Health Law and Policy Commons^™

Pharmacy-Based Travel Health Services In The United States, Keri Hurley-Kim, Jeffery Goad, Sheila Seed, Karl M. Hess

Pharmacy Faculty Articles and Research

The aim of this paper is to review pharmacy laws and regulations, pharmacist training, clinic considerations, and patient care outcomes regarding pharmacy-based travel health services in the United States. Pharmacists and pharmacies in the United States are highly visible and accessible to the public, and have long been regarded as a source for immunization services. As international travel continues to increase and grow in popularity in this country, there is a pressing need for expanded access to preventative health services, including routine and travel vaccinations, as well as medications for prophylaxis or self-treatment of conditions that may be acquired overseas. …

Multiple Sclerosis Drugs Have Been Getting A Lot More Expensive, Ben Jay

Capstones

Multiple Sclerosis is a very expensive disease. According to a 2016 study in the American Journal of Managed Care, treating it can cost patients anywhere from $30,000 to $100,000 per year, which can meet or even exceed the average US household median income, depending on how severe your case is. For a disease that has no known cure, and requires frequent medical attention to manage symptoms that can completely debilitate a person if left untreated, that can mean spending $4.1 million over the course of a lifetime, according to the same study. However, in the last 20 years, that …

Super Unleaded Malbec? A Case Study In Flawed International Standard Setting At The Codex Alimentarius, Justin Schwegel

Journal of Food Law & Policy

The World Trade Organization’s (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) provides rules on the adoption and enforcement of SPS measures. It also presumes that food safety regulations adopted by WTO Members that conform to relevant international standards are consistent with the SPS Agreement. The relevant international standard setting body for food safety is the Codex Alimentarius Commission, which conducts most of its food safety risk management work through subsidiary bodies such as the Codex Committee on Contaminants in Food (CCCF). CCCF establishes maximum limits for food contaminants and codes of practice for reducing food …

Ethical Cannabis Lawyering In California, Francis J. Mootz Iii

St. Mary's Journal on Legal Malpractice & Ethics

Cannabis has a long history in the United States. Originally, doctors and pharmacists used cannabis for a variety of purposes. After the Mexican Revolution led to widespread migration from Mexico to the United States, many Americans responded by associating this influx of foreigners with the use of cannabis, and thereby racializing and stigmatizing the drug. After the collapse of prohibition, the federal government repurposed its enormous enforcement bureaucracy to address the perceived problem of cannabis, despite the opposition of the American Medical Association to this new prohibition. Ultimately, both the states and the federal government classified cannabis as a dangerous …

Using The Engagedmd Multimedia Platform To Improve Informed Consent For Ovulation Induction, Intrauterine Insemination, And In Vitro Fertilization, Jody L. Madeira, Jennifer Rehbein, Mindy S. Christianson, Miryoung Lee, J. Preston Parry, Guido Pennings, Steven R. Lindheim Md

Articles by Maurer Faculty

Objective: To study patient and provider feedback on how a multimedia platform (EngagedMD) helps patients to understand the risks and consequences of in vitro fertilization (IVF), ovulation induction (OI), and intrauterine insemination (IUI) treatments and the impact of the informed consent process.

Design: Prospective survey study.

Setting: IVF units in the United States.

Patient(s): Six-thousand three-hundred and thirty-three patients who viewed the multimedia platform before IVF or OI-IUI treatment at 13 U.S. IVF centers and 128 providers.

Intervention(s): Quantitative survey with 17 questions.

Main Outcome Measure(s): Assessment of the impact of a multimedia platform on patient anxiety, comprehension, and satisfaction …

Legal Principles And Seminal Legal Cases In Oocyte Donation, Jody L. Madeira, Susan L. Crockin

Articles by Maurer Faculty

Oocyte donation has played an increasingly important role in assisted reproductive technologies since the early 1980s. Over the past 30 years, unique legal standards have evolved to address issues in the oocyte donation procedure itself as well as the disputes over issues, such as parentage, that inevitably arise with new technologies, particularly for individuals seeking to build nontraditional families. This essay will explore oocyte donation's legal aspects as well as seminal law concerning the procedure, including statutory law (uniform and model provisions and enacted state laws) and selected judicial opinions concerning surrogacy and parentage, testing of oocyte donors, mix-ups of …

Practice-Based Research Networks Ceding To A Single Institutional Review Board, Jeanette M. Daly, Tabria Weiner Harrod, Kate Judge, Leann C. Michaels, Barcey T. Levy, David L. Hahn, Lyle J. Fagnan, Donald E. Nease Jr.

