Abortion Is Way More Common Than Most Voters Think

By Gregory M. Lipper

A new Vox survey reveals that a majority of registered voters underestimate the rate of abortion, and that the abortion rate is most likely to be understimated by men, college graduates, and those with higher salaries:

More educated and higher-income Americans are especially likely to believe that abortion is rare.

For example, 54 percent of Americans without a college degree underestimate abortion rates, compared with 70 percent of those with graduate degrees. And 51 percent of those earning less than $50,000 underestimate the frequency of abortion, compared with 69 percent of those earning more than $175,000.

The split happens when you look at gender, too. Women would near certainly have more experience with abortion than men. Our poll shows that 67 percent of men underestimate the frequency of abortion, compared with 57 percent of women.

Fortunately for those who support abortion rights, no Supreme Court Justices are wealthy, well-educated men…

Greg Lipper (@theglipper) is Senior Litigation Counsel at Americans United for Separation of Church and State.

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

This week we interviewed Nicole B. Porter at the University of Toledo College of Law. Nicole has served as Associate Dean for Academic Affairs at Toledo. Her research interests focus on the employment rights of women and individuals with disabilities. She teaches Employment Discrimination, Disability Law, Criminal Law, Contracts, and Feminist Legal Theory.
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Nicole’s expertise on the Americans with Disabilities Act is nonpareil, and she discussed several dimensions of ADA practice and advocacy. Nicole’s recent scholarship in the area includes Special Treatment Stigma After the ADA Amendments ActThe Difficulty Accommodating Healthcare Workers, Withdrawn Accommodations, and The New ADA BacklashThe show includes both background on the ADA’s purpose and initial reception, as well as up-to-date analysis of its present application.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Should healthcare systems implement routine recontacting services in clinical practice? Some legal and logistical considerations

By Daniele Carrieri, Angus Clarke, Anneke Lucassen, Susan Kelly

Advances in genetic and genomic medicine are resulting in better diagnosis and treatment of some health conditions, and the question of whether former patients should be recontacted is therefore timely. Recontacting patients to inform them of new information or new testing, that could be relevant to their health or that of their biological relatives is made more pressing by the increasing use of whole genome approaches in healthcare, where variants previously of unknown significance (VUSs) may now have known disease effects.  However, there is currently no consensus about whether or not healthcare professionals have a duty or responsibility to recontact former patients in light of this new information. There is also very little empirical evidence in this area. In a recent article published in Genetics in Medicine, we present the results of a survey of recontacting practices of clinical genetics services across the United Kingdom (UK). As far as we know, this is the first study that specifically explores current recontacting practices in clinical genetic services.

One of the questions of the survey asked was whether clinical genetics services should implement routine recontacting systems. The majority of genetic services were undecided for several reasons.  The main arguments given in favor of implementing such systems revolved around patient choice and the idea of keeping patients up to date.  The main arguments against pointed to the logistical difficulties of implementing recontacting systems and the possible legal implications of doing so, if that were seen as establishing a new standard of care without the additional resources required for this to be a sustainable activity. Continue reading

NHPC 2016: Growing National Debt Requires Strategic Changes in Health Care Spending

By Cornelia Hall, Master of Public Policy Candidate, Harvard Kennedy School, Class of 2017

This is the third entry in a three-part series on the AcademyHealth National Health Policy Conference, held in Washington, DC, on February 1-2.  Read the first entry here and the second entry here.

The national debt as a percentage of GDP has spiked in the last several years, rising from approximately 35% in 2007 to nearly 74% in 2015.  Federal budget projections suggest that this trend will continue, with the debt nearly exceeding the size of the economy by 2040.  Discussion about these predictions frequently returns to the topic of health care.  Indeed, as the “baby boomer” generation retires and enrolls in Medicare, federal health care spending is expected to rise dramatically.  In an NHPC plenary session, federal budget experts explored this topic and discussed possible methods of controlling the growth of health care spending in years to come. Continue reading

What is the IMD Exclusion that everyone is talking about?

By Emma Sandoe

A less covered provision of Medicaid law that has been in existence since the establishment of the program in 1965 and has been making some news over the past several months, the IMD exclusion is a provision that restricts Medicaid payments for certain institutions, potentially reducing the access to available services for low-income individuals with mental illnesses. If you haven’t been hearing everyone talking about it… well, I guess you talk with fewer health policy nerds than I do.

