Academic Fellow Rachel Sachs in the SCOTUSblog, on King v. Burwell

Academic Fellow Rachel Sachs was quoted today in the SCOTUSblog:

Wednesday’s oral arguments in King v. Burwell, the challenge to the availability of tax subsidies for individuals who purchase their health insurance on a marketplace created by the federal government, continue to dominate coverage of and commentary on the Court.  In The Wall Street Journal, Louise Radnofsky and Jess Bravin report that “Justice Samuel Alito ’s suggestion that the Supreme Court could delay for months the impact of a decision to gut the health law revives the possibility that at least a dozen states could take action to limit the effect of such a ruling.”  AtFiveThirtyEight, Oliver Roeder writes that “Solicitor General Donald Verrilli won Wednesday’s oral arguments in King v. Burwell, the latest challenge to the Affordable Care Act. Or at least that’s what the wisdom of the crowd is telling us.”

[...]  At Harvard’s Bill of Health Blog, Rachel Sachs notes that “the Court displayed a more sophisticated understanding of the consequences of a decision striking down the subsidies in states that have not established their own exchanges.”

Read the full article here. See Rachel Sachs’ original post here.

MONDAY (3/9): Gender (Re)assignment: Legal, Ethical, and Conceptual Issues

genderreassignment_slideGender (Re)assignment: Legal, Ethical, and Conceptual Issues

Monday, March 9, 2015 12:00 PM

Pound Hall, Room 102, Harvard Law School, 1563 Massachusetts Avenue, Cambridge, MA

Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality.  Join us for a wide-ranging panel discussion.

Panelists include:

  • Noa Ben-Asher, Visiting Associate Professor of Law, Harvard Law School
  • Elizabeth F. Emens, Isidor and Seville Sulzbacher Professor of Law, Columbia Law School
  • Gerald L. Neuman, J. Sinclair Armstrong Professor of International, Foreign, and Comparative Law, Harvard Law School
  • Matthew J.B. Lawrence, Academic Fellow, Petrie-Flom Center
  • Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School, and Faculty Director, Petrie-Flom Center

This event is free and open to the public. Lunch will be served.

Cosponsored by the Human Rights Program at Harvard Law School and Lambda at Harvard Law School.

Check out the latest news from the Petrie-Flom Center!

PFC_Banner_DrkBlueCheck out the March 6th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

KIngKing v. Burwell and the Future of the Affordable Care Act

April 1, 2015

8:00 AM – 12:00 PM
Wasserstein Hall, Milstein East B
Harvard Law School
1585 Massachusetts Avenue
Cambridge, MA

A full agenda is available on our website. Register here!

This Term, in King v. Burwell, the Supreme Court will consider whether the Affordable Care Act permits the government to extend tax-credit subsidies to citizens of states that have chosen not to establish their own insurance exchange. If the Court rules that these subsidies are not permitted under the law, the fallout will be extensive and possibly devastating to state insurance markets, and countless local, state, and federal actors will have to decide how to move forward.  This event will bring together scholars and practitioners in the fields of law, public health, and economics to evaluate the oral argument in the case and consider how the Court is likely to rule before exploring the likely impacts of a decision against the government and finally beginning to build groundwork for politically-viable fixes at all levels of public and private involvement.

This event is supported by the Oswald DeN. Cammann Fund.

For more on news and events at Petrie-Flom, see the full newsletter.

Introducing New Blogger Zack Buck

Isaac BuckIsaac D. (“Zack”) Buck is joining Bill of Health as a regular contributor.

Zack is an assistant professor at Mercer University School of Law in Macon, Georgia, where he teaches torts and various health law courses.  His scholarship focuses on how the enforcement of health care fraud and abuse laws impacts American quality of care.  In 2013, he was selected as a Health Law Scholar as part of the ASLME Health Law Scholars Workshop at Saint Louis University School of Law, and he has participated in the new scholars programs at both AALS and SEALS.

