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Articles 1 - 30 of 3426

Full-Text Articles in Health Law and Policy

Humanizing Work Requirements For Safety Net Programs, Mary Leto Pareja Sep 2019

Humanizing Work Requirements For Safety Net Programs, Mary Leto Pareja

Faculty Scholarship

This Article explores the political and policy appeal of work requirements for public benefit programs and concludes that inclusion of such requirements can be a reasonable design choice, but not in their current form. This Article’s proposals attempt to humanize these highly controversial work requirements while acknowledging the equity concerns they are designed to address. Drawing on expansive definitions of “work” found in guidance published by the Centers for Medicare and Medicaid (“CMS”) and in various state waiver applications, this Article proposes that work requirements be approved for Medicaid (as well as other benefit programs) only if they encompass ...


Informed Consent Pediatrics, Nationwide Children's Hospital Aug 2019

Informed Consent Pediatrics, Nationwide Children's Hospital

Training Materials

Learning about the components of the Informed Consent process in the Pediatric Clinical Trial setting


Assisted Dying For Prison Populations - Lessons From And For Abroad.Pdf, Jocelyn Downie, Adelina Iftene, Megan Steeves Aug 2019

Assisted Dying For Prison Populations - Lessons From And For Abroad.Pdf, Jocelyn Downie, Adelina Iftene, Megan Steeves

Articles & Book Chapters

No abstract provided.


Designing Development Programs For Non-Traditional Antibacterial Agents, Kevin Outterson, John Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan Darrow Jul 2019

Designing Development Programs For Non-Traditional Antibacterial Agents, Kevin Outterson, John Rex, Holly Fernandez Lynch, I. Glen Cohen, Jonathan Darrow

Faculty Scholarship

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level ...


The Kids Are Not Alright: Leveraging Existing Health Law To Attack The Opioid Crisis Upstream, Yael Cannon Jul 2019

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 ...


The Two Most Important Questions For Ethical Public Health, John Coggon, Lawrence O. Gostin Jul 2019

The Two Most Important Questions For Ethical Public Health, John Coggon, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Public health ethics is a distinct and established field, and it is important that its approaches and rationales are understood widely in the public health community. Such understanding includes the capacity to identify and combine principled and practical concerns in public health. In this paper, we present a background to the ideas that motivate public health ethics as a field of research and practice, and rationalize these through a critical ethico-legal approach to analysis. Two essential points of inquiry are identified and formulated to allow philosophical and practical agendas regarding public health to be combined. These come through asking the ...


Moving Beyond Medical Debt, Brook E. Gotberg, Michael D. Sousa Jul 2019

Moving Beyond Medical Debt, Brook E. Gotberg, Michael D. Sousa

Faculty Publications

In recent years it has become clear that medical costs are imposing severe financial burdens on American families, sometimes to the point that bankruptcy becomes the only escape from crippling debt. When evaluating the well-established connection between outstanding medical debt and consumer bankruptcy, most existing empirical studies attempt to quantify the percentage of consumer bankruptcies that are "caused" by unmanageable medical indebtedness. This Article addresses what we believe to be a more significant line of empirical inquiry, namely, the connection between health insurance coverage and consumer bankruptcy as a more precise measurement of how national health insurance programs may or ...


Best Practices For Member Outreach And Engagement: How Effective Acos Build Understanding And Respect, Jessica Carpenter, Jocelyn Gordon Jun 2019

Best Practices For Member Outreach And Engagement: How Effective Acos Build Understanding And Respect, Jessica Carpenter, Jocelyn Gordon

Commonwealth Medicine Publications

Targeted strategies and sustained efforts at member outreach and engagement are helping Accountable Care Organizations (ACOs) and their Community Partners (CPs) achieve their shared goals for delivering patient-centered care. The most successful organizations focus on activities designed to create a stronger connection with their members, building trust and a better understanding of individuals’ characteristics and care needs. Positive results of these efforts include successful person-centered care planning, improved compliance with care plans and prescriptions, and implementation of recommended lifestyle changes — changes that help support independent living, reduce medical costs and complications, and drive improvements in member satisfaction.


