Health Law and Policy Commons^™

Panel 3: Chronic Pain, Psychogenic Pain, And Emotion, Robert Dinerstein

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Dietary Supplements Are Not All Safe And Not All Food: How The Low Cost Of Dietary Supplements Preys On The Consumer, Joanna K. Sax

Faculty Scholarship

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural' with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco -- a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) only has limited ability to regulate the entry of …

The Aca, Provider Mergers And Hospital Pricing: Experimenting With Smart, Lower-Cost Health Insurance Options, Susan A. Channick

Faculty Scholarship

This paper addresses the issue of whether the recent significant uptick in provider mergers and the implementation of the Affordable Care Act have a particularly adverse effect on provider pricing in the commercial insurance market. Uncompetitive provider markets exacerbate already existing high cost issues such as lack of transparency in provider pricing, patient behavior that conflates reputation and quality, and payers’ inability, or at least reluctance, to exclude high-price providers from their networks. The ACA’s incentives for providers to coordinate patient care and hospitals’ revenue losses from reductions in Medicare reimbursement create further rationales for consolidation. The burden of finding …

Biosimilar Naming: A Call For Uniformity In A Complex Field, Jacqueline Genovese

Brooklyn Journal of International Law

Recombinant technology has opened a pathway for a means of producing a variety of therapeutic proteins and generating the growth of the biopharmaceutical industry. Further, due the patent expirations of a number of biologics in the coming years, there has been an increased interest in the development of generic biologics, also known as biosimilars, and a widespread push for biosimilar FDA approval in the United States. While the pressure for the expansion of biosimilar approval is warranted, the FDA must be cautious when implementing regulatory guidelines. Since biologics differ greatly from small-molecule drugs, biologics have a distinct approval process. The …

Why Data Privacy Law Is (Mostly) Constitutional, Neil M. Richards

Scholarship@WashULaw

Laws regulating the collection, use, and disclosure of personal data are (mostly) constitutional, and critics who suggest otherwise are wrong. Since the New Deal, American law has rested on the wise judgment that, by and large, commercial regulation should be made on the basis of economic and social policy rather than blunt constitutional rules. This has become one of the basic principles of American Constitutional law. Although some observers have suggested that the Supreme Court’s recent decision in Sorrell v. IMS Health (2011) changes this state of affairs, such readings are incorrect. Sorrell involved a challenge to a poorly-drafted Vermont …

“Play Or Pay”: Interpreting The Employer Mandate Of The Patient Protection And Affordable Care Act As It Relates To Tribal Employers, Rachel Sibila

American Indian Law Review

No abstract provided.

Children's Health In A Legal Framework, Elizabeth S. Scott, Clare Huntington

Faculty Scholarship

The interdisciplinary periodical Future of Children has dedicated an issue to children’s health policy. This contribution to the issue maps the legal landscape influencing policy choices. The authors demonstrate that in the U.S. legal system, parents have robust rights, grounded in the Constitution, to make decisions concerning their children’s health and medical treatment. Following from its commitment to parental rights, the system typically assumes the interests of parents and children are aligned, even when that assumption seems questionable. Thus, for example, parents who would limit their children’s access to health care on the basis of the parents’ religious belief have …

Kickbacks And Contradictions: The Anti-Kickback Statute And Electronic Health Records, Daniel E. Rheiner

Vanderbilt Journal of Entertainment & Technology Law

The Obama Administration has made the universal adoption of electronic health records a major policy priority, passing the Health Information Technology for Economic and Clinical Health (HITECH) Act, which creates incentives for physicians and hospitals to computerize their medical records. This effort has been largely successful, as evidenced by the significant increase in medical providers who have adopted electronic health records. However, for the President to achieve his goal of computerizing all medical records in the United States, he will need to ensure that other federal laws do not conflict with the incentive structure created by the HITECH Act. The …

Agencies, Polarization, And The States, Gillian E. Metzger

Faculty Scholarship

Political polarization is all the rage. Yet administrative agencies are strikingly absent from leading accounts of contemporary polarization. To the extent they appear, it is largely as acted-upon entities that bear the fallout from the congressional-presidential confrontations that polarization fuels, or as the tools of presidential unilateralism. This failure to incorporate administrative agencies into polarization accounts is a major omission. Agencies possess broad grants of preexisting authority that they can use to reshape governing policy and law, often at presidential instigation, thereby putting pressure on Congress to respond. In the process, they can construct new alliances and arrangements that have …

Remodeling Federal Medical Malpractice Act: A Possible Improvement To The Affordable Care Act, Nancy Kubasek, Tiffany Durham

Loyola of Los Angeles Law Review

During the debates about healthcare reform, the Congressional Budget Office found that federal medical liability reform could drastically reduce federal budget deficits, yet political and legal scholars could not reach agreement about the best way for the Patient Protection and Affordable Care Act (PPACA) to provide such reform. Instead, provisions were made to fund state level demonstration projects. The law that is considered one of the most successful models to date of conventional tort reform is the Medical Injury Compensation Reform Act of California. This Article exams that legislation and discusses how we might use what can be learned from …

