Health Law and Policy Commons^™

Bridging The Gap Between Intent And Status: A New Framework For Modern Parentage, Yehezkel Margalit

Hezi Margalit

The last few decades have witnessed dramatic changes in the conceptualization and methodologies of determining legal parentage in the U.S. and other countries in the western world. Through various sociological shifts, growing social openness and bio-medical innovations, the traditional definitions of family and parenthood have been dramatically transformed. This transformation has led to an acute and urgent need for legal and social frameworks to regulate the process of determining legal parentage. Moreover, instead of progressing in a piecemeal, ad-hoc manner, the framework for determining legal parentage should be comprehensive. Only a comprehensive solution will address the differing needs of today’s …

From Baby M To Baby M(Anji): Regulating International Surrogacy Agreements, Yehezkel Margalit

Hezi Margalit

In 1985, when Kim Cotton became Britain’s first commercial surrogate mother, Europe was exposed to the issue of surrogacy for the first time on a large scale. Three years later, in 1988, the famous case of Baby M drew the attention of the American public to surrogacy as well. These two cases implicated fundamental ethical and legal issues regarding domestic surrogacy and triggered a fierce debate about motherhood, child-bearing, and the relationship between procreation, science and commerce. These two cases exemplified the debate regarding domestic surrogacy - a debate that has now been raging for decades. Contrary to the well-known …

The Medicine Shoppe V. Loretta Lynch: Pharmacists’ Corresponding Responsibility With Physicians Under Dea Interpretation Of The “Legitimate Medical Purpose” Standard, Jeffrey C. Grass Jd, Ms, Aclm

Jeffrey C. Grass JD, MS, ACLM

The Medicine Shoppe v. Loretta Lynch et al. 14-1223 will assist pharmacists and pharmacy owners in understanding their duties “corresponding responsibility to assure that its prescriptions for controlled substances are issued for a legitimate medical purpose” and “in the practitioner's usual course of professional practice.” In the meantime, pharmacists need to know that they are not immune from administrative, regulatory or criminal prosecution under the CSA solely due to their status. Rather, they are expected to dispense drugs for the bona fide treatment of a patient's disease. Under this regime, he or she must exercise sound professional judgment when evaluating …

Guidelines For Physician-Assisted Suicide, Raphael Cohen-Almagor

raphael cohen-almagor

This paper proposes a set of guidelines for physician-assisted suicide (PAS). This set of guidelines integrates pertinent guidelines that were adopted in Oregon, where physician-assisted suicide is legal, in the Netherlands and Belgium where euthanasia is legal, in Switzerland where assisted suicide is practiced, and in the Northern Territory of Australia, where physician-assisted suicide was legal for a short period of time.

The Hidden Ball Trick: Major League Baseball’S Collective Bargaining Agreement Attempts To Hide Tobacco Use By Players, Lee N. Gilgan

Lee N Gilgan

No sport has failed to protect its players, fans and the public from tobacco to the degree of Major League Baseball. The statistics of tobacco are shocking, especially within the sport. While some stadiums have made steps toward a remedy, the Collective Bargaining Agreement and State Law need to become the primary source of regulation.

The Treatment For Malpractice – Physician, Enhance Thyself: The Impact Of Neuroenhancements For Medical Malpractice, Harvey L. Fiser

Harvey L. Fiser

No abstract provided.

