Introducing Guest Blogger John Tingle

Editor’s Note, June 2016: Thanks to John’s many contributions, he is now a Regular Contributor.

John TingleJohn Tingle is joining Bill of Health as a guest contributor. John’s main area of focus will be on what is happening in the UK in the areas of patient safety, clinical negligence litigation and complaints in health care. Policy documents issued in these areas by various governmental health bodies, NGOs and international health organisations such as WHO will be discussed. He will also be taking a comparative perspective and will be exploring the policies and publications of other countries on these issues. Issues such as human rights in healthcare, medical and nursing accountability, hospital transparency, governance and accountability are also key concepts for discussion.

John is Reader in Health Law at Nottingham Law School, Nottingham Trent University in the UK. He has a fortnightly magazine column in the British Journal of Nursing where he focusses on patient safety and the legal aspects of nursing and medicine. John teaches Tort and Medical Law on the LLB at Nottingham Trent and Patient Safety on the LLM in Health Law and Ethics. Read More

FDA Announces Draft Guidance That Would Limit Enforcement Discretion for FMT

By Rachel Sachs

Yesterday, the FDA announced a new draft guidance regarding its exercise of its enforcement discretion around the investigational new drug (IND) requirements as they apply to fecal microbiota transplantation, or FMT.  For almost three years now, the FDA has exercised its enforcement discretion for FMT under a rather permissive set of guidelines, enabling patients to access FMT while companies shepherd a set of products through the clinical trial process.  I recently co-authored an article about the FDA’s regulation of FMT, and I’m concerned about this new guidance, in terms of safety, access, and regulatory clarity.  This is one of the wonkiest posts I’ve written in some time (and that’s saying something), so I’ll endeavor to be as clear as possible.

What is FMT and why is it important? To make a long story short, it’s a poop transplant.  Filtered stool from a healthy donor is transplanted into the gastrointestinal tract of a sick patient.  Although scientists are continuing to explore the use of FMT for a range of indications, we already know that FMT is a startlingly effective treatment for recurrent C. difficile infection.  C. difficile infections have become among the most common hospital-acquired infections in the United States, with more than 450,000 total incident infections annually.  Unfortunately, many of these infections are resistant to antibiotics: with those 450,000 infections came 80,000 recurrences and 29,000 deaths.  But FMT may provide a way forward.  A recent randomized trial of patients with recurrent C. difficile infections was stopped early, when 94% of patients in the FMT group were cured, as compared to roughly 30% of those getting only antibiotics.

How is the FDA involved? In May 2013, the FDA announced that fecal microbiota would be regulated as a drug.  All uses of FMT would therefore need to be part of an IND application, and patients who wanted to be treated with FMT for recurrent C. difficile would need to participate in a clinical trial to do so.  Physicians and scientists responded with concern, arguing that available evidence supporting FMT’s effectiveness as a therapy for recurrent C. difficile infection was too compelling for regulators to restrict its availability to clinical trials.  As such, in July 2013, the FDA announced that it would exercise enforcement discretion when FMT was used to treat patients “with C. difficile infection not responding to standard therapies,” so long as the treating physician obtained informed consent. Read More

Short-Term Emergency Commitment Laws and their Impact on Firearm Possession Rights

By Andrew T. Campbell, Esq.

The Policy Surveillance Program recently updated its dataset analyzing state laws governing the short-term emergency commitment process. This dataset includes state laws that limit an individual’s right to possess a firearm following short-term emergency commitment. This aspect of the law captured by the dataset is particularly relevant given the unfortunate rise in mass shootings throughout the United States in recent years, with the latest shooting occurring in Kalamazoo, Michigan on February 21 (see also Deadliest U.S. mass shootings – 1984-2015 from the Los Angeles Times). These mass shooting tragedies have spurred debate and legislative action on gun control, to which issues of mental health have become inextricably intertwined despite research that indicates that mental illness is only a small factor in violence (see for example Mental health legislation complicated by gun control debate from The Washington Post; and Debate over gun control, mental health starts anew from CBS News). Additionally, on January 5, 2016, President Obama announced an executive action to battle gun violence, which includes a $500 million investment toward increasing access to mental health care.

With respect to the legal landscape, federal law restricts the sale of firearms to individuals who have been adjudicated as a “mental defective” or “committed to any mental institution.” Committed to a mental institution in this instance encompasses long-term involuntary commitments, but does not include those admitted for observation, i.e., short-term emergency commitment. Some states, however, have gone further and have enacted more extensive legislation that limits the right to possess a firearm for individuals who have been subject to short-term emergency commitment. With short-term emergency commitment, law enforcement officers and certain other individuals have the right to involuntarily admit individuals to a mental health care facility for a short period of time if they are displaying symptoms of a mental illness and pose a danger to themselves or others. Read More

‘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. Read More

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. Read More

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. Read More

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.

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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? Read More

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. Read More