Journal of Patient-Centered Research and Reviews

Historically, a single research project involving numerous practice-based research networks (PBRNs) required multiple institutional review boards (IRBs) to be involved in approval of the project. However, to avoid redundancies, federal IRB regulations now allow cooperative research projects that involve more than one institution to use reasonable methods of cooperative IRB review and to cede authority for review and oversight of the project to a single lead IRB. Through ceding, a lead IRB has the authority for review and oversight of the project delegated by all participating sites’ IRBs and becomes the IRB of record for the ceded sites. In the …

Patient Safety And The Ageing Physician: A Qualitative Study Of Key Stakeholder Attitudes And Experiences, Andrew A. White, William M. Sage, Paulina H. Osinska, Monica J. Salgaonkar, Thomas H. Gallagher

Faculty Scholarship

Background Unprecedented numbers of physicians are practicing past age 65. Unlike other safety-conscious industries, such as aviation, medicine lacks robust systems to ensure late-career physician (LCP) competence while promoting career longevity.

Objective To describe the attitudes of key stakeholders about the oversight of LCPs and principles that might shape policy development.

Design Thematic content analysis of interviews and focus groups.

Participants 40 representatives of stakeholder groups including state medical board leaders, institutional chief medical officers, senior physicians (>65 years old), patient advocates (patients or family members in advocacy roles), nurses and junior physicians. Participants represented a balanced sample from …

Identifying The Newly Insurable Medicaid Coverage Gap Population Under The Affordable Care Act: Who They Are And Where They Live, Samuel L. Woodruff

Capstone Experience: Master of Public Health

The goal of this Capstone Project is to better define and geographically locate the potential distribution of individuals who fall within the current Medicaid Coverage Gap and those populations who would be eligible for Medicaid under the expansion of Medicaid within the state of Nebraska. Using data from multiple United States Census Bureau sources, along with available data from the Health Resources and Services Administration (HRSA), this project looks to also locate populations of these individuals that may live within established Medically Underserved Areas (MUA's) or Health Professional Shortage Areas (HPSA's) within the state. American Community Survey 5-year Public Use …

Attitudes Toward Contraception Among Fourth Wave College-Aged Women, Caroline L. Lewis

Student Publications

This research examines how college-aged women today view contraception in comparison to the ways it has been viewed by previous generations of women, as well as what they view the future of contraception in the United States to look like. This has been done through a lens of political action and advocacy, which has defined the fight for access to contraception and reproductive justice throughout history. In light of the recent threats on contraception and the corresponding responsive social movements, such as the Women’s March, women in the United States are shifting their views on the matter, but what actions …

Adoption Process For The Model Aquatic Health Code: An Example, William D. Ramos, Allison L. Fletcher, Mike Mettler, Marcus A. Yoder

International Journal of Aquatic Research and Education

In 2014 the U.S. Centers for Disease Control and Prevention (CDC) published the first edition of the Model Aquatic Health Code (MAHC). This document represented the inaugural introduction of a federal policy guideline with a direct focus in the area of aquatic venue operation and maintenance with the sole purpose of improving the nature of public health in the field. The Indiana State Department of Health (ISDH) began the review and adoption process soon after the policy’s release. The ISDH process is proposed as one method for others to consider. The background and history of the MAHC are presented in …

Zika, Pregnancy, And The Law, Sam F. Halabi

Arkansas Law Review

The public health emergency surrounding the spread of the Zika virus has resurrected and brought into sharp relief some of the most vexing questions surrounding the relationship between pregnancy and law: the appropriate circumstances, if any, in which fetal tissue research is permissible; when and how the government may sponsor statements intended to influence reproductive decisions; and how to balance the health and rights of both women and their unborn children when health threats target both.