The “Conscience” Rule: How Will It Affect Patients’ Access To Health Services?, Lawrence O. Gostin Jun 2019

The “Conscience” Rule: How Will It Affect Patients’ Access To Health Services?, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

On May 2, 2019, the US Department of Health and Human Services (HHS) and Office of Civil Rights (OCR) released a final rule that heightens the rights of hospitals and health workers to refuse to participate in patients’ medical care based on religious or moral grounds. The rule covers OCR’s authority to investigate and enforce violations of 25 federal “conscience protection” laws. Tied to the US Constitution’s spending power, the rule applies to state and local governments, as well as public and private health care professionals and entities if they receive federal funds such as Medicare or Medicaid ...


State Abortion Restrictions And The New Supreme Court: Women’S Access To Reproductive Health Services, Rebecca Reingold, Lawrence O. Gostin Jun 2019

State Abortion Restrictions And The New Supreme Court: Women’S Access To Reproductive Health Services, Rebecca Reingold, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The US Supreme Court’s landmark 1973 ruling in Roe v Wade established a privacy right to choose abortion. In 1992, Planned Parenthood of Southeastern Pennsylvania v Casey reaffirmed Roe with the Supreme Court calling reproductive decisions “the most intimate and personal choices a person may make…central to personal dignity.” Casey allows abortion regulations, but states cannot impose an “undue burden,” where the law’s “purpose or effect” places a substantial obstacle in a woman’s path in accessing an abortion previability.

State abortion restrictions—meaning laws that restrict whether, when, and under what circumstances a woman may obtain ...


University Of Massachusetts Medical School Report To Minnesota Department Of Human Services Health And Incarceration Project, Katharine London, Jeremy Tourish Jun 2019

University Of Massachusetts Medical School Report To Minnesota Department Of Human Services Health And Incarceration Project, Katharine London, Jeremy Tourish

Commonwealth Medicine Publications

On behalf of the Minnesota Department of Health Services, Health Law & Policy experts from our Public and Private Health Solutions group completed a literature review of successful efforts to improve the health of previously incarcerated individuals. In addition, our experts conducted five focus groups to obtain recommendations from experienced professionals who work directly with previously incarcerated individuals regarding interventions likely to improve the health of this unique population.

This study came about at the direction of Minnesota Legislature. They were interested in developing a methodology for paying higher rates to health care providers who provide services to high cost and ...


The Public Charge Rule As Public Health Policy, Medha D. Makhlouf Jun 2019

The Public Charge Rule As Public Health Policy, Medha D. Makhlouf

Faculty Scholarly Works

A recent Gallup poll found that health care, the economy, and immigration are the top three most important political issues for U.S. voters. Public charge policy—which relates to the admission of noncitizens based on the likelihood that they will not become dependent on the U.S. government for support—lies at the intersection of these three topics. At the same time, immigration and welfare reform are prominent agenda items for the current administration. On October 10, 2018, the Department of Homeland Security (DHS) released a Notice of Proposed Rulemaking that would transform public charge policy that has existed ...


The Lancet Commission On Global Health Law: The Transformative Power Of Law To Advance The Right To Health, Lawrence O. Gostin Jun 2019

The Lancet Commission On Global Health Law: The Transformative Power Of Law To Advance The Right To Health, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

A new report by The Lancet-O’Neill-Georgetown University Commission on Global Health and the Law shows how law can fulfill the global pledge of the human right to health, while “leaving no one behind.” I call this “global health with justice.” We need both health and justice. By global health, I mean ever increasing indicators of good health and increased longevity in all countries around the world. By justice I mean that the global “good” of health must be fairly distributed both within and among countries. The Lancet Commission report offers a comprehensive roadmap towards realizing the law’s power ...


Legal Remedies To Address Stigma-Based Health Inequalities In The United States: Opportunities And Challenges, Valarie Blake, Mark L. Hatzenbuehler Jun 2019

Legal Remedies To Address Stigma-Based Health Inequalities In The United States: Opportunities And Challenges, Valarie Blake, Mark L. Hatzenbuehler

Faculty Scholarship

Stigma is an established driver of population-level health outcomes. Antidiscrimination laws can generate or alleviate stigma and, thus, are a critical component in the study of improving population health.


