Health Law and Policy Commons^™

Through The Icu Darkly: Transparency And The Texas Advance Directives Act, John J. Locurto

Faculty Articles

Conflicts arise when a physician deems life-sustaining interventions futile, but a patient or surrogate presses for treatment to continue. The Texas Advance directives Act uses a procedural approach to resolve these disputes. The Act’s multi-step scheme is nationally recognized, yet the public knows little about how it works. The Texas legislature should fix this by requiring hospitals to report how they use the Act’s dispute resolution mechanism.

Against The "Safety Net", Matthew B. Lawrence

Faculty Articles

Then-Representative Jack Kemp and President Ronald Reagan originated the “safety net” conception of U.S. health and welfare laws in the late 1970s and early 1980s, defending proposed cuts to New Deal and Great Society programs by asserting that such cuts would not take away the “social safety net of programs” for those with “true need.” Legal scholars have adopted their metaphor widely and uncritically. This Article deconstructs the safety net metaphor and counsels against its use in understanding health and welfare laws. The metaphor is descriptively confusing because it means different things to different audiences. Some understand the safety net …

Reflections On The Effects Of Federalism On Opioid Policy, Matthew B. Lawrence

Faculty Articles

One thing we have seen today that we talk about in health law all the time is how the policy, the laws and institutions up at the 10,000 foot level, can so dramatically influence the personal, people’s lived experiences. Our speakers today have done a really great job of drawing out abstract institutional questions and also showing us how those questions have influenced the lives of real people in often tragic ways. Another thing we have seen that we talk about in administrative law all the time is the importance of expertise, especially given how hard it is to trace …

Assumed Compliance, Stacey A. Tovino

Faculty Articles

No abstract provided.

Covid-19, Telehealth, And Substance Use Disorders, Stacey A. Tovino

Faculty Articles

No abstract provided.

Disclosing Deviations: Using Guidelines To Nudge And Empower Physician-Patient Decision Making, Melissa Ballengee Alexander

Faculty Articles

Americans fail to receive recommended care roughly half the time, reflecting poor decision making that threatens their health. This Article offers an innovative solution: require physicians to disclose clinical practice guideline recommendations to patients during informed consent. Behavioral economics suggest that insisting physicians and patients discuss guidelines, before deviating from them, could be surprisingly effective at nudging more rational care choices. At the same time, such disclosure should also educate and empower patients, serving autonomy.

Previous scholarship on unwarranted variances in care has focused primarily on malpractice reforms, largely ignoring the role of cognitive bias and the importance of patients …

The Federalism Challenges Of Protecting Medical Privacy In Workers' Compensation, Ani B. Satz

Faculty Articles

This Article is the first to address the challenges of federalism in protecting medical privacy in workers’ compensation after the promulgation of the HPR and to propose legal change. The Article argues that workers’ compensation programs must align with the federal privacy protections of the HPR and proposes actions for the U.S. Department of Health and Human Services (HHS) and states to remedy departures. Part I discusses the complex relationship between the HPR and workers’ compensation. This relationship is often misunderstood by legislatures and courts, compounding the challenges of federalism in this area. Specifically, Part I addresses the HPR’s § …

Regulatory Gaps In Drug Compounding: Implications For Patient Safety, Innovation, And Fraud, Joanna Shepherd

Faculty Articles

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound …

Deputizing Family: Loved Ones As A Regulatory Tool In The “Drug War” And Beyond, Matthew B. Lawrence

Faculty Articles

Many laws use family members as a regulatory tool to influence the decisions or behavior of their loved ones, i.e., they deputize family. Involuntary treatment laws for substance use disorder are a clear example; such laws empower family members to use information shared by their loved ones to petition to force their loved ones into treatment without consent. Whether such deputization is helpful or harmful for a patient’s health is a crucial and dubious question discussed in existing literature, but use of family members as a regulatory tool implicates important considerations beyond direct medical impacts that have not been as …

Florida Law, Mobile Research Applications, And The Right To Privacy, Stacey A. Tovino

Faculty Articles

This Article investigates whether state law contains comprehensive privacy, security, and breach notification standards that could apply to independent scientists who conduct mobile app mediated health research. Focusing only on Florida law, this Article assesses potentially relevant and applicable sources of privacy, security, and breach notification standards for health data of the type obtained during mobile app mediated health research studies. This Article concludes that, with one exception, Florida law tends to fall into one of two categories: (1) the law contains at least one data privacy, security, or breach notification standard, but the standard is limited in application to …

