The United States leads the world in incarceration. The “War on Drugs” and prioritizing punishment over rehabilitation has led to mass imprisonment, mainly of the nation’s most vulnerable populations: people of color, the economically disadvantaged and undereducated, and those suffering from mental illness. Although these social disparities are striking, the health discrepancies are even more pronounced. What can be done to address this health and human rights crisis?
This conference will examine various aspects of human rights and health issues in our prisons. In collaboration with educators, health professionals, and those involved in the criminal justice system—including former inmates, advocates, and law enforcement—the conference will clarify the issues, explore possible policy and educational responses, and establish avenues for action.
Last week, while the health law world focused on the Republicans’ renewed attempt to repeal and replace the ACA, the Ninth Circuit struck an ominous blow to public health. As we have noted previously, federal courts in recent years have relied on an increasingly expansive interpretation of the First Amendment to prioritize the rights of commercial speakers over the health and safety of the public. This new-found appreciation for commercial speech has resulted in decisions striking down a wide-range of public health regulations and has led food and beverage companies to make “ever-bolder arguments aimed at limiting longstanding government authority to protect the public’s health.” In American Beverage Association v. City and County of San Francisco, those bolder arguments were accepted by the court, putting public health regulations in greater peril.
American Beverage Association concerned a challenge to a 2015 San Francisco ordinance requiring certain advertisements of sugar-sweetened beverages (SSBs) to display over at least 20% of the area of the advertisement a warning stating: “Warning: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.”
Think of the last few times you’ve had a very lifelike dream. Running, reading, or having conversations with others, are all activities that might happen during a particularly vivid dream. But would this be considered consciousness? Surely being in a state of sleep is not the same as being in a waking state; but if you are able to communicate, to attend a lecture, perhaps even to give a lecture whilst you sleep, what does this mean in terms of your brain’s activity? Very deep in the sleep cycle, a person may not respond immediately to touch or sound or any other sensory stimulus. That is, they may not wake up, though it cannot be ruled out that an external stimulus might influence the sub-conscious mind and hence their dream. We’ve all had the experience of hearing an alarm “in our dream” which is really our real alarm, yet our mind re-interprets it and incorporates it into our dream until we regain consciousness, i.e., wake up. What if you couldn’t wake up from your unconscious state? And if so, what would this mean for how your brain processes your thoughts? In effect, what would it mean for your lived reality if you could only live in your mind?
Beyond being a fun thought experiment, these may be some very relevant questions now that doctors have treated a vegetative-state patient with an experimental therapy leading him to regain partial consciousness.
It was reported yesterday in National Geographic, Popular Science, the Guardian, and elsewhere that a 35-year-old man who had been in a persistent vegetative state (PVS) for 15 years has shown signs of consciousness after receiving a pioneering therapy involving nerve stimulation. The French researchers reported their findings to the journal Current Biology. Led by Angela Sirigu, a cognitive neuroscientist and director of the Institut des Sciences Cognitives Marc Jeannerod in Lyon, France, a team of clinicians tried an experimental form of therapy called vagus nerve stimulation (VNS) which involves implanting a device into the chest designed to stimulate the vagus nerve. It works by giving off miniscule electrical shocks to the vagus nerve, a critical brain signal that interfaces with parasympathetic control of the heart, lungs, and digestive tract.
In July 2017, Cambridge University Press will publish Law, Religion, and Health in the United States, co-edited by outgoing Petrie-Flom Center Executive Director Holly Fernandez Lynch, Faculty Director I. Glenn Cohen, and Elizabeth Sepper, Professor of Law at Washington University School of Law. This edited volume stems from the Center’s 2015 annual conference, which brought together leading experts to identify the various ways in which law intersects with religion and health care in the United States, examine the role of law in creating or mediating conflict between religion and health care, and explore potential legal solutions to allow religion and health care to simultaneously flourish in a culturally diverse nation.
About the book: While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else – patient or physician, secular or devout – interested in how US law interacts with health care and religion.
