Legislation Commons^™

Medical Board Of California, Mason Bettencourt, Betsy Gopinath

California Regulatory Law Reporter

No abstract provided.

Department Of Managed Health Care, Kaitlyn Enticknap, Monet Mccord, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

The Kids Are Not Alright: Leveraging Existing Health Law To Attack The Opioid Crisis Upstream, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The opioid crisis is now a nationwide epidemic, ravaging both rural and urban communities. The public health and economic consequences are staggering; recent estimates suggest the epidemic has contracted the U.S. labor market by over one million jobs and cost the nation billions of dollars. To tackle the crisis, scholars and health policy initiatives have focused primarily on downstream solutions designed to help those who are already in the throes of addiction. For example, the major initiative announced by the U.S. Surgeon General promotes the dissemination of naloxone, which helps save lives during opioid overdoses.

This Article argues that the …

Money That Costs Too Much: Regulating Financial Incentives, Kristen Underhill

Indiana Law Journal

Money may not corrupt. But should we worry if it corrodes? Legal scholars in a range of fields have expressed concern about “motivational crowding-out,” a process by which offering financial rewards for good behavior may undermine laudable social motivations, like professionalism or civic duty. Disquiet about the motivational impacts of incentives has now extended to health law, employment law, tax, torts, contracts, criminal law, property, and beyond. In some cases, the fear of crowding-out has inspired concrete opposition to innovative policies that marshal incentives to change individual behavior. But to date, our fears about crowding-out have been unfocused and amorphous; …

Good Of My Patient: Who Gets To Decide?, Lauren Ruvo

Tennessee Journal of Race, Gender, & Social Justice

Physicians play a crucial role in helping patients make life or death decisions. However, all healthcare professionals have personal beliefs and biases that influence these decisions. This paper explores how physicians are able to uphold the Hippocratic ideal of doing what is in the best interest of the patient while taking into account their personal beliefs and biases. The paper begins by analyzing existing schools of thought around how to do what is best for the patient. While there are many different views, this paper looks at the main three: the bioethical movement, the paternalistic approach to medicine, and the …

Department Of Managed Health Care, Kaitlyn Enticknap, Monet Mccord, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Medical Board Of California, Mason Bettencourt, Debra Jorgensen

California Regulatory Law Reporter

No abstract provided.

Puffing Away Parental Rights: A Survey And Analysis Of Whether Secondhand Smoke Exposure Is Child Abuse, Karly Huml

Journal of Law and Health

The steps taken thus far to protect children in public areas, custody cases, and in vehicles show the legislature's awareness of the chemical harms of secondhand smoke for children. This article will analyze those steps and discuss what they mean for both parents' and children's constitutional rights. This article proposes that the legislature take a vital fourth step by including secondhand smoke exposure in child abuse laws. Section II of this article provides the history of smoking tobacco and its transition from a trendy social status to an unpopular, harmful habit. Section II also introduces the steps that have been …

Solving The Opioid Epidemic In Ohio, Lacy Leduc

Journal of Law and Health

On May 31, 2017, Ohio Attorney General Mike DeWine took a step in fighting Ohio's opioid epidemic, bringing the first of many lawsuits against five top pharmaceutical companies. However, under Federal and State law, there is an exception called the Learned Intermediary Doctrine, which can absolve drug manufacturers of liability from any misconduct that might be found and transfer that liability to a treating physician. This exception is the way many drug manufacturers were able to avoid being held responsible in the past. This Note proposes that with the current pending lawsuit in the State of Ohio, an exception to …

A Brand-Name Drug Company May Violate Section Two Of The Sherman Act By Mislabeling A Submitted Patent In The Orange Book: An Implication From In Re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), Ping-Hsun Chen

Brooklyn Journal of Corporate, Financial & Commercial Law

The Hatch-Waxman Act encourages generic drug companies to submit an abbreviated new drug application (“ANDA”) for a generic version of a drug approved by the U.S. Food and Drug Administration (“FDA”). Nevertheless, a mechanism exists for a brand-name drug company to adjudicate a patent infringement dispute before the FDA approves an ANDA. The mechanism includes the regulatory scheme of patent information submission implemented by the FDA. 21 U.S.C. § 355(b)(1) requires that patent information be correct. False patent information destroys the objectives of the Hatch-Waxman Act. In re Actos End-Payor Antitrust Litigation, 848 F.3d 89 (2d Cir. 2017), may demonstrate …

The Impact Of H.B. 214: A Critical Analysis Of The Texas "Rape Insurance" Bill, Lucie Arvallo

St. Mary's Law Journal

Texas House Bill 214 (H.B. 214) is subject to challenge under the Supreme Court precedent protecting a woman’s right to choose. Passed in 2017, H.B. 214 regulates Texas insurance markets by prohibiting coverage for an elective abortion unless a woman affirmatively opts into such coverage through a separate contract and pays a separate premium. Similar restrictions on insurance coverage for elective abortion in other states have been met with mixed results in the courts. What sets H.B. 214 apart from other regulations of insurance coverage for abortion is that it does not include any exceptions for abortions in cases of …

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 …

21st Century Cures Act: The Problem With Preemption In Light Of Deregulation, Megan C. Andersen

University of Michigan Journal of Law Reform

The 21st Century Cures Act introduced innovative changes to the Food and Drug Administration’s regulatory processes. In an effort to address the slow, costly, and burdensome approval process for high-risk devices, the Cures Act modernized clinical trial data by allowing reviewers to determine whether devices merit expedited review and to consider post-market surveillance data in the premarket approval process. These changes will get life-saving devices to the people who need them faster than ever before. But the tradeoff is a greater risk of injury to the patient. The 2008 Supreme Court decision Riegel v. Medtronic, Inc., held that any …