The Subsidy Question In King V. Burwell, Antonio F. Perez

Scholarly Articles

On the surface, King v. Burwell appears to be a simple case about statutory interpretation. In the Affordable Care Act (widely known as Obamacare), when Congress referred to the “State,” in the provision triggering federal subsidies to insurance consumers for purchases made from federally-authorized insurance providers selling federally-authorized insurance products, should the “State” be understood to refer to the federal market (i.e., exchanges) as well as “State” markets. Simple tools of statutory construction–namely, that Congress knew full well how to refer to a “federal” exchange and failed to do so–would seem to be sufficient to supply a result. It would …

Why The Government Of Canada Won't Regulate Assisted Human Reproduction: A Modern Mystery, Jocelyn Downie, Dave Snow, Francoise Baylis

Articles, Book Chapters, & Popular Press

The Canadian Assisted Human Reproduction Act (AHR Act), passed in 2004, prohibits both paying consideration to a surrogate mother and purchasing sperm and ova from a donor (sections 6-7). Both prohibitions are subject to section 12, which was intended to permit reimbursement of expenditures incurred by surrogate mothers and gamete donors and reimbursement for loss of work-related income for surrogate mothers. Remarkably, more than ten years after the AHR Act received Royal Assent, and in spite of repeated calls for greater legal clarity, Health Canada has not drafted regulations pursuant to section 12 of the AHR Act, which is not …

Denaturalizing Transparency In Drug Regulation, Matthew Herder

Articles, Book Chapters, & Popular Press

In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function - namely, of enabling standard setting through a more participatory, public …

The Four Stages Of Youth Sports Tbi Policymaking: Engagement, Enactment, Research, And Reform, Hosea H. Harvey, Dionne L. Koller, Kerri M. Lowrey

All Faculty Scholarship

This article advances, for the first time, a framework for situating public health law interventions as occurring in a predictable four-stage process. In this article, written in connection with our panel at the Public Health Law Research Conference (2014), we briefly apply this four-stage framework to youth sports TBI laws, and conclude that public health lawmaking in this area is consistent with prior high-visibility public health law interventions.

Could Data Broker Information Threaten Physician Prescribing And Professional Behavior?, Marco D. Huesch, Michael K. Ong, Barak D. Richman

Faculty Scholarship

Privacy is threatened by the extent of data collected and sold by consumer data brokers. Physicians, as individual consumers, leave a ‘data trail’ in the offline (e.g. through traditional shopping) and online worlds (e.g. through online purchases and use of social media). Such data could easily and legally be used without a physician’s knowledge or consent to influence prescribing practices or other physician professional behavior. We sought to determine the extent to which such consumer data was available on a sample of more than 3,000 physicians, healthcare faculty and healthcare system staff at one university’s health units. Using just work …

Markets, Morals, And Limits In The Exchange Of Human Eggs, Kimberly D. Krawiec

Faculty Scholarship

No abstract provided.

Hiv Infrastructure Study Birmingham, Alabama, Susan S. Reif, Kristen Sullivan, Carolyn Mcallaster, Miriam Berger

Faculty Scholarship

No abstract provided.

One Size Does Not Fit All: What Does High Impact Prevention Funding Mean For Community-Based Organizations In The Deep South?, Carolyn Mcallaster, Jerry Fang

Faculty Scholarship

No abstract provided.

The Surprising Relevance Of Medical Malpractice Law, Michael D. Frakes

Faculty Scholarship

The academic community has largely reached a consensus that medical malpractice reform is unlikely to be a meaningful source of health-care cost containment. This Article suggests that it would be premature to conclude based on the evidence underlying this academic sentiment that physicians are universally insensitive to the parameters of medical malpractice law and that liability reform has no role to play in the health-care-costs debate. On the contrary, this Article demonstrates that the medical-liability system, under particular structures and conditions, may indeed have a meaningful connection to health-care spending patterns.

The shortcoming of the existing empirical literature that has …

Do Physicians Respond To Liability Standards?, Michael D. Frakes, Matthew Frank, Seth Seabury

Faculty Scholarship

In this paper, we explore the sensitivity in the clinical decisions of physicians to the standards of care expected of them under the law, drawing on the abandonment by states over time of rules holding physicians to standards determined by local customs and the contemporaneous adoption of national-standard rules. Using data on broad rates of surgical interventions at the county-by-year level from the Area Resource File, we find that local surgery rates converge towards national surgery rates upon the adoption of national-standard rules. Moreover, we find that these effects are more pronounced among rural counties.

A Closer Look: Deep South Has The Highest Hiv-Related Death Rates In The United States, Susan S. Reif, Donna Safley, Carolyn Mcallaster

Faculty Scholarship

No abstract provided.

