In November Serena Williams, indisputably one of the greatest – if not the greatest – tennis player in history gave birth to her daughter by emergency Caesarean section. After the surgery, Williams reported to an attending nurse that she was experiencing shortness of breath and immediately assumed she was experiencing pulmonary embolism. The star athlete has a history of blood clots and had discontinued blood thinners before the surgical delivery. Contrary to William’s requests for a CT scan and blood thinners, medical staff assumed that pain medication had made her confused. A later CT scan confirmed Williams’ self-diagnosis. Stripping out the fact of Williams’ identity turns this near-miss into a terrifyingly common story in US maternal care, albeit one with a happier ending than many. The global trend in maternal death rates – the rate of women dying in childbirth and post-childbirth – has rapidly decreased over the past 15 years. At the same time, the US, despite recording one of the highest per capita income levels in the world, has one of the highest maternal mortality rates in the developed world.
This new post by Francis X. Shen appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.
Another year, another failed Alzheimer’s drug trial. In what is becoming routine news, in 2017, another Alzheimer’s drug failed in clinical trial, leading to the apt headline: “The List of Failed Alzheimer’s Drug Treatments Keeps Growing.” Moreover, there seem to be few evidence-based options even to limit cognitive decline. Research continues of course, and there remain multiple—and potentially promising—pharmacological interventions in the Food and Drug Administration (FDA) pipeline.
One of the reasons that successful drugs have been elusive is scientists are still trying to figure out the exact underlying neurobiology of Alzheimer’s. The past year saw the publication of a major scientific study showing that in mice, the gene variant ApoE4 (which is linked to a much higher risk for Alzheimer’s) affects both β-amyloid and tau buildup in the brain. The study’s implication of tau was important because the scientific community has been debating the “amyloid hypothesis,” whether the field’s sometimes singular focus on β-amyloid buildup was misguided. This debate is so intense that in 2017 it even made its way to the pages of The Atlantic. […]
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This new post by Wendy E. Parmet appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.
Non-citizen immigrants are the canaries in the health care coal mine. Disproportionately poor, non-white, and non-English speaking, and without access to the franchise, they are among the most vulnerable groups in the United States. Consequently, they are often the first to experience the gaps, inefficiencies, and conflicts in our health care system. Meanwhile, anti-immigrant sentiment often spills into health policy debates, as was evident in 2009 when opponents of the bill that became the Affordable Care Act (ACA) focused their opposition on the erroneous claim that it would cover undocumented immigrants. It is therefore not surprising that the first year of the Trump administration, which has focused its domestic agenda on restricting immigration and repealing the ACA, has proven especially perilous for immigrants who need health care.
As a group, immigrants tend to be healthier than the native-born population. They are also far less likely to have insurance. In 2015, for example, 18 percent of lawfully present nonelderly adult immigrants, and 42 percent of undocumented immigrants were uninsured, compared to only 11 percent of United States citizens. Immigrants’ low insurance rate is partly due to the fact that they disproportionately work in sectors of the economy in which employer-sponsored insurance is uncommon. But the law also plays a significant role. Even before the Trump administration took office, immigrants faced an array of legal barriers to obtaining health insurance. Most importantly, the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PROWRA) prohibited undocumented immigrants from accessing most federally-funded insurance programs (including Medicaid, Medicare and Children’s Health Insurance Program (CHIP)). PRWORA also barred most authorized immigrants (except refugees) from benefiting from federally-funded programs for five years after obtaining legal status. And although the ACA made it easier for many documented immigrants to gain coverage, it left PROWRA in place. The ACA also limited participation in the exchanges to immigrants who are “lawfully present,” a category that the Obama administration decided did not include the approximately 800,000 young adults who participated in the Deferred Action for Childhood Arrivals (DACA) program. […]
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This new post by Robert Greenwald and Judith Solomon appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.
For more than 50 years, Medicaid has been our nation’s health care safety net. Medicaid allows our lowest-income, sickest, and often most vulnerable populations to get care and treatment, and supports the health of more than 68 million Americans today. As an entitlement program, Medicaid grows to meet demand: There is no such thing as a waiting list. This vital health program found itself under fire in 2017, and while there were no major reductions in funding or enrollment, it is far from safe in 2018. Whether by new legislation or actions the Trump administration may take, the threats to Medicaid are not going away anytime soon.