This brief essay examines data from the U.S. Orphan Drug Act, including specifically the FDA designations of an indication for a drug to treat an orphan disease, and the likelihood that once the designation is made, the FDA will approve the drug for that indication. This is one empirical measure of the risks associated with the development of new drugs to treat U.S. defined orphan diseases. Note that 75 percent of all novel cancer drugs approved in the United States from 2010 to 2016 qualified as orphan products. The essay also reports the average time between the FDA designation and the FDA approval for orphan indications.
The main findings are that since 2010, the average time from orphan designation to approval is 5.3 years, and the likelihood of FDA approval for an orphan indication, which varies over time and across business cycles, was .22 from 1990 to 2017, and since 2010, was .25.
The essay concludes with a comparison to other studies of the risks of drug development.
On January 5, 1983, the U.S. Orphan Drug Act became law as Public Law 97-414. Over the past 34 years the Act has been amended numerous times, often extending or expanding the benefits, which currently include a 50 percent tax credit for qualifying clinical trials, exemptions or discounts on prescription drug user fees, an easier and faster path to FDA approval, and seven years of marketing exclusivity for an approved orphan indication.Continue reading →
Presentation: “How Dangerous are Youth Sports for the Brain? A Review of the Evidence”
This paper is not available for download. To request a copy in preparation for the workshop, please contact Jennifer Minnich at jminnich at law.harvard.edu.
Francis X. Shen is the third Senior Fellow in 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. He is an Associate Professor at the University of Minnesota Law School, where he heads the Shen Neurolaw Lab. He also serves as Executive Director of Education and Outreach for the MacArthur Foundation Research Network on Law and Neuroscience.
Professor Shen completed his BA in economics and English at the University of Chicago in 2000, his JD at Harvard Law School in 2006, and his PhD in government and social policy at Harvard University and the Kennedy School of Government in 2008. During graduate school he was a doctoral fellow in the Harvard University Multidisciplinary Program in Inequality & Social Policy, supported by the National Science Foundation. From 2007-09, he was a teaching fellow, lecturer, and assistant director of undergraduate studies in the Harvard Department of Government and received five Certificates of Distinction for Excellence in Teaching from Harvard’s Derek Bok Center. Continue reading →
Over at HuffPo, Craig Konnoth has a short-but-smart piece exploring the Constitutionality of the logrolling deals now underway to persuade Alaska Senator Lisa Murkoswki to support the latest effort to repeal Obamacare. Would other states have a right to object to a deal that showered special benefits on Alaska? Konnoth explains how an “equal sovereignty” principle has emerged in recent Supreme Court decisions, and suggests that it may provide some grounds for challenging this sort of special treatment.
I am left wondering about the longstanding practices of states requesting and receiving waivers from the Federal government. For example, Maryland has for decades enjoyed a Medicare waiver, which allows it to regulate prices. Massachusetts has a $52B waiver to put its Medicaid members in accountable care organizations. Do these violate equal sovereignty too?
Maybe the answer is that all states are treated equally in their right to apply for such waivers, under several explicit statutory vehicles, which have yielded several hundred such applications. These are not simply bribes to secure votes in Congress. On the other hand, some of these waivers were very much the result of politically-charged negotiations between conservative governors (such as Indiana’s Mike Pence) and the Obama administration, who granted these waivers as a way to expand insurance coverage. Maybe that’s not so different than what Murkowski is demanding?