Fraud, Abuse, And Opioids, Stacey A. Tovino

Faculty Articles

This Article analyzes recent government enforcement actions involving two health care fraud and abuse authorities, including the federal Anti- Kickback Statute and the federal civil False Claims Act, in cases involving opioids. Part II of this Article examines recent government enforcement actions involving the federal Anti-Kickback Statute, which prohibits (among other conduct) the exchange of remuneration for opioid prescriptions, patient referrals for drug testing services, and patient referrals for addiction treatment services if such prescriptions or services are reimbursed in whole or in part by a federal health care program. Part III of this Article examines recent government enforcement actions …

Going Rogue: Mobile Research Applications And The Right To Privacy, Stacey A. Tovino

Faculty Articles

This Article investigates whether nonsectoral state laws may serve as a viable source of privacy and security standards for mobile health research participants and other health data subjects until new federal laws are created or enforced. In particular, this Article (1) catalogues and analyzes the nonsectoral data privacy, security, and breach notification statutes of all fifty states and the District of Columbia; (2) applies these statutes to mobile-app-mediated health research conducted by independent scientists, citizen scientists, and patient researchers; and (3) proposes substantive amendments to state law that could help protect the privacy and security of all health data subjects, …

State Benchmark Plan Coverage Of Opioid Use Disorder Treatments And Services: Trends And Limitations, Stacey A. Tovino

Faculty Articles

Professor Tovino offers a survey of state benchmark plan coverage of opioid use disorder treatments and services, and identifies trends and limitations relevant thereto. Part II of the article provides background information regarding opioid use disorder and the treatments and services available for individuals with this disorder. Part III reviews federal mental health parity law and federal mandatory mental health and substance use disorder law as applied to insurance coverage of treatments and services for opioid use disorder, with a focus on the Affordable Care Act's (ACA's) state benchmark health plan selection requirement and the effect on that requirement of …

Substance Use Disorder Insurance Benefits: A Survey Of State Benchmark Plans, Stacey A. Tovino

Faculty Articles

Professor Tovino presents the results of a survey of state benchmark health plan coverage of substance use disorder treatments and services, including treatments and services for opioid use disorder.

A Timely Right To Privacy, Stacey A. Tovino

Faculty Articles

On December 28, 2017, the federal Department of Health and Human Services ("HHS") settled its fiftieth case involving potential violations of the privacy, security, and breach notification rules ("Rules") that implement the Health Insurance Portability and Accountability Act ("HIPAA") and the Health Information Technology for Economic and Clinical Health Act ("HITECH"). This Article catalogues and examines currently available enforcement actions involving the HIPAA and HITECH Rules, including the cases in which HHS has entered into a settlement agreement with a HIPAA covered entity or business associate, the cases in which HHS has imposed a civil money penalty on a HPAA …

The Morality Of Compulsory Licensing As An Access To Medicines Tool, Margo A. Bagley

Faculty Articles

This Article contemplates the validity of theft rhetoric in relation to the right of countries to grant compulsory licenses from an unconventional perspective; that of biblical teachings on what it means to steal.

Part I describes the use of theft rhetoric in relation to IP infringement broadly and drug-patent compulsory licenses in particular.

Part II challenges the contention, suggested by theft rhetoric, that compulsory licenses are morally wrong as a form of stealing, by considering the meaning of theft in the context of its Judeo-Christian origins.

Part III considers the cogency of the accusation that the issuance of compulsory licenses …

A Right To Care, Stacey A. Tovino

Faculty Articles

In this Article, Professor Stacey Tovino examines the right to care through a personal and historical lens, then attempts to fill a scholarly gap in legal literature surrounding the right to skilled care and rehabilitation for patients with group or commercial insurance. Professor Tovino first recounts the history of Medicare coverage for skilled care and rehabilitation, then she examines the limitations of group and commercial insurance, finally concluding by asserting a right to care.

Remarks On Patient Privacy: Problems, Perspectives, And Opportunities, Stacey A. Tovino

Faculty Articles

No abstract provided.

Autonomy And Accountability: Why Informed Consent, Consumer Protection, And Defunding May Beat Conversion Therapy Bans, Melissa Ballengee Alexander

Faculty Articles

No abstract provided.

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

Faculty Articles

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

Faculty Articles

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 …

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

Faculty Articles

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 …

Teaching The Hipaa Privacy Rule: Illustrative Comparisons, Stacey A. Tovino

Faculty Articles

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 …

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

Faculty Articles

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 …

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

Faculty Articles

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 …

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

Faculty Articles

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 …

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

Faculty Articles

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 …

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

Faculty Articles

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 …

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

Faculty Articles

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 …

Denying The Dyad: How Criminalizing Pregnant Use Harms The Baby, Taxpayers And Vulnerable Women, Melissa Ballengee Alexander

Faculty Articles

No abstract provided.