King v. Burwell And A Right To Health Care

Bill of Health contributor Gregory Curfman has a new piece up at the Health Affairs Blog discussing the Supreme Court’s decision in King v. Burwell in the broader context of Americans’ right to care. From the piece:

Do Americans have a fundamental right to health care? This oft-debated question is timely given the Supreme Court’s stunning ruling yesterday in King v. Burwell, in which health insurance subsidies on the federal exchange were upheld in a 6-3 decision.

Here I will place the King v. Burwell opinion in the larger context of to what extent Americans are provided a right to care. The Constitution itself does not stipulate a general right to health care, but a patchwork of rights to certain aspects of health care have emerged over time from both constitutional and statutory law.

Read the full piece at the Health Affairs Blog!

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

Check out the June 26th 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:
PFC_Logo_300x300APPLICATIONS OPEN!
2015-2016 Petrie-Flom Center Student Fellowship

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics.

The Petrie-Flom Center Student Fellowship is a competitive one-year program designed to support Harvard graduate students interested in pursuing independent scholarly projects related to health law policy, biotechnology, and bioethics. With intensive mentorship from Petrie-Flom Center affiliates, student fellows are expected to produce a piece of publishable scholarship by the end of the academic year, at which point they are awarded a modest stipend. Student fellows blog regularly at Bill of Health, the Center’s blog, where their work receives substantial public exposure; participate in and organize Center events; and enroll in the Health Law Policy and Bioethics Workshop, which provides the opportunity to interact with leading scholars in the field.

Applications will be accepted on a rolling basis until 9AM, Friday, August 7, 2015. Notifications of awards will be made by August 21, 2015. For more information, please visit our website.

For further questions, contact Administrative Director Cristine Hutchison-Jones, chutchisonjones@law.harvard.edu.

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

Tackling Medicaid In Massachusetts

This new post by Jeffrey Sánchez appears 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 Affordable Care Act (ACA) provides a number of tools to address longstanding problems in our fragmented health care system. At the national level, the Centers for Medicare and Medicaid Services (CMS) are redefining Medicare through initiatives that promote payment and delivery reform, such as Shared Savings and Value-Based Purchasing. States are also seeking their own opportunities to move away from inefficient systems that reward volume over quality. In particular, state Medicaid programs have the potential to play a major role in these efforts.

Given the number of individuals Medicaid covers, it has the biggest potential impact in improving health care. Medicaid covers more than 1 in 5 Americans, funding more than 16 percent of total personal health spending in the United States. With ACA Medicaid expansion, enrollment increased in 2014 by 8.3 percent and led to an increased overall Medicaid spending growth of 10.2 percent. Total Medicaid spending growth in 2015 is expected to be 14.3 percent with a 13.2 percent enrollment growth. This is not an insignificant portion of both state and federal health care dollars. Thoughtful and concerted reforms to Medicaid have the potential to reduce spending and improve care quality. […]

Read the full article here.

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

Check out the June 12th 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:

NOW HIRING!

Petrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants. The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields. Illustrative projects include the following:

  • Defining the clinical trials recruitment problem, including cataloguing various barriers to recruitment, outstanding data needs, and possible solutions, and developing a research agenda
  • Evaluating whether there are ways to prioritize trials and allocate research participants as a scarce resource
  • Considering innovative trial designs as a potential mechanism to address the recruitment problem
  • Developing a recruitment/retention toolkit to help investigators develop successful recruitment/retention plans
  • Addressing the proper parameters of remuneration to subjects
  • Developing surveys to learn more about participant motivations, expectations, and concerns
  • Conducting additional empirical research to develop knowledge that can improve clinical trial recruitment/retention

For more information and to apply, view the full job description!

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

How Institutional Review Boards Can Support Learning Health Systems While Providing Meaningful Oversight

This new post by Mildred Solomon appears 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.

Increasingly, health systems are studying their own practices in order to improve the quality of care they deliver. But many organizations do not know whether the data they collect at the point of care constitutes research, and if so, whether it requires informed consent. Further, many investigators report that institutional review boards (IRBs) place unreasonable burdens on learning activities, impeding systematic inquiry that is needed to enhance care.

