby

All Faculty Scholarship

Nearly everyone has experienced a burn and the resulting pain. Now imagine that you suffer a third-degree radiation burn that injures all the layers of your skin as well as the tissue, causing you extreme pain. . The burn turns your skin white, cherry red, or black and may produce blisters that are dry, hard, and leathery-looking. The burn can also be seen on the surface of your lungs and gastrointestinal tract. If the burn is big enough you will need skin grafts and surgery to replace the skin and tissue that will never grow back, as well as treatment …

Missing The 'Target': Preventing The Unjust Inclusion Of Vulnerable Children For Medical Research Studies, Ruqaiijah Yearby

All Faculty Scholarship

The central purpose of medical research on children is to generate new knowledge that can improve children’s health, subject to ethical standards that promote justice. Incorporated in U.S. law, international law, and European Union law, the Justice Principle prohibits targeting in medical research, which is the selection of research subjects because of their manipulability and compromised position, rather than for reasons directly related to the problem being studied. Unfortunately, medical research studies involving children have too often violated the Justice Principle, by targeting children in a compromised position due to their health status and vulnerable to manipulability because of their …