Health Law and Policy Commons^™

"Hash"Ing Out Inequality In The Legal Recreational Cannabis Industry, Maya Rahwanji

Northwestern Journal of International Law & Business

No abstract provided.

Mdl Immunity: Lessons From The National Prescription Opiate Litigation, Roger Michalski

American University Law Review

No abstract provided.

Health Care Costs And The Arc Of Innovation, Neel U. Sukhatme, Maxwell Gregg Bloche

Georgetown Law Faculty Publications and Other Works

Health care costs continue their inexorable rise, threatening America’s long-term fiscal stability, competitiveness, and standard of living. Over the past half-century, efforts to rein in spending have uniformly failed. In this Article, we explain why, breaking with standard accounts of regulatory and market dysfunction. We point instead to the nexus of economics, mutual empathy, and social expectations that drives medical innovation and locks in low-value technologies. We show how law reflects and reinforces this nexus and how and why health-policy-makers avert their gaze.

Next, we propose to circumvent these barriers instead of surmounting them. Rather than targeting today’s excessive spending, …

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

Scholarly Works

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 …

Fraud, Abuse, And Opioids, Stacey A. Tovino

Scholarly Works

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

Scholarly Works

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, …

Using The Ada's 'Integration Mandate' To Disrupt Mass Incarceration, Robert Dinerstein

Scholarly Articles in Law Reviews & Journals

As a result of the disability rights movement's fight for the development of community-based services, the percentage of people with intellectual and developmental disabilities (I/DD) and mental illness living in institutions has significantly decreased over the last few decades. However, in part because of government failure to invest properly in community-based services required for a successful transition from institutions, individuals with disabilities are now dramatically overrepresented in jails and prisons. The Americans with Disabilities Act's (ADA) "integration mandate" -- a principle strengthened by the Supreme Court's 1999 Olmstead v. L.C. decision, entitling individuals with disabilities to receive services in the …

Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle

Scholarly Articles in Law Reviews & Journals

Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …

Right To A Healthy Prison Environment: Health Care In Custody Under The Prism Of Torture, Juan E. Mendez

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Manufactured Emergencies, Robert Tsai

Scholarly Articles in Law Reviews & Journals

Emergencies are presumed to be unusual affairs, but the United States has been in one state of emergency or another for the last forty years. That is a problem. The erosion of democratic norms has led to not simply the collapse of the traditional conceptual boundary between ordinary rule and emergency governance, but also the emergence of an even graver problem: the manufactured crisis. In an age characterized by extreme partisanship, institutional gridlock, and technological manipulation of information, it has become exceedingly easy and far more tempting for a President to invoke extraordinary power by ginning up exigencies. To reduce …

Health Law: Sb 17 And State Regulation Of Drug Pricing, Jaime S. King, Katherine L. Gudiksen

The Judges' Book

No abstract provided.

Punishment Without Process: Victim Impact Proceedings For Dead Defendants, Bruce Green, Rebecca Roiphe

Articles & Chapters

After Jeffrey Epstein committed suicide in jail, two judges allowed his accusers to speak in court. This article argues that the proceedings were inappropriate because the criminal case ends when the defendant dies. If the conviction and appeal are not final, there is no finding of guilt, and the defendant is still presumed innocent. Allowing accusers to speak at this time violates the principle of due process and threatens to undermine faith in judges and the criminal justice system in general. While courts are at times legally required to hear from victims of crimes, they were not allowed to do …

Manufactured Emergencies, Robert L. Tsai

Faculty Scholarship

Emergencies are presumed to be unusual affairs, but the United States has been in one state of emergency or another for the last forty years. That is a problem. The erosion of democratic norms has led to not simply the collapse of the traditional conceptual boundary between ordinary rule and emergency governance, but also the emergence of an even graver problem: the manufactured crisis. In an age characterized by extreme partisanship, institutional gridlock, and technological manipulation of information, it has become exceedingly easy and far more tempting for a President to invoke extraordinary power by ginning up exigencies. To reduce …

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 …

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, …

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.

Occupational Licensing And The Limits Of Public Choice Theory, Ryan Nunn, Gabriel Scheffler

Articles

No abstract provided.

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

Articles

No abstract provided.

Conversion Therapy: A Brief Reflection On The History Of The Practice And Contemporary Regulatory Efforts, Tiffany C. Graham

Scholarly Works

This brief symposium essay offers a broad-stroke sketch of the history of conversion therapy, its current status as a locus of regulation, and some preliminary questions about the direction the law might take to protect individuals who elect or are forcibly subjected to the practice.