As a result, some commentators have argued that our human research participant protection regulatory framework needs a dramatic overhaul. Yet, it is not the regulations that must change.

Instead, IRBs should educate themselves about quality improvement and comparative effectiveness research, exempt studies that qualify for exemption, and provide waivers to informed consent, when that is appropriate. At the Department of Health and Human Services, the Office for Human Research Protections (OHRP) must clarify the regulations that have an impact on this type of research, create better guidance about how IRBs should regulate such research, including illustrative case studies to guide IRBs.

Read the full post here.

Journal of Law and the Biosciences (JLB): Call for Harvard Student Submissions

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish  the  Journal  of  Law  and  Biosciences  (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a New Developments section, comprised  of  brief  summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie-­Flom Center is responsible for providing the New Developments for one issue per annual volume.

We are currently seeking Harvard graduate students to contribute papers to be published in JLB’s New Developments section in early 2016. In previous years, New Developments have been generated from scratch specifically for JLB, based on selection from submitted proposals. This year, we are taking a different approach by publishing already complete (or to-be-completed by the deadline) original student papers (such as student notes, course papers, etc.) written by graduate students from any Harvard school.  New Developments are limited to 5000 words, including footnotes and references,  and  should  be  on  a  topic  of  relevance  to  law  and  the  biosciences,  in particular a topic of relatively recent concern, controversy, or change. They should focus on  describing  the  issue  at  hand,  explaining  why  it  is  relevant  to  scholars  and practitioners, and providing analysis and questions for further consideration.

Interested students should submit their papers and CVs for consideration no later than September 7, 2015 (earlier  is  welcome). Up  to  four  papers will be selected for publication in the New Developments section of JLB. Applicants will be notified by the end of September. Selected students will receive comments on their papers by the end of October, and will also be responsible for providing comments to the other selected students. Revisions will be due by the end of November, and final submissions to JLB will be due by the end of December 2015.

Please send all application materials, and direct all questions, to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Upcoming Event (6/30): Visible Solutions – How Neuroimaging Helps Law Re-envision Pain

brain_pain_slide_270_174_85Visible Solutions:
How Neuroimaging Helps Law Re-envision Pain

Tuesday, June 30, 2015
8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West A
Harvard Law School [Map]

Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain? Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.

Panelists include: Continue reading

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

pfc-web-logoCheck out the May 28th 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:

NEW EVENT!

glassesofwine_slidePetrie-Flom / Center for Bioethics Reception at ASLME 38th Annual Health Law Professors Conference

June 4, 2015 7:30 – 9:30 PM
Hilton St. Louis at the Ballpark
1 South Broadway, St. Louis, MO

Come learn more about the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Bioethics at Harvard Medical School at this jointly-hosted dessert reception at the 2015 annual ASLME Health Law Professors Conference.

We hope to see you there!

For more information, please contact Brooke Tempesta at Brooke_Tempesta@hms.harvard.edu.

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

Yale Law School Seeks Executive Director for New Health Law Center

YaleLaw_300x300

Solomon Center for Health Law and Policy Yale Law School

Executive Director

The Yale Law School is delighted to announce the launch of the Solomon Center for Health Law and Policy, an exciting new Center at Yale Law School dedicated to training the next generation of health law leaders—academics, CEOS, lawyers, and government officials—and having an impact today on the most important health care issues.

The Solomon Center is seeking applications for the position of Executive Director. The Solomon Center coordinates a diverse program of activities that serve students and scholars at Yale and contribute both locally and internationally to the study of health law—with a particular focus on health governance, industry and the practice of medicine.

The Executive Director, under the supervision of the Solomon Center faculty director, Professor Abbe Gluck, will be responsible for managing the day-to-day activities of the Center.  This will include working with and helping to select student and post-graduate fellows, planning events, including workshops and the annual conference, maintaining the website, building the center’s national reputation, working on grants, supervising scholarship and projects of the center, mentoring health law students, working with the many colleagues, organizations, and interested individuals with whom the Solomon Center collaborates, both within the Law School, across Yale University and outside the University.  The Executive Director will be an ambassador of the Center. He/she must be outgoing and a self-starter and will be responsible for building a broad network for the program.

