Public Briefing on Contraceptives Coverage Mandate from KFF

Holly Fernandez Lynch Leave a comment

For those of you following the contraceptives coverage mandate litigation:

Later this month, the Supreme Court will hear two cases from for-profit corporations, Hobby Lobby Stores and Conestoga Wood Specialties, challenging the Affordable Care Act’s (ACA) requirement to cover contraceptives on religious grounds. On Tuesday, March 11, two weeks before the hearings, the Kaiser Family Foundation will host a public briefing and panel discussion from 9:30am-11:00am ET in its Washington, DC office to discuss the implications of these court cases on the ACA, corporate and individual religious protections, and civil rights. For those unable to attend, a live webcast will be hosted on kff.org.

Speakers include:

Welcome and Introduction Alina Salganicoff, Ph.D. (Moderator),Vice President and Director, Women’s Health Policy, Kaiser Family Foundation

An Overview of the Contraceptive Coverage Requirement and Legal Challenges Laurie Sobel, J.D., Senior Policy Analyst, Women’s Health Policy, Kaiser Family Foundation

The Religious Freedom Restoration Act and its Application to These Cases Marci A. Hamilton, J.D., Paul R. Verkuil Chair in Public Law at the Benjamin N. Cardozo School of Law, Yeshiva University

Possible Rulings and Outcomes Tom Goldstein, J.D., Publisher SCOTUSblog, Partner Goldstein & Russell, P.C.

Panel Discussion on Implications


When: Tuesday, March 11, 9:30am-11:00am ET, (Registration and breakfast beginning at 9:00am)

Where: Barbara Jordan Conference Center, Kaiser Family Foundation Offices, 1330 G Street, NW, Washington, D.C., (one block west of Metro Center)

RSVP: Please register online to attend this event in person.

Live Webcast: A live webcast will be available on kff.org.

TOMORROW: Evaluating the Revised Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

The Petrie-Flom Center Staff Leave a comment

Evaluating the Revised Diagnostic and Statistical Manual of Mental Disorders (DSM-5)

Tuesday, March 11, 2014, 12:00pm

Wasserstein Hall 3018, Harvard Law School, 1585 Massachusetts Ave.

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.

Panelists:

  • 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

This event is free and open to the public. Lunch will be provided. For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

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

Merit Affidavits and the Poor

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By Alex Stein

Two days ago, the Appellate Court of Connecticut affirmed the dismissal of an indigent plaintiff’s action to void a statute requiring plaintiffs to support malpractice suits against medical professionals by an opinion letter from a similar healthcare provider. The plaintiff claimed that this statute, Conn. General Statutes § 52–190a, is unconstitutional insofar as it applies to indigent plaintiffs who cannot afford paying medical experts’ fees. The plaintiff filed this action against the State of Connecticut, a number of state legislators and courts, and the Connecticut Medical Insurance Company. He asked the court to grant him declaratory judgment, injunctive relief, and compensation.

The court dismissed the action due to the presence of the sovereign and legislative immunities and the plaintiff’s failure to show a violation of his constitutional entitlement. The Appellate Court affirmed that decision. Traylor v. Gerratana, — A.3d —-, 2014 WL 839165 (Conn.App. 2014).

In most states, similar merit-affidavit requirements presented no constitutional problems. Arkansas, Oklahoma, and possibly Florida are exceptions. Expert testimony is a must in nearly every medical malpractice case: proof of malpractice and causation is virtually never possible without an expert. Asking plaintiffs to upfront their expenditure on that testimony doesn’t strike me as too onerous.

The merit-affidavit requirement does not worsen the dismal situation of indigent plaintiffs. There is no reason to believe that a plaintiff who cannot hire an expert ahead of trial would somehow become able to do so when his case goes to trial. At both points in time, he will depend on charity and litigation funding. The legal system should eliminate this dependency and the consequent denial of access to justice to the poor. Things are bad enough when the haves come out ahead most of the time. Allowing a malpractitioner to go scot free when the patient he injured is too poor to file a suit will make things much worse.

