Health Law and Policy Commons^™

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

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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

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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

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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 …

Why Some Religious Accommodations For Mandatory Vaccinations Violate The Establishment Clause, Hillel Y. Levin

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All states require parents to inoculate their children against deadly diseases prior to enrolling them in public schools, but the vast majority of states also allow parents to opt out on religious grounds. This religious accommodation imposes potentially grave costs on the children of non-vaccinating parents and on those who cannot be immunized. The Establishment Clause prohibits religious accommodations that impose such costs on third parties in some cases, but not in all. This presents a difficult line-drawing problem. The Supreme Court has offered little guidance, and scholars are divided.

This Article addresses the problem of religious accommodations that impose …

Teaching The Law Of American Health Care, Elizabeth Weeks, Nicole Huberfeld, Kevin Outterson

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In writing our casebook, The Law of American Health Care, we started from scratch, rethinking the topics to include and themes around which to organize them. Like many health law professors, we were schooled in and continued to propound the traditional themes of cost, quality, access, and choice. While those concerns certainly pervade many areas of health care law, our casebook's overarching themes emphasize different issues, namely: federalism, individual rights, fiduciary relationships, the modem administrative state, and market regulation. These new themes, we believe, better capture the range of issues and topics essential for the new generation of health lawyers. …

Adjudicating Religious Sincerity, Nathan Chapman

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Recent disputes about the “contraception mandate” under the Affordable Care Act and about the provision of goods and services for same-sex weddings have drawn attention to the law of religious accommodations. So far, however, one of the requirements of a religious accommodation claim has escaped sustained scholarly attention: a claimant must be sincere. Historically, scholars have contested this requirement on the ground that adjudicating religious sincerity requires government officials to delve too deeply into religious questions, something the Establishment Clause forbids. Until recently, however, the doctrine was fairly clear: though the government may not evaluate the objective accuracy or plausibility …

Posthumous Organ Donation As Prisoner Agency And Rehabilitation, Amanda Seals Bersinger, Lisa Milot

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Unlike U.S. citizens generally, who are encouraged to become organ donors through drivers' license designations, advance directives, and state registries, in most instances inmates are barred from donating their organs until release.

To date, the scholarship in favor of allowing inmates to donate their organs has largely focused on the benefit these donations could offer patients languishing on organ transplant lists, while objections center on the vulnerability of the imprisoned potential donors and their inability to make decisions freely. A donor-focused case for donation, however, is missing in this debate. This Article fills that gap by setting out the philosophical …

An Opening For Civil Rights In Health Insurance After The Affordable Care Act, Valarie K. Blake

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Section 1557, the civil rights provision of the Affordable Care Act (“ACA”), is unmatched in its reach, widely applying race, gender, disability, and age discrimination protections across all areas of healthcare. This Article will explore the value added of a civil rights approach to combating health insurance discrimination when combined with other ACA anti-discrimination efforts that were designed to regulate the health insurance market. It will emphasize the role that section 1557 can play in combatting healthcare disparities and will explore the utility of disparate impact and disparate treatment claims to those cases. Lastly, the Article will posit that two …

Of Mice And Men: On The Seclusion Of Immigration Detainees And Hospital Patients, Stacey A. Tovino

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With a special focus on federal provisions strictly regulating Medicare-participating hospitals' use of seclusion, this Article uses developments in health law as a lens through which the uses and abuses of seclusion in immigration detention centers might be assessed and through which the standards governing detention centers might be improved. In particular, this Article argues that the unenforceable standards governing seclusion in immigration detention, including the most recent version of ICE's Performance-Based National Detention Standards, were incorrectly modeled on correctional standards developed for use in jails and prisons with respect to convicted criminals. This Article asserts that correctional standards are …

What Is (And Isn't) Healthism, Jessica L. Roberts, Elizabeth Weeks Leonard

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What does it mean to discriminate on the basis of health status? Health is, of course, relevant in a number of ways. It can speak to the length of our lives, our ability to perform mentally and physically, our need for health care, and our risk of injury and incapacity. But the mere relevance of a particular attribute does mean that considering it should be legally permissible. Moreover, the potential harms that may result from health-status discrimination raise important moral questions. This Essay explores when differentiating on the basis of health is socially acceptable and, by contrast, when it is …

The Legal And Medical Ethical Entanglements Of Infant Male Circumcision And International Law, Paul Mclaughlin

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The practice of infant male circumcision has been debated by legal and medical experts for years. The practice, once seen as a social norm, has come under opposition by children’s rights, legal, and medical organisations around the world. In order to meet the requirements of international treaty law and allow infant male children the fullest opportunity for self determination, infant male circumcision must be treated under the law and by medical practitioners with the same degree of opposition that female genital mutilation has received.

