Wellness programs remain a popular feature of the employer landscape, but the legal environment surrounding them has long been uncertain. In April 2015, the Equal Employment Opportunity Commission took a significant step toward resolving this uncertainty by formally proposing a ruleclarifying the applicability Americans with Disabilities Act of 1990 (ADA) to wellness programs.
In doing so, it staked out middle ground between an approach that would have sharply limited the use of incentives in wellness programs, and a more permissive approach consistent with regulations already in place under the Affordable Care Act (ACA). The proposed rule has the potential to shape, or reshape, future wellness programs. The extent to which it will do so, however, remains uncertain. […]
Tom Shakespeare is Senior Lecturer at Norwich Medical School, the University of East Anglia. From his website:
My primary research interests are in disability studies, medical sociology, and in social and ethical aspects of genetics. I have had a long involvement with the disabled people’s movement in UK and internationally. In the context of disability arts, I have also been active in arts and culture, and was a member of Arts Council England from 2003-2008. While at Newcastle University, I developed an interest in science communication and public engagement, and helped develop the café scientifique movement in UK and across the world, as well as promoting sci-art projects. During my five years at WHO, I helped produce and launch key reports such as the World Report on Disability (WHO 2011) and International Perspectives on Spinal Cord Injury (WHO 2013), and was responsible for the UN statement on forced, coerced and otherwise involuntary sterilization (WHO 2014). This grew my interest in disability and international development.
I did my PhD at Cambridge University and then worked at the Universities of Sunderland, Leeds and Newcastle, before spending five years working at the World Health Organization in Geneva. In February 2013, I started my current post at Norwich Medical School. I continue to consult for WHO, World Bank and other UN agencies.
1993-1996 Lecturer, University of Sunderland
1996-1999 Research Fellow, University of Leeds
1999-2008 Research Fellow, University of Newcastle, where I co-founded and developed the Policy, Ethics and Life Sciences Research Institute.
2008-2013 Technical officer, Department of Violence and Injury Prevention and Disability, World Health Organization, Geneva.
New Guidelines issued by the IOC (International Olympic Committee) offer a new policy for the participation of transgender athletes in sports competitions. According to the new policy, transgender athletes should be given the option to compete without having to undergo genital re-construction surgery. Female to Male (F-M) transgender athletes will be allowed to compete without further limitations, however Male to Female (M-F) transgender athletes would be allowed to compete only after receiving hormonal treatment intended to keep testosterone levels under a fixed threshold for at least a year before the competition. This is a significant change to the previous guidelines, which recommended that transgender athletes be eligible to compete only after a genital re-construction surgery and two years of hormonal therapy. The committee explained that the change of policy was due to “current scientific, social and legal attitudes on transgender issues”. The overriding objective of all policies according to the IOC was ‘fair competition’, so whereas genital appearance was not considered to affect fairness, testosterone levels are still understood to generate a competitive edge.
The penalty for Bostonian jaywalkers can take dollars out of repeat offenders wallets. The $1 fine for jaywalking in the Massachusetts metropolis may be a ridiculous example of statutory dollar figures losing their significance, but the statutory dollar figures associated with Medicaid eligibility are anything but a laughing matter for millions of families.
The eligibility requirements around Medicaid expansion have ended the decades old practice of limiting assets for Medicaid coverage for children and parents. However, in order to qualify for many existing Medicaid programs, the elderly and people with disabilities in many states must still verify that their assets fall below a certain dollar figure. Oftentimes, this dollar figure is statutory and requires state legislatures to act in order to have the figure rise with inflation.
Asset tests were first incorporated into Medicaid law under the original legislation because welfare benefits required strict means and asset tests. These levels were determined at the state level. As eligibility was separated from welfare eligibility, specific dollar figures on assets were added to eligibility criteria and were meant to curb enrollment by “welfare queens” or people that qualify for social assistance fraudulently or with significant assets. President Reagan first campaigned on the concept of “welfare queens” in his failed 1976 bid for the presidency. But these fraudulent cases that the policy is meant to restrict are limited and more often the imposed asset tests prevent working-age adults from reducing dependency on social welfare programs.
