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Wendy Mariner on ‘The Week in Health Law’ Podcast

Midterm Takeaways Director’s Cut: I am joined by Professor Wendy Mariner, Professor of Health Law at Boston University School of Public Health and Professor of Law at Boston University School of Law. It was three days after the midterm elections and we thought it would be a good idea to reflect on some of the health law and policy stories. Here’s the complete list.

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Wendy Parmet on ‘The Week in Health Law’ Podcast

the week in health law podcast logoIf you listened to the last episode of TWIHL you may recall that it was recorded early on October 26, 2018 just before I kicked off our conference on the intersection of health care and immigration policy.

Thereafter, it was my distinct pleasure to welcome Wendy Parmet as our keynote speaker.

Professor Parmet is the Matthews Distinguished University Professor of Law and Director, Center for Health Policy and Law; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs. With Patricia Illingworth she authored The Health of Newcomers, Immigration, Health Policy, and the Case for Global Solidarity, published last year by NYU Press. Wendy was most generous in letting me share her compelling talk here on TWIHL. Read More

Reports on the Opioid Crisis are Full of Misidentified Problems and Poorly Calibrated Solutions

This post is part of a symposium from speakers and participants of Northeastern University School of Law’s annual health law conference, Diseases of Despair: The Role of Policy and Law, organized by the Center for Health Policy and Law.

All the posts in the series are available here.

By Nicolas Terry

The epidemic associated with Opioid Use Disorder (OUD) has birthed a proliferation of reports, many with notable provenance. They include the Surgeon General’s Report (2016), the President’s Commission on Combating Drug Addiction and the Opioid Crisis (2017),  and the National Governors Association Recommendations for Federal Action to End the Nation’s Opioid Crisis (2018). We can add innumerable regional and state reports to that list.

Placed next to each other, their recommendations are broadly similar. While they may differ somewhat to the extent that they emphasize criminalization versus medicalization, overall, they tend to coalesce around harm reduction (such as broad naloxone availability and syringe exchanges), upstream opioid reduction strategies (such as prescription limits and prescription drug monitoring programs), and increased public health surveillance based on improved data collection and analysis.

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Thad Pope on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Our guest this week is Thaddeus Mason Pope, Director of the Health Law Institute and Professor of Law at Mitchell Hamline School of Law. Thad is also a Ph.D. with multiple global academic posts. This week we discuss grave and complex problems in end of life care, focusing on the tragic case of Jahi McMath. Thad recently published “Brain Death Forsaken,” and offers a wealth of insight on this and similar situations. The definition of death has complex implications for insurance, reimbursement, malpractice, and even criminal law.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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.

Carl Ameringer on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week features a first time visit from Carl Ameringer, professor of health policy and politics at Virginia Commonwealth University in Richmond, Virginia. A lawyer with a PhD in political science, he is an expert on issues surrounding our national debate on health care reform. We discuss his latest book “US Health Policy and Health Care Delivery: Doctors, Reformers, and Entrepreneurs,” published by Cambridge University Press. Our conversation connects the past and future of American health care, from 19th century development to the ACOs of the ACA. We close with some reflections on path-dependence: is American exceptionalism a permanent impediment to health sector rationalization, or does it provide some models for improvement? Muddling through history, policy, and law has rarely been more edifying, and we hope you enjoy the conversation as much as we did.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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.

Dystopian Memes on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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It’s a stormy healthcare landscape out there, so this show is all lightning round. We cover several areas:

Litigation: Nic provides the Ariadne’s thread through a labyrinthine pharma-tort judgment out of California. The metal on metal hip litigation has resulted in a big judgment, but medical device regulation is still fundamentally broken. Disgruntled Centene enrollees are suing the ACA insurer of last resort for ultra-narrow networks (and Washington state is not happy, either). Washington may lead the way for future narrow network regulation or consent decrees. We followed up on the duodenoscope superbug litigation saga, focusing on duties to translate foreign language emails in discovery.

Regulation: We discussed a crisis in long-term care, following up on last week’s discussion with Paul Osterman. Medicare is not making it any easier for many who qualify for help. We reviewed the new priorities of HHS’s Conscience Rights, er, Civil Rights Division (and potential responses to conscience claims). The rise of Medicaid work requirements is a hot topic, as Kentucky Governor Bevin imposed them last week. Read More

Andrea Matwyshyn on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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A special holiday, near-double episode of TWIHL, featuring a return visit from Andrea Matwyshyn, Professor of Law at Northeastern University, co-director of NEU law school’s Center for Law, Innovation, and Creativity (CLIC), and a US-UK Fulbright Commission Cyber Security Scholar (2016-2017). In addition to her appointment on the law faculty, she is a professor of computer science (by courtesy).

The episode focused on AI, regulation of cutting edge medical devices, and security. We mentioned, in passing, explainable AI, European regulation to require it in certain settings, the general problems raised by AI in health care, and recent developments regarding both mental health apps and devices. Andrea developed her idea of the “Internet of Bodies,” making a compelling case that the law of software liability needs to evolve to address the high stakes of software failure in critical medical devices. We concluded with some year-end reflections on the annus horribilis we shall gladly bid adieu in 10 days. In the meantime, happy holidays to all our listeners!

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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.

Back To School Special Part 2 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Our annual Back To School Special returns in time for a new semester. In this second part, we welcome TWIHL All-Stars Erin Fuse BrownZack Buck, and Jessica Roberts. In this part, topics included state health laws in the time of Trump, price and cost issues, ERISA, MIPS, a fraud and abuse case to watch, and genetic “property” statutes.

We ended with some general thoughts about what we learned from the reform and repeal saga of the past seven months. In the spirit of the Sage of Baltimore, H.L. Mencken, Frank recommended Gabriel Lenz’s Follow the Leader as a reflection on the limits of democracy. And be sure to follow our guests who are on Twitter at @efusebrown and @jrobertsuhlc.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

Erika Lietzan on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week’s TWIHL is a deep dive into pharmaceutical patent protection and its intersection with the FDA new drug approval process. We touch on molecular drugs, biosimilarsdata exclusivity, market exclusivity, the runway to generics, and fascinating differentials between different drug types or families. This is an intensely complex area and we were glad to have the benefit of a truly expert guide, Erika Lietzan, Associate Professor of Law at the University of Missouri, @lietzan on Twitter, and author of the blog Objective Intent, which explores legal and policy issues associated with the FDA.

Erika was a partner at Covington & Burling, and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010 (creating a pathway for approval of biosimilars), from initial thinking as early as 2002 through negotiation of the primary legislative language in 2006 and 2007, passage in 2009, and enactment in 2010. After enactment she co-authored a comprehensive “legislative history” of this process in the Food and Drug Law Journal. She also worked with individual companies and trade associations on implementation issues from 2010 through 2014.

Erika is an elected member of the American Law Institute, serves in the leadership of the Food & Drug Law Institute and served for many years in the leadership of the Science and Technology Section of the American Bar Association. She is also an active member of the American Health Lawyers Association, the American Intellectual Property Law Association, and the American Society of Law, Medicine, and Ethics.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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