Before joining Mercer, Professor Buck was a visiting assistant professor at Seton Hall University School of Law in Newark, New Jersey, where he taught bioethics, mental health law, and health care fraud and abuse.  He also has served as a visiting professor at Hamline University School of Law in St. Paul, Minnesota, where he has taught health care fraud and abuse.  He formerly practiced law at Sidley Austin LLP in Chicago.  Zack holds a J.D. from the University of Pennsylvania Law School, where he served as an Arthur Littleton and ­­H. Clayton Louderback Legal Writing Instructor and an associate editor of the University of Pennsylvania Journal of International Law.  He also holds a Masters of Bioethics from the University of Pennsylvania School of Medicine Center for Bioethics and a B.A. with highest distinction from Miami University (OH).

Recent publications:

The “Right to Try” – Compassionate Use of Experimental Medicine, 5th Annual Cathy Shine Lecture

SHINE_headerThe “Right to Try” –  Compassionate Use of Experimental Medicine

5th Annual Cathy Shine Lecture

Thursday, March 19, Noon – 1 p.m.
Boston University Medical Campus Instructional Building
Bakst Auditorium
72 East Concord Street, Boston, MA
Free and open to the public
Reception will follow

Is it fair to use social media or personal connections to get experimental drugs? Is it possible to reconcile so-called “right to try” laws—which allow patients access to novel, unapproved treatments—with evidence-based medicine and a drug-approval process charged with ensuring safe and effective medicines? Professor Caplan examines whether the duty to rescue should play a role in regulatory policies, physician advocacy, and corporate behavior in the US. Continue reading

Open Payments: Early Impact And The Next Wave Of Reform

A new post by Tony Caldwell and Christopher Robertson on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

The Physician Payments Sunshine Act, a provision in the Affordable Care Act, seeks to increase the transparency of the financial relationships between medical device and drug manufacturers, physicians, and teaching hospitals. Launched on September 30, 2014 by the Centers for Medicare & Medicaid Services (CMS), the Open Payments database collects information about these financial relationships and makes that information available to the public.

As of early February, the Open Payments database includes documentation of 4.45 million payments valued at nearly $3.7 billion made from medical device and pharmaceutical manufacturers to 546,000 doctors and 1,360 teaching hospitals between August 2013 and December 2013. This included 1.7 million records (totaling $2.2 billion) without the names of physicians or teaching hospitals who received the payments.

These records were intentionally de-identified by CMS because the records had not been available for review and dispute for 45 days, or because the records were not matched by CMS to a single physician or teaching hospital due to missing or inconsistent information within the submitted records. Future reports will be published annually and will include data collections from a full 12 month period. [...]

Continue reading here.

Bioethicist Art Caplan: Why Are Guns a Taboo Topic on Campaign Trail?

A new piece by contributor Art Caplan on NBC News:

Guns are a medical issue — no matter how often the NRA denies it. Eight national health groups, including the American Academy of Pediatrics, just released a joint statement echoing that sentiment.

But among the barrage of media questions leveled at politicians on the presidential campaign trail, no one is asking the contenders about firearms. The topic appears to be strangely and entirely off limits.

Everything else seems to be fair game: Do you think President Obama loves this country? What do you think about vaccines? Do you believe in evolution? Did you embellish anything on your resume? Do embryos have rights? Are you too old, fat, short, ill-tempered, religious, atheistic, feminist, or in the pocket of your donors to make a good President? [...]

Continue reading here.

Naturopaths — Not What The Doctor Ordered For Vaccine Exemptions

A new piece by contributor Art Caplan in Forbes:

There are lots of reasons why measles, having gone to Disneyland, is enjoying a comeback around the United States and Canada. Unfounded fears of autism scare some parents. Others buy the daffy conspiracy theory that pharmaceutical companies are just pushing vaccination to make a buck. Some parents invoke religious concerns despite that fact that hardly any religions think vaccination is bad and most teach that it is an obligation in order to protect children and the vulnerable in the community.