The Collective Fiduciary, Lauren R. Roth

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Can fiduciaries be made to serve public goals? The movement under the Patient Protection and Affordable Care Act (“ACA”) towards universal access to health insurance requires us to focus on the fiduciary relationships between large organizations providing access to healthcare and the populations they serve. These relationships have become a collective undertaking instead of a direct, personal relationship.

In this Article, I introduce the concept of the collective fiduciary in response to the shift towards uniform, national goals in the realm of health insurance and healthcare. Only through a collective approach can we hold fiduciaries accountable for the welfare of …

Can Dna Be Speech?, Jorge R. Roig

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DNA is generally regarded as the basic building block of life itself. In the most fundamental sense, DNA is nothing more than a chemical compound, albeit a very complex and peculiar one. DNA is an information-carrying molecule. The specific sequence of base pairs contained in a DNA molecule carries with it genetic information, and encodes for the creation of particular proteins. When taken as a whole, the DNA contained in a single human cell is a complete blueprint and instruction manual for the creation of that human being. In this article we discuss myriad current and developing ways in which …

Regulating Healthcare Robots: Maximizing Opportunities While Minimizing Risks, Drew Simshaw, Nicolas Terry, Kris Hauser, M. L. Cummings

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No abstract provided.

Irresponsibly Taxing Irresponsibility: The Individual Tax Penalty Under The Affordable Care Act, Francine J. Lipman, James Owens

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In recent decades, Congress has used the federal income tax system increasingly to administer and deliver social benefits. This transition is consistent with the evolution of the American welfare system into workfare over the last several decades. As more and more social welfare benefits are conditioned upon work, family composition, and means-tested by income levels, the income tax system where this data is already systematically aggregated, authenticated, and processed has become the go-to administrative agency.

Nevertheless, as the National Taxpayer Advocate Nina Olson has noted there are “substantial differences between benefits agencies and enforcement agencies in terms of culture, mindset, …

Crossing The Line: Daubert, Dual Roles, And The Admissibility Of Forensic Mental Health Testimony, Sara Gordon

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Psychiatrists and other mental health professionals often testify as forensic experts in civil commitment and criminal competency proceedings. When an individual clinician assumes both a treatment and a forensic role in the context of a single case, however, that clinician forms a dual relationship with the patient—a practice that creates a conflict of interest and violates professional ethical guidelines. The court, the parties, and the patient are all affected by this conflict and the biased testimony that may result from dual relationships. When providing forensic testimony, the mental health professional’s primary duty is to the court, not to the patient, …

Reconciling The Premium Tax Credit: Painful Complications For Lower And Middle-Income Taxpayers, Francine J. Lipman, James E. Williamson

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The Patient Protection and Affordable Care Act (ACA) makes available to certain middle and lower-income individuals a refundable tax credit, the Premium Tax Credit (PTC), designed to help them pay the premiums on their qualified health care plans. To achieve Congress’s goal of making health insurance affordable, the PTC is most often provided directly to an individual’s insurance provider each month in advance of actually claiming the PTC on the individual’s year-end annual tax return. Of the almost twelve million individuals who have enrolled in health insurance through the federal and state health exchanges in 2015, 85% of these individuals …

The Grapes Of Wrath: On The Health Of Immigration Detainees, Stacey A. Tovino

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This Article challenges the lack of health care provided to individuals in U.S. Immigration and Customs Enforcement (“ICE”) custody. As background, many immigration detainees are physically and emotionally vulnerable at the time of initial confinement due to a history of torture and trauma, which may include human trafficking, sexual violence, political oppression, psychosocial trauma, and acculturative stress. Detention can exacerbate preexisting vulnerabilities and contribute to severe physical and mental illness as well as death. Between October 2003 and October 2015, 153 individuals died while in ICE custody. Although most proposals for detainee health reform borrow heavily from constitutional law, international …

Gambling Disorder, Vulnerability, And The Law: Mapping The Field, Stacey A. Tovino

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This Article seeks to descriptively map the sub-field of gambling disorder and the law and ask whether individuals with gambling disorder are vulnerable under the law. Like other scholarship that descriptively maps ethical, legal, and social implications of lesser known conditions and developments, this Article seeks to describe the treatment of individuals with gambling disorder in a variety of illustrative, but not exhaustive, legal contexts, to identify the limited scholarship assessing the application of the law to individuals with gambling disorder, and to invite members of the health law academy to bring their significant expertise to bear on these issues …

Complying With The Hipaa Privacy Rule: Problems And Perspectives, Stacey A. Tovino

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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 a final rule governing the use and disclosure of protected health information by covered entities and their business associates (Privacy Rule).

This Article addresses the question of what it means for …

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

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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 …

Off-Label Drug Marketing, The First Amendment, And Federalism, David Orentlicher

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In this article, Professor Orentlicher explores free speech and federalism issues arising from FDA regulation of off-label uses and off-label marketing of drugs. In light of the FDA's desire to respect state government authority, together with other considerations discussed in this article, he argues for the rejection of the analysis of the Caronia court and to give the FDA significant leeway in its regulation of off-label marketing.