Regulation Of Radioactive Fracking Waste, Elizabeth Ann Glass Geltman, Nichole Leclair

Publications and Research

Natural gas extracted form shale reached record production totals in 2015 in the United States and the US Energy Information Administration (EIA) forecasts natural gas production will continue to increase. Wastes from shale gas extraction can contain the radioactive isotopes radium-226 (Ra-226) and radium-228 (Ra-228), which decay further into radon (Rn). Exposure to radon, a form of naturally occurring radioactive materials (NORM), is the leading cause of lung cancer in the United States, after smoking. This article explores how states handle the disposal of technologically enhanced naturally occurring radioactive materials (TENORM) and/or NORM waste from oil and gas operations to …

Implementing A Public Health Perspective In Fda Drug Regulation, Patricia J. Zettler, Margaret Foster Riley, Aaron S. Kesselheim

Faculty Publications By Year

There is, without question, a public health crisis in the United States arising from both illicit and prescription opioid misuse, addiction, and overdose. The Food and Drug Administration (FDA) is one regulator with an important role to play in minimizing the harms associated with prescription opioids, while also ensuring that prescription opioids are available for the evidence-based management of pain. One question, however, is to what extent the agency can consider in its decisions to approve opioids and keep existing ones on the market the provider and patient behaviors contributing to the epidemic. This is, in part, because FDA’s approval …

The Morality Of Compulsory Licensing As An Access To Medicines Tool, Margo A. Bagley

Faculty Articles

This Article contemplates the validity of theft rhetoric in relation to the right of countries to grant compulsory licenses from an unconventional perspective; that of biblical teachings on what it means to steal.

Part I describes the use of theft rhetoric in relation to IP infringement broadly and drug-patent compulsory licenses in particular.

Part II challenges the contention, suggested by theft rhetoric, that compulsory licenses are morally wrong as a form of stealing, by considering the meaning of theft in the context of its Judeo-Christian origins.

Part III considers the cogency of the accusation that the issuance of compulsory licenses …

The U.S. Science And Technology “Triple Threat”: A Regulatory Treatment Plan For The Nation’S Addiction To Prescription Opioids, Michael J. Malinowski

Journal Articles

No abstract provided.

Aligning Opioid Prescribing Pathways, Andrea Lai, Outpatient Pharmacy, Haley Pelletier, Suneela Nayak, Stephen Tyzik, Ruth Hanselman

MaineHealth Maine Medical Center

There is a drug epidemic sweeping the State of Maine and it continues to worsen each passing year. In 2017, the Maine legislature passed Public Law Chapter 488 to strengthen the controlled substance prescription monitoring program. An outpatient pharmacy, located in a large acute care hospital, created a performance improvement project to clarify opioid prescription and resolve any non-compliance with Chapter 488.

After a root cause analysis, several KPIs were established to include tracking the number of phone calls made by pharmacists to non-compliant providers to clarify scripts, provide one on one education and ultimately resolve non-compliance. Repeat offenders were …

The Fight Against Breast Cancer: A Policy And Programmatic Approach, Nandi Robinson

Master's Projects and Capstones

Abstract

Breast cancer continues to remain a significant health issue for women. Previously thought to only occur among postmenopausal women, breast cancer has impacted women of different ages; and rates of breast cancer have various impacts among different ethnic groups. For women living in a toxic environment, many of them have become the new wave of breast cancer cases. Screening and detection have succeeded in decreasing mortality rates. However, more research is needed in finding an efficient method of treatment. In the effort to assist in the fight against breast cancer through a policy and programmatic angle, I am fulfilling …

Pharmaceutical Federalism, Patricia J. Zettler

Faculty Publications By Year

There is growing interest in states regulating pharmaceuticals in ways that challenge the U.S. Food and Drug Administration’s (FDA) federal oversight. For example, in 2013 Maine enacted a law to permit the importation of unapproved drugs, reflecting concerns that federal requirements are too restrictive, while in 2014 Massachusetts banned an FDA-approved painkiller, reflecting concerns that federal requirements are too lax. This Article provides an account of this recent state interest in regulating drugs and considers its consequences. It argues that these state regulatory efforts, and the nascent litigation about them, demonstrate that the preemptive reach of the FDA’s authority extends …

