Health Law and Policy Commons^™

The Injustice Of Inclusion And Fair Opportunity: Exploiting Children In Medical Research For The Benefit Of An Unworthy Society, Ruqaiijah Yearby

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The history of pediatric medical research has been characterized as a history of child abuse. Usually, the debate regarding the use of children in medical research has centered on questions of Autonomy (informed consent) and Beneficence (the best interest of the child based on a benefit risk analysis). The debate has rarely focused on the question of which children should participate in medical research by discussing the legal principle of Justice (prohibits use of vulnerable populations for medical research who are already overly burdened for medical research unrelated to health issues affecting them and requires that populations who participate in …

What Patients With Disabilities Teach Us About The Everyday Ethics Of Health Care, Elizabeth Pendo

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In Healers: Extraordinary Clinicians at Work, by David Schenck and Dr. Larry Churchill, and in What PatientsTeach: The Everyday Ethics of Health Care, their follow-up with Joseph Fanning, the authors look at theeveryday experience of health care and the relationships that shape it. This article expands upon that inquiry by exploring the experiences and challenges of patients with disabilities and by exploring what patients withdisabilities can teach us about the everyday ethics of health care.

The authors of What Patients Teach provide a framework in which to focus on the everyday experience ofhealth care from the perspective of patients. This …

Out Of The Black Box And Into The Light: Using Section 1115 Medicaid Waivers To Implement The Affordable Care Act's Medicaid Expansion, Sidney D. Watson

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What price Medicaid expansion? The Supreme Court's decision in National Federation of Independent Business (NFIB) v. Sebelius,' sparked intense debate about how the Secretary of Health & Human Services (HHS) would respond to pressure from recalcitrant states. Policy experts and Sunday-moming pundits predicted that Red States would demand Section 1115 waivers of federal Medicaid rules as the quid pro quo for implementing the Affordable Care Act's (ACA) Medicaid expansion that covers adults with incomes up to 133% of the federal poverty level (FPL). They prophesized that the Obama Administration, desperate to move implementation forward, would have little leverage in its …

Ebola, Quarantine, And Flawed Cdc Policy, Robert Gatter

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The CDC’s Interim Guidance for Monitoring and Movements of Persons with Potential Ebola Virus Exposure is deeply flawed because it disregards the science of Ebola transmission. It recommends that officials quarantine individuals exposed to the virus but who do not have any symptoms of illness, ignoring the fact that only those with Ebola symptoms can communicate the virus to others. Consequently, any quarantine order based on the Guidelines is surely unconstitutional and illegal under most states’ public health statutes — as exemplified by the State of Maine’s failed petition to quarantine Nurse Kaci Hickox in October 2014. This article examines …

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

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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.

A Policy In Flux: New York State’S Evolving Approach To Human Subjects Research Involving Individuals Who Lack Consent Capacity (Forthcoming), Valerie Gutmann Koch

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No abstract provided.

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

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As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …

“Of Vital Importance”: The New York State Task Force On Life And The Law’S Report And Recommendations For Research With Human Subjects Who Lack Consent Capacity (With Susie A. Han), Valerie Gutmann Koch

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No abstract provided.

Medicaid, Marketplaces, And Premium Assistance: What Is At Stake In Arkansas? The Perils And Pitfalls Of Medicaid Expansion Through Marketplace Premium Assistance, Sidney D. Watson

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On September 27, 2013, Arkansas became the first state to obtain federal approval for a Section 1115 demonstration waiver to require adults eligible for the Affordable Care Act's (ACA) Medicaid Expansion to enroll in private plans offered through the State's new Health Insurance Marketplace rather than traditional Medicaid.² Hailed as a "game changer," Republican lawmakers dubbed this Marketplace Premium Assistance approach a new Medicaid "private option."' ³ Others described it as a potential "middle ground" in efforts to expand Medicaid that may be more politically palatable for those who oppose "Obamacare."...