What is the IMD exclusion?

According to the good people at the National Alliance on Mental Illness (NAMI), the IMD exclusion can be defined as: Institutions for Mental Disease (IMDs) are inpatient facilities of more than 16 beds whose patient roster is more than 51% people with severe mental illness. Federal Medicaid matching payments are prohibited for IMDs with a population between the ages of 22 and 64. IMDs for persons under age 22 or over age 64 are permitted, at state option, to draw federal Medicaid matching funds.

Why does Medicaid have this provision?

This is because when Medicaid first started, states were responsible for the care of people with severe mental illness. States cared for many people with mental illnesses in a custodial setting; essentially states often were providing people a place to sleep but no mental health services. When drafting the Medicaid bill, the federal government did not want to supplant this existing state program with federal Medicaid funding. Additionally, while President Johnson was notorious for not spending a large amount of time on the cost of Medicare, the addition of these services would add $1.8 billion to the Medicaid budget, nearly doubling the first year price tag.

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NHPC 2016: Care Integration as a Potential Alternative to Health Care Consolidation

By Cornelia Hall, Master of Public Policy Candidate, Harvard Kennedy School, Class of 2017

This is the second entry in a three-part series on the AcademyHealth National Health Policy Conference, held in Washington, DC, on February 1-2, 2016. Read the first entry here

Consolidation in the health care sector, particularly among providers and private insurers, has been rising since the Affordable Care Act passed in 2010.  Major movement is currently underway among the “Big Five” private insurance companies: Humana, Cigna, UnitedHealthcare, Aetna, and Anthem.  Two proposed “horizontal” mergers, currently under review by the Department of Justice Antitrust Division, would reduce these “Big Five” to the “Big Three.”  In this context, NHPC panelists discussed private sector consolidation’s potential impact on the cost, quality, and coverage of health care.  Several panelists expressed concern about the effects of consolidation on patients and the costs of services.  They also indicated, however, that the health care system’s ongoing transition to more coordinated care could help to offset potentially negative consequences of consolidation.

As the Justice Department analyzes the proposed mergers, industry analysts on the NHPC panel suggested that insurer consolidation could negatively affect patient experiences in the health care system.  Sarah Lueck of the Center on Budget and Policy Priorities noted that the Affordable Care Act was designed to improve market competition, but the proposed insurance mergers could increase enrollees’ premiums and harm transparency for consumers.  She pointed out that this competition among providers also drives quality of care, which could suffer under consolidation. Continue reading

Tracking Oil and Gas Laws

For three and half years, the Intermountain Oil & Gas BMP Project has been working on a collection of datasets and maps at LawAtlas.org that focus on water quality, water quantity, and air quality statutes and regulations within oil and gas development in the United States, specifically related to horizontal drilling and hydraulic fracturing (better known as fracking).

Most recently this collection of seven datasets expanded from 13 states (CO, LA, MT, ND, NM, NY, OH, OK, PA, TX, UT, WV, and WY) to 17 states (adding IL, CA, AR, and AK) and added regulations from four federal agencies – Bureau of Land Management, Bureau of Indian Affairs, U.S. Forest Service, and the Environmental Protection Agency. The research, which was funded in part by the Public Health Law Research program (PHLR), is meant to shed light on the regulations in place in the industry, and establish a baseline for how the industry is regulated.

Samelson head shot

Matt Samelson, JD

Matt Samelson, JD, a consultant attorney at University of Colorado Boulder Getches-Wilkinson Center for Natural Resources, Energy, and the Environment, spoke with PHLR about his work and the recent developments in this project.

PHLR: What is the mission of the Intermountain Oil and Gas BMP Project? Continue reading

Data Mining and Pregnancy Prediction

By Katherine Kwong

Our private health decisions may not be as private as we’d like to think. A recent article in the Wall Street Journal revealed a potentially uncomfortable situation: employers using health care analytics companies to mine employees’ health data to determine which employees may be about to make certain health decisions.