How Did You Know That? Protecting Privacy Interests Of Research Participants Via Certificates Of Confidentiality, Jonathan S. Miller

Jonathan S Miller

Answering novel medical hypotheses requires investigators to have robust and demographically diverse biospecimens and genetic data to facilitate their research. Doing so however also requires adequate participation by human subjects willing to consent to the donation and use of their biospecimens and genetic data for future unforeseen research. Although advances in scientific methodologies and technologies to understand the etiology of diseases and facilitate the development of improved therapeutics are critical to enhancing the common good; these advances pose informational risks associated with the re-identification of individuals. The conundrum exists about how to mitigate the privacy concerns associated with potential re-identification …

Closing The Door To Lost Earnings Under The National Childhood Vaccine Injury Act Of 1986, Aaron M. Levin

Aaron M Levin

After a wave of lawsuits against vaccine manufacturers hindered the profitability and production of life-saving vaccines, Congress enacted The National Childhood Vaccine Injury Act of 1986. The Act offers an incentive for individuals to get vaccinated in order to mitigate the population’s exposure to disease, while encouraging the continued production of these serums by pharmaceutical companies. Although imperfect, the Vaccine Act fosters promise in filtering out frivolous claims and provides a central route for due process to the individuals who suffer from a vaccine-related injury. By removing a potential state tort issue to the Federal Circuit, Congress created a reasonably …

Resolution 07-11-2015, To Require Lifeguard Supervision For K-12 Swim Physical Education Classes, Catherine L. Rucker

Catherine L Rucker

To Amend California Education Code section 51222 to require that K-12 school districts that offer aquatics physical education shall provide certified lifeguards.

Hospital Quality Improvement: Are Peer Review Immunity, Privilege, And Confidentiality In The Public Interest?, Michael D. Benson Md, Jordan B. Benson Cpa, Jd, Mark S. Stein Jd, Phd

Michael D Benson MD

Participants in the hospital peer-review process enjoy enormous protections under federal and state law. We contend that these protections – immunity, evidentiary privilege, and confidentiality – retard quality improvement in health care. As a result of these protections, the current peer-review system produces both improper severity and improper leniency. We propose to reform the system by eliminating all federal and state statutory protections for the peer-review process. A public process that is open to review and open to challenge by all interested parties will better promote health-care quality.

Shared Responsibility Regulation Model For Cross-Border Reproductive Transactions, Sharon Bassan

Sharon Bassan

The term “cross-border reproductive transactions” refers to the phenomenon of tens of thousands of people who travel from one country to another to purchase reproductive services, in order to have a child. The foci of this paper are the lion share of cross-border reproductive transactions, specifically between consumers, i.e., intended parents from affluent countries, and suppliers of reproductive services, egg sellers and surrogate mothers, the majority of whom are from lower middle-income countries. Strong concerns regarding the morality of consumers’ states’ policy arise when a country nationally restricts or bans commercial surrogacy, while accepting the results of cross-border reproductive transactions …

Trazos Y Reflexiones En Torno A La Marca Farmacéutica, Javier André Murillo Chávez

Javier André Murillo Chávez

No abstract provided.

Internazionale Medico Scientifica, S.R.L, Mohamad Ali Ali Yousefkhani Mr

Mohamad Ali Ali Yousefkhani

No abstract provided.

Advancing Health Care The Old-Fashioned Way, Craig B. Garner

Craig B. Garner

Though cutting-edge technology serves as the foundation for modern American healthcare, an accurate measure of progress must consider the occasional conflict between society and science. Even as yesterday’s medical miracles give way to what are now considered “state of the art” practices, it is the duty of health care providers to remain mindful of both sides of the equation, balancing the capabilities of today’s technologies with the needs of today’s patient. If society and science are not in sync, patient care will suffer, and sometimes we can only advance healthcare through old-fashioned methods.

The Cost Of Confusion: The Paradox Of Trademarked Pharmaceuticals, Hannah W. Brennan

Hannah W Brennan

The United States spends nearly $1,000 per person annually on drugs—40 percent more than the next highest spender, Canada, and more than twice the amount France and Germany spend. Although myriad factors contribute to high drug spending in the United States, the crucial role that intellectual property laws play in inhibiting access to cheaper, generic medications is among one of the best documented. Yet, for the most part, the discussion of the relationship between intellectual property law and drug spending has centered on patent protection. Recently, however, a few researchers have turned their attention to a different exclusivity—trademark law. New …

A Brave New Medicare, Craig B. Garner

Craig B. Garner

Next month the Affordable Care Act turns five, and by all accounts the influence of this historic legislation will forever change the landscape of health care in the United States, regardless of its ultimate fate. As each passing year introduces thousands of new regulatory pages to an already expansive body of federal and state law, praise for what has come to be known as health care reform is only rivaled by the relentless partisan calls for its repeal.