Supporting Mothers With Mental Illness: Postpartum Mental Health Service Linkage As A Matter Of Public Health And Child Welfare Policy, Jesse Krohn, Msed, Jd, Meredith Matone, Drph, Mhs

Journal of Law and Health

Through our work in youth advocacy as, respectively, legal and public health professionals, we are all too aware of the high levels of health care fragmentation experienced during pregnancy and postpartum by poor, young mothers of color. Meredith Matone’s research highlights the heightened risk of fragmentation for girls with histories of child welfare involvement. For example, she found that 66.7% of young mothers who had resided in out-of-home placements and who had taken antipsychotic medication prior to becoming pregnant failed to fill prescriptions for antipsychotics in their first postpartum year. Put another way, two-thirds of these vulnerable young mothers—a far …

Legal Mapping Analysis Of State Telehealth Reimbursement Policies, Kate E. Trout, Sankeerth Rampa, Fernando A. Wilson, Jim P. Stimpson

Publications and Research

Background: There exists rapid growth and inconsistency in the telehealth policy environment, which makes it difficult to quantitatively evaluate the impact of telehealth reimbursement and other policies without the availability of a legal mapping database. Introduction: We describe the creation of a legal mapping database of state-level policies related to telehealth reimbursement of healthcare services. Trends and characteristics of these policies are presented.

Materials and Methods: Information provided by the Center for Connected Health Policy was used to identify state-wide laws and regulations regarding telehealth reimbursement. Other information was retrieved using: (1) LexisNexis database, (2) Westlaw database, and (3) retrieval …

Rape Crisis Center Professionals' Perception Of Sexual Violence Policy: A Qualitative Analysis, Stephanie Manieri

Scholarly and Creative Works Conference (2015 - 2021)

The purpose of this study is to collect information about the perceptions of rape crisis center professionals regarding the current policies surrounding sexual violence crimes that victimize people over the age of 18. This research aims to gather information about effective and ineffective policies from professionals who are first- responders to sexual assaults.

Projected Financial Losses Experienced By Community Health Centers Under A Scenario Of Major Cuts In Key Sources Of Federal Funding: 2018-2022, Avi Dor, Eric Luo, Ali Moghtaderi, Anne Rossier Markus

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

Congress is currently considering options to significantly reduce federal funding for the Medicaid expansion and the Marketplace subsidies implemented under the Affordable Care Act (ACA). Separately, the Health Centers Fund, which currently accounts for 70% of all federal health center grant funding, is set to expire in September 2017. These potential changes in federal funding could have a dramatic impact on health centers and the communities they serve. The purpose of this brief is to simulate the potential combined impact of these major changes in federal funding that will directly affect community health centers. Secondarily, this brief also assesses the …

How Could Repealing Key Provisions Of The Affordable Care Act Affect Community Health Centers And Their Patients?, Sara J. Rosenbaum, Jessica Sharac, Thao-Chi Tran, Anne Rossier Markus, David Reynolds, Peter Shin

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

Analyses of repeal of the Affordable Care Act (ACA) have tended to focus on coverage. This study, which gauges the potential effects of repealing certain ACA provisions, looks at the question of primary health care access itself, with a focus on medically underserved communities. A survey developed and fielded in early 2017 asked community health centers to estimate the impact of ending the Health Centers Fund established under the ACA as well as ending expanded Medicaid coverage and subsidies designed to make private insurance affordable for lower income patients. Forty-one percent of health centers responded; 69 percent were located in …

The Economic And Employment Consequences Of Repealing Federal Health Reform: A 50 State Analysis, Leighton Ku, Erika Steinmetz, Erin Brantley, Brian K. Bruen

Health Policy and Management Issue Briefs

Donald Trump and Congressional leaders have stated their intent to repeal the Patient Protection and Affordable Care Act (ACA or Obamacare). This report examines the consequences of repealing two key elements: (1) federal premium tax credits that help low and middle income Americans afford insurance policies bought through the Health Insurance Marketplaces (exchanges) and (2) federal payments to states for expansions of Medicaid eligibility for low-income adults. Congress passed similar legislation (H.R. 3762) in late 2015, which President Obama vetoed.