In Universal Health Services v. United States ex rel. Escobar (UHS), the Supreme Court upheld the Civil False Claims Act (FCA) theory of “implied certification,” under which the submission of a claim for reimbursement “implies” that the claimant is in compliance with the statutes, regulations, and contract provisions necessary for that claim to be paid. Escobar was filed by the parents of a young woman who died after receiving Medicaid-covered mental health treatment from a Massachusetts clinic that violated state licensing and supervision regulations. Her parents alleged that the clinic’s claims were fraudulent because they implicitly (and falsely) represented that the facility was in compliance with the relevant provisions. A district court dismissed the suit, but the First Circuit reversed. In a unanimous opinion written by Justice Thomas, the Supreme Court held that where a defendant “makes specific representations about the goods or services provided, but knowingly fails to disclose . . . noncompliance with a statutory, regulatory, or contractual requirement[,] . . . liability may attach if the omission renders those representations misleading.” But cautioning that such misrepresentations must be “material to the Government’s payment decision,” the Court reversed and remanded because the First Circuit had applied an impermissibly broad test.
Escobar was not the only federal appellate case to grapple with implied certification in recent years. In 2015, the year the First Circuit considered Escobar, no fewer than four federal appellate cases confronted the theory. Arguably the most important of these cases, at least from the standpoint of national security, was United States ex rel. Badr v. Triple Canopy, Inc., a Fourth Circuit case reversing the dismissal of a suit alleging that a military contractor had falsified marksmanship scores for Ugandan security guards hired to protect Al Asad Airbase in Iraq. Noting that the contract did not expressly condition payment on marksmanship, the district court had concluded that the claims did not contain any factually false statements. The Fourth Circuit disagreed, upholding the allegations under the theory of implied certification. Perhaps due to the tragic facts and sympathetic plaintiffs, or perhaps in recognition of the important role Medicare and Medicaid FCA cases now occupy, the Court instead chose to review Escobar rather than Triple Canopy. Nevertheless, in light of Escobar,Triple Canopy was reversed and remanded for further proceedings. On May 16, 2017, the Fourth Circuit issued its long-awaited decision on remand.
Pancreatic cancer is one of the deadliest illnesses out there. The five-year survival rate of patients with the disease is only about 7%. This is, in part, because few observable symptoms appear early enough for effective treatment. As a result, by the time many patients are diagnosed the prognosis is poor. There is an app, however, that is attempting to change that. BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies. Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.
Diagnostic apps like BiliScreen represent a huge step forward for preventive health care. Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis. One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.
I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease. These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings. They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability. There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them. BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone. Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.
If you are fortunate enough to have an insurance plan with extensive coverage and low co-pays for prescription drugs, chances are you may not be overly concerned with the U.S. drug price catastrophe. For millions of Americans without such a plan, getting the much-needed prescribed medicine often involves frustrating multi-player exchanges between the pharmacy, the insurance company, and the doctor, due to complications such as drug pricing and pre-authorization.
The NYT recently launched an investigation into a simple question: “Why Are Drug Prices So High?” One surprising revelation from the study is that deep drug pricing problems may have been contributing to the ongoing opioid crisis, as insurers restrict patient access to less addictive alternatives. For instance, UnitedHealthcare stopped covering Butrans – a drug that had successfully helped Alisa Erkes to ease her excruciating abdominal pain for two years – just to lower its own expenses. Instead, Alisa’s doctor had to put her on long-acting morphine – a drug in a higher category for risk of abuse and dependence than Butrans. However, since it costs the insurance company only $29 a month, UnitedHealthcare covered it with no questions asked. Continue reading →
Graham Cassidy § 105 would repeal the ACA “employer mandate”. Although its sponsors claim that the bill will give states a great deal of flexibility, it will do nothing to help states ensure that employers provide their employees with decent health insurance; quite the reverse. It will also give employers the freedom to ignore the popular ACA requirement that allows children up to age 26 to receive coverage through their parent’ plans, at least when their parents get health insurance from their employers. Here’s why.