Currently, antidiscrimination laws are often underenforced and are sometimes conceptualized by courts and lawmakers in ways that are too narrow to fully reach all forms of stigma and all individuals who are stigmatized.


To remedy these limitations, we propose the creation of a new population-level surveillance system of antidiscrimination law and its enforcement, a central body to enforce antidiscrimination laws, as well as a collaborative research initiative to enhance the study ...


Health Care's Market Bureaucracy, Allison K. Hoffman May 2019

Health Care's Market Bureaucracy, Allison K. Hoffman

Faculty Scholarship at Penn Law

The last several decades of health law and policy have been built on a foundation of economic theory. This theory supported the proliferation of market-based policies that promised maximum efficiency and minimal bureaucracy. Neither of these promises has been realized. A mounting body of empirical research discussed in this Article makes clear that leading market-based policies are not efficient — they fail to capture what people want. Even more, this Article describes how the struggle to bolster these policies — through constant regulatory, technocratic tinkering that aims to improve the market and the decision-making of consumers in it — has produced a massive ...


Who Takes Action To Promote The Health Of Refugees And Migrants, Lawrence O. Gostin, Ibrahim Abubakar, Ranieri Guerra, Sabina F. Rashid, Eric A. Friedman, Zsuzsanna Jakab May 2019

Who Takes Action To Promote The Health Of Refugees And Migrants, Lawrence O. Gostin, Ibrahim Abubakar, Ranieri Guerra, Sabina F. Rashid, Eric A. Friedman, Zsuzsanna Jakab

Georgetown Law Faculty Publications and Other Works

Migration is a defining issue of our time, with 1 billion migrants globally, of whom 258 million have crossed borders. Climate change and political instability propel ever-greater displacement, with major detriments to health. Policies that fail to prevent human trafficking or guarantee essential services undermine Universal Health Coverage (UHC) and the global pledge to “leave no one behind.” The World Health Assembly should robustly implement WHO’s Global Action Plan (GAP) on the Health of Refugees and Migrants.ugees and Migrants.


What A Long Strange Trip It’S Been For The 3.8% Net Investment Income Tax, Ausher M.B. Kofsky, Bryan P. Schmutz May 2019

What A Long Strange Trip It’S Been For The 3.8% Net Investment Income Tax, Ausher M.B. Kofsky, Bryan P. Schmutz

Maryland Law Review Online

No abstract provided.


The Legal Determinants Of Health: Harnessing The Power Of Law For Global Health And Sustainable Development, Lawrence O. Gostin, John T. Monahan, Jenny Kaldor, Mary Debartolo, Eric A. Friedman, Katie Gottschalk, Susan C. Kim, Ala Alwan, Agnes Binagwaho, Gian Luca Burci, Luisa Cabal, Katherine Deland, Timothy Grant Evans, Eric Goosby, Sara Hossain, Howard Koh, Gorik Ooms, Mirta Roses Periago, Rodrigo Uprimny, Alicia E. Yamin May 2019

The Legal Determinants Of Health: Harnessing The Power Of Law For Global Health And Sustainable Development, Lawrence O. Gostin, John T. Monahan, Jenny Kaldor, Mary Debartolo, Eric A. Friedman, Katie Gottschalk, Susan C. Kim, Ala Alwan, Agnes Binagwaho, Gian Luca Burci, Luisa Cabal, Katherine Deland, Timothy Grant Evans, Eric Goosby, Sara Hossain, Howard Koh, Gorik Ooms, Mirta Roses Periago, Rodrigo Uprimny, Alicia E. Yamin

Georgetown Law Faculty Publications and Other Works

Health risks in the 21st century are beyond the control of any country. In an era of globalization, promoting public health and equity requires cooperation and coordination both within and among states. Law can be a powerful tool for advancing global health, yet it remains significantly underutilised and poorly understood. Working in partnership, public health lawyers and health professionals can become champions for evidence-based laws to ensure the public’s health and safety.