Congressional Threats To Medicaid’s Expansion, Structure, And Funding
Throughout 2017, Republicans tried unsuccessfully to roll back the Affordable Care Act (ACA), including the law’s expansion of Medicaid. Underpinning each effort was the oft-stated belief, held by Republican leadership, that the expansion was a disastrous move that extended coverage to more than 12 million able-bodied people who should not be getting health insurance from the government. While these unsuccessful efforts were commonly referred to as attempts to “repeal and replace the ACA,” every bill that gained any traction in 2017 went far beyond repealing only the ACA’s Medicaid expansion. The proposals also included plans to fundamentally alter the way in which the traditional Medicaid program is structured and paid for. […]
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By John Tingle
In tort law we have a very well-known Latin phrase, ‘Res Ipsa Loquitur’ (the thing speaks for itself). An inference of negligence can be raised by the events that occurred. In the National Health Service (NHS) in England there is a similar concept,‘the Never Event’. The Never Event concept is a USA import into the NHS and was introduced from April 2009. The list of what is to be regarded as a Never Event has been revised over the years in the NHS and is currently set out by NHS Improvement.
Never events include, wrong site surgery, wrong implant/prosthesis, retained foreign object post procedure, mis-selection of a strong potassium solution, administration of medication by the wrong route and so on. Never Events are defined in NHS policy documentation as:
“…patient safety incidents that are wholly preventable where guidance or safety recommendations that provide strong systemic protective barriers are available at a national level and have been implemented by healthcare providers. Each Never Event type has the potential to cause serious patient harm or death. However, serious harm or death does not need to have happened as a result of a specific incident for that incident to be categorised as a Never Event.” (p.6) Continue reading
By Aobo Dong
The passage of the Republican tax reform bill affects the health care industry in ways that might be confusing and unpredictable for tens of millions of Americans. Due to political rhetoric and inaccurate portrayal of the bill, it seems as if the Individual Mandate – an essential element in the ACA – has been fully repealed. Nonetheless, as Health Affairs rightly points out, Section 5000A still remains in the statute to require “minimal essential coverage” for all individuals. Therefore, although the tax bill repealed the tax penalty for not having insurance coverage, the law still technically mandates individuals to acquire health insurance. Moreover, the tax penalty repeal will not take effect until the 2019 tax year, so individuals who are uninsured for more than 2 months in the 2018 tax year may still be liable for paying the tax penalty, unless future laws and regulations, or an executive order from Trump, indicates otherwise.
Under the new regulatory landscape, what could be some potential repercussions for Health Care Sharing Ministries (HCSMs)? These ministries, largely run by evangelical Christians who believe in the merit of private cost sharing, have been benefiting from the Individual Mandate since the inception of the ACA. Under Section 5000A, HCSM members are exempt from paying the tax penalty. The dearth of legal exemptions available and the widespread dislike of Obamacare among white evangelical communities in America likely fueled the rapid growth of HCSMs in recent years. Members pay their monthly “shares” to each other to cover health insurance expanses, without going through a central insurance or governmental agency for redistribution. Continue reading
This new post by Benjamin Sommers and John McDonough appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.
Efforts to repeal and replace the coverage expansions in the Affordable Care Act (ACA) as well as the tax increases that financed them were persistent throughout 2017. Even after the congressional Republicans’ highly visible failures earlier this year, they kept coming back—finally succeeding in zeroing out the penalties in the ACA’s individual mandate as part of federal tax cut legislation signed into law in late December.
Of keen interest and importance now is the question: What’s next for the ACA?
Originally, many ACA supporters assumed during the years of the Obama administration that once the law’s major coverage provisions took effect in January 2014, the reality on the ground of a successful coverage expansion and broader insurance benefits would transform the ACA into a popular program—growing in acceptance and inevitability as Social Security, Medicare, and Medicaid all did before it. […]
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This new post by Audrey Morse Gasteier appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.
The effective repeal of the federal individual mandate represents one of the most significant changes to the Affordable Care Act (ACA) since its implementation. Especially on the heels of the federal government’s sudden withdrawal of cost-sharing reduction payments this past October, the instability that the federal mandate repeal could introduce to health insurance markets is material. However, states can craft reaction strategies to protect against such effects.
In Massachusetts, where I manage policy and strategy for the state-run insurance exchange, we’ve now spent a decade administering our own state-based individual mandate. And, while our state is unique in many ways—our experience may prove useful to policy makers in other states considering locally tailored pathways to maintaining coverage gains. State-administered mandates or alternative policies to encourage broad coverage across a state’s population can be a tool to foster premium stability and healthy issuer participation, but we have found that mandates can also introduce extra advantages such as the promotion of consistent benefit floors and enabling effective outreach to the uninsured. […]
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Cross-posted from the Psychology Today blog, where it originally appeared on January 15, 2018.
Let’s call it for what it is: Placing prisoners in solitary confinement is tantamount to torture and it needs to stop.