While this type of data analytics can be used to predict a variety of health conditions (ranging from an increased risk of diabetes to back surgery to pregnancy), the most attention-grabbing example discussed was pregnancy. By obtaining permission to analyze employees’ medical information, companies such as Castlight are able to look at factors such as search queries and whether employees have been filling their birth control prescriptions to predict pregnancies. Some commentators expressed concerns that this type of information could be used by companies in improper ways. Continue reading

NHPC 2016: Provider Engagement Can Unify Diverse Payment Reform Efforts

By Cornelia Hall, Master of Public Policy Candidate, Harvard Kennedy School, Class of 2017

This is the first entry in a three-part series on the AcademyHealth National Health Policy Conference, held in Washington, DC, on February 1-2, 2016. 

At AcademyHealth’s 2016 National Health Policy Conference earlier this month, payment reform was a pervasive theme.  Its prominence was not surprising.  Indeed, in early 2015, HHS Secretary Sylvia Burwell announced the agency’s goal to have 30% of traditional, fee-for-service Medicare payments tied to quality or value through alternative payment models by the end of 2016, and 50% by the end of 2018.  As the current sea change in health care moves the system towards these goals, the conference’s panelists explored various aspects of the transition to value-based payment. Speakers who discussed the issue included leaders in government, clinical practice, and private insurance.  They sent an overarching message that payment reform efforts will continue to take a variety of forms — on parallel tracks with cross-cutting themes — rather than a single approach.  Representatives from provider organizations particularly stressed the necessary groundwork for these efforts to be effective.

The Center for Medicare and Medicaid Innovation (CMMI) under the federal Centers for Medicare & Medicaid Services (CMS) is operating dozens of payment- and quality-focused models and demonstrations across the country.  The breadth of payment models and their varying degrees of success represent different approaches to health care reform, such as population- and episode-based payment.  On his panel, CMMI Deputy Director Dr. Rahul Rajkumar noted that this breadth is designed to appeal to diverse providers that differ in type and readiness for payment reform.  Indeed, a health care system that has operated for decades with multiple payers, little care coordination, fragmented use of technology, and inconsistent definitions of quality care is undergoing monumental transformation.  The transition from fee-for-service to value-based payment thus involves some experimentation to identify the most effective approach. Continue reading

Jacobus and Catalyst Continue to Race for Approval of LEMS Drug

By Dalia Deak

The latest development in the race for approval between Jacobus Pharmaceutical Company and Catalyst Pharmaceuticals is a ‘refuse to file’ letter that the FDA issued to Catalyst indicating that Catalyst’s New Drug Application for Firdapse was incomplete. Both companies are competing for approval of slightly modified forms of a drug—3,4-diaminopyridine, or 3,4-DAP— to treat Lambert-Eaton myasthenic syndrome (LEMS). The winner will receive 7 years of exclusive marketing rights to the drug.

LEMS is an autoimmune disorder that affects an estimated 3,000 people in the United States. It is a rare, debilitating disorder that is marked by progressive weakening of the muscles that often begins in young adulthood. The drug in question was initially discovered in the 1970s in Scotland, with researchers in Sweden demonstrating its use in LEMS patients in the 1980s. Jacobus Pharmaceutical Company has been providing a free base form of the drug to patients with a LEMS diagnosis since the early 1990s at no cost (with the exception of postage), though the drug had never received FDA approval.

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Evolving Industry Structures in Biosimilar Development

By Rachel Sachs

Yesterday, I had the privilege to moderate a fantastic event here at the Petrie-Flom Center on Assessing the Viability of FDA’s Biosimilars Pathway.  Bringing together expert panelists from legal practice (Donald R. Ware, Partner, Foley Hoag LLP), industry (Konstantinos Andrikopoulos, Lead IP Counsel, Manufacturing, Biogen, Inc.), and academia (W. Nicholson Price II, Assistant Professor of Law, University of New Hampshire School of Law), the event explored different aspects of the biosimilars issue, considering the guidances issued (and still to be issued) by the FDA, the role of the “patent dance” in biosimilar litigation, and whether Europe’s experience with biosimilars has helpful lessons for our own situation.  For those who weren’t able to make it, video of the event will be posted on the Petrie-Flom Center’s website soon.