Ashley is young woman who was born in 1997 with a severe mental and physical disability that prevented her from ever eating, walking or talking by herself. Her mental capacity was also not expected to develop further than that of an infant. In 2004, When she was six and a half years old, Ashley‘s parents and the Seattle Children’s hospital physicians who had been treating her sought to perform on Ashley a novel medical intervention that would include hormonal treatment for growth attenuation, surgical removal of her breast buds, and a hysterectomy. This surgical intervention was presented as beneficial to Ashley by allowing her parents to take care of her longer and postpone institutionalization. The removal of breast buds and hysterectomy were meant to spare Ashley the pain and discomfort of menstruation and the development of fully-developed breasts, and also to “avoid sexualization” in order to make her less vulnerable to sexual abuse when she was ultimately institutionalized. Continue reading →
A recent study in JAMA by Dorner, Jacobs, and Sommers released some good and bad news about provider coverage under the Affordable Care Act (ACA). The study examined whether health plans offered on the federal marketplace in 34 states offered a sufficient number of physicians in nine specialties. For each plan, the authors searched for the number of providers covered under each specialty in each state’s most populous county. Plans without specialist physicians were labeled specialist-deficient plans. The good: roughly 90% of the plans covered more than five providers in each specialty. The bad: 19 plans were specialist-deficient and 9 of 34 states had at least one specialty deficient plan. Endocrinology, psychiatry, and rheumatology were the most commonly excluded specialties.
Here’s where it gets ugly.
Excluding certain specialists from coverage can be a way for insurers to discriminate against individuals with certain conditions by excluding them from their plans. By excluding rheumatologists, insurers may prevent enrolling individuals with rheumatoid arthritis; by excluding endocrinologists, insurers may prevent enrolling individuals with diabetes. Individuals with chronic conditions need to see specialists more frequently than healthier adults, and how easily a patient with chronic conditions can see a specialist can affect his health care outcomes.
The study adds to the growing body of empirical research showing that even after the ACA, insurers may be structuring their plans to potentially discriminate against individuals with significant chronic conditions. In January, Jacobs and Sommers published a study showing that some plans were discriminating against patients with HIV/AIDS through adverse tiering by placing all branded and generic HIV/AIDS drugs on the highest formulary tier. Another study found that 86% of plans place all medicines in at least one class on the highest cost-sharing tier. These studies show that despite being on a health plan, individuals with certain chronic conditions may still have trouble accessing essential treatments and services. Continue reading →
Last week, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule implementing section 1557 of the Affordable Care Act (ACA). Section 1557 applies the Rehabilitation Act of 1973 to the ACA so that a covered entity cannot discriminate against an individual on the basis of a disability in any health program or activity. The proposed rule clarified how OCR intended to enforce and interpret section 1557’s nondiscrimination provision.
As Timothy Jost and other commentators have noted, the government’s proposed interpretation of section 1557 significantly expands the number of health entities that need to meet the Rehabilitation Act’s nondiscrimination requirements. The regulation proposes to encompass all entities that operate a health program or activity, any part of which receives federal financial assistance. The regulation then broadly interprets “federal financial assistance” to include “subsidies and contracts of insurance.” Thus, an insurer receiving premium tax credits or cost-sharing reduction payments through participating in a health insurance Marketplace would need to ensure that all its health plans meet the Rehabilitation Act’s nondiscrimination requirements, regardless of whether the plans are sold through the Marketplace, outside the Marketplace, or through an employee benefit plan. This broad interpretation means that the Rehabilitation Act’s nondiscrimination provisions will now apply to a number of previously excluded plans.
Expanding the number of plans needing to meet section 1557’s nondiscrimination requirements will provide greater protection to more individuals with disabilities. In the United States, the Rehabilitation Act and the Americans with Disabilities Act (ADA) prohibit discrimination against individuals with disabilities. Both acts protect disabled individuals, but courts have consistently interpreted only the Rehabilitation Act as prohibiting insurers from designing their health plans to discriminate against individuals with disabilities. On the other hand, courts have held that the ADA provides a safe harbor for insurers when designing their benefit plans. Thus, some insurers under the ADA may be able to exclude all drugs treating HIV/AIDS from their formulary or place all drugs treating HIV/AIDS on the highest cost-sharing tier, benefit designs that the Rehabilitation Act would likely prohibit. See also Kelsey Berry’s post on this topic. Continue reading →
What should the future look like for brain-based pain measurement in the law? This is the question tackled by our concluding three contributors: Diane Hoffmann, Henry (“Hank”) T. Greely, and Frank Pasquale. Professors Hoffmann and Greely are among the founders of the fields of health law and law & biosciences. Both discuss parallels to the development of DNA evidence in court and the need for similar standards, practices, and ethical frameworks in the brain imaging area. Professor Pasquale is an innovative younger scholar who brings great theoretical depth, as well as technological savvy, to these fields. Their perspectives on the use of brain imaging in legal settings, particularly for pain measurement, illuminate different facets of this issue.