The practice of placing incarcerated individuals in solitary confinement dates back to the 1820s in America when it was thought that isolating individuals in prison would help with their rehabilitation. Yet, over the past two centuries, it has become clear that locking people away for 22 to 24 hours a day is anything but rehabilitative. Solitary confinement is so egregious a punishment that in 2011, the U.N. Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment condemned its use, except in exceptional circumstances and for as short a time as possible, and banned the practice completely for people with mental illnesses and for juveniles.
Despite its barbarity, the United States continues to place thousands of people, including individuals with mental illnesses and children, in solitary confinement, sometimes for decades. Thirty years ago, Dr. Stuart Grassian, who recently spoke at Harvard Medical School’s “Behind Bars: Ethics and Human Rights in U.S. Prisons” conference, evaluated 14 individuals placed in solitary confinement and found the same symptoms in many of them: hypersensitivity to external stimuli; perceptual disturbances, hallucinations, and derealisation experiences; affective disturbances, such as anxiety and panic attacks; difficulties with thinking, memory and concentration; the emergence of fantasies such as of revenge and torture of the guards; paranoia; problems with impulse control; and a rapid decrease in symptoms immediately following release from isolation. Taken together, Dr. Grassian proposed that these symptoms amount to a pathopsychological syndrome.
By Martin Hevia
Over the past few years, more and more global health luminaries and leading NGOs have called for a Framework Convention on Global Health (FCGH), for using the strongest instrument of international law to advance the quest for health equity.
In the globalization era, the highest attainable level of health cannot be achieved by States acting on their own. A FCGH treaty would facilitate the coordinated global effort needed to achieve the highest attainable level of health everywhere. It would reform global governance for health to enhance accountability, transparency, and civil society participation and protect the right to health in trade, investment, climate change, and other international regimes, while catalyzing governments to institutionalize the right to health at community through to national levels.
The FCGH Alliance membership includes more than 30 organizations and individuals from Africa, Asia, Latin America, North America, and Europe that believe that unconscionable global and local health inequities are fundamentally unjust.
We know this is an ambitious undertaking, but we are convinced that a FCGH would be a historical shift in global health.
For more info, please visit Here are some articles on the idea of an FCGH.
The Next WHO Director-General’s Highest Priority: A Global Treaty on the Human Right to Health (Lancet Global Health, 2016) (pdf)
A Vote for the World’s Health, Absent From the Headlines (DevEx, 2016)
An Independent Review and Accountability Mechanism for the Sustainable Development Goals: The Possibilities of a Framework Convention on Global Health (Health and Human Rights Journal, 2016) (pdf)
Towards a Framework Convention on Global Health: A Transformative Agenda for Global Health Justice (Yale Health Policy, Law, and Ethics, 2013)
A Framework Convention on Global Health: A Catalyst for Justice (WHO Bulletin, 2012) (pdf)
This new post by Wendy Mariner appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.
Congress has been busy enacting and proposing changes to the Affordable Care Act (ACA)’s regulation of private health insurance, from repealing the tax on individuals without minimum essential coverage to the Alexander-Murray bill intended to shore up the private market. These changes do not play well together. Three reasons are explored here: the great wall, which divides advocates with different goals; whipsawed insurance markets, in which insurers are simultaneously pulled in different directions; and, of course, the cost of care, which each reform shifts onto different entities.
The Great Wall
A great ideological wall makes it almost impossible to reach national consensus on whether or how to regulate private insurance markets. The wall divides people—especially in Congress—who believe in personal responsibility for one’s health care costs from those who believe in social responsibility for many such costs or social solidarity. The former believe that you are responsible for your own health and you should be free to buy (or not buy) health care and health insurance as you choose. In this view, health insurance is a commercial product that is properly priced according to actuarial risk. Ideally, competition among insurers can produce affordable products of reasonable quality.
Those who favor in social responsibility for health care believe that health depends on more than personal behavior; it depends on the social determinants of health, including education, income, occupation, housing, and environmental factors. This view recognizes that illness is not always predictable and millions of people cannot afford needed health care. (Many also believe that access to health care is a human right as set forth in the Universal Declaration of Human Rights.) In this view, insurance is not a commodity, but a method of financing health care that should be available to all in need, and therefore a social responsibility. To enable everyone to have access to affordable care within a private market, government must regulate private insurers (and providers) more extensively than would be necessary in a public insurance system. […]
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Recently, people in Vermont have been talking about launching a Safe Injection Facility (SIF) to address drug harms arising with the opioid epidemic. With more deaths than ever, trying new approaches make sense — especially “new” approaches like SIFs that have two decades of solid international evidence of efficacy behind them. Several cities are actively considering the same intervention.