But I wanted to write here about one of the very last questions we explored during the panel, because its implications are more far-reaching than we had the time to consider.  The situation is as follows:  In the decades after the Hatch-Waxman Act created a generic pathway for small-molecule drugs, companies typically specialized in developing either innovator or generic drugs, but not both.  And although generic drug companies had great capacity for innovating in manufacturing, they were not research companies in the way that we think about innovator companies.  The situation has changed somewhat over the years, as generic companies began to invest in innovative products, and as innovator companies put out authorized generics, but in general this broad division within industry has persisted.

In the biologic context, by contrast, the biosimilar applications being filed with the FDA are more typically being filed by innovator companies themselves or by subsidiaries thereof.  For instance, the only biologic approved in the United States thus far is marketed by Sandoz, which is part of the innovator company Novartis.  Instead of a situation in which innovators battle generic companies for access to the market, now innovator companies are battling themselves.  There are a host of reasons for this development, most notably including the complex manufacturing processes involved in the biologics space and the need for the development of expertise there.

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Women, Girls, and Mass Incarceration: A Hidden Problem

Goodwin-Headshot11By Michele Goodwin

Mass incarceration’s invisible casualties are women and children.  Too often, they are the forgotten in a tragic American tale that distinguishes the United States from all peer nations.  Simply put, the U.S. incarcerates more of its population than anywhere else in the world–and by staggering contrast.  While the U.S. locks away over 700 men and women for every 100,000, here are comparable figures from our peer nations:  England (153 in 100,000), France (96 in 100,000), Germany (85 in 100,000), Italy (111 in 100,000), and Spain (159, in 100,000).  The U.S. accounts for less than 5% of the globes population, yet locks away nearly 25%.  Sadly, this has grave social, medical, psychological, and economic consequences.

Congressional Briefing on Women, Girls, and Mass Incarceration

In a recent essay, published in the Texas Law Review, I explained that, the population of women in prison grew by 832% in the period between 1977-2007—nearly twice the rate as men during that same period. More conservative estimates suggest that the rate of incarceration of women grew by over 750% during the past three decades. This staggering increase now results in more than one million incarcerated in prison, jail, or tethered to the criminal justice system as a parolee or probationer in the U.S. The Bureau of Justice Statistics underscores the problem, explaining in a “Special Report” that “[s]ince 1991, the number of children with a mother in prison has more than doubled, up 131%,” while “[t]he number of children with a father in prison has grown [only] by 77%.” Continue reading

Humanizing Pain: Advocacy, Policy and Law on Abortion, Execution and Juvenile Life Without Parole

By Robert Kinscherff

I recently attended a presentation on Fetal Pain: An Update on the Science and Legal Implications, jointly sponsored by the Center for Law, Brain and Behavior (Massachusetts General Hospital) and the Petrie-Flom Center (Harvard Law School).  Presenters were Amanda Pustilnik, JD (University of Maryland School of Law) and Maureen Strafford, MD (Tufts University School of Medicine). Video of the event is available on the website, and I encourage everyone to watch the full discussion for themselves.

Doctor Strafford delivered a masterful overview of the trajectory of scientific perspective and research about children and pain.  Over the course of her career, the medical perspective has transformed from “children do not feel pain” to “children do not remember pain” to inquiry into “when and how children feel pain.” Strafford described the medical complexities of understanding the physical and subjective aspects of pain as well as the impossibility of confidently “pinpointing” the exact point in fetal development when a neonate experiences pain.

Professor Pustilnik gave an equally compelling review of law and legal language regarding abortion, particularly law that specifically references fetal pain as a reason for limiting abortion.   This served to frame a conversation about pain and suffering in the law and the ways in which law reflects normative considerations and provides rhetoric (viewed respectively by partisans as “compelling” or “inflammatory”) to political discourse. In this case, discourse about fetal pain both attracts attention and is intended to facilitate empathy for the neonate. Continue reading

Update: Another Wave of ICD Settlements

By Zack Buck

There has been an update to a story I recently blogged about here.