The O'Neill Institute/Georgetown University Lancet Commission on Law and Global Health articulates the vital role of law – through legal instruments, legal capacities, and institutional reforms ...


Infants Exposed To Homelessness: Health, Health Care Use, And Health Spending From Birth To Age Six, Robin E. Clark, Linda Weinreb, Julie M. Flahive, Robert W. Seifert May 2019

Infants Exposed To Homelessness: Health, Health Care Use, And Health Spending From Birth To Age Six, Robin E. Clark, Linda Weinreb, Julie M. Flahive, Robert W. Seifert

Commonwealth Medicine Publications

Homeless infants are known to have poor birth outcomes, but the longitudinal impact of homelessness on health, health care use, and health spending during the early years of life has received little attention. Linking Massachusetts emergency shelter enrollment records for the period 2008-15 with Medicaid claims, we compared 5,762 infants who experienced a homeless episode with a group of 5,553 infants matched on sex, race/ethnicity, location, and birth month. Infants born during a period of unstable housing resulting in homelessness had higher rates of low birthweight, respiratory problems, fever, and other common conditions; longer neonatal intensive care ...


“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin May 2019

“Big” Food, Tobacco, And Alcohol: Reducing Industry Influence On Noncommunicable Disease Prevention Laws And Policies, Belinda Reeve, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

The food, tobacco and alcohol industries have penetrated markets in low- and middle-income countries (LMICs), with a significant impact on these countries’ burden of noncommunicable diseases (NCDs). Tangcharoensathien and colleagues describe the aggressive marketing of unhealthy food, alcohol and tobacco in LMICs, as well as key tactics used by these industries to resist laws and policies designed to reduce behavioural risk factors for NCDs. This commentary expands on the recommendations made by Tangcharoensathien and colleagues for preventing or managing conflicts of interest and reducing undue industry influence on NCD prevention policies and laws, focusing on the needs of LMICs. A ...


Will Ending Certain Drug Rebates Lower List Prices And Patient Out-Of-Pocket Costs?, Mckenzie Taylor, Stephanie Tran Apr 2019

Will Ending Certain Drug Rebates Lower List Prices And Patient Out-Of-Pocket Costs?, Mckenzie Taylor, Stephanie Tran

Commonwealth Medicine Publications

Earlier this year, the Department of Health and Human Services (HHS) proposed changes to the current pricing and contracting system for federal health care programs, Medicare Part D and Medicaid.This proposal aligns with the Trump Administration’s blueprint for lowering drug prices which we have written about previously.


Data Re-Use And The Problem Of Group Identity, Leslie Francis, John G. Francis Apr 2019

Data Re-Use And The Problem Of Group Identity, Leslie Francis, John G. Francis

Utah Law Faculty Scholarship

Reusing existing data sets of health information for public health or medical research has much to recommend it. Much data repurposing in medical or public health research or practice involves information that has been stripped of individual identifiers but some does not. In some cases, there may have been consent to the reuse but in other cases consent may be absent and people may be entirely unaware of how the data about them are being used. Data sets are also being combined and may contain information with very different sources, consent histories, and individual identifiers. Much of the ethical and ...


Law & Health Care Newsletter, Spring 2019 Apr 2019

Law & Health Care Newsletter, Spring 2019

Law & Health Care Newsletter

No abstract provided.


Deputizing Family: Loved Ones As A Regulatory Tool In The "Drug War" And Beyond, Matthew J.B. Lawrence Apr 2019

Deputizing Family: Loved Ones As A Regulatory Tool In The "Drug War" And Beyond, Matthew J.B. Lawrence

Faculty Scholarly Works

Many laws use family members as a regulatory tool to influence the decisions or behavior of their loved ones, i.e., they deputize family. Involuntary treatment laws for substance use disorder are a clear example; such laws empower family members to use information shared by their loved ones to petition to force their loved ones into treatment without consent. Whether such deputization is helpful or harmful for a patient’s health is a crucial and dubious question discussed in existing literature, but use of family members as a regulatory tool implicates important considerations beyond direct medical impacts that have not ...


