January 2017
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Between Complacency and Panic: Legal, Ethical and Policy Responses to Emerging Infectious Diseases
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JLME Update

JLME 44.4 is now available online. Take a look at the Table of Contents for this issue titled "Health Reform: Assessing the Affordable Care Act and Moving Forward."

Letter From The Editor
The Journal of Law, Medicine & Ethics has a long and distinguished history of engagement with American presidential elections during my tenure as Editor. It began in 2004 when we were looking for an important symposium to feature the newly-designed JLME-the first aesthetic change in more than a decade. We eventually settled on "National Health Reform and America's Uninsured," and asked the brilliant George Washington University scholar Sara Rosenbaum to edit the issue. Sara brought together an outstanding team of writers and researchers, the symposium became one of the most popular in the history of our publication, and the very cover of the issue (featuring the image of a man with a broken umbrella) became a symbol nearly synonymous with JLME.


Introduction: The Affordable Care Act at Six: Reaching for a New Normal
Sara Rosenbaum and Jane Hyatt Thorpe

In 2008, on the eve of health reform, the Journal of Law Medicine & Ethics published a special national health reform issue, guest edited by Sara Rosenbaum and Jeanne Lambrew. The guest authors for that special edition discussed many aspects of the challenge confronting the nation that ultimately would move front and center during the debate and enactment of the law. Jeanne went on to become one of the principal architects of the law and its implementation.

Symposium Articles
Early Experience with the ACA: Coverage Gains, Pooling of Risk, and Medicaid Expansion
Linda J. Blumberg and John Holahan

The accomplishments of the Affordable Care Act (ACA) are varied and measurable, including a substantial decrease in the number of people uninsured, increased competition and low premium growth in many nongroup insurance markets, reductions in financial barriers to access to care, and prohibitions on nongroup and fully insured small group discrimination based on health status. However, any substantial health system changes, like those implemented via the ACA, will inevitably produce advantages and disadvantages that vary across different subpopulations, depending upon their circumstances at a particular point in time. The time frame over which gains and losses are assessed is particularly critical, since individuals spending more on their own premiums when they are young or perfectly healthy than they would otherwise (as is likely the case under the ACA) may save substantially later when a serious illness or injury strikes.

Making Health Care Truly Affordable after Health Care Reform
Timothy Stoltzfus Jost and Harold A. Pollack

The most immediate health care problem faced by most Americans is affordability. A recent poll by the Kaiser Family Foundation found that the cost of health care, health insurance, and drugs was the most important health issue to voters considering potential presidential candidates. A recent New York Times/Kaiser Family Foundation study found that over half of all Americans without health insurance - and 20 percent of Americans with health insurance - face problems dealing with medical debt.

Health Reform in a New Presidency: The Challenge of Finding Common Ground
Gail R. Wilensky

Forecasting specific policy changes that could result from a forthcoming election is generally a daunting task. Anticipating the types of changes that may occur, depending on whether there is single party control of the White House and Congress or split control of government as has been occurring most of the last two decades, usually is somewhat easier to do. But predicting the potential policy changes that may occur after the 2016 election is even more challenging than usual. The deep level of anger, and dissatisfaction with the "establishment" candidates and with the political parties that has manifested itself in the support for anti-establishment candidates, increase the uncertainty of the election results and the types of policy changes that will follow.

Minding Ps and Qs: The Political and Policy Questions Framing Health Care Spending
William M. Sage

Within five years of Medicare's enactment in 1965, liberal social activists Barbara and John Ehrenreich conjured a new demon - the "medical-industrial complex" - which they associated with large, profit-seeking entities that were supplanting individual physicians, acquiring political influence, and plundering public funds. The choice of words, of course, echoed those of conservative President Dwight Eisenhower, who in his televised Farewell Address three days before leaving office in 1961 had warned the nation of a "military-industrial complex." If one edits Eisenhower's original text to substitute "healthcare" for "military," parallels emerge between the American public's fear of Communist invasion or thermonuclear war and its fear of disease or death in their potential for serious economic mischief.