Some specific responsibilities of the Executive Director/ Fellow include the following: Continue reading

Petrie-Flom is hiring a new postdoctoral fellow in clinical research ethics!

PFC Logo-RGB-Round-Otlns-NewPetrie-Flom Center/Harvard Catalyst Fellow in Clinical Research Ethics

Job Description

This is a newly created full-time position for a post-doctoral employee fellow in clinical research ethics to support the work of the Petrie-Flom Center at Harvard Law School in its collaboration with the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst, Harvard’s Clinical and Translational Science Center. The fellow must have strong knowledge of clinical research and its regulation, with particular interest in the regulatory, ethical, and practical aspects associated with recruitment and retention of research participants.  The position will provide the opportunity to interact with a wide range of stakeholders, such as IRB members, administrators, investigators, institutional leadership, patient advocates, and other community members. This position allows for a maximum of 10% effort in furtherance of the fellow’s own research agenda(s) in related fields.  Illustrative projects include the following: Continue reading

Neuroethics Seminar Videos Available Online

In case you couldn’t attend in person, be sure to check out the videos from the Neuroethics Seminar series at the Center for Bioethics at Harvard Medical School! Topics include:

  • Hacking the Brain: Neuroenhancement with Noninvasive Brain Stimulation
  • Does Brain-Based Lie Detection Belong in American Courtrooms?
  • Does Brain Difference Affect Legal and Moral Responsibility?

View these videos and more here.

Rutgers Journal of Bioethics: Call for Papers (8/30)

From the Rutgers Journal of Bioethics:

As members of the Bioethics Society of Rutgers University, we hope to raise general awareness of issues in bioethics within the Rutgers community by method of discussion and publication. Although the beliefs and opinions regarding bioethical issues of this group are not unanimous, we are united by our ardent belief that the student population at Rutgers should be made aware of the implications of biological research, medicine, and other topics of bioethical controversy. In order to bring to light these issues, we are now accepting any papers that fall under the vast umbrella that is bioethics. All papers will be considered for possible publication. Some example subjects are medical treatment, biological warfare, research ethics, medical sociology, social justice, history of medicine/science, medical case analysis, eugenics, gene therapy, human cloning, medical malpractice, and healthcare policy; however, you are not limited to these topics.

DEADLINE: AUGUST 30, 2015

Continue reading

International Neuroethics Society Student Essay Contest: Deadline 5/20!

Remember to submit your 2000 word essay for consideration in the INS Student Essay Contest.  The top two submissions will be awarded:

  • $250 Michael Patterson Travel Stipend to attend the 2015 INS Annual Meeting in Chicago, IL (Oct 15-16), where there will be special networking opportunities,
  • One year free INS student membership,
  • Essay published in the Kopf Carrier (Newsletter of Kopf Instruments) as part of the “Neuroethics in Neuroscience Series” edited by Judy Illes (Director, National Core for Neuroethics, UBC),
  • Essay fast-tracked for peer-review if it (or a subsequent draft) is subsequently submitted to the American Journal of Bioethics Neuroscience (AJOB-N); separate submission would be required.

Who can apply: All current post-secondary students of any nationality; a student is defined as anyone enrolled in a degree granting program (undergraduate, graduate, or professional) during the 2014-2015 academic year.

Requirements: Essays must be 2000 words or less, written in English, and double spaced.  Cover page and essay should be saved as a single file in the format “Surname_INS_Student_Essay_Prize.doc” and emailed to administrator@neuroethicssociety.org with the subject line: “INS Student Essay Prize”.  Additional requirements can be found on the INS website.

Selection Criteria: Essays will be judged on originality of argument, rigor of defense, and quality of prose; a short-list will be generated by the Student Essay Prize Judging Committee and the top two selected from the shortlist through forum discussion.

Deadline: 5 p.m. ET on May 20, 2015

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

Check out the May 15th 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:

brain_pain_slide_270_174_85REGISTER NOW!
Visible Solutions: How Neuroimaging Helps Law Re-envision Pain

June 30, 2015, 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein West A
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Can brain imaging be a “pain-o-meter” that tells courts when a person is in pain?  Can fMRI help us discern whether intractable chronic pain is “all in your head” or all in the brain – or will it require us to reconsider that distinction? Leading neuroscientists, legal scholars, and bioethicists will debate standards and limits on how the law can use brain science to get smarter about a subject that touches everyone.