As announced by the Department of Justice (DOJ) on Wednesday, another 51 hospitals have settled allegations that the hospitals placed implantable cardioverter defibrillators (ICDs) in the chests of patients without complying with Medicare’s mandatory waiting periods.  These 51 settlements amount to $23 million, meaning that the DOJ’s ICD review has now has resulted in settlements with more than 500 hospitals totaling more than $280 million.

According to the DOJ, this is the final stage of the investigation, concluding an initiative that has highlighted the tension that exists between fraud enforcement, medical necessity, and reimbursement standards (recent articles here, here, and here).

Monday, 2/22, Health Law Workshop with Tom Shakespeare

HLS Health Law Workshop: Tom Shakespeare

February 22, 2016 5:00 PM
Hauser Hall 102
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Download the Papers:
“Disability and social rights: Family and intimate relations”
“Nasty, Brutish, and Short? On the Predicament of Disability and Embodiment”

Tom Shakespeare is Senior Lecturer at Norwich Medical School, the University of East Anglia. From his website:

My primary research interests are in disability studies, medical sociology, and in social and ethical aspects of genetics. I have had a long involvement with the disabled people’s movement in UK and internationally. In the context of disability arts, I have also been active in arts and culture, and was a member of Arts Council England from 2003-2008.  While at Newcastle University, I developed an interest in science communication and public engagement, and helped develop the café scientifique movement in UK and across the world, as well as promoting sci-art projects.  During my five years at WHO, I helped produce and launch key reports such as the World Report on Disability (WHO 2011) and International Perspectives on Spinal Cord Injury (WHO 2013), and was responsible for the UN statement on forced, coerced and otherwise involuntary sterilization (WHO 2014).  This grew my interest in disability and international development.

I did my PhD at Cambridge University and then worked at the Universities of Sunderland, Leeds and Newcastle, before spending five years working at the World Health Organization in Geneva.  In February 2013, I started my current post at Norwich Medical School.  I continue to consult for WHO, World Bank and other UN agencies.

1993-1996             Lecturer, University of Sunderland

1996-1999             Research Fellow, University of Leeds

1999-2008             Research Fellow, University of Newcastle, where I co-founded and developed the Policy, Ethics and Life Sciences Research Institute.

2008-2013             Technical officer, Department of Violence and Injury Prevention and Disability, World Health Organization, Geneva.

For more information, visit his website.

‘The Week in Health Law’ Podcast

By Nicolas Terry

This week we interviewed Dayna Matthew, Professor of Law at the University of Colorado Law School. Professor Matthew brings an interdisciplinary approach to the study of health law. She holds a joint appointment at the Colorado School of Public Health and is co-founder of the Colorado Health Equity Project, a medical legal partnership whose mission is to remove barriers to good health for low income clients by providing legal representation, research, and policy advocacy. twihl 5x5

We discussed her excellent new book, Just Medicine: A Cure for Racial Inequality in American Health Care.  The book discusses shocking disparities in US health care treatment and outcomes, and proposes a bold agenda for addressing them. Laws like the ACA and even the CRA (as presently written) are not capable of addressing present manifestations of bias (both inside and outside formal health care institutions). Professor Matthew develops the Biased Care Model as a core contributions to advance understanding of health and health care disparities. She also proposes concrete legislative changes, discussed on the show, to counteract biased care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Tomorrow, 3/2! The Limits to Consumerism in Healthcare: A lecture by Mary Anne Bobinski

medical doctor comforting senior patient

The Limits to Consumerism in Healthcare: A lecture by Mary Anne Bobinski
March 2, 2016 12:00 PM
Wasserstein Hall, Room 1010
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

It is often said that health care has moved from paternalism, in the form of “doctor knows best,” to consumerism, in which patients expect to be able to obtain treatment consistent with their values and preferences. This presentation will explore some of the limits to consumerism in health care, with a particular focus on circumstances where patient values or preferences conflict with provider values, professional ethics, or societal norms captured in legislation or court decisions. Considerable attention has been devoted to constraints on patient choice in areas such as abortion and end of life care. This presentation will focus more broadly on the justifications and techniques for constraining patient choice in areas such as access to assisted reproductive technologies, risky therapies, pre-exposure prophylaxis for HIV, and extreme plastic surgery. Although the discussion will focus on the U.S., selected examples from Australia, Canada, and the U.K. will also be considered.

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