One of the biggest barriers is uncertainty about how federal drug control authorities will react. Although there are reasonable arguments that SIFs for public health do not violate the Controlled Substances Act, and the national opioid task force has broadly called for extraordinary action, there has been no explicit support from the Trump administration and no effort to carve out space in the law from Congress. Continue reading
Drug overdose is a leading cause of death in Americans under 50. Opioids are responsible for most drug-related deaths killing an estimated 91 people each day. In Part I of this three-part series, I discuss how the President’s Commission on Combatting Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In Part II I explore how the Commission dismissed medical interventions used successfully in the U.S. and abroad such as kratom and ibogaine. In this third part of the series, I explain how the Commission ignored increasingly proven harm reduction strategies such as drug checking and safe injection facilities (SIFs).
In its final report released November 1, 2017, the President’s Commission acknowledged that “synthetic opioids, especially fentanyl analogs, are by far the most problematic substances because they are emerging as a leading cause of opioid overdose deaths in the United States.” While speaking before the House Oversight Committee last month, the Governor of Maryland Larry Hogan stated that of the 1180 overdose deaths in his state this year, 850 (72%) were due to synthetic opioids. Street drugs are often contaminated with fentanyl and other synthetics. Dealers add them to heroin, and buyers may not be aware that they are consuming adulterated drugs. As a result, they can be caught off guard by their potency, which contributes to respiratory depression and death. Synthetic opioids such as fentanyl are responsible for the sharpest rise in opioid-related mortality (see blue line in Fig. 1 below). Continue reading
By Scott Burris, JD
There is a lot of interest in civil commitment these days, as a possible tool to fight two big health problems. As we continue to watch the rates of opioid-related deaths climb, and in the wake of an unfunded emergency declaration by President Trump, some policymakers are looking to involuntarily commit overdose survivors for drug treatment. On the gun violence side, experts like Jeffrey Swanson have argued for applying gun-access restrictions that now cover people subject to long-term civil commitment to those subjected to short-term civil commitment.
With those kinds of ideas in the air, it is important to recognize how little modern data we have on commitment and its effects. In a recent article in the Washington Post discussing commitment for opioid treatment, Michael Stein and Paul Christopher emphasize how little we know. I entirely agree on the need for more research, and offer a couple of things to help.
The first is the Policy Surveillance Program’s LawAtlas dataset that maps civil commitment laws across all 50 states and the District of Columbia. If we’re going to examine these laws and their impact, this is the place to start. We also put out the call to anyone interested in studying this to work with us not only to update this data through 2017, but also to make sure we’re mining these laws and their characteristics for the right information in these circumstances — Are we asking the right questions? Continue reading
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.
Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.
Anne Case and Angus Deaton shocked the world with their 2015 report that noted an increase in all-cause mortality among middle-aged white non-Hispanic men and women in the United States. This pattern is not occurring in other groups within the United States and Europe. Their report, and others since then, have linked this trend to so-called deaths of despair (death from suicide, chronic substance use, and overdoses) and their linkage to other determinants of health (education, labor markets, marital patterns). A recent update to the report makes it clear that this trend is no longer limited to any particular geographic region within the United States.
This year’s NUSL Center for Health Policy and Law annual conference and associated scholarship will bring together experts, policymakers, and academics to discuss the causes behind such trends, and to explore potential political, policy, and legal responses for addressing broader determinants that affect the physical and mental health of Americans dying from these diseases of despair. Deeper examination into similar patterns among diverse populations, as well as analysis of continuing racial, ethnic, and socioeconomic disparities, will be central to the discourse.
By Mason Marks
The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.
Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Continue reading
Earlier this month, CVS announced plans to buy Aetna— one of the nation’s largest health insurers—in a $69 billion deal. Aetna and CVS pitched the deal to the public largely on the promise of controlling costs and improving efficiency in their operations, which they say will inhere to the benefit of consumers. The media coverage since the announcement has largely focused on these claims, and in particular, on the question of whether this vertical integration will ultimately lower health care costs for consumers—or increase them. There are both skeptics and optimists. A lot will turn on the effects of integrating Aetna’s insurance with CVS’s pharmacy benefit manager services.
But CVS and Aetna also flag another potential benefit that has garnered less media attention—the promise in combining their data. CVS CEO Larry Merlo says that “[b]y integrating data across [their] enterprise assets and through the use of predictive analytics,” consumers (and patients) will be better off. This claim merits more attention. There are three key ways that Merlo might be right. Continue reading
Health Law Year in P/Review
December 12, 2017 8:30 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
Register for this event
The Sixth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2017 and what to watch out for in 2018. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.