Health Law and Policy Commons^™

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 …

Physician Encounters With Human Trafficking: Legal Consequences And Ethical Considerations, Jonathan Todres

Faculty Publications By Year

There is growing recognition and evidence that health care professionals regularly encounter - though they may not identify - victims of human trafficking in a variety of health care settings. Identifying and responding appropriately to trafficking victims or survivors requires not only training in trauma-informed care but also consideration of the legal and ethical issues that arise when serving this vulnerable population. This essay examines three areas of law that are relevant to this case scenario: criminal law, with a focus on conspiracy; service provider regulations, with a focus on mandatory reporting laws; and human rights law. In addition to …

Consumer Financial Protection In Health Care, Erin C. Fuse Brown

Faculty Publications By Year

There are inadequate consumer protections from harmful medical billing practices that result in unavoidable, unexpected, and often financially devastating medical bills. The problem stems from the increasing costs shifting to patients in American health care and the inordinate complexity that makes health care transactions nearly impossible for consumers to navigate. A particularly outrageous example is the phenomenon of surprise medical bills, which refers to unanticipated and involuntary out-of-network bills in emergencies or from out-of-network providers at in-network facilities. Other damaging medical billing practices include the opaque and à la carte nature of medical bills, epitomized by added “facility fees,” as …

The Indirect Consequences Of Expanded Off-Label Promotion, Patricia J. Zettler

Faculty Publications By Year

The U.S. Food and Drug Administration’s (FDA) policies have been a battleground for litigation about First Amendment protections for commercial speech. In the last five years, the FDA’s position that “off-label” promotion of approved prescription drugs—when a manufacturer promotes a drug for a use for which the FDA has not approved it—leads to violations of the Federal Food, Drug, and Cosmetic Act has been subject to successful legal challenges. Although the merits of these off-label promotion decisions are well traversed in the literature, this Article explores the potential indirect consequences of recently-recognized protections for off-label promotion. This Article demonstrates that—as …

Private Right Of Action Jurisprudence In Healthcare Discrimination Cases, Allison M. Tinsey

Law Student Publications

Section 1557 of the Affordable Care Act provides that entities covered by the Act which receive federal funds are prohibited from discriminating on the basis of race, color, national origin, sex, age or disability. But since the provision’s enactment and the U.S. Department of Health and Human Services’ promulgation of a regulation creating a private right of action for alleged discrimination under the Act, courts have disagreed on whether a private right of action exists to enforce Section 1557. This Comment summarizes the courts’ confusion in applying the holding of Alexander v. Sandoval and Chevron deference to the nondiscrimination provision …

“Pay To Prescribe”: A Case For Strengthened Enforced Of The Fcpa In The Global Pharmaceutical Industry In 2017 And Beyond, John T. Jessee Jr.

Law Student Publications

This paper will use recent Foreign Corrupt Practices Act (FCPA) enforcement actions to argue that a revamped and increased enforcement of the FCPA’s anti-bribery provisions in the pharmaceutical industry will be an absolutely critical task in 2017 and beyond, as there is much work to be done in cleaning up the industry. The paper will begin by outlining a brief history of the FCPA and examining its basic enforcement provisions. It will then examine the nature of the pharmaceutical industry’s bribery through a detailed analysis of several recent high profile enforcement cases within the industry. Lastly, the paper will propose …

How States Can Respond To The Ahca: Using The Mccarran-Ferguson Act, David Gamage, Darien Shanske

Articles by Maurer Faculty

No abstract provided.

Transparency, Leslie P. Francis

Utah Law Faculty Scholarship

Transparency is one of the key concepts of privacy protection. Transparency means openness about data collection, use, and retention. Individuals need to know what information about them is being collected, how it is being collected, how it is to be used and shared, how it is protected, what has been learned from data use, how what has been learned might benefit them, and how they can seek correction or redress for security breaches or other unjustified uses or disclosures of data. This chapter begins with a highly salient recent example of transparency in action: the principled commitment to transparency in …

Mitchell's Story: A Cautionary Tale Of Underlying Cardiovascular Disease And The Call For Increased Pre-Participation Sports Physicals At The Intercollegiate Level, Jessica M. Goldstein