Snotty Hand-Washing

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Hand-washing is one of the mainstays of public health and of good clinical practice. Images of surgeons with their hands raised in the air, as they enter the OR to have a nurse help them don sterile latex gloves after having meticulously washing their hands, have been immortalized by pop-culture representations of medicine. Indeed, learning the “surgical hand-wash” is one of the glorified coming-of-age rituals for med students. It quite literally initiates aspiring physicians into being legally and morally allowed to cut people open for their own benefit.

Proper hand-washing is crucial for non-surgical clinical practice as well. At my hospital, clinicians are supposed to wash or sanitize their hands as soon as they enter a patient’s room, and after they have made any contact with a patient. And although the procedure for “clinical hand-washing” is much less thorough than its surgical counterpart, there’s still an evidence-based, 11 step process that WHO officially recommends in its annual “SAVE LIVES: Clean Your Hands Campaign.“

The rationale for all this rigor in medical practice is pretty obvious, and any hospital-based physician who doesn’t have overly dry skin without moisturizing is probably shirking an important responsibility. However, the clinical obsession over asepticism has spilled over to mainstream culture, but not without some controversy.

Relax: I’m not going to get into the debate over the hygiene hypothesis. I’m also not even going get back on the bacterial-resistance soapbox (except for one quick point–although asepticism in clinical settings certainly does help prevent resistance, it might be counterproductive beyond the clinical setting as wiping out benign bacteria might simply open more ecological space for nastier bugs).

I just want to point out that simple repugnance is probably a better explanation  for the hygiene-neurosis of current times than any legitimate public health concern. Normal people today would probably have seemed like obsessed germophobes fifty years ago. What’s interesting is there’s lots of neat evidence that even the most visceral types of disgust are socially constructed. For example, Norbert Elias’ treatise on snot in “The History of Manners” (1982) describes dinner-table behavior that was deemed perfectly polite by in the most sophisticated European social circles of previous centuries, but which would probably make even the coarsest sailor of today vomit in disgust. I’ll leave you with some highlights, taken from pages 143-148 of this wonderful (yet long, two volume) work by Elias.

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Petrie-Flom Intern’s Weekly Round-Up, 2/28-3/7

The Petrie-Flom Center Staff Leave a comment

By Chloe Reichel

The majority of people in La Crosse, Wisconsin have advance directives. The initiative to increase the utilization of advance care planning began as a way of helping patients, but resulted in large decreases in health care expenditures.

Due to Texas’ recently passed regulations on abortion clinics, two clinics closed this week. Abortion clinics in Texas are required to have a physician with admitting privileges at a hospital within 30 miles of the clinic under the new regulations.

A new law passed recently in Arizona would limit access to medication used for medical abortions. Planned Parenthood of Arizona filed a lawsuit this Wednesday to contest the law.

An HIV-positive baby treated with aggressive drugs immediately after birth was reportedly cured of the disease. This is the second such case of this treatment working, and is a promising development for the future of HIV treatment.

On Wednesday it was announced that Americans will be allowed to keep insurance plans that are not compliant with the Affordable Care Act. These plans will continue to be offered for the next two years.

Two surveys have found that uninsured Americans largely have not signed up for insurance following the implementation of the Affordable Care Act. Some suggest that the changes to the new healthcare law that have occurred since its adoption may be responsible for these low rates of enrollment.

In Washington state, people who operate medical marijuana dispensaries are worried about the effects of the state’s recent legalization of recreational marijuana. They worry that the increased demand for marijuana will put smaller dispensaries out of business.

Twenty-six states have introduced mandatory programs that emphasize private long-term care over nursing homes. Many states have modeled their plans after Tennessee, but long-term care in this state is suboptimal for many residents.