When Is A Change Going To Come?: Separate And Unequal Treatment In Health Care Fifty Years After Title Vi Of The Civil Rights Act Of 1964, Ruqaiijah A. Yearby

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ON June 19, 1963, when the Civil Rights Act was first introduced, President John F. Kennedy said in a message to Congress:

Events of recent weeks have again underlined how deeply our Negro citizens resent the injustice of being arbitrarily denied equal access to those facilities and accommodations, which are otherwise open to the general public. That is a daily insult, which has no place in a country proud of its heritage-- the heritage of the melting pot, of equal rights, of one nation and one people. No one has been barred on account of his race from fighting or …

Response To "Pervasive Sequence Patents Cover The Entire Human Genome", Shine Tu, Christopher M. Holman, Adam Mossoff, Ted M. Sichelman, Michael Risch, Jorge L. Contreras, Yaniv Heled, Gregory Dolin, Lee Petherbridge

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In a widely reported article by Jeffrey Rosenfeld and Christopher Mason published in Genome Medicine, significant misstatements were made, because the authors did not sufficiently review the claims – which define the legal scope of a patent – in the patents they analyzed. Specifically, the authors do not provide an adequate basis for their assertion that 41% of the genes in the human genome have been claimed.

The Dangers Of Psychotropic Medication For Mentally Ill Children: Where Is The Child’S Voice In Consenting To Medication? An Empirical Study, Donald H. Stone

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When a child with a mental illness is being prescribed psychotropic medication. who decides whether the child should take the medication — the parent or the child? What if the child is sixteen years of age? What if the child is in foster care: Should the parent or social service agency decide? Prior to administering psychotropic medication, what specific information should be provided to the person authorized to consent on behalf of the child? Should children be permitted to refuse psychotropic medications? If so, at what age should a child he able to refuse such medication What procedures should be …

Exclusivity Without Patents: The New Frontier Of Fda Regulation For Genetic Materials, Gregory Dolin

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Over the last twenty years, the legal and scientific academic communities have been embroiled in a debate about the patent eligibility of genetic materials. The stakes for both sides could not be higher. On one hand are the potential multi-billion dollar profits on the fruits of research (from newly discovered genes), and on the other is scientists' ability to continue and expand research into the human genome to improve patients' access to affordable diagnostic and therapeutic modalities. This debate is currently pending before the Supreme Court, which is considering a petition for certiorari in Ass'n for Molecular Pathology v. U.S. …

Forgotten Fathers, Daniel L. Hatcher

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Poor fathers like John are largely forgotten, written off as a subset of the unworthy poor. These fathers struggle with poverty – often with near hopelessness – within multiple systems in which they are either entangled or overlooked, such as child-support and welfare programs, family courts, the criminal justice system, housing programs, and the healthcare, education, and foster-care systems. For these impoverished fathers, the “end of men” is often not simply a question for purposes of discussion but a fact that is all too real. In the instances in which poor fathers are not forgotten, they are targeted as causes …

Why Broccoli? Limiting Principles And Popular Constitutionalism In The Health Care Case, Mark D. Rosen, Christopher W. Schmidt

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Crucial to the Court’s disposition in the constitutional challenge to the Affordable Care Act (ACA) was a hypothetical mandate to purchase broccoli, which Congress never had considered and nobody thought would ever be enacted. For the five Justices who concluded the ACA exceeded Congress’s commerce power, a fatal flaw in the government’s case was its inability to offer an adequate explanation for why upholding that mandate would not entail also upholding a federal requirement that all citizens purchase broccoli. The minority insisted the broccoli mandate was distinguishable. This Article argues that the fact that all the Justices insisted on providing …

Unique Proposals For Limiting Legal Liability And Encouraging Adherence To Ventilator Allocation Guidelines In An Influenza Pandemic, Valerie Gutmann Koch

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No abstract provided.