Marquette Sports Law Review

None

The Statutory Case Against Off-Label Promotion, Nathan Cortez

Faculty Journal Articles and Book Chapters

The Federal Food, Drug, and Cosmetic Act (FDCA) does not expressly prohibit companies from marketing or promoting drugs for unapproved, off-label uses. The FDA itself acknowledges that off-label promotion is not a prohibited act under the statute, or an element of any such act. Instead, the FDA uses off-label promotion as evidence of other statutory violations. This Article engages in perhaps the most thorough statutory construction analysis of the FDCA on this question, finding that the statute does support the FDA's functional ban on off-label promotion. Using various tools of construction, I find that several sections of the FDCA assume …

Patient Outcomes And Managed Care: What Was The Impact Of The State Regulatory Backlash?, Tina C. Highfill

Theses and Dissertations

Hundreds of state regulations were passed during the “managed care backlash” of the late 1990s and early 2000s. Many of these anti-managed care regulations eased or eliminated constraints on patient utilization of health care services imposed by managed care organizations. Other regulations gave managed care providers more flexibility in the way they practiced care or helped patients appeal denials of claims. Despite the effort undertaken to pass these regulations, limited research exists on whether the regulations achieved their goal. To fill this gap, this study takes advantage of the variety of regulations enacted during the managed care backlash of the …

Regulatory Obstacles To Harm Reduction: The Case Of Smoking, Jonathan H. Adler

Faculty Publications

The inability of many smokers to quit is a significant public health problem. The demand for a product that can help smokers kick the habit is an entrepreneurial opportunity. In surveys, a majority of smokers express concern for their health and a desire to kick the habit.

Electronic cigarettes (“e-cigarettes” or “e-cigs”) appear to be the most promising smoking alternative to enter the market to date. E-cigarettes have the potential to satisfy smokers’ craving for nicotine in a less dangerous way. The available evidence suggests e-cigarettes expose smokers (and others) to a fraction of the health risks posed by combustible …

How Assuming Autonomy May Undermine Wellness Programs, Jessica L. Roberts, Leah R. Fowler

Health Matrix: The Journal of Law-Medicine

In recent years, corporate wellness programs have become a routine aspect of the employer-provided health-insurance system. While they vary tremendously in their requirements and incentives, what these programs share is the common goal of modifying employee behavior to improve health and, as a result, to lower costs. However, the effectiveness of wellness programs has been called into question.

Sex Education: Funding Facts, Not Fear, Rachel Rubenstein

Health Matrix: The Journal of Law-Medicine

The article offers information on the funding sex education programs enacted by the government for teaching about abstinence as the best method for avoiding sexually transmitted diseases and unintended pregnancy and risks factors associated with it in the U.S. Topics discussed include analysis of California Healthy Youth Act as a model for adequate sex education; different forms of sex education; and enactment of Abstinence Education Grant Program for the same.

Implementing Medicaid Health Homes To Provide Medication Assisted Treatment To Opioid Dependent Medicaid Beneficiaries, Page M. Smith

Kentucky Law Journal

No abstract provided.

Public Policy And The Legislative Process, Sheila A. Leander, David F. Walz

Book Chapters

No abstract provided.

Controlling Excessive Off-Label Medicare Drug Costs Through The False Claims Act, David Kwok

Health Matrix: The Journal of Law-Medicine

High prescription drug prices are driving ever-increasing United States healthcare costs, and the federal government is following this alarming trend …

Using Taxes To Support Multiple Health Insurance Risk Pools, David Gamage, Darien Shanske

Articles by Maurer Faculty

In most markets, it is considered desirable for consumers to have more choices. But health insurance regulation is different. When it comes to health insurance, giving consumers more choices can result in the market collapsing — leaving the sickest and most needy consumers without any good choices at all. To mitigate this problem, the Affordable Care Act’s Exchanges were designed around maintaining a single exchange-based risk pool. However, one problem with this approach taken by the Affordable Care Act is that the regulations designed to maintain the single exchange-based risk pool have the side effect of limiting some potentially positive …

How Much Of Health Care Antitrust Is Really Antitrust?, Spencer Weber Waller

Faculty Publications & Other Works

No abstract provided.

Health Care Is Not A Typical Consumer Good And We Should Not Rely On Incentivized Consumers To Allocate It, Lawrence E. Singer

Faculty Publications & Other Works

No abstract provided.