This post describes their provocative contributions – which stake out different visions but also reinforce each other. The post also highlights the forthcoming conference-based book with Oxford University Press and introduces future directions for the use of the brain imaging of pain – in areas as diverse as the law of torture, the death penalty, drug policy, criminal law, and animal rights and suffering. Please read on!
The recent meeting at Harvard on neuroimaging, pain, and the law demonstrated powerfully that the offering of neuroimaging as evidence of pain, in court and in administrative hearings, is growing closer. The science for identifying a likely pattern of neuroimaging results strongly associated with the subjective sensation of pain keeps improving. Two companies (and here) recently were founded to provide electro-encephalography (EEG) evidence of the existence of pain. And at least one neuroscientist has been providing expert testimony that a particular neuroimaging signal detected using functional magnetic resonance imaging (fMRI) is useful evidence of the existence of pain, as discussed recently in Nature.
If nothing more is done, neuroimaging evidence of pain will be offered, accepted, rejected, relied upon, and discounted in the normal, chaotic course of the law’s evolution. A “good” result, permitting appropriate use of some valid neuroimaging evidence and rejecting inappropriate use of other such evidence, might come about. Or it might not.
We can do better than this existing non-system. And the time to start planning a better approach is now. (Read on for more on how)
By Frank Pasquale, Professor of Law, University of Maryland Carey School of Law
Many thanks to Amanda for the opportunity to post as a guest in this symposium. I was thinking more about neuroethics half a decade ago, and my scholarly agenda has, since then, focused mainly on algorithms, automation, and health IT. But there is an important common thread: The unintended consequences of technology. With that in mind, I want to discuss a context where the measurement of pain (algometry?) might be further algorithmatized or systematized, and if so, who will be helped, who will be harmed, and what individual and social phenomena we may miss as we focus on new and compelling pictures.
Some hope that better pain measurement will make legal disability or damages determinations more scientific. Identifying a brain-based correlate for pain that otherwise lacks a clearly medically-determinable cause might help deserving claimants win recognition for their suffering as disabling. But the history of “rationalizing” disability and welfare determinations is not encouraging. Such steps have often been used to exclude individuals from entitlements, on flimsy grounds of widespread shirking. In other words, a push toward measurement is more often a cover for putting a suspect class through additional hurdles than it is toward finding and helping those viewed as deserving.
Of Disability, Malingering, and Interpersonal Comparisons of Disutility (read on for more)
As someone who has been greatly concerned about and devoted much of my scholarship to legal obstacles to the treatment of pain, I applaud Professor Pustilnik for increasing attention to the role of neuroimaging in our efforts to understand our experience of pain and how the law does or does not adequately take into account such experience. Pustilnik has written eloquently about this issue in several published articles but her efforts to bring together scientists, medical experts, legal academics, and judges (see also here) deserves high praise as a method for illuminating what we know and do not know about pain and the brain and to what extent brain imaging can serve as a diagnostic tool or an external validator of pain experience.
In this post, I discuss how DNA testing serves as a precedent for how to develop responsible uses of new technologies in law, including, potentially, brain imaging for pain detection. The ethical, legal, and social implications (ELSI) of DNA research and testing were integral to developing national protocols and rules about DNA. Brain imaging of pain needs its own ELSI initiative, before zealous adoption outpaces both the technology and the thinking about the right guiding principles and limitations.
The idea of brain images serving as a “pain-o-meter” to prove or disprove pain in legal cases is clearly a premature use of this information and likely an over simplification of the mechanisms of pain expression. However, the potential for an objective diagnostic tool or indicator of the pain experience is something that lawyers representing clients in criminal, personal injury, workers comp or disability cases may find too attractive to resist and attempt to have admitted in the courtroom. This state of affairs brings to mind the ways in which lawyers have attempted to use genetic test results, initially obtained for medical purposes, in litigation. (Read on for more about ELSI in DNA and several national pain initiatives that could adopt the Human Genome Project and DNA ELSI model).
A potential difficulty, but also an opportunity, relating to using neuroimaging evidence in legal cases arises from the difficulty brain researchers have in separating emotional and physical pain. We know that pain and emotion are tightly linked. In fact, “emotion” is in the very definition of pain. The IASP definition of pain is: “An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.” Yet, the legal system deals with “physical” versus “psychiatric” versus “emotional” pain in different ways.
Chronic pain is associated with anxiety, depression, and stress. These factors can exacerbate the pain, and pain can exacerbate them. Pain’s sensory and emotional components connect in a “feed-forward” cycle. It may not be possible to entirely separate the sensory and emotional components of pain, biologically or experientially. But it might be necessary for the purposes of legal cases, as important areas of law create sharp distinctions between physical and emotional, or body and mind.