Does The Right To Elective Abortion Include The Right To Ensure The Death Of The Fetus?, Stephen G. Gilles

Stephen G Gilles

Is the right to an elective abortion limited to terminating the woman’s pregnancy, or does it also include the right to ensure the death of the fetus? Important as this question is in principle, in today’s world the conduct that would squarely raise it cannot occur in practice. The right to elective abortion applies only to fetuses that are not viable, which by definition means that they have been determined to have no realistic chance of surviving outside the uterus. Even if abortion providers used fetus-sparing methods rather than the fetus-killing methods they currently prefer, pre-viable fetuses would die within …

The Affordable Care Act: A “Preventative-Focused” Healthcare Regime To Improve Reproductive Cancer Outcomes Among Women Of Lower Socio-Economic Status, Rachele M. Hendricks

Rachele M Hendricks-Sturrup

No abstract provided.

Obstacles To Ph1n1 Vaccine Availability: The Complex Contracting Relationship Between Vaccine Manufacturers, Who, Donor And Beneficiary Governments, Sam Halabi

Sam Halabi

Vaccines are the most important line of defense to protect public health and the spread of disease during influenza pandemics. Yet the 2009 experience with pandemic H1N1 influenza showed that manufacturers, wealthy and poor governments were completely unprepared for the demands that global demand for vaccine production and distribution might impose. This chapter analyzes the failures of the system in 2009-10 with the aim of facilitating greater preparedness for future influenza pandemics.

Selling Hospice, Sam Halabi

Sam Halabi

Americans are increasingly turning to hospice services to provide them with medical care, pain management, and emotional support at the end of life. The increase in the rates of hospice utilization is explained by a number of factors including a “hospice movement” dating to the 1970s which emphasized hospice as a tool to promote dignity for the terminally ill; coverage of hospice services by Medicare beginning in 1983; and, the market for hospice services provision, sustained almost entirely by governmental reimbursement. On the one hand, the growing acceptance of hospice may be seen as a sign of trends giving substance …

Addressing Prescription Opioid Abuse Concerns In Context: Synchronizing Policy Solutions To Multiple Public Health Problems, Kelly Dineen

Kelly Dineen

No abstract provided.

Forfeiting Federalism: The Faustian Pact With Big Tobacco, Ryan Dreveskracht

Ryan Dreveskracht

This article discusses the effects of the largest legal settlement in United States history: the so-called Master Settlement Agreement, or “MSA.” Part I discusses the settlement generally, and its intended effect on the U.S. tobacco market. Parts II through IV discuss the unintended consequences of the settlement. Specifically, Part II considers how states got into their current disarray, and how a perceived state windfall of billions of dollars ended up putting states on what by all accounts now appears to be very real risk of insolvency. Part III examines how the major tobacco companies are using the states’ dire financial …

Workshop Democracy: Making Policy In Cote D'Ivoire, Max Levin

Max Levin

Development experts would benefit from a better understanding of how policy is made in developing countries. In this article, I describe how health policy is made in Cote d’Ivoire, from the perspective of a Westerner embedded in the Ministry of Health for 10 months. I provide a narrative of how one health system reform—performance-based financing—moved from policy idea to enacted reform. I describe the origins of the reform in Cote d’Ivoire, how the government came to support the reform, and then the mechanics of how the reform was enacted. I then present observations on how policymaking in Cote d’Ivoire differs …

