It’s a stormy healthcare landscape out there, so this show is all lightning round. We cover several areas:
Litigation: Nic provides the Ariadne’s thread through a labyrinthine pharma-tort judgment out of California. The metal on metal hip litigation has resulted in a big judgment, but medical device regulation is still fundamentally broken. Disgruntled Centene enrollees are suing the ACA insurer of last resort for ultra-narrow networks (and Washington state is not happy, either). Washington may lead the way for future narrow network regulation or consent decrees. We followed up on the duodenoscope superbug litigation saga, focusing on duties to translate foreign language emails in discovery.
Like many other areas of law, protections against sex discrimination experienced dramatic fluctuation in 2017. Safeguards and norms thought to be firmly planted by the Obama administration were reversed. And because the field of anti-discrimination law tends toward cross-disciplinary borrowing of standards and interpretations, the effect of a single change—in employment or education, for example—is amplified in others, like health care. The year in sex discrimination proved to be a paradigmatic example of progressive advocates wanting badly for things to be one way, but it’s the other way (See Note 1).
In 2017, the apple of discord here involved interpretation of Title IX’s prohibition of discrimination “on the basis of sex.” Progressive advocates understand that phrase expansively, to encompass at least discrimination that occurs because of sex, gender identity, sexual stereotyping, and sexual orientation. Conservatives, unsurprisingly, interpret the language as narrowly delimited to distinctions made only on the basis of biological sex assigned at birth. We all bore witness to a severe swing of this pendulum in 2017. […]
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. […]
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. […]
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. […]
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 →
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. […]
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. […]
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.
On Valentine’s Day we celebrate love. But the criminal law often sees love and passion turned into violence. How does this happen? And how should law respond? Many doctrines, most notably the “heat of passion” defense – which historically has been used disproportionately to excuse the crimes of men against women – rely on a distinction between defendants who acted “emotionally” instead of “rationally.” But modern neuroscience has debunked the idea that reason and emotion are two entirely different mental states. This panel will explore how law should respond to this neuroscientific challenge to long-held doctrine.
Lisa Feldman-Barrett, PhD, University Distinguished Professor of Psychology and Director of the Interdisciplinary Affective Science Laboratory at Northeastern University; Research Scientist, Department of Psychiatry, Northeastern University; Research Neuroscientist, Department of Radiology, Massachusetts General Hospital; Lecturer in Psychiatry, Harvard Medical School; Faculty Affiliate, the Center for Law, Brain & Behavior, Massachusetts General Hospital
Judge Nancy Gertner (ret.), Senior Lecturer on Law, Harvard Law School and Managing Director, Center for Law, Brain & Behavior, Massachusetts General Hospital
Moderator: Francis X. Shen, PhD, JD, Senior Fellow in Law and Applied Neuroscience, the Petrie-Flom Center in Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Law, Brain & Behavior at Massachusetts General Hospital; Associate Professor of Law and McKnight Land-Grant Professor, University of Minnesota Law School; Executive Director of Education and Outreach, the MacArthur Foundation Research Network on Law and Neuroscience
Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
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. […]
Congress has enacted a tax bill that repeals the Affordable Care Act (ACA) penalties for individuals who fail to enroll in health insurance. Open enrollment for the 2018 plan year may stay roughly even with 2017 exchange enrollment—lackluster performance that some blame on what they call “Trump sabotage”. Some Republicans are urging Congress to appropriate funds for cost sharing reduction (CSR) payments and a national reinsurance pool, presumably to promote enrollment and moderate premium increases. Will Democrats vote to resolve the CSR problem and reinstitute reinsurance—policies many say they support? Or will it be business as usual on Capitol Hill with strict party-line votes (and the inevitable failure of ACA fixes)? Would that change anything about the way the nongroup insurance market operates next year?
The short answers are no, yes, and no. Here are some thoughts about why the status quo is likely to remain largely undisturbed by political speech-making and over-reaction from the editorial pages. My comments are based loosely on my presentation at the Petrie-Flom Health Law Year in P/Review conference held at Harvard University on December 12, 2017.
Exchange Enrollment For 2018
Early reports showed a more rapid pace of exchange enrollment this year than last. As of December 15, 2017, 8.8 million people in the 39 states using the federal exchange had selected plans. That is less than last year’s total of 9.2 million enrollments through Healthcare.gov, but not the dramatic reduction that advocates may have expected. […]
This is the latest of a series of cases involving disputes between ex husbands and ex wives (or in some cases unmarried former partners) regarding the disposition of cryopreserved pre-embryos. These cases, that have been percolating in a large number of states for what has now been 25 years (!) and have come out in a myriad of ways on a myriad of theories as Eli Adashi and I recently detailed in the Hastings Center Report.
One thing many of these cases have in common, though, is that the Courts have avoided reaching the fundamental federal Constitutional question I wrote about now 10 years ago in the Stanford Law Review: Does the party opposing the implantation of embryos upon dissolution of the marriage have a right not to procreate recognized by the federal Constitution? I have argued that we need to realize we are talking about possible rights (plural) not to procreate and in particular separate out:
The right to be a gestational parent
The right not to be a gestational parent
The right to be a genetic parent
The right not to be a genetic parent
The right to be legal parent
The right not to be a legal parent.
This case demonstrates well why such a distinction is important.
Not since Rene Descartes gazed from his garret window in early 17th-century Paris and wondered whether those were men or hats and coats covering “automatic machines” he saw roaming the streets has the issue of personal identity and your cranium been of such import. Descartes feared a world that he alone occupied due to deception by the devil. Today we face a different mind-body challenge in the form of a devil we know: Italian neuroscientist Sergio Canavero. He recently announced that the first human head transplant is imminent.
For bioethicists, the moral critiques of this surgery practically write themselves: Are we merely our bodies? How can a person so ill as to wish to trade in his lifelong corporeal companion be considered competent to consent to such a drastic procedure? How can family members consent to donate a body that they could very well run into — and recognize — at the beach or gym? What if a left-handed person received a right-handed body? What if a lifelong Chicago Bears fan woke to find himself attached to the green-and-gold-tattooed torso of a former Packers fan? Would transplant recipients need to buy whole new wardrobes? Who will pay? […]
Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.
To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.
This event is free and open to the public, but seating is limited and registration is required. Register now!
As detailed in Part 1, Ontario government just enacted the Health Sector Payment Transparency Act, a Canadian first in terms of transparency. The act requires that “transfers of value” (or payments), related to medical products (drugs and medical devices), between a payor and a recipient be reported to the Health Ministry. The Act gives the Ministry unprecedented powers to require, analyze, and publish such data online.
A Transformational Act?
Will this act radically transform the practices and the public knowledge that we have about the financial relations of the medical industry? The effective implementation of the regulations will tell us. However, the fact that Innovative Medicines Canada (formerly known as Rx&D, IMC is the organization representing the interests of the pharmaceutical industry in Canada, like PhRMA in the US) has concerns about the Act is a rather positive sign that this legislation might result into pro-social changes. IMC is invoking both ideological concerns (industry’s interactions with HCPs imply cooperation rather than influence) and logistical concerns (“if the threshold for payments is low, a sales representative could easily lose a receipt and forget to report it”), as well as its own commitment to limiting undue influences. Continue reading →
Drug overdose is a leading cause of death in Americans under 50. Opioids are responsible for most drug-related deaths killing an estimated91 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 →