It's the Prices, Advanced Capitalism, and the Need for Rate Setting - Stupid
David M. Frankford

For roughly 40 years the United States has engaged in an experiment unique among wealthy nations, using competition to control expenditures. The basic idea was to make consumers or their agents "sovereign" by breaking up providers' collective power over the financing and delivery of health care. It hasn't worked. Expenditures in the United States are high and growing higher. Whether measured as a percentage of gross domestic product (GDP) (17.1%) or as dollars spent per capita ($9,086), expenditures are nearly 50% higher than the countries with the next highest level of expenditures: France (11.6% GDP) or Switzerland ($6,325 per capita). Although recently growth has flattened somewhat, spending has accelerated again, growing by 5.3% between 2013 and 2014, 4.5% per capita. This rate of growth is projected to continue, averaging 5.8% - 4.8% per capita - from 2015-2025, and consuming 20.1% of GDP by 2025. Additionally, the policy world has now reached general agreement that the title of a seminal article explains the principal driver of our expenditure problem: It's the Prices Stupid: Why the United States Is So Different from Other Countries. If anything, the ACA's expansion of coverage makes the problem even more urgent because, aside from efforts, which are weak in most states, to control the premiums of plans sold in the Marketplaces - a very small slice of the overall insurance market - and the legislated cuts in Medicare payment, the ACA contains no mechanisms to control price and expenditures.

The Affordable Care Act's Day(s) in Court
Mark A. Hall

So much has been written about judicial challenges to the Affordable Care Act (ACA) that one hardly knows where to begin, and end, in summing up what all has happened in the past six years. We have not seen federal law fought so fiercely since the Civil Rights era. To undermine the ACA, opponents have mobilized at numerous political, social, and legal fronts - not the least of which has been the Supreme Court. But, somewhat below the public's radar have been well over a hundred challenges in lower courts across the country. Some of these strike at the ACA's core, or seek to do serious damage; others merely nip at its heels.

Medicaid's Role in Health Reform and Closing the Coverage Gap
Diane Rowland and Barbara Lyons

Medicaid coverage matters for millions of low-income Americans, and especially for those with ongoing and serious health challenges. A source of comprehensive and affordable coverage, Medicaid has long been a cornerstone of federal and state efforts to improve access and health outcomes for very poor and medically vulnerable populations. The Affordable Care Act (ACA) leveraged Medicaid's role in serving the poor to broaden the program's reach to millions of low-income uninsured adults, and positioned the program as a fundamental component of the newly established continuum of public and private coverage. Today, Medicaid provides comprehensive, affordable coverage for over 70 million people and has been the key driver in the historic and rapid decline in the number of uninsured that has occurred since implementation of the ACA coverage expansions in 2014.

After the Affordable Care Act: Health Reform and the Safety Net
Peter Shin and Marsha Regenstein

Despite the historic contributions of the Affordable Care Act (ACA) in expanding coverage, millions of Americans face obstacles to obtaining health care. Low-income, publicly insured, uninsured, immigrant, and otherwise vulnerable individuals and families rely on safety net providers for virtually all of their health care needs. Commonly defined by their mission or legal requirement to serve large numbers of uninsured and Medicaid populations, safety net providers have developed considerable expertise over the past decades in managing the care of populations at risk of poorer health. Yet numerous financial and operational challenges continue to plague mission-driven safety net organizations, and it proves challenging to provide high-quality care to growing numbers of patients in the absence of a sufficiently robust and stable source of financing. Medicaid provider fees have remained low relative to other payers and lower-income privately insured individuals often cannot cover deductibles and other out-of-pocket provider payments. Gaps in coverage remain, with millions of immigrants either excluded from insurance options or subject to long waiting periods. Uninsured low-income adults continue to be excluded from Medicaid coverage in the 19 states that have chosen not to expand their Medicaid programs.


Who Do You Trust?
Maxwell J. Mehlman

When I was a kid, there was a popular afternoon TV gameshow with the grammatically irregular name of the title of this commentary. I have chosen its name for the title because the question it asks is perhaps the most important in health policy, and because, like the show, the question resonates with the average American and not just with academics and policy wonks. In the current U.S. health care system, as it is being reshaped by the Affordable Care Act, who do you trust?

Show Us the Data: The Critical Role Health Information Plays in Health System Transformation
Jane Hyatt Thorpe, Elizabeth A. Gray, and Lara Cartwright-Smith

As the American healthcare system continues its journey toward a value-driven enterprise, the need for better access to patient health information and related data is a common concern from operating rooms to boardrooms. Improving quality and lowering costs are high priorities among healthcare stakeholders, but using and exchanging health information across the care continuum to support these priorities has proved to be challenging. Sharing health information for public health activities, social service functions, and research is equally critical but even more daunting. For example, essential public health activities such as identifying population health patterns, allocating resources, and preventing disease also require robust access to patient health information. Without an interoperable electronic information exchange infrastructure that supports sharing patient health information across the healthcare delivery system and, increasingly, outside of the healthcare delivery system, true transformation still remains out of reach.