Agenda

The full agenda will be announced in the coming weeks. Check back here for news!

Registration

This event is free and open to the public, but seating is limited and registration is required. Register now!

This event is 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. Cosponsored by the Center for Bioethics at Harvard Medical School, and with support from the Oswald DeN. Cammann Fund. 

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

The ACA, The ADA, And Wellness Program Incentives

This new post by Kristen Madison appears 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.

Wellness programs have been enthusiastically embraced by employers seeking to promote health and hoping to control costs. On April 20, 2015, program proponents received long awaited news: the Equal Employment Opportunity Commission (EEOC) issued a proposed rule clarifying how the Americans with Disabilities Act (ADA) would apply to wellness programs. Many large employers likely breathed a sigh of relief upon reading the rule, but the rule is not final and may reignite a longstanding debate over the appropriate use of wellness incentives.

Wellness programs have become common in the workplace. A 2014 Kaiser Family Foundation survey found that among large employers offering health benefits, just over half offered an opportunity to complete a health risk assessment (HRA), a questionnaire that is often a gateway for the provision of health risk information and other wellness program components (Exhibit 12.8 in the Kaiser survey). A similar fraction offered biometric screenings (Exhibit 12.1), such as tests for cholesterol or blood pressure, or measurement of body mass index. Some screening programs test for cotinine, which is associated with nicotine exposure.

Some wellness programs offer financial incentives such as premium adjustments or gift cards. The 2014 survey found that more than half of large employers using HRAs provide incentives for their completion, and more than a third of these incentives equaled or exceeded $500 (Exhibit 12.10). A federally commissioned report prepared by RAND suggests that incentives are effective in increasing HRA completion. […]

Read the full article here.

Bioethicist Art Caplan: A Potential Solution to the Shortage of Solid Organs for Transplantation

A new opinion piece by contributor Art Caplan along with Stephen Wall and Carolyn Plunkett, in JAMA:

In the United States, the majority of deaths occur unexpectedly, outside hospitals or in emergency departments. Rarely do these deaths provide opportunities for organ donation. In Europe, unexpected deaths provide substantial numbers of transplantable organs through uncontrolled donation after circulatory determination of death (UDCDD). UDCDD considers decedents candidates for donation even when death is unexpected, regardless of location, as long as preservation begins after all life-sustaining efforts have been exhausted.

More than 124 000 patients are wait-listed for organs in the United States, a number that increases annually despite attrition from 10 500 who die or become too sick for transplantation.1 United States policy currently promotes organ recovery from 3 sources; neurologic deaths, controlled circulatory deaths, and live donors for kidneys and partial livers.

However, these approaches are incapable of meeting increasing US demand for transplants. During controlled donation after circulatory determination of death (CDCDD), the time from cessation of life support to circulatory arrest often exceeds 60 minutes. Prolonged hypotension leads to irreparable organ damage, thus limiting the effect of CDCDD on organ supply. Live donation primarily affects kidney supply; it is unlikely that altruistic donation will ever meet demand. Although many changes in public policy regarding cadaveric donation are debated (markets and presumed consent), none is likely to become law or make substantial differences in organ supply. […]

Read the full article here.

TODAY (5/8-9)! Law, Religion, and Health in America: 2015 Annual Conference

2015 Petrie-Flom Center Annual Conference
stethoscope_bible_slide“Law, Religion, and Health in America”
May 8-9, 2015
Wasserstein Hall
Milstein East ABC

Harvard Law School
1585 Massachusetts Ave.,
Cambridge, MA [Map]

Religion and medicine have historically gone hand in hand, but increasingly have come into conflict in the U.S. as health care has become both more secular and more heavily regulated.  Law has a dual role here, simultaneously generating conflict between religion and health care, for example through new coverage mandates or legally permissible medical interventions that violate religious norms, while also acting as a tool for religious accommodation and protection of conscience. 

This conference will identify the various ways in which law intersects with religion and health care in the United States, understand 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.