Harvard Effective Altruism: Josh Greene this Tuesday

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Emotion, Reason and Altruism
with Professor Joshua Greene

Tuesday, March 11th, 7 PM,
Fong Auditorium, Boylston Hall
Why do people have radically different opinions as to who to help and how? How can we get along with people who seem to fundamentally disagree with us about what to want? Professor Josh Greene addresses this and more in Emotion, Reason, and Altruism.
Joshua Greene direct Harvard’s Moral Cognition Lab, which uses cutting edge cognitive neuroscience techniques to study how people actually make moral decisions, integrating thinking from philosophy, social science, and social psychology to address questions of why people disagree as much as they do, and what we can do about it.

3/20-21: Risk, Perception, and Response Conference at Harvard School of Public Health

The Petrie-Flom Center Staff Leave a comment

Risk, Perception, and Response Conference

March 20-21, 2014

Harvard School of Public Health
677 Huntington Avenue
Boston, MA 02115

This event will be webcast. Link will be posted here on March 20 and 21.

View draft agenda and papers.

To register, click here. There is no charge for registration.

To receive related notifications, subscribe to our mailing list.

Sunstein to be Keynote Speaker

We are pleased to announce that Cass R. Sunstein will be the keynote speaker for HCRA’s Risk, Perception, and Response conference. Mr. Sunstein is the Robert Walmsley University Professor at Harvard and founded the Program on Behavioral Economics and Public Policy at Harvard Law School. He is the author of numerous articles and books, includingNudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008) and most recently Simpler: The Future of Government (2013). From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs.

Conference Overview 

How people react to scientific evidence of risk is mediated by many factors, including how risk information is perceived and communicated, how we react to social and cultural influences, and how choices are structured. Examples abound of situations where individuals’ risk perceptions lead them to act in ways that appear contrary to their own interests, overreacting to or neglecting risks. How can situations in which individuals are likely to respond poorly be identified, and what can be done to improve their responses? To increase our understanding of the factors that contribute to these behaviors and to develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.

Click here to view the detailed agenda.

FDA’s Draft Methodological Approach to Identifying High-Risk Foods

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By Ching-Fu Lin

Last month, the Food and Drug Administration (FDA) published a draft methodological approach for designating high-risk foods (HRFs) as required by section 204(d)(2) of the Food Safety Modernization Act (FSMA).  HRFs identified by the FDA are subject to additional record-keeping requirements, and more frequent foreign inspections and mandatory third-party certification requirements.  The FDA is seeking comments, scientific data, and information from stakeholders to revise this draft HRF approach and to create a preliminary HRF list.

Among many available risk tools (e.g. qualitative, semi-quantitative, and quantitative methods), a semi-quantitative risk ranking model has been selected by the FDA as the most appropriate methodology for the HRF list.  There are many reasons for choosing this model, including the fact that – as explained by the FDA – it is “data-driven and comprehensive, using explicit criteria related to public health risk; … adaptive to a variety of hazards; and … flexible to consider different foods or categories of food.”

Based on the draft semi-quantitative risk ranking model, the FDA is considering and evaluating a set of seven criteria that match the factors specified in section 204(d)(2)(A) of FSMA: Read More

Tips from a former medical student – Part II

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By Deborah Cho

[See Part I here]

Last week, I wrote the first of a two-part series on tips that may be helpful for law students and lawyers interested in or working in health/medical law.  I continue with Tip #4 here.

4. If you need to learn about a disease, procedure, or drug that you know nothing about, your best starting point is probably Wikipedia.  Google will lead you to some incorrect answers, and diagnose-yourself websites will give you answers that are much too broad to use practically in legal practice.  Once you have familiarized yourself with the general topic on Wikipedia, you can then go back to your search engine of choice for more specific terms and weed out the wrong information.  Starting on PubMed or GoogleScholar probably isn’t the best idea either because most of what you’re reading will be highly technical and the articles you find will likely be about novel uses or instances of whatever you’re searching.  Another fantastic source is UpToDate, an evidence-based Wikipedia-like source for healthcare providers, but many people may not have access to all the information on this site.

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