Open Science Precision Medicine In Canada: Points To Consider, Palmira Granados Moreno, Sarah E. Ali-Khan, Benjamin Capps, Timothy Caulfield, Damien Chalaud, Aled Edwards, E. Richard Gold, Vasiliki Rahimzadeh, Adrian Thorogood, Daniel Auld, Gabrielle Bertier, Felix Breden, Roxanne Caron, Priscilla M.D.G. César, Robert Cook-Deegan, Megan Doerr, Ros Duncan, Amalia M. Issa, Jerome Reichman, Jacques Simard, Derek So, Sandeep Vanamala, Yann Joly

Faculty Scholarship

Open science can significantly influence the development and translational process of precision medicine in Canada. Precision medicine presents a unique opportunity to improve disease prevention and healthcare, as well as to reduce health-related expenditures. However, the development of precision medicine also brings about economic challenges, such as costly development, high failure rates, and reduced market size in comparison with the traditional blockbuster drug development model. Open science, characterized by principles of open data sharing, fast dissemination of knowledge, cumulative research, and cooperation, presents a unique opportunity to address these economic challenges while also promoting the public good.

The Centre of …

The Shadows Of Life: Medicaid's Failure Of Health Care's Moral Test, Barak D. Richman, Kushal T. Kadakia, Shivani A. Shah

Faculty Scholarship

North Carolina Medicaid covers one-fifth of the state’s population and makes up approximately one-third of the budget. Yet the state has experienced increasing costs and worsening health outcomes over the past decade, while socioeconomic disparities persist among communities. In this article, the authors explore the factors that influence these trends and provide a series of policy lessons to inform the state’s current reform efforts following the recent approval of North Carolina’s Section 1115 waiver by the Centers for Medicare and Medicaid Services. The authors used health, social, and financial data from the state Department of Health and Human Services, the …

Out Of The Freezer And Into The Policy Fire: Quandaries In Reproductive Cryopreservation, Rebecca Feinberg

Scholarly Works

The field of assisted reproduction is advancing rapidly and is ripe for regulation and guidance. In 2018, over four thousand frozen eggs and embryos were lost to approximately one thousand patients at Ahuja University Hospital in Cleveland, Ohio, due to an accidental thaw of a cryopreservation tank. The precedent that will be set by the Ahuja class-action case is significant for both past events and future possibilities and is core to the discussion of policy involving the cryopreservation of gametes and embryos.

Who Guards The Guardians? Simplifying The Discovery Of Electronic Medical Records, Joseph Deangelis

University of Colorado Law Review

As medical errors reign as a leading cause of death and injury in the United States, the efficient and effective resolution of medical negligence disputes becomes increasingly necessary, albeit uncommon. Despite the frequency of medical errors, the quality of medical care in the United States has increased over the last several decades. This improvement has been due in no small part to the widespread adoption of Electronic Medical Records (EMRs) by healthcare providers across the country. While EMR systems have done their part to improve patient care, they are not designed for litigation. Indeed, the widespread use of EMR technology …

Exploring The Development Of Three Law-Based Competency Models For Public Health Practitioners, Montrece Mcneill Ransom, Brianne Yassine

Journal of Social, Behavioral, and Health Sciences

As public health promotion and protection become increasingly complex and integrated into various fields, public health law is emerging as an important tool for public health professionals. To ensure that public health professionals are adequately trained public health law, public health law-related competencies should to be integrated into educational and other programming. This article provides three competency models developed by the Public Health Law Program at the Centers for Disease Control and Prevention: (a) the public health emergency law competency model, (b) the public health law competency model, and (c) the legal epidemiology competency model. These competency models provide a …

Powerful Speakers And Their Listeners, Helen Norton

Publications

In certain settings, law sometimes puts listeners first when their First Amendment interests collide with speakers’. And collide they often do. Sometimes speakers prefer to tell lies when their listeners thirst for the truth. Sometimes listeners hope that speakers will reveal their secrets, while those speakers resist disclosure. And at still other times, speakers seek to address certain listeners when those listeners long to be left alone. When speakers’ and listeners’ First Amendment interests collide, whose interests should prevail? Law sometimes – but not always – puts listeners’ interests first in settings outside of public discourse where those listeners have …

Pregnancy And The First Amendment, Helen Norton

Publications

Suppose that you are pregnant and seated in the waiting room of a Planned Parenthood clinic, or maybe in a facility that advertises “Pregnant? We Can Help You.” This Essay discusses the First Amendment rules that apply to the government’s control of what you are about to hear.

If the government funds your clinic’s program, the U.S. Supreme Court has held that it does not violate the First Amendment’s Free Speech Clause when it forbids your health-care provider from offering you information about available abortion services. Nor does the government violate the Free Speech Clause, the Court has held, when …

Drugs' Other Side Effects, Craig J. Konnoth

Publications

Drugs often induce unintended, adverse physiological reactions in those that take them—what we commonly refer to as “side-effects.” However, drugs can produce other, broader, unintended, even non-physiological harms. For example, some argue that taking Truvada, a drug that prevents HIV transmission, increases promiscuity and decreases condom use. Expensive Hepatitis C treatments threaten to bankrupt state Medicaid programs. BiDil, which purported to treat heart conditions for self-identified African-Americans, has been criticized for reifying racial categories. Although the Food & Drug Administration (“FDA”) has broad discretion under the Food, Drugs, and Cosmetics Act (“FDCA”) to regulate drugs, it generally considers only traditional …