Cultivating Innovation In Precision Medicine Through Regulatory Flexibility At The Fda, Jordan Paradise

Faculty Publications & Other Works

No abstract provided.

A Little Less Regulation: Why Federal Pain Management Laws Are Hurting State Efforts To Combat The Opioid Epidemic, Michael Waldrop

Mitchell Hamline Law Review

No abstract provided.

On Health, Law, And Religion, Stacey A. Tovino

Scholarly Works

The Supreme Court recently decided a number of cases involving health, law, and religion, including Whole Woman's Health v. Hellerstedt, Zubik v. Burwell, and Burwell v. Hobby Lobby Stores, Inc. These cases were important for understanding constitutional undue burden limitations and the boundaries of religious exercise during the Obama Administration. Unfortunately, the Supreme Court's recent opinions addressing health, law, and religion have little value for many health law professors and most practicing health care attorneys. These individuals, tasked with teaching and applying the thousands of federal and state statutes, regulations, and government guidance documents that address a wide …

Disparities In Private Health Insurance Coverage Of Skilled Care, Stacey A. Tovino

Scholarly Works

This article compares and contrasts public and private health insurance coverage of skilled medical rehabilitation, including cognitive rehabilitation, physical therapy, occupational therapy, speech-language pathology, and skilled nursing services (collectively, skilled care). As background, prior scholars writing in this area have focused on Medicare coverage of skilled care and have challenged coverage determinations limiting Medicare coverage to beneficiaries who are able to demonstrate improvement in their conditions within a specific period of time (the Improvement Standard). By and large, these scholars have applauded the settlement agreement approved on 24 January 2013, by the U.S. District Court for the District of Vermont …

The Hipaa Privacy Rule And The Eu Gdpr: Illustrative Comparisons, Stacey A. Tovino

Scholarly Works

In this Article, Professor Tovino compares and contrasts three illustrative concepts and rights in the Privacy Rule and/or the GDPR, including the concepts of authorization and consent, the rights of amendment and rectification, and the right to erasure. Identified similarities reflect the core values of HHS and the EU with respect to maintaining the confidentiality and privacy of personal data and protected health information, respectively. Identified differences reflect the Privacy Rule's original, narrow focus on health industry participants and individually identifiable health information compared to the GDPR's broad focus on data controllers and personal data. Other differences reflect, perhaps, the …

Trial And Error: Legislating Adr For Medical Malpractice Reform, Lydia Nussbaum

Scholarly Works

The U.S. healthcare system has a problem: hundreds of thousands of people die each year, and over a million are injured, by medical mistakes that could have been avoided. Furthermore, over ninety percent of these patients and their families never learn of the errors or receive redress. This problem persists, despite myriad reforms to the medical malpractice system, because of lawmakers' dominant focus on reducing providers' liability insurance costs. Reform objectives are beginning to change, however, and the vehicle for implementing these changes is alternative dispute resolution ("ADR"). Historically, legislatures deployed ADR to curb malpractice litigation and restrict patients' access …

Teaching The Hipaa Privacy Rule, Stacey A. Tovino

Scholarly Works

Twenty years ago, President Clinton signed the Health Insurance Portability and Accountability Act of 1996 (HIPAA) into law. Over the past two decades, the federal Department of Health and Human Services (HHS) has published several sets of rules implementing the Administrative Simplification provisions within HIPAA as well as the Health Information Technology for Economic and Clinical (HITECH) Act within the American Recovery and Reinvestment Act (ARRA). These rules include, but certainly are not limited to, a final rule published on January 25, 2013, governing the use and disclosure of protected health information by covered entities and their business associates (the …

The Use And Abuse Of Mutual-Support Programs In Drug Courts, Sara Gordon

Scholarly Works

There is a large gap between what we know about the disease of addiction and its appropriate treatment, and the treatment received by individuals who are ordered into treatment as a condition of participation in drug court. Most medical professionals are not appropriately trained about addiction and most addiction treatment providers do not have the education and training necessary to provide appropriate evidence-based services to individuals who are referred by drug courts for addiction treatment. This disconnect between our understanding of addiction and available addiction treatment has wide-reaching impact for individuals who attempt to receive medical care for addiction in …

A Population Health Framework For Teaching Health Law, Robert Gatter

Saint Louis University Law Journal

No abstract provided.