Brief Of Amici Curiae Health Law & Policy Scholars And Prescription Policy Choices In Support Of Respondents On The Constitutional Validity Of The Medicaid Expansion, Kevin Outterson, Laura Hermer, Nicole Huberfeld, Elizabeth Weeks Leonard, Sara Rosenbaum, Sidney D. Watson

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The Medicaid expansion in Section 2001(a)(1)(C) of the Patient Protection and Affordable Care Act is one part of Congress’s comprehensive effort to expand access to health care coverage. This expansion is not revolutionary, but builds on many prior statutory amendments to Medicaid. Nor does it alter the voluntary nature of the Medicaid program – as before, States remain free to decline federal funding. The Petitioners and their amici have mischaracterized the expansion to obscure these facts, hoping this Court will unravel this hard-fought legislative enactment.

The question presented is whether Congress may offer States generous additional funding for Medicaid, with …

Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch

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Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions and the trial-and-error nature of drug prescription. However, pharmacogenomics may not be the panacea for all development and prescription problems. This article explores some of the obstacles to pharmacogenomic advancement including industry reluctance to pursue research because of potentially prohibitive costs associated with developing products and legal liability concerns. The implications pharmacogenomics has for drug research and development as well as various areas of law …

Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch

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The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling its direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and – highlighting the challenges associated with a new paradigm of “patient-driven” genomic research – focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article …

Racial Disparities In Accessing Health Care And Health Status, Ruqaiijah Yearby

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Point (Overview): Interpersonal and institutional racial biases are the principal reasons for racial disparities in accessing health care and disparities in African Americans’ health status, which can only be addressed by acknowledging and putting an end to interpersonal and institutional racial bias in the health care system that adversely affects the health status African-Americans.

Counterpoint (Overview): The irrational structure of health care, which is based on ability to pay, rather than need is the main cause of racial disparities in health, which will not be equalized until the structure of the health care system is fixed or when African Americans’ …

Regulators As Market-Makers: Accountable Care Organizations And Competition Policy, Thomas L. Greaney

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Of the many elements animating structural change under health reform, Accountable Care Organizations (ACOs) have drawn the greatest attention. The ACO strategy entails regulatory interventions that at once aim to reshape the health care delivery system, improve outcomes, promote adoption of evidence based medicine and supportive technology, and create a platform for controlling costs under payment system reform. Ambitious aims to be sure. Implementation, however, has proved a wrenching process. This article looks at the intersection of markets and regulation under the Affordable Care Act. Specifically, it analyzes regulatory interventions under the MSSP designed to foster commercial market competition. Assessing …

Breaking The Cycle Of “Unequal Treatment” With Health Care Reform: Acknowledging And Addressing The Continuation Of Racial Bias, Ruqaiijah A. Yearby

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Since the Civil War access to health care in the United States has been racially unequal. This racially unequal access to health care remains even after the passage of Title VI of the Civil Rights Act of 1964 (“Title VI”) and the election of an African-American President. Both of these events held the promise of equality, yet the promise has never been fulfilled. Now, many hail the passage of the Patient Protection and Affordable Health Care Act (“ACA”) as the biggest governmental step in equalizing access to health care because it has the potential to increase minority access to health …

Advancing Health Law & Social Justice In The Clinic, The Classroom And The Community, John J. Ammann

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Law school clinics are paramount to developing law school graduates who embrace their “special responsibility for the quality of justice,” as well as their role in ensuring equal access to justice for marginalized, impoverished and underserved members of society. This responsibility permeates every aspect of lawyering, especially the practice of health law. This article explores, first, how clinics and social justice fit into the practice of health law and into the training of future health law attorneys and policymakers. Second, it defines social justice in the context of health and, finally, it provides examples that demonstrate how we can, and …

Gender, Family, And Work, Marcia L. Mccormick

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The country has prohibited sex discrimination since the 1960’s, but society continues to view women and men differently because women give birth, breastfeed, and are traditional caregivers. This article takes a historical look at court decisions and legislative efforts to address equality where men and women are not similarly situated and also explores recent developments and current debates, such as caregiver discrimination, lactation rooms and breaks, and the Affordable Care Act’s contraceptive mandate. Despite the abundance of legislation and court decisions over the past forty years, much progress still needs to be made.