The Expanding Role Of Pharmacists: A Positive Shift For Health Care, Ashley Chiara Mar 2019

The Expanding Role Of Pharmacists: A Positive Shift For Health Care, Ashley Chiara

Commonwealth Medicine Publications

When reflecting upon the impactful members of a patient’s healthcare team, much consideration is given to the patient’s nurses, primary care physician and specialists. However, with nearly nine in 10 Americans living within five miles of a community pharmacy, and four in five receiving prescription benefits through a pharmacy benefit manager (PBM), the role of the pharmacist in orchestrating a patient’s care on the front lines is often overlooked.


Supervised Injection Facilities: Legal And Policy Reforms, Lawrence O. Gostin, James G. Hodge, Chelsea L. Gulinson Feb 2019

Supervised Injection Facilities: Legal And Policy Reforms, Lawrence O. Gostin, James G. Hodge, Chelsea L. Gulinson

Georgetown Law Faculty Publications and Other Works

The US Centers for Disease Control and Prevention reported that more than 70 000 deaths from drug overdoses occurred in 2017, including prescription and illicit opioids, representing a 6-fold increase since 1999. Innovative harm-reduction solutions are imperative. Supervised injection facilities (SIFs) create safe places for drug injection, including overdose prevention, counseling, and treatment referral services. Supervised injection facilities neither provide illicit drugs nor do their personnel inject users. Supervised injection facilities are effective in reducing drug-related mortality, morbidity, and needle-borne infections. Yet their lawfulness remains uncertain. The Department of Justice (DOJ) recently threatened criminal prosecution for SIF operators, medical personnel ...


Payment Reform For Kids, Robert W. Seifert Feb 2019

Payment Reform For Kids, Robert W. Seifert

Commonwealth Medicine Publications

Comprehensive care for children – including greater attention to behavioral health, socio-emotional development, and strong family relationships – may hold the key to lifelong health and well-being. With this premise, a group in Connecticut has just published recommendations for improving pediatric primary care through payment reform.


Fighting Novel Diseases Amidst Humanitarian Crises, Lawrence O. Gostin, Neil R. Sircar, Eric A. Friedman Feb 2019

Fighting Novel Diseases Amidst Humanitarian Crises, Lawrence O. Gostin, Neil R. Sircar, Eric A. Friedman

Georgetown Law Faculty Publications and Other Works

Humanitarian crises are becoming more prevalent and, frequently, more complex, in zones of mis-governance, lack of government presence, and even active conflict, marked by public mistrust and insecurity. The WHO and other health emergency responders lack the capacities and mandate to adequately respond. The current Ebola outbreak in an area of an active insurgency in the Democratic Republic of the Congo is just such a crisis. The State Department has banned U.S. personnel from the outbreak zone due to safety concerns, leaving the population feeling abandoned, potentially increasing the threat to the few brave health workers who remain.

We ...


Lowering Out Of Pocket Drug Costs For Consumers, Mylissa K. Price Jan 2019

Lowering Out Of Pocket Drug Costs For Consumers, Mylissa K. Price

Commonwealth Medicine Publications

Prohibiting gag clauses could help lower consumer out-of-pocket pharmacy costs - if Pharmacy Benefits Managers don't raise prices to make-up the difference. Mylissa Price closes our blog series on President Trump's Blueprint to Lower Drug Costs in this final entry.


Living, Aging, And Dying In Healthy And Just Societies: Life Lessons From My Father, Lawrence O. Gostin Jan 2019

Living, Aging, And Dying In Healthy And Just Societies: Life Lessons From My Father, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

My father passed away at 102 years old. He lived, aged, and died well. But that is rare in the United States and globally. The World Health Organization defines palliative care “throughout the life course” as improving quality of life for patients and families and relieving pain and suffering, while paying special attention to physical, psychosocial, and spiritual functioning. That’s the global vision, but then there’s the reality. Palliative care, in practice, has been little more than pain relief at life’s end—and in much of the world, not even that.

We need to reimagine palliation, embracing ...