One key reason behind falling vaccination rates is that if you believe any of the above untruths it is very easy to get an exemption. Most states let you out on religious or philosophical grounds. Every state excuses you or your kids for health reasons. So you might presume those ducking vaccines get approval to dodge vaccination from physicians. Uh uh. In 17 states, D.C. and Puerto Rico naturopaths, healers who believe in a mishmash of nutritional medicine, botanical medicine, naturopathic physical medicine including chiropractic manipulative therapy, rolfing, iridology, and homeopathy among other New Agey philosophies can get licenses in their state. There are thousands practicing in the United States. Put aside the issue of why states are recognizing these ‘healers’ who rely on an evidence base only a few steps above astrology and palm-reading. The fact is in many states a naturopath can excuse a child from vaccination. And since many naturopaths take a pretty dim view of vaccination they give a lot of exemptions. [...]

Read the full article here.

An Opening for Measles: Anti-Vaccination Trend a Growing Concern

An article in the Harvard Gazette about our panel “Measles, Vaccines, and Protecting Public Health,” convened on February 25, 2015:

The numbers paint a telling picture. In the United States of the 1950s there were between 3 million and 4 million annual cases of measles, a highly infectious virus that causes severe flu-like symptoms and a spreading red rash. Roughly 48,000 of those infected each year were hospitalized, and 400 to 500 died.

By 2000, through an effective and widely used vaccine, measles was essentially eliminated in the United States.

But for the last several years, the Centers for Disease Control and Prevention has reported a significant uptick. Last year, the CDC recorded more than 644 cases from 27 states, the worst since 2000. Only two months into 2015 the United States is facing more than 150 cases reported across the country, many of them tied to a December outbreak at Disneyland in California.

The resurgence involves measles-stricken travelers and American parents who don’t vaccinate their children. [...]

Continue reading here.

TOMORROW (3/4): The Policeman at the Elbow: The Neuroscience of Addiction, Self-Control, and Criminal Responsibility

The Policeman at the Elbow: The Neuroscience of Addiction, Self-Control, and Criminal Responsibility

drugs_freebasing_slideWednesday, March 4, 2015
12:00 PM 

Wasserstein Hall, Room 3019
Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA 02138

Do criminal penalties have any deterrent effect on drug addicts – people who already are willing to throw away their jobs, relationships, or even lives for their “fix”?  What does brain science tell us about addicts’ capacities to exert self control and to be held criminally responsible?  This panel discussion brings together a leading neuroscientist of addiction, a criminal law scholar, and a former judge to ask whether the law should reconsider aspects of responsibility and punishment in light of new science about self-control.

Panelists:

  • Joshua Buckholtz, Assistant Professor, Harvard University Department of Psychology
  • Amanda Pustilnik, Senior Fellow in Law and Applied Neuroscience, Petrie-Flom Center/Center for Law Brain and Behavior, and Associate Professor of Law at the University of Maryland School of Law
  • Judge Nancy Gertner, Senior Lecturer on Law, Harvard Law School

Part of the Project on Law and Applied Neuroscience.

Hospital-Based Active Shooter Incidents: Sanctuary Under Fire

Petrie-Flom Faculty Director I. Glenn Cohen has published a new co-authored article in the The Journal of the American Medical Association on active shooter incidents in hospital settings. From the article:

On January 20, 2015, Michael J. Davidson, MD, a cardiothoracic surgeon, was fatally shot on the premises of the Brigham and Women’s Hospital in Boston, Massachusetts. In the year leading up to this tragic day, a total of 14 active shooter incidents occurred in hospitals throughout the United States, leaving 15 fatalities in their wake. This reality and its potential amplification by copycats has reignited the debate over the adequacy of current and future hospital security arrangements. In this Viewpoint, we discuss the evolving frequency of hospital-based active shooter incidents, the relevant legal framework, and the role of hospitals and physicians in countering this threat.

As defined by the US Department of Homeland Security, an active shooter incident is one wherein “an individual is actively engaged in killing or attempting to kill people in a confined and populated area.” By several accounts, the overall prevalence of this otherwise rare occurrence is increasing. A study by the Federal Bureau of Investigation (FBI) reveals the overall number of active shooter incidents to have increased from 6.4 per year (2000-2006) to 16.4 per year (2007-2013). Similar rates have been reported for the hospital setting wherein the average number of active shooter incidents has increased from 9 per year (2000-2005) to 16.7 per year (2006-2011), claiming 161 lives in the process. It would thus appear that the frequency of hospital-based active shooter incidents has evolved to constitute at least a monthly occurrence. [...]