Sickeningly Sweet: Analysis And Solutions For Adverse Dietary Consequences Of European Agricultural Law, Emilie K. Aguirre

Faculty Scholarship

Sixty-nine percent of adults in the United States, sixty-four percent in the United Kingdom, and over one-third worldwide are overweight or obese. These staggering figures continue to grow, with accompanying emotional, physical, and economic consequences, both for individuals and society as a whole. The role law plays in facilitating this global trend is significant, and yet puzzlingly, little recognized or understood. The current food system is profoundly structurally flawed: it establishes unhealthy dietary behaviors as the default option for consumers. This Article is the first to examine how agricultural law has facilitated these unhealthier diets for the past fifty years, …

Toward A Structural Theory Of Implicit Racial And Ethnic Bias In Health Care, Dayna Bowen Matthew

Publications

No abstract provided.

The Due Process Conundrum: Using Matthews V. Eldridge As A Standard For Private Hospitals Under The Healthcare Quality Improvement Act, Amy L. Moore

Law Faculty Scholarship

This Article examines the procedural due process protections afforded to physicians under the Health Care Quality Improvement Act of 1986 (HCQIA), focusing on the statutory requirement of “adequate notice and hearing” in professional peer review proceedings. Although HCQIA was enacted to promote effective peer review and improve the quality of medical care by granting immunity to hospitals and review bodies, the statute conditions immunity on compliance with certain fairness standards. The Article identifies a doctrinal gap between the statute’s safe harbor provisions and the broader, undefined requirement of adequacy, noting that courts frequently resolve immunity questions at summary judgment under …

Nowhere To Run, Nowhere To Hide: The Absence Of Public Policy On Intimate Partner Violence Abrogates The Rights To Health Care And Bodily Integrity Under The South African Constitution, Stu Woolman, Courtenay Sprague

Cardozo Journal of Equal Rights & Social Justice

An estimated 31-55% of South African women experience lfetime intimate partner violence ("IPV'). The imminent danger of physical, psychological or sexual violence that all South African women face daily not only threatens their very existence, it impairs their development and agency, and thus the ability of each woman to pursue a lfe that reflects her own comprehensive vision of a fulfilling way of being in the world. This article first establishes the legal basis for the proposition that the South African Constitution and South Africa's international obligations require a form of public intervention that has the ability to diminish IP …

The Missing Victims Of Health Care Fraud, Anthony Kyriakakis

Utah Law Review

Over the past few decades, combating criminal health care fraud has become one of the highest priorities of federal law enforcement, which views and treats it as a financial crime that causes vast economic losses to the government and private insurers. But the crime also causes, or threatens, physical harms to individual health care patients, a class of victims that the criminal justice system often fails to recognize. This Article is the first to explore how structures and hidden levers of power within the criminal justice bureaucracy lead agents and prosecutors to select—and ignore—particular harms and victims and, more importantly, …

The Dsm-5 And Criminal Defense: When Does A Diagnosis Make A Difference?, Nancy Haydt

Utah Law Review

In June 2013, the American Psychiatric Association published the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (“DSM-5”). The DSM-5 was intended to be an updated guidebook for the clinical diagnosis of mental disorders. It received mixed reviews from the mental health community. The reception from the forensic mental health community is likewise varied. The evolution of conceptualizing mental illness, its origins and treatment efficacy, may weaken the authority of the DSM and further confuse its application in forensic situations. This Article explores the possible effects of the DSM-5 in criminal cases.

Does The Dsm-5 Threaten Autism Service Access?, Rebecca Johnson

Utah Law Review

The present paper addressed the question: how will the DSM-5 revisions impact access to autism services? While media commentators posited a straightforward link between DSM-5 changes and service access, we should consider the different strength of couplings between a DSM diagnosis and entitlement access by investigating the factors that result in a diagnoses translation into service access. The Article began by outlining the pre DSM-5 policy background for autism entitlements. This background helps contextualize the policy environment into which the DSM-5 changes entered. Rather than examining autism medical and educational services in isolation, we should conceive of these services as …

The Universality Of Medicaid At Fifty, Nicole Huberfeld

Faculty Scholarship

This essay, written for the Yale Law School symposium on The Law of Medicare and Medicaid at 50, explores how the law of Medicaid after the ACA creates a meaningful principle of universalism by shifting from fragmentation and exclusivity to universality and inclusivity. The universality principle provides a new trajectory for all of American health care, one that is not based on individual qualities that are unrelated to medical care but rather grounded in non-judgmental principles of unification and equalization (if not outright solidarity). This essay examines the ACA's legislative reformation, which led to universality, and its quantifiable effects. The …

Should Patient Responsibility For Costs Change The Doctor-Patient Relationship?, Christopher Robertson

Faculty Scholarship

Copays, deductibles, coinsurance, and reference prices all now expose patients to increasingly larger shares of the costs of health care. Extant research on cost sharing has primarily focused on its impact on patients, their health care spending, and their health outcomes. Scholars have paid much less attention to the question of how patient exposure to health care costs may impact physicians and their relationships with their patients. This Essay is given on the occasion of a symposium motivated by two recent books by David Schenck, Larry Churchill, and Joseph Fanning that highlight the relational aspects of health care ethics. Accordingly, …