Highlights:

Keynote Lecture: Religious Liberty, Health Care, and the Culture Wars

 Plenary Session: The Contraceptives Coverage Mandate Litigation

The conference is free and open to the public, but seating is limited. View the full agenda and register online!

The 2015 Petrie-Flom Center Annual Conference, Law, Religion, and Health in America, is supported by the Oswald DeN. Cammann Fund.

TODAY! (5/7) After Hobby Lobby: What Is Caesar’s, What Is God’s? Pre-Conference Session

Pre-Conference Session

Hobby_Lobby_slide_270_174_85“After Hobby Lobby: What Is Caesar’s, What Is God’s?”
May 7, 2015, 4:00 – 6:00 PM
Wasserstein Hall, Milstein East BC
Harvard Law School,
1585 Massachusetts Ave.,
Cambridge, MA [Map]

As prelude to the 2015 Petrie-Flom Center Annual Conference, “Law, Religion, and Health in America,” please join us for a pre-conference session examining the role of religion in the American public sphere. Our expert panel will discuss the nature of conscience and conscientious objection, religious freedom, and religious accommodation from philosophical, theological, historical, legal, and political perspectives.

Panelists:

  • J. Dionne, Jr., Columnist, The Washington Post; Senior Fellow, The Brookings Institution
  • Diane L. Moore, Senior Lecturer on Religious Studies and Education and Senior Fellow at the Center for the Study of World Religions, Harvard Divinity School
  • Charles Fried, Beneficial Professor of Law, Harvard Law School
  • Frank Wolf, Representative, Virginia’s 10th Congressional District, U.S. House of Representatives, 1981-2015 (retired)
  • Moderator: Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
  • Moderator:  Glenn Cohen, Professor of Law, Harvard Law School and Faculty Director, Petrie-Flom Center

The panel will be followed by a light reception at 6 PM.

This event is free and open to the public, but seating is limitedRegister online.

The pre-conference session is co-sponsored by the Petrie-Flom Center and the Ambassador John L. Loeb, Jr. Initiative on Religious Freedom and Its Implications at the Center for American Political Studies at Harvard University.

Bioethicist Art Caplan: Deep-Fat Fryers in Schools is Business, Not Freedom

A new piece by contributor Art Caplan on NBC News:

How bad is the obesity epidemic among kids in America?

Bad enough that 69 percent of young adults in Minnesota cannot serve in the military due to obesity-related health problems, according to a recent report “Too Fat, Frail and Out-of-Breath to Fight,” from a group of retired generals.

And how is one public official responding to the child obesity crisis? With a call for more fried foods in school. The Texas Agriculture Commissioner, Sid Miller, says he wants to restore deep-fat fryers in Texas school cafeterias. In his mind, this “isn’t about french fries, it’s about freedom.”

The freedom to develop cardiovascular disease?

School cafeterias are the front line on the battleground for childhood obesity prevention. They serve as test kitchens for interventions designed to increase the consumption of fruits and vegetables and decrease the intake of processed and fried foods. In 2012 the USDA and First Lady Michelle Obama announced standards for more nutritious school food. As part of the rules, schools are expected to serve fruits, vegetables and whole grains daily, and limit calories in servings. […]

Read the full article here.

Bioethicist Art Caplan: Rein It In, Dr. Oz

A new piece by contributor Art Caplan on Medscape [Note: free registration required]:

Dr Mehmet Oz is in trouble again. He was accused by 10 physicians in a letter of promoting quackery. They demanded that Columbia University Medical Center fire Dr Oz. Now, I can say with some authority that as “America’s Doctor”—the person who, for many Americans, is the voice of medicine—he is not going to be fired. His show is not going to end. That isn’t going to happen.

Dr Oz has evoked this response from these 10 physicians because he continues to push the border of legitimacy on his shows with respect to touting things for which there isn’t much evidence. And that is a problem. Many doctors tell me that when Dr Oz endorses something—green coffee beans, some neti pot to cure the common cold—whatever it is, they are going to be asked about it, and their patients run out and buy it. He has enormous power when it comes to the platform he has built. And let’s face it: He is an effective communicator. His show is fun to watch. I understand why the American people are paying attention to Dr Oz. […]

Read the full article here.