This report analyzes how the repeal of these policies could affect state-level employment, economies and fiscal conditions. If tax credits …

Health Reform Repeal Could Cause 3 Million People To Lose Jobs And Trigger Broad Economic Disruption, Leighton Ku, Erika Steinmetz, Erin Brantley, Brian K. Bruen

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

Issue: The incoming Trump administration and Republicans in Congress are seeking to repeal the Affordable Care Act (ACA), likely beginning with the law’s insurance premium tax credits and expansion of Medicaid eligibility. Research shows that the loss of these two provisions would lead to a doubling of the number of uninsured, higher uncompensated care costs for providers, and higher taxes for low-income Americans.

Goal: To determine the state-by-state effect of repeal on employment and economic activity.

Methods: A multistate economic forecasting model (PI+ from Regional Economic Models, Inc.) was used to quantify for each state the effects of the federal …

Community Health Centers: Recent Growth And The Role Of The Aca, Sara Rosenbaum, Julia Paradise, Anne Rossier Markus, Jessica Sharac, Chi Tran, David Reynolds, Peter Shin

Geiger Gibson/RCHN Community Health Foundation Research Collaborative

Community health centers are the nation’s largest source of comprehensive primary care for medically underserved communities and populations. Under the Affordable Care Act (ACA), increased patient revenues due to the expansion of Medicaid and private health insurance, along with substantially increased direct federal investment in the program, have led to growth in the number of health centers and their capacity to provide services. This brief draws on 2015 federal data on health centers and our 2016 Survey of Health Centers’ Experiences and Activities under the Affordable Care Act to provide a snapshot of health centers and their patients, analyze recent …

Law-Based Arguments And Messages To Advocate For Later School Start Time Policies In The United States, Clark J. Lee, Dennis M. Nolan, Steven W. Lockley, Brent Pattison

Homeland Security Publications

The increasing scientific evidence that early school start times are harmful to the health and safety of teenagers has generated much recent debate about changing school start times policies for adolescent students. Although efforts to promote and implement such changes have proliferated in the United States in recent years, they have rarely been supported by law-based arguments and messages that leverage the existing legal infrastructure regulating public education and child welfare in the United States. Furthermore, the legal bases to support or resist such changes have not been explored in detail to date. This article provides an overview of how …

How Understanding And Application Of Drug-Related Legal Instruments Affects Harm Reduction Interventions In Cambodia: A Qualitative Study, Sovannary Tuot, Chanrith Ngin, Khuondyla Pal, Sochenda Sou, Ghazal Sawez, Phylicia Morgan, Siyan Yi

Background: Harm reduction interventions in Cambodia face numerous obstacles because of conflicting understanding and interests and inconsistencies in the implementation by law enforcement officials. This study aims to examine how understanding and application of Drug Control Law (DCL) and Village/Commune Safety Policy (VCSP) affects harm reduction interventions in Cambodia from the standpoints of law enforcement officials, people who inject drugs and people who use drugs (PWID/PWUD), as well as other key stakeholders.

Methods: This qualitative study was conducted in the capital city of Phnom Penh in 2015. We held five focus group discussions (FGDs) with groups of PWID/PWUD, …

Evolving Workforce Roles In Medicare Next Generation Acos, Clese E Erikson

Health Workforce Research Center Publications

The purpose of this study was to explore key workforce strategies in Next Generation Accountable Care Organizations (Next Gen ACOs), the latest evolution in Medicare ACOs. We conducted semi-structured interviews with leaders from seven of the initial 18 Next Gen ACOs to better understand their perceptions regarding how workforce roles are changing to support the Next Gen ACO model. Key Questions:

1. What new and expanded roles for existing health workforce members are reported by Next Generation ACO leaders?
2. Has use of the health workforce changed as a result of Next Gen waivers for telehealth, home visits, and use of SNFs? …