Moving to the Next Phase of Reform
Stuart M. Butler

We have two general goals in the continuing process of health care reform. The first is to widen effective insurance coverage while also seeking to control costs. The second is, within the health system, to accomplish improvements in health by encouraging local innovation and addressing the social determinants of health. Social determinants are nonmedical factors that influence health, such as socioeconomic status, employment, and housing conditions. Mounting research shows these factors to be strongly correlated with health. Addressing them requires us to bring together different sectors (such as education and housing), in addition to healthcare, as well as different streams of financial resources. While a multi-sector strategy is technically difficult, there is broad bipartisan support for it: empowering local institutions - de Tocqueville's "little platoons" - and breaking down regulatory and budgetary silos to address problems appeals to both left and right.

Independent Articles

Regulating Information or Allowing Deception? Pharmaceutical Sales Visits in Canada, France, and the United States
Roojin Habibi, Line Guénette, Joel Lexchin, Ellen Reynolds, Mary Wiktorowicz, and Barbara Mintzes

The pharmaceutical industry devotes considerable resources to the promotion and marketing of its products in order to support their market share while under patent protection. Pharmaceutical sales representatives' ("sales reps") visits, along with the free samples they distribute, are the largest promotional spending category. Pharmaceutical industry spending on promotion surpasses that for research, and there is evidence that such marketing influences the quality, quantity, and cost of physician prescribing.

Struggles in Defining and Addressing Requests for "Family Balancing": Ethical Issues Faced by Providers and Patients
Robert Klitzman

Major controversies continue regarding whether and when assisted reproductive technology (ART) providers should perform preimplantation genetic screening (PGS) for sex selection for nonmedical reasons. Physicians may screen embryos for sex determination to prevent the transmission of serious sex-associated diseases, including conditions for which highly predictive genetic markers have yet to be identified. But, given disturbing rates of increased births of males over females in certain countries, concerns arise about a possible "slippery slope" when utilizing this technique, resulting in sexism and gender discrimination.

Food Labeling and Consumer Associations with Health, Safety, and Environment
Joanna K. Sax and Neal Doran

Sectors of the public and consumer advocacy groups are increasingly calling for a variety of food labeling measures, particularly regarding food derived from genetically modified organisms/genetically engineered (GMO/GE) and the use of the label "natural." The potential for new labeling regulations raises questions about the information that consumers either receive or believe they receive from such labels. Articles in the popular press and advocates of mandatory labeling cite the right of consumers to know the contents of their food, with a special emphasis on consumer concerns for health, safety, and the environment. The purpose of the current study was to examine the extent to which consumers associate health, safety, and the environment with specific labels and specific food products.

Are Military and Medical Ethics Necessarily Incompatible? A Canadian Case Study
Christiane Rochon and Bryn Williams-Jones

Most medical codes of ethics, based as they are in the Hippocratic Oath, state that physicians have a primary obligation to act in and protect their patients' best interests.

Columns

Currents in Contemporary Bioethics: HIPAA Compliance and Training: A Perfect Storm for Professionalism Education
Julie L. Agris and John M. Spandorfer

To improve the efficiency and effectiveness of the health care system, the Health Insurance Portability and Accountability Act (HIPAA) of 1996, included "Administrative Simplification" provisions that required the Department of Health and Human Services (HHS) to adopt national standards for electronic health care transactions and federal privacy provisions to safeguard the protected health information (PHI) within those transactions. The HIPAA Privacy and Security Rules (HIPAA Rules) are meant to ensure the protection of PHI while allowing the flow of health information necessary to provide high quality health care and protect the public's well-being. Both HIPAA Rules require training of a covered entity's (CE) workforce on the substance of these protections. In addition, the HIPAA Rules require that business associates (BA) and their subcontractors be similarly trained. As with provisions throughout HIPAA, the HIPAA Rules strike a balance by allowing implementation flexibility considering the diversity of CEs in the health care industry.

Calendar
JLME 44.4 Calendar of Events

Public's Health
Public Health and the Law: Mitigating Risks to Pregnant Teens from Zika Virus
Andrew D. Maynard, Diana M. Bowman, and James G. Hodge, Jr.

Continuously emerging positive correlations between Zika virus and fetal developmental conditions, including serious disabilities like microcephaly, raise concerns for pregnant women and their partners globally and in the United States. While there remains considerable uncertainty over the precise risks, recent estimates place the probability of microcephaly due to Zika infection in the first trimester between 1% and 13%. Additional, more latent infant disabilities collectively labeled as congenital Zika syndrome (CZS) further heighten fears. Due to the asymptomatic nature of Zika infection, current lack of vaccines, testing limitations, and non-efficacious treatments, the Centers for Disease Control and Prevention (CDC) has advised women who are, or may become, pregnant, to avoid Zika infection altogether.

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