Neurolaw includes some fascinating issues that lack any practical legal significance – for example whether we should consider anyone responsible for anything they do, given that all behavior is physically caused by brain processes. It also includes some legally important issues that lack intellectual juiciness – like regulatory issues surrounding neurotechnology.
Pain, I learned at this meeting, is at the heart of many legal proceedings. A major problem to be solved in these proceedings is the determination of whether someone is truly in pain. Chronic pain in particular may not have physically obvious causes. There may be clinical and circumstantial evidence of pain – like adhering to a medication regime, seeking surgeries or other interventional procedures, and avoiding pleasurable activities – but often the major evidence of pain is just what someone says that it is. However, the motivation exists to lie about pain – to sue for more money, to obtain disability benefits – and so an objective measure of pain, a “pain-o-meter,” would be helpful.
France recently confronted its version of America’s 2005 Schiavo case (in which the Florida Supreme Court upheld a spouse’s determination to end life support to a permanently unconscious patient despite the patient’s parents’ objections). In 2014, France’s Conseil d’Etat ruled that artificial nutrition and hydration (ANH) could be withdrawn from a permanently vegetative patient based on oral statements that the patient had made, while competent, indicating unwillingness to be medically sustained in such a condition. The patient’s objecting parents then sought a declaration from the European Court of Human Rights (ECHR) that such termination of life support would violate the European Convention on Human Rights. On June 5, 2015, the ECHR rejected the objecting parents’ contention, finding that France’s approach met human rights standards both in the process and the criteria followed by medical personnel in deciding to end life support. Lambert v. France, #46043/14 (ECHR 2015).
Vincent Lambert, then 32 years old, was grievously injured in a 2008 traffic accident. He suffered massive brain trauma and was hospitalized for the next 7 years at Reims University Hospital. His precise medical status was initially uncertain. In July 2011, a medical evaluation found him to be “minimally conscious plus.” Over the next year and a half, he underwent 87 speech therapy sessions which failed to establish any code of communication between Mr. Lambert and his surroundings. In early 2013, the attending physician, Dr. Kariger, initiated a process to review Mr. Lambert’s condition and to determine whether the ANH sustaining Mr. Lambert should be withdrawn.
The process that followed was extensive. During 2013, Dr. Kariger consulted with 6 physicians concerning the patient’s mental status and held 2 family meetings at which Mr. Lambert’s wife, Rachel, his parents, and 8 siblings were present. In January 2014, Dr. Kariger announced his determination to end artificial nutrition and reduce hydration. Dr. Kariger’s written report explained that Mr. Lambert had become permanently unaware of his environment and, according to accounts of Mr. Lambert’s prior oral expressions, he would not wish to be medically sustained in such a debilitated condition. Five of the six medical consultants agreed, as did the patient’s wife and 6 of his 8 siblings.
29-year old Brittany Maynard has captured national headlines this week by publicly announcing her intention to end her own life on November 1st. She did so in an effort to raise funds for and awareness of the non-profit Compassion and Choices.
Maynard was diagnosed earlier this year with an aggressive brain cancer and has moved to Oregon for access to its death with dignity laws. Those laws have allowed her to be prescribed a fatal dose of medication by a physician to be taken at the time and place of her choosing. Maynard sees the prescription as a means of avoiding a potentially long, painful and de-humanizing decline in her health.
In light of Maynard’s case, virtually every major media outlet has featured a bit of medical ethics this week. Maynard’s own voice first appeared in People Magazine, announcing her intention to end her own life. Therein, Maynard is clear that she does not consider herself to be planning for suicide. Continue reading →
I am excited to join the Petrie-Flom Center as the first Senior Fellow in Law & Applied Neuroscience. This fellowship is the product of an innovative partnership between the Petrie-Flom Center and the Center for Law, Brain and Behavior (CLBB) at Massachusetts General Hospital. This partnership aims to translate developments in neuroscience into legal applications, remaining sensitive to the normative dimensions of many – if not all – legal questions. The field of law & neuroscience is large and growing, addressing questions that intersect with nearly every area of law and a huge range of social and human concerns. CLBB is bringing together scientists, bioethicists, and legal scholars to look at questions ranging from criminal responsibility and addiction, to mind-reading and brain-based lie detection, to how the brain’s changes over our lifecourse affect our capacities to make decisions.