The Affordable Care Act (ACA) was designed to foster and build on health insurance plans that employers in the US provide to their employees. With limited exceptions such as provisions about wellness plans, it left in place the Employee Retirement Income Security Act of 1974 (ERISA), the federal statute that governs benefits that employers offer their employees. Rather than amending ERISA to place new federal requirements on employer-provided plans, ACA imposed a tax penalty (called a “shared responsibility payment”) on employers (with at least 50 full-time equivalent employees) with employees who receive tax credits for purchasing insurance through the ACA exchanges. This is the ACA “employer mandate,” aimed to deter employers from dumping their existing health care plans. It is the ACA provision that supported the mantra: “you’ll get to keep the insurance you have.” This mandate is imposed through a tax and otherwise leaves in place the regulatory vacuum created by ERISA. Let me explain how.
ERISA, enacted in 1974, is the federal statute that governs employee “welfare” plans: benefits, including health benefits, that employers offer their employees. Although ERISA imposes quite substantial requirements on pension plans, it imposes only disclosure and fiduciary responsibilities on welfare plans. Employers must state clearly for their employees what they are given—but may also reserve the right to change plans, as long as they tell their employees that they might do this. Employers also must manage their plans as a good fiduciary would, but this does not mean that employers must offer minimum benefits to their employees, or indeed any benefits at all. Continue reading →
This week we are joined by R. Alta Charo, the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin at Madison. Alta has also has served on the faculty of the UW Masters in Biotechnology Studies program and the Dept. of Medical History and Bioethics at the School of Medicine & Public Health at the University of Wisconsin.
Alta has written for JAMA and NEJM on stem-cell tourism (and its lessons for gene editing), among many other topics, applying her expertise on law & medical technology to a wide array of cutting edge controversies. Our conversation focuses on risk perception and reality in areas ranging from CRISPR-Cas9 (the breakthrough gene-editing technique) to teen pregnancy and reproductive health services. A distinguished scholar and top-level advisor to government and NGOs, Alta offers invaluable insights on a rapidly changing technological and political landscape.
The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher RadioTunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw
Last November, the National Health Executive (NHS) in the UK lost an appeal in the UK Court of Appeal regarding their failure to fund PrEP for individuals at risk of contracting HIV. PrEP, or Pre-Exposure Prophylaxis is a common term for regimes of anti-viral medication taken by individuals to lower their risk of being infected with HIV. Marketed as Truvada, clinical test results published by the National institute of Health in 2010 declared that the treatment could reduce the risk of contracting HIV by up to 90%, a rate that seemed farcical even in a world where information about HIV is more accessible than ever, and medical experimentation with cures has been steadily gaining steam. Based on those results, the U.S. Center for Disease Control issued interim guidelines for using the drug, despite the fact that it was over a year away from FDA approval, aware that doctors had been prescribing it off-label for HIV treatment. The titular quote is from former President Obama, speaking on World AIDS Day in 2011 about the breakthrough that PrEP represented. The story raises some fascinating questions about how doctors interact with experimental medicines when facing down diseases that will otherwise seriously compromise quality of life for patients, and even kill, but nonetheless remain unsanctioned by national healthcare providers and largely available through backchannels.
Block grants are all the rage. Take the latest G.O.P. proposal to repeal and replace the Affordable Care Act: the Graham-Cassidy bill. It proposes to replace the current system and instead give grants to the states, essentially taking the funds the federal government now spends under the ACA for premium subsidies and Medicaid expansion and give those funds to the states as a lump sum with little regulation.
There is a complicated formula by which the bill proposes divvying up this money among the states. Many think the formula is unfair, that it benefits red states over blue states, and that it just flat isn’t enough money. These are incredibly important concerns. But let’s put them to the side for just a moment and consider the theory behind block granting. Is there any world, for instance assuming that the amount and allocation of the funding could be resolved (probably crazy talk), in which switching to block granting may actually improve upon the status quo?
Proponents of block granting health care make two main arguments. First, it will reduce costs. By block granting Medicaid and the ACA subsidies, we end the blank check open entitlement that these programs have become and give states more skin in the game. Second, these cost savings will come from empowering states to innovate. States will become more efficient, improve quality, and solve their own state-specific problems.
These arguments have an understandable appeal. But how will states really react to providing health care coverage on a budget? Continue reading →
“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).
Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading →
From “Pharma Bro” Martin Shkreli to huge price jumps for the EpiPen to the Hepatitis C treatment that costs $1000 per pill, pharmaceutical pricing is a major issue in the news and in Washington. The regular introduction of new, often expensive therapeutics as well as controversial price increases for familiar drugs attract bipartisan attention and ensure that drug costs will remain an important topic of public policy debate.
This panel of experts will discuss current laws and regulations governing pharmaceutical pricing in the United States, the impact of breakthrough therapeutics on drug pricing, and the future of drug pricing policy in the United States.
Join Larry Levitt for a talk about the future of the Affordable Care Act and health care in America.
Larry Levitt is Senior Vice President for Special Initiatives at the Kaiser Family Foundation and Senior Advisor to the President of the Foundation. Prior to joining the Foundation, he served as a Senior Health Policy Advisor to the White House and Department of Health and Human Services. He holds a bachelors degree in economics from the University of California at Berkeley, and a masters degree in public policy from Harvard University’s Kennedy School of Government.
Jody L. Madeira is Professor of Law and Louis F. Niezer Faculty Fellow at the Indiana University Maurer School of Law. Her scholarly interests primarily involve the intersection of law and emotion in criminal and family law. Madeira’s new book, Killing McVeigh: The Death Penalty and the Myth of Closure, applies collective memory to criminal prosecution and sentencing, exploring the ways in which victims’ families and survivors came to comprehend and cope with the Oklahoma City bombing through membership in community groups as well as through attendance and participation in Timothy McVeigh’s prosecution and execution. She is also actively involved in empirical research projects assessing patient decision making and informed consent in assisted reproductive technology (ART).
Additionally, Madeira investigates the effects of legal proceedings, verdicts, and sentences upon victims’ families; the role of empathy in personal injury litigation; and the impact of recent developments in capital victims’ services upon the relationship between victims’ families and the criminal justice system.
Madeira earned her JD magna cum laude from the University of Pennsylvania School of Law, where she was elected to the Order of the Coif and served as Senior Articles Editor for the University of Pennsylvania Journal of Constitutional Law. She clerked for the Hon. Richard D. Cudahy at the U.S. Court of Appeals for the Seventh Circuit. She then came to Harvard as a Climenko Fellow and Lecturer in Law, where she taught legal research and writing as well as a seminar on the cultural life of capital punishment. Madeira also recently served as a Research Associate at the Capital Punishment Research Initiative at the School of Criminal Justice, University at Albany, State University of New York.
Presently in England clinical negligence costs are high and are set to grow even higher. The National Audit Office (NAO) has recently examined clinical negligence costs and they go into some detail on the costs of claims and make a number of important recommendations in a report. Very useful insights are given on the management of clinical negligence claims in the NHS. There is a focus on clinical negligence claims managed through the NHS Resolution’s indemnity scheme, the Clinical Negligence Scheme for Trusts (CNST). Trusts pay contributions to this scheme which is a risk pool and when a legal claim is made against them NHS Resolution takes over the claim and meets the associated costs. The NAO argue that urgent changes are needed to deal with the problem of the increasing costs of clinical negligence claims.
Stakeholders’ engagement is key to achieving the promises of precision medicine research. It is needed in order to establish a sufficiently powered cohort of diverse groups that will allow tailoring disease diagnosis, treatment, and prevention to individual variability in genes, environment, and lifestyle. It is also needed to ensure that research priorities are in sync with the health needs of participants and for curtailing health disparities in the US.
Cognizant of these issues, precision medicine initiatives, including are increasingly investing time and resources to engage potential participants in their studies. the All of Us Research Program (AoU) is exemplary in this regard, focusing in particular on racial and ethnic minorities as well as Native Americans who have been historically underrepresented in genomic research.
But what about people with disabilities?
This question may seem to be off target. After all, persons with disabilities have long been prime targets of genotyping, and their enrollment in genomic research is ongoing.