The Problem With Value-Based Purchasing, Craig B. Garner

Craig B. Garner

From its inception on October 1, 2012, the Hospital Value-Based Purchasing (“VBP”) Program shifted Medicare’s paradigm to emphasize performance over costs in determining hospital reimbursement. Reducing the overall Medicare reimbursement to hospitals by an estimated $1.4 billion for Fiscal Year (“FY”) 2015, the VBP Program was quick to secure the attention of the nation’s health care providers. Technically “budget neutral,” the VBP Program will return this same $1.4 billion to hospitals the following year in the form of performance incentives. As the Federal Government waits to assess the accuracy of its prediction, the FY 2015 reduction of 1.50% will finally …

Just As Fragile As A Patient, Craig B. Garner

Craig B. Garner

The American hospital has evolved greatly over the past 100 years, from the almshouse once visited mainly by the desolate and poor as a last resort to that enigmatic, cutting edge institution which today forms the foundation of modern American health care. Advances in technology and medical science have transformed what were once terminal illnesses into minor health inconveniences, with the real battles against serious health threats typically occurring inside the four walls of a patient’s local hospital.

Medicare: The Perpetual Balance Between Performance And Preservation, Craig B. Garner

Craig B. Garner

Passed by Congress and signed by President Lyndon Johnson into law in 1965, Medicare has weathered storms from all directions, growing to be the preeminent standard for health insurance in the United States. The idea of losing Medicare as a vital public benefit still remains the single greatest fear with which each passing generation of Americans must contend, and yet, these challenges over the past fifty years, designed to fortify Medicare’s foundation and ensure its longevity, continue to take a toll on the program. The most recent climate of reform includes changes implemented by the Patient Protection and Affordable Care …

Transformations In Health Law Practice: The Interections Of Changes In Healthcare And Legal Workplaces, Louise G. Trubek, Barbara J. Zabawa, Paula Galowitz

Louise G Trubek

The passage and implementation of the Affordable Care Act is propelling transformations in health care. The transformations include integration of clinics and hospitals, value based care, patient centeredness, transparency, computerized business models and universal coverage. These shifts are influencing the practice of health law, a vibrant specialty field considered a “hot” area for new lawyers. The paper examines how the transformations in health care are intersecting with ongoing trends in law practice: increase in in-house positions, collaboration between medical and legal professionals, and the continued search for increased access to legal representation for ordinary people. Three health law workplace sites …

Resolution 10-08-2014, To Improve Automated External Defibrillator (Aed) Accessibility, Catherine L. Rucker

Catherine L Rucker

To amend California Health and Safety Code section 1797.196 to require that automatic external defibrillators (AED) units be stored in readily accessible and highly visible locations.

Consciousness And Futility: A Proposal For A Legal Redefinition Of Death, Christopher Smith

Christopher R Smith

Recent controversies in Texas (with the Marlise Muñoz case) and in California (with the Jahi McMath case) have highlighted a lamentable flaw in the current legal conception of human death, and the difficulty of defining when death finally occurs. The unworkable notion of “brain-death” remains the law in every state in the union, yet the philosophical and scientific foundations of this notion remain open to attack. This article posits that death is a fundamentally social construct, and that it is society at large (through its laws, public opinions, religious attitudes, etc.) that actually defines death. This essay then argues that …

Curb Your Enthusiasm For Pigouvian Taxes, Victor Fleischer

Victor Fleischer

Pigouvian (or "corrective") taxes have been proposed or enacted on dozens of products and activities that may be harmful in excess: carbon, gasoline, fat, sugar, guns, cigarettes, alcohol, traffic, zoning, executive pay, and financial transactions, among others. Academics of all political stripes are mystified by the public’s inability to see the merits of using Pigouvian taxes more frequently to address serious social harms.

This enthusiasm for Pigouvian taxes should be tempered. A Pigouvian tax is easy to design—as a uniform excise tax—if one assumes that each individual causes the same amount of harm with each incremental increase in activity on …