The political paralysis plaguing gun laws notwithstanding, hospitals are not without recourse in seeking to mitigate the threat of active shooter incidents. On the local advocacy front, advancing and enacting bills for gun-free zones in health care settings constitutes a worthy effort in that a comparable federal statute remains unlikely. Concurrently, selective locale-specific enhancement of hospital security arrangements may increase deterrence, thereby mitigating risk and civil liability. [...]

Read the full article here.

Obamacare and States Rights: on the same side of the line this time, in King v. Burwell

By Abbe Gluck

Next week the Court hears a major challenge to Obamacare, King v. Burwell. Readers of this blog know the case has deep importance for health care. But it also is a big case for law. I have previously detailed why the case is the big test for the Court’s current text-oriented statutory-interpretation philosophy known as textualism. Today, in Politico, I explain why the case is also fundamentally about state rights. The question is whether the Court’s many federalism-protecting doctrines–which, let’s not forget, the Court applied against the Government in the last Obamacare case–whether those federalism doctrines, like the Court’s textualist rules, are sufficiently legitimate and objective such they will apply regardless of which side they happen to support, even in a case as politicized as this one. After all, isn’t that the point of having a rule of law in the first place?

Here is an excerpt and a link. Continue reading

FREE REGISTRATION! Families Matter: Ethically, Legally, and Clinically

Families Matter: Ethically, Legally, and Clinically

child_pediatrician_slide_270_200_85_c1March 18 – 20, 2015

Harvard Medical School
Joseph B. Martin Conference Center
77 Avenue Louis Pasteur
Boston, MA 02115

A full agenda is available on our website.

We often talk, in bioethics, about individual autonomy.  Yet our most challenging ethical, legal and clinical controversies in health care often center around family roles and responsibilities: How should we handle parents’ refusals of medically recommended treatment or, conversely, parents’ requests to medicate or surgically alter their children?  What should be known, and by whom, about a child’s genome, especially when genetic information effects other family members?  What weight should be given to family interests in decisions about a child’s health care?  How should we think about 3-parent embryos? Gamete donors? Gestational mothers? What rights and responsibilities should fathers have with regard to decisions about abortion and adoption, for example, as well as health care decisions for their offspring?  Health care decisions might be messier, but maybe they would also be better if we gave more attention to family matters, and how families matter.

This multidisciplinary program has been developed to inform and deliberate with ethicists, health care providers, attorneys and the public about changes in conceptions of the family and medical technologies and practices that challenge moral conventions and contemporary law.  Faculty experts and participants will engage in thoughtful discussion regarding a broad range of ethical and legal issues that arise from new ways of creating and new ways of understanding families and providing health care for expectant parents, growing fetuses, infants, children, adolescents….and their families.

Co-sponsored with the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund.

Experts Talk Vaccine Opt-Out Parameters

An article in the Harvard Crimson about our panel “Measles, Vaccines, and Protecting Public Health,” convened on February 25, 2015:

There is a delicate balance between preserving individual rights and protecting public health when it comes to vaccines, experts argued at a panel discussion at Harvard Law School on Wednesday.

In the wake of the recent outbreak of measles in California, the panel emphasized the need for Americans to be more informed in their decisions for or against vaccination. While allowing an opt-out option to remain in place, the panel proposed making the opt-out process for vaccines more difficult. [...]

To read the full article, click here.

What Happens When A Retail Pharmacy Decides To Stop Selling Cigarettes?

A new post by Andrew Sussman on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

The sale of cigarettes and tobacco products at retailers with pharmacies has received considerable attention over the past year. The national debate reignited in February 2014, when CVS/pharmacy announced that we would quit the sale of cigarettes and tobacco products in our 7,800 pharmacies nationwide. In September 2014, we announced we were officially tobacco free — one month earlier than planned. This was met with kudos from the media, public health officials, and even the President of the United States.

But one question that did not receive anywhere near that level of attention was whether or not our actions would make a difference in the prevalence of smoking and, ultimately, in the public health.