Pursuing High Performance In Rural Health Care, A. Clinton Mackinney, Keith J. Mueller, Andrew F. Coburn, Jennifer P. Lundblad, Timothy D. Mcbride, Sidney D. Watson

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In 2001, the Institute of Medicine (IOM) called for transformation of the United States health care system to make it safe, effective, patient-centered, timely, efficient, and equitable.1 The journey toward these six aims in public policy and the private sector is underway, but fundamental challenges detailed by the IOM remain. Patients are injured at alarming rates, wide variation in care exists across geographies, patients complain of insensitive and/or inaccessible health care providers, health care costs are nearly twice that in other developed countries, and nearly 50 million Americans lack health insurance. As a result, our health care is often fragmented, …

Shifting Public Health Priorities And The Global Effort To Prevent A Bird Flu Pandemic, Robert Gatter

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Global strategy to control highly pathogenic avian influenza (HPAI) has changed dramatically since 2003 when it was first reported that a confirmed bird flu jumped the species barrier to infect a human in Hong Kong. Evidence of this shift in priorities in the global fight against HPAI can be found most clearly in program funding trends. In late 2008 and into 2009, financial commitments from international donors for all HPAI programs dropped significantly. Meanwhile, within HPAI programs, funding shifted substantially away from animal biosecurity projects and into human response and preparedness work. This Article examines three reasons for this shift …

A Visual Guide To Nfib V. Sebelius, Colin Starger

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Though Chief Justice Roberts ultimately provided the fifth vote upholding the Affordable Care Act (ACA) under the Tax Power, his was also one of five votes finding the ACA exceeded Congress’ power under the Commerce Clause.

The doctrinal basis for Roberts’ Commerce Clause analysis was hotly contested. While Roberts argued that the ACA’s purported exercise of Commerce power “finds no support in our precedent,” Justice Ginsburg accused the Chief Justice of failing to “evaluat[e] the constitutionality of the minimum coverage provision in the manner established by our precedents.”

These diametrically opposed perspectives on “precedent” might prompt observers to ask whether …

Confine Is Fine: Have The Non-Dangerous Mentally Ill Lost Their Right To Liberty? An Empirical Study To Unravel The Psychiatrist’S Crystal Ball, Donald H. Stone

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This Article will examine the reverse trend in civil commitment laws in the wake of recent tragedies and discuss the effect of broader civil commitment standards on the care and treatment of the mentally ill. The 2007 Virginia Tech shooting, the 2011 shooting of Congresswoman Giffords, and the 2012 Aurora movie theatre shooting have spurred fierce debates about the dangerousness of mentally ill and serve as cautionary tale about what happens when warning signs go unnoticed and opportunities for early intervention missed. This piece will explore the misconception about the role medication and inpatient civil commitments should play in prevention …

Implementing Health Reform At The State Level: Access And Care For Vulnerable Populations, John V. Jacobi, Sidney D. Watson, Robert Restuccia

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The Affordable Care Act¹ (ACA) promises to improve access to coverage and care for two vulnerable groups: low-income persons who are excluded by a lack of resources and chronically ill and disabled people who are excluded by the dysfunction of our existing insurance and care delivery systems. ACA’s sprawling provisions raise a wealth of implementation challenges that are exacerbated by the compromises required to move reform through Congress. In particular, the compromise between regulatory/public program advocates and advocates for private, market-driven programs requires thoughtful regulatory coordination between public and private health systems.

The anticipated increase in coverage is roughly …

Racial Inequities In Mortality And Access To Health Care: The Untold Peril Of Rationing Health Care In The United States, Ruqaiijah A. Yearby

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On February 25, 2007, a 12-year-old African American boy named Deamonte Driver died of a toothache because he did not receive a routine $80 tooth extraction that may have saved him, which was covered by his insurer: Medicaid. Unable to afford $80 or find a dentist that took Medicaid, Deamonte wound up in the emergency room, underwent two brain surgeries, and was in the hospital for six weeks of treatment, which cost approximately $250,000. In the end, Deamonte still died from a brain infection caused by the spread of the bacteria from the abscess in his mouth.

While Deamonte did …