REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Health Care Sharing Ministries (HCSMs) after Tax-Penalty Repeal

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portrayal of the bill, it seems as if the Individual Mandate – an essential element in the ACA – has been fully repealed.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 Therefore, although the tax bill repealed the tax penalty for not having insurance coverage, the law still technically mandates individuals to acquire health insurance.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

Searching For Stability: The Political Future Of The Affordable Care Act

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. […]

Read the full article here!

With The Federal Individual Mandate Gone, States Might Step Up: Lessons From Massachusetts

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. […]

Read the full article here!

Solitary Confinement: Torture, Pure and Simple

Cross-posted from the Psychology Today blog, where it originally appeared on January 15, 2018. 

By Gali Katznelson and J. Wesley Boyd

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.

Continue reading

Crimes of Passion: New Neuroscience vs. Old Doctrine

Crimes of Passion: New Neuroscience vs. Old Doctrine
February 14, 2018 12:00 PM
Wasserstein Hall, Milstein West (2019)
Harvard Law School, Cambridge, MA

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.

Panelists:

  • 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.

Whither Private Health Insurance Now?

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. […]

Read the full article here!

The Individual Insurance Market In 2018: Business As Usual?

This new post by Joseph Antos 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 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. […]

Read the full article here!

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Colorado Supreme Court Hears Important Case Re Constitutional Issues on Dispute About Frozen Preembyros – My Take on Oral Argument

By I. Glenn Cohen

On Tuesday, January 9th, the Colorado Supreme Court heard oral argument in In Re Marriage of Rooks. (Kudos to them for live streaming and archiving!)

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.

Continue reading

Bioethicist Art Caplan: A New Mind-Body Problem

A new piece by Bill of Health contributor Arthur Caplan, with Lisa Kearns, in The Hastings Center Bioethics Forum:

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? […]

Read the full article here!

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

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!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Will the Sun Shine All Over Canada? Making Transparent the Financial Relationships of the Medical Industry (Part 2: Towards Effective Transparency)

By Jean-Christophe Bélisle-Pipon

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

The Opioid Crisis Requires Evidence-Based Solutions, Part III: How the President’s Commission on Combating Drug Addiction Dismissed Harm Reduction Strategies

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

Will the Sun Shine All Over Canada? Making the Financial Relationships of the Medical Industry Transparent (Part 1: Theoretical Transparency)

By Jean-Christophe Bélisle-Pipon

While Canada is often viewed positively for its public, comprehensive, universal, and accessible health care system, not all is rosy. Canada often lags behind other countries in terms of pharmaceutical policies. Sometimes, this is advantageous (e.g., delaying the approval of a product to wait for more clinical data or real-world efficiency, so to better assess risk-benefit and determining the maximum selling price), but more often simply a problem: until recently, transparency in Canada was more a buzzword than a strong and assumed government stance.

However, a few days ago in Ontario, the omnibus Strengthening Quality and Accountability for Patients Act received royal assent, thus enacting the Health Sector Payment Transparency Act. This clearly marked the beginning of shedding light on the financial relationships and payments to health care providers and organizations made by the medical industry (pharmaceutical and medical device companies), the explicit goal being to strengthen patient trust in the health care system (including research and education activities) by allowing patients to assess whether their health care providers are subject to influence by industry and to foster more informed choice. While the United States enacted the Physician Payments Sunshine Act (PPSA) in 2010, which requires payment disclosure, this is a first in Canada.

The main provisions of the Act Continue reading

Register Now! The Policy, Politics & Law of Cancer Conference, Feb 8-9, 2018 at Yale Law School

Introducing Blogger Jean-Christophe Bélisle-Pipon 

The Petrie-Flom Center is pleased to welcome Jean-Christophe Bélisle-Pipon to the Bill of Health as our newest contributor!

Jean-Christophe is a Visiting Researcher at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School,  a Canadian Institutes of Health Research Postdoctoral Fellow, and a Fellow at the Health Law Institute at Dalhousie University.

A bioethicist by training, he is particularly interested in the marketing of health products and the resulting moral responsibility of regulators and industries. While his undergraduate studies in physics led him to pure science, his interest in the field of health and bioethics grew during his experiences in the pharmaceutical industry, where he worked for 6 years in clinical research and regulatory affairs, as well as in business intelligence, sales, and marketing.

His research also focuses on patient engagement in research by exploring ethical and logistical dimensions as well as providing guidance for capacity development of future researchers. Jean-Christophe is also interested in how researchers can engage the general public to reflect on the most pressing ethical issues of our time, including by mingling arts and bioethics to advance these reflections in the public space. He will be the new Managing Editor of the Journal of Law and the Biosciences beginning January 2, 2018.

Welcome, Jean-Christophe!

Considering Direct-to-Consumer Genetic Testing? Spit with Caution

By Gali Katznelson

A friend and I had been vaguely entertaining the idea of ordering genetic testing kits for some time. Then, Black Friday happened. My friend called me to share that 23andMe was on sale, 50% off, for 1 more hour! Typing our credit card information into Amazon, we tossed around some half-reasoned arguments in favor of our impulsive purchases: “this’ll be a fun science experiment”, “what if we catch something preventable in time to make lifestyle changes?” and, “we really should be contributing our data to research for the public good.” Within minutes, two kits were ordered and thanks to the magic powers of Amazon Prime, these boxes appeared on our doorsteps within days. Few things in life are as exciting as receiving a mail delivery, but as we unwrapped our packages, finding the words “Welcome to You” plastered on our shiny white Pandora’s boxes, somehow our excitement began to dwindle. One month later, our boxes remain unopened.

Genetic testing is clearly something we should have given more thought before the marketing geniuses got the best of us. Here are some questions anyone considering taking a direct-to-consumer (DTC) genetic test should answer (ideally before buying the test):

Continue reading

The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President’s Commission on Combating Drug Addiction Ignored Promising Medical Treatments

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.

Continue reading