Clinical Criteria For Physician Aid In Dying, David Orentlicher

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More than 20 years ago, even before voters in Oregon had enacted the first aid in dying (AID) statute in the United States, Timothy Quill and colleagues proposed clinical criteria AID. Their proposal was carefully considered and temperate, but there were little data on the practice of AID at the time. (With AID, a physician writes a prescription for life-ending medication for a terminally ill, mentally capacitated adult.) With the passage of time, a substantial body of data on AID has developed from the states of Oregon and Washington. For more than 17 years, physicians in Oregon have been authorized …

Controlling Health Care Spending: More Patient "Skin In The Game?", David Orentlicher

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In this article, Professor Orentlicher explores the high cost of healthcare and the trend in health insurance to shift the cost of health care to patients in an attempt to influence their behavior and health decisions. He examines such strategies as reference pricing, scaled cost-sharing, and employee wellness programs.

The House Edge: On Gambling And Professional Discipline, Stacey A. Tovino

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On March 26, 2014, the Iowa Supreme Court revoked the license to practice law of Cedar Rapids attorney Susan Hense. Admitted to the Iowa Bar in 1996, Hense subsequently misappropriated $837,000 in client trust funds to feed her addiction to casino gambling. This Article assesses how attorneys like Hense who are addicted to gambling are treated in professional disciplinary actions, including license suspension, revocation, and reinstatement proceedings. Themes that emerge include public misunderstanding of gambling disorder, stigma against individuals with gambling disorder, statutory recognition of substance addictions but not behavioral addictions, and mandatory attendance at religion based fellowship meetings as …

Subsidized Egg Freezing In Employment: Autonomy, Coercion, Or Discrimination?, Ann C. Mcginley

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In 2014, Apple and Facebook announced that they would provide up to $20,000 for female employees to freeze their eggs as an employment benefit. These announcements raised mixed reviews. Some applauded the decision because they believe that egg freezing may offer to women more control over their reproductive choices. Others argued that the new benefit sends the wrong message to women and that encouraging good parenting by giving better parental leave and child care policies would be more beneficial to families. Others were concerned that this “benefit” applies only to professional or managerial-class women, but may not be helpful to …

The Danger Zone: How The Dangerousness Standard In Civil Commitment Proceedings Harms People With Serious Mental Illness, Sara Gordon

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Almost every American state allows civil commitment upon a finding that a person, as a result of mental illness, is gravely disabled and unable to meet their basic needs for food and shelter. Yet in spite of these statutes, most psychiatrists and courts will not commit an individual until they are found to pose a danger to themselves or others. All people have certain rights to be free from unwanted medical treatment, but for people with serious mental illness, those civil liberties are an abstraction, safeguarded for them by a system that is not otherwise ensuring access to shelter and …

Best Practices For A State Alzheimer's Disease Registry: Lessons From Georgia, Elizabeth Weeks Leonard, Rui Bu, Amanda Alexandra Brown

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In May 2014, the Georgia General Assembly enacted legislation establishing the Alzheimer’s Disease Registry (“Registry”) in order to generate new data for research and policy planning. The Task Force bill followed similar federal legislation. This state action has not only drawn tremendous attention to the continued prevalence of Alzheimer’s disease among the population of Georgia but also raised a series of questions regarding the practicability, legality, and effectiveness of the Registry. The lessons learned in Georgia, as Registry implementation moves forward, will provide guidance for other states interested in collecting similar data. In Part I of this article we describe …

To Accommodate Or Not To Accommodate: (When) Should The State Regulate Religion To Protect The Rights Of Children And Third Parties?, Hillel Y. Levin, Allan J. Jacobs, Kavita Arora

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When should we accommodate religious practices? When should we demand that religious groups instead conform to social and legal norms? Who should make these decisions, and how? These questions lie at the very heart of our contemporary debates in the field of Law and Religion.

Particularly thorny issues arise where religious practices may impose health-related harm to children within a religious group or to third parties. Unfortunately, legislators, scholars, courts, ethicists, and medical practitioners have not offered a consistent way to analyze such cases and the law is inconsistent. This Article suggests that the lack of consistency is a troubling …

The 'Uberization' Of Healthcare: The Forthcoming Legal Storm Over Mobile Health Technology's Impact On The Medical Profession, Fazal Khan

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The nascent field of mobile health technology is still very small but is predicted to grow exponentially as major technology companies such as Apple, Google, Samsung, and even Facebook have announced mobile health initiatives alongside influential healthcare provider networks. Given the highly regulated nature of healthcare, significant legal barriers stand in the way of mobile health’s potential ascension. I contend that the most difficult legal challenges facing this industry will be restrictive professional licensing and scope of practice laws. The primary reason is that mobile health threatens to disrupt historical power dynamics within the healthcare profession that have legally enshrined …