Pharmaceutical Price Gouging: The Need For Direct Regulation On The Gray Market, Nicole Rende

Journal of Civil Rights and Economic Development

(Excerpt)

This Note proposes federal legislation that will ultimately shut down the Pharmaceuticals gray market. The federal government should directly regulate the gray market and the price gouging mechanisms used. Congress should pass the Fair Accountability and Innovative Research Drug Pricing Act of 2016, currently proposed. This Act will increase price transparency and provide a civil penalty for wrong doers. In addition to the passage of this Act, there needs to be a direct attack on the gray market by creating an act that does not allow companies to participate in these distributions and ultimately form monopolies. This act needs …

Beyond The Ethical Boundaries Of Solidarity: Increasing Vaccination Rates Through Mandatory Education To Solidarity, Nili Karako- Eyal Dr.

Texas A&M Law Review

Mandatory vaccination laws require children to be vaccinated against certain communicable diseases to attend school. These laws also provide exemptions to school vaccination requirements.1 All states exempt children from vaccination requirements for medical reasons, and most states also provide an exemption for religious and/or other personal reasons.2 Seven states include an educational component in their religious or philosophical exemption process, requiring that parents receive information regarding the benefits of vaccination and the risks of not being vaccinated.3 Of these seven states, five require that information regarding the social benefits of vaccination will be provided to parents.4

This type of legislation …

Table Of Contents, Seattle University Law Review

Seattle University Law Review

No abstract provided.

A Prescription For Charity Care: How National Medical Debt Ills Can Be Alleviated By Integrating State Financial Assistance Policies Into The Nonprofit Tax Exemption, Margarita Kutsin

Seattle University Law Review

Despite having the most expensive healthcare system in the world, the United States has been consistently ranked as having the worst system in terms of equity, efficiency, and healthcare outcomes among industrialized nations. The effects of these systemic issues are grounded in the patient experience as nearly forty-four percent of individuals have forgone recommended treatments and thirty-two percent have reported that they were unable to afford a prescription due to the high cost, according to a study conducted in 2018. Health is sacred, and financial circumstances should not determine the difference between treatment and illness, or life and death. “Financial …

An Analysis And Critique Of Mental Health Treatment In American State Prisons And Proposal For Improved Care, Shelby Hayne

Scripps Senior Theses

Mental health treatment in state prisons is revealed to be highly variable, under-funded, and systematically inadequate. Existing literature exposes this injustice but fails to provide a comprehensive proposal for reform. This paper attempts to fill that gap, outlining a cost-effective, evidence-based treatment proposal, directly addressing the deficits in care revealed through analysis of our current system. In addition, this paper provides historical overviews of the prison system and mental health treatment, utilizing theoretical perspectives to contextualize this proposal in the present state of affairs. Lastly, the evidence is provided to emphasize the potential economic and social benefits of improving mental …

"You Have The Data"...The Writ Of Habeas Data And Other Data Protection Rights: Is The United States Falling Behind?, Sarah L. Lode

Indiana Law Journal

In Part I of this Note, I will discuss the writ of habeas data that has been developed primarily, but not exclusively, in Latin American countries. I will discuss the intricacies of the writ, how it evolved, and how it is applied today. Using Argentina as an example, I will discuss how the writ would be used by an Argentine citizen to protect her personal data. Part II summarizes the previously employed data protection scheme in the European Union, the Data Protection Directive (“the Directive”), and will also discuss the new EU data protection regulation, the General Data Protection Regulation …

Predetermined? The Prospect Of Social Determinant-Based Section 1115 Waivers After Stewart V. Azar, Griffin Schoenbaum

Dickinson Law Review (2017-Present)

Section 1115 of the Social Security Act allows the Secretary of Health and Human Services (the “Secretary”) to waive some of Medicaid’s requirements so states can enact “demonstration projects.” A demonstration project is an experiment a state can conduct by modifying aspects of its Medicaid program. To waive Medicaid’s requirements for this purpose, the Secretary must determine that the proposed demonstration project will likely assist in promoting Medicaid’s objectives.

Using this standard, President Trump’s Secretary has approved waiver requests to enact demonstration projects that contain “community engagement” requirements. The U.S. District Court for the District of Columbia has heard each …

Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan

Texas A&M Law Review

This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s differing interpretations of the …

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, …

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.

There’S A Pill For That! State Law Approaches To Workplace Drug Testing Policy In The Age Of Prescription Opioids, Katie Meikle

Journal of Legislation

No abstract provided.

The Unconstitutionality Of The Protecting Access To Care Act Of 2017’S Cap On Noneconomic Damages In Medical Malpractice Cases, Kaeleigh P. Christie

Journal of Legislation

No abstract provided.

Sb 17 - Alcoholic Beverages, Lauren A. Newman, Erin N. Winn

Georgia State University Law Review

Georgia law previously allowed counties and municipalities to permit the sale of alcoholic beverages on Sundays from 12:30 P.M. until 11:30 P.M. This Act, deemed “the Brunch Bill,” authorizes the counties and municipalities that have affirmatively voted by referendum to sell alcoholic beverages on Sundays to sell them earlier, at 11:00 A.M., if approved by a second referendum vote. This change applies to restaurants that make at least 50% of their revenue from the sale of food and hotels, and Georgia wineries.

Department Of Managed Health Care, Jennifer Pardue, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Medical Board Of California, Kayla Watson, J. D. Fellmeth

California Regulatory Law Reporter

No abstract provided.

Board Of Pharmacy, Mariam J. Saleh, Bridget Fogarty Gramme

California Regulatory Law Reporter

No abstract provided.