Read the full post here.

BOOK LAUNCH (3/11): Identified versus Statistical Lives: An Interdisciplinary Approach

Book Launch: Identified versus Statistical Lives: An Interdisciplinary Approach

March 11, 2015 12:00 PM

Wasserstein Hall, Room 2012 Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Identified versus Statistical Lives: An Interdisciplinary Approach is an edited volume that grew out of the 2012 conference “Identified versus Statistical Lives: Ethics and Public Policy,” cosponsored by the Petrie-Flom Center, Edmond J. Safra Center for Ethics, and the Harvard Global Health Institute. The essays address the identified lives effect, which describes the fact that people demonstrate a stronger inclination to assist persons and groups identified as at high risk of great harm than those who will or already suffer similar harm, but endure unidentified. As a result of this effect, we allocate resources reactively rather than proactively, prioritizing treatment over prevention. Such bias raises practical and ethical questions that extend to almost every aspect of human life and politics.

The book talk and discussion will feature:

  • I. Glenn Cohen, co-editor, Petrie-Flom Faculty Director, Professor of Law at Harvard Law School
  • Norman Daniels, co-editor, Professor of Population Ethics and Professor of Ethics and Population Health, Harvard School of Public Health
  • Nir Eyal, co-editor, Professor of Global Health and Social Medicine (Medical Ethics), Harvard Medical School

Co-sponsored by the Harvard Law School Library, with support from the Harvard Global Health Institute.

NEW DATE (3/9): Gender (Re)assignment: Legal, Ethical, and Conceptual Issues

genderreassignment_slideGender (Re)assignment: Legal, Ethical, and Conceptual Issues

Monday, March 9, 2015 12:00 PM

Pound Hall, Room 102, Harvard Law School, 1563 Massachusetts Avenue, Cambridge, MA

Trans and intersex individuals face a series of legal, medical, and social challenges. This panel explores these overlapping issues, including: healthcare coverage of treatments such as gender reassignment therapy, the legal recognition of trans identities, intersexuality, and asexuality.  Join us for a wide-ranging panel discussion.

Panelists include:

  • Noa Ben-Asher, Visiting Associate Professor of Law, Harvard Law School
  • Elizabeth F. Emens, Isidor and Seville Sulzbacher Professor of Law, Columbia Law School
  • Gerald L. Neuman, J. Sinclair Armstrong Professor of International, Foreign, and Comparative Law, Harvard Law School
  • Matthew J.B. Lawrence, Academic Fellow, Petrie-Flom Center
  • Moderator: I. Glenn Cohen, Professor of Law, Harvard Law School, and Faculty Director, Petrie-Flom Center

This event is free and open to the public. Lunch will be served.

Cosponsored by the Human Rights Program at Harvard Law School and Lambda at Harvard Law School.

TOMORROW: Patients with Passports: Medical Tourism, Law, and Ethics

Cohen_Medical_Tourism_slidePatients with Passports: Medical Tourism, Law, and Ethics
I. Glenn Cohen and Dr. Robert Klitzman

Tuesday, February 24, 5:30 – 7:00 PM ET

Carnegie Council for Ethics in International Affairs

Merrill House 170 East 64th Street, New York, NY 10065-7478

Live Video Stream HERE

 

Medical tourism is a growing, multi-billion dollar industry involving millions of patients who travel abroad each year to get health care.

Some seek services like hip replacements and travel to avoid queues, save money, or because their insurer has given them an incentive to do so. Others seek to circumvent prohibitions on accessing services at home and go abroad to receive abortions, assisted suicide, commercial surrogacy, or experimental stem cell treatments.

How safe are these procedures? How do you ensure that you will be protected if anything should happen?

I. Glenn Cohen is professor of law at Harvard Law School and director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics. He is the author of Patients with Passports: Medical Tourism, Law, and Ethics.

Dr. Robert Klitzman will lead the conversation. He is a professor of psychiatry in the College of Physicians and Surgeons and the Joseph Mailman School of Public Health and the director of the Masters of Bioethics Program at Columbia University.

This event is part of Carnegie Council’s Global Health Series.