In the first year of this joint venture, we will be focusing on a set of issues with potentially huge implications for the law: The problem of pain. Pain is pervasive in law, from tort to torture, from ERISA to expert evidence. Pain and suffering damages in tort add up to billions of dollars per year; disability benefits, often awarded to people who suffer or claim to have chronic pain, amount to over one hundred billion annually. Yet legal doctrines and decision-makers often understand pain poorly, relying on concepts that are out of date and that can cast suspicion on pain sufferers as having a problem that is “all in their heads.”
Now, brain imaging technologies are allowing scientists to see the brain in pain – and to reconceive of many types of pain as diseases of the central nervous system. Brain imaging shows that, in many cases, the problem is literally in sufferers’ heads: Long-term pain changes the structure and function of the brain, perpetuating non-adaptive pain and interfering with cognitive and emotional function. Continue reading →
The U.S. Supreme Court has not in recent years held the views of the American Psychological Association (APA) in so high regard as it did this week.
In 2012, the Court set aside the APA’s arguments for why due process requires the exclusion of eyewitness testimony obtained under suggestive circumstances that rendered it especially likely to be unreliable.
And in 2011, when the Court struck down on free speech grounds a state regulation on violent video games, it gave short shrift to the APA’s warnings about those games’ connection to violent behavior in young boys.
But in its recent death penalty decision, Florida v. Hall, the Court relied heavily on important APA insights in declaring it unconstitutional for states to set an IQ cutoff to determine whether a prisoner is eligible to receive capital punishment. Continue reading →
In our legal system, colleges may not make admissions decisions in order to ameliorate historical (or presumably other) inequalities, but may make decisions that take into account the particular situation of the applicant or that strive to create a diverse student body. Justice Powell rejected the former two goals in Part IV of his Bakke opinion, which went uncontradicted in the Grutter opinion that followed it and, most recently, the Fisher opinion almost exclusively focused on the diversity justification. Whether or not it appears in court opinions however, the issue of transformative justice is very much at stake – colleges, as the gatekeeper to many of the high honors and offices of our society, can control the distribution of a set of goods to the rising generation and decide how equally they are distributed among certain groups. Here we will imagine that transformative justice is indeed the goal of affirmative action.
Colleges have two tools by which they can currently select among students based on disadvantage (historical or otherwise). First, there is the demographic and socioeconomic information disclosed in the application. Although these questions are optional, for those students who answer the questions, schools may use these answers as signals for disadvantage and take this into account. Second, there is the essay questions, which frequently ask about an instance in which the applicant overcame adversity. Here the applicant can demonstrate the degree of disadvantage experienced or explain some more nuanced disadvantage not revealed in the first part.
These two tools are far from perfect, but let us take our imagining further and envision a world in which colleges could accurately determine disadvantage. If it decides to take on the latter, mental health may pose an insurmountable problem – individuals with intellectual disabilities may not be able to thrive in the setting offered by the institutions that select them.
In recent years, providers have attempted to shift how health care is delivered so as to include the patient in the decision-making process. This concept of shared decision-making was most memorably relayed to me in medical school through a critical lesson during which we were instructed to replace the word “noncompliant” with “non-adherent” when describing patients who were unwilling or unable to stick with treatment regimens. Noncompliance painted a picture of a paternalistic provider mandating the rules of play, while the patient cowered below as a disobedient subordinate. It also implied that the patient did something wrong by breaking the rules and that the actions of the patient ought to be modified to fit the rules, rather than the other way around. On the other hand, non-adherence signified that the patient was a contributing partner in the development of the treatment plan and, further, that he may be justified for not abiding by the terms of his plan.
There were two overarching reasons for the shift to the shared decision-making model: first, that this would produce better overall clinical results and second, that this view shows more respect for patient autonomy. Providers were learning and accepting that treatment plans prescribed within their vacuums could fail to be affordable, intelligible, or even realistic given a patient’s life circumstances.
So how does this relate to law students and lawyers?
The DSM is the reference used by clinicians, researchers, and insurers to diagnose and classify mental disorders, with the intent to provide specific, objective criteria by which to assess symptoms and determine whether to pay for treatment. The American Psychiatric Association released the manual’s fifth edition in May 2013, nearly twenty years after the fourth edition, to substantial public and professional criticism. Please join us for a discussion of the new revisions and their implications for patients, medical practice, research, and the law.
Steven E. Hyman, Director of the Stanley Center for Psychiatric Research at the Broad Institute and Harvard University Distinguished Service Professor of Stem Cell and Regenerative Biology
Anne Becker, Maude and Lillian Presley Professor of Global Health and Medicine, Harvard Medical School
Nita Farahany, Professor of Law, Professor of Genome Sciences & Policy, and Professor of Philosophy at Duke University
Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School; Faculty Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics