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

Prime Health: Should Amazon Purchase a Hospital Chain?

Cross-posted from Medium.

By Nicolas Terry

The devotees of digital health and disruption recently lit up the Internet after reports that Amazon had deployed a secret health tech team codenamed 1492 (presumably a reference to healthcare visionary Columbus). The real surprise would be if Amazon did not have such a team in place. Other tech companies, Alphabet, Apple, IBM, Samsung, et al, understand that, while a latecomer to technologies, future healthcare will be data-driven and that there will be multiple opportunities to sell cloud storage, analytics services, and immodestly-priced wearables.

But, let’s pose a far more interesting question. What if Amazon decided to go beyond participating in upstart digital health with its interest in wellness, and took a swing at traditional healthcare and sickness? What, in other words, if Amazon purchased a hospital chain or network? Let’s assume that “1492” is the internal code name for Prime Health. On its face, the idea of what only a few years ago was just an online bookseller entering the healthcare field seems ridiculous. After all, healthcare is more complicated by several orders of magnitude than any other industry. Also, healthcare is particularly hard for outsiders to disrupt due to intrinsic market failures, overarching structural issues, the illiquidity of healthcare data, provider and patient heterogeneity, underperforming HIT technologies, third-party reimbursement, and so on. Saliently, healthcare is not about warehousing hard goods and distributing them with AI-based logistics. Rather, healthcare is all about bricks-and mortar facilities, services more that goods, face-to-face interactions, neighborhoods, customer needs that cannot be left to “spoil,” and a “last mile” problem that is incredibly hard to solve with technology. In other words, it’s quite like selling groceries. However, here’s the thing, Amazon recently purchased the upscale grocery chain Whole Foods for $13.4 Billion! Continue reading

Leslie Francis and John Francis on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Two very special guests and the Pod’s first power couple interview. This week we talk with Leslie P. Francis and John G. Francis about their new book, Privacy: What Everyone Needs to Know. Leslie Francis is a professor of law and a professor of philosophy at the University of Utah, and John Francis is a research professor in the Political Science Department, also at the University of Utah.

Leslie is one of our leading privacy scholars and John is an expert in comparative politics and regulatory policy, ethics, and data policy. We explored privacy theory, how privacy differs between economic domains, and the relative benefits of consent, use, and delinking regulation.

As the Francises explain, “A great deal is at stake for individuals, groups, and societies if privacy is misunderstood, misdirected, or misused. Popular understanding of privacy doesn’t match the heat the concept generates. With a host of cultural differences as to how privacy is understood globally and in different religions, and with ceaseless technological advancements, it is an increasingly complex topic.”

We cover several areas of health privacy, and also zoom out and consider health data in the context of other recent controversies in data protection and management (such as the right to be forgotten). The Francises seamlessly weave together legal, philosophical, bioethical, and regulatory perspectives on privacy while providing direct yet nuanced answers to common questions about it. We hope TWIHL listeners will enjoy this conversation, and check out the book!

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

Jaime King on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Hastings law professor and antitrust expert Jaime King joins us to discuss competition and consolidation in healthcare delivery. We discussed (apparently) pro-competitive collaborations, price transparency models, the limits of demand-side reforms, Gobeille’s interpretation of ERISA as a major blow to state initiatives, and innovative cross-market merger activity. Be sure to follow Jaime’s scholarly work at SSRN, and to keep up with her Source on Health Care Price & Competition, which has up-to-the-minute aggregators on key issues in health care finance.

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

The 100th ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week, we celebrate Episode 100! Like Episode 1 from 2015, it’s just the two of us–revisiting topics from the first show, commenting on the current health policy landscape, and exploring past and present projects in health information law, privacy, data protection, and AI. Nic’s SSRN page is here, and Frank’s is here.

And we leave you with two of our recent public lectures: Nic Terry’s Rome Lecture (Appification to AI and Healthcare’s New Iron Triangle), and Frank Pasquale’s reflections on the political economy of health automation (inter alia).  Enjoy!

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

Wendy Parmet on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Our return guest this week is Wendy Parmet, Matthews Distinguished University Professor of Law, Professor of Public Policy and Urban Affairs, Director of the Program on Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support at Northeastern University School of Law.  Professor Parmet is a leading voice internationally on cutting edge issues in public health. She also recently won the ASLME’s Jay Healey Health Law Teachers Award.

Our discussion focused on The Health of Newcomers: Immigration, Health Policy, and the Case for Global Solidaritya recent book of Wendy’s (co-authored with philosopher Patricia Illingworth). This is a far-reaching interdisciplinary inquiry, which closely examines the interdependence of natives and newcomers across several health dimensions. Our discussion progresses into an old Pod favorite, “Docs and Glocks,” before ending with some observations on the current state of scientific knowledge regarding opioid interventions.

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Nathan Cortez on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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With help from our good friend Nathan Cortez from SMU School of Law we discuss the American Health Care Act. Nathan is a thought leader in both health law and policy and administrative law and legislation–intersecting forms of expertise particularly valuable in these turbulent times.

In addition to coming to grips with some of its complex provisions, we speculated on how it will fare in the Senate, given emerging details about working groups and Democratic bridge-building by the Gang of Three (Joe Manchin, Heidi Heitkamp, and Tim “Copper Plan” Kaine). Here Professor Cortez’s expertise on Reconciliation and the Byrd Amendment proved essential. We also, let truth be told, took the opportunity to get a few things off our collective chests!

For background on AHCA: Andy Slavitt has been a diligent collector of summaries & critical commentary. In a media environment where the lies being told about AHCA’s effects on coverage are described as “flagrant,” “bald-faced,” and “gas-lighting,” expert voices are needed now more than ever. Some predict that the class warfare embodied in the bill’s distributional effects would cause a “humanitarian crisis” if it came to pass; others worry it would undo the pillars of not merely Obamacare and Medicaid, but also employer-sponsored plans. One thing appears certain: expect bankruptcy law to renew its advance onto health law syllabi. Continue reading

Deborah Stone on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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We are joined by Deborah Stone, Distinguished Visiting Professor in the Heller School for Social Policy and Management at Brandeis University. She is famous for her classic, Policy Paradox: The Art of Political Decision Making, a magisterial account of goals, problems, and solutions in a wide array of policy conflicts.

Policy Paradox has had four editions over 25 years and has been translated into five languages. As Stone argues in the book, “behind every policy issue lurks a contest over conflicting, though equally plausible, conceptions of the same abstract goal or value.” Recognizing the deep pluralism of values and aims, Stone wisely counsels that “the job of the policy designer…is to understand the rules of the game well enough to know the standard moves and countermoves, and to think about them strategically.”

With this theoretical structure firmly in mind, we discuss the ACA and healthcare in the world of Trump. We also asked Deborah about her article “Caring Communities: What Would it Take?,” a patient-centered, care-focused counter-narrative to technocratic quantification. Grounding present conflicts in a longer-term view of the role of policymakers in a democracy, Stone offers perspective on the future of health equity in a polity where even the basic concept of risk pooling now appears contestable.

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 Radio, Tunein 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.

Heather Howard on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Health policy researcher Heather H. Howard returns to the pod and, not surprisingly, Medicaid was the focus of our talk. Howard is a lecturer at Princeton University’s Woodrow Wilson School, where she teaches courses on implementation of the Affordable Care Act (ACA), the social determinants of health, and state and local health policy. She works with states implementing health reforms and served as New Jersey’s Commissioner of Health and Senior Services from 2008-2010. She tweets at @HeatherHHoward.

We discussed various Medicaid issues; the extent non-expansion was driven by policy or politics, work requirements under Section 1115 waivers, state administrative costs associated with draconian Medicaid expansion criteria (particularly when compared to the macroeconomic effects of a robust healthcare system), cost-sharing and the “private option” in existing state plans, and the likelihood of Section 1332 waivers moving states to universal care or, at least, meaningful innovation.

Our lightning round addressed various issues, including an Altarum study on the macroeconomic effects of the ACA, and state AG’s actions regarding mHealth apps and privacy.

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 Radio, Tunein 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.

Judy Solomon on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we discussed the future of the ACA with Judy Solomon of the Center for Budget and Policy Priorities. Judy is Vice President for Health Policy at CBPP, where she focuses on Medicaid and the Children’s Health Insurance Program. She is also an expert on issues related to the implementation of the ACA, particularly policies to make coverage available and affordable for low-income people.

As new alternatives to the ACA emerge, we discussed the wide range of policies that may be in the offing for state Medicaid waivers. CBPP has a fascinating and up-to-date series of posts on the transition from Obamacare to Trumpcare. Follow Judy on Twitter at @JudyCBPP, which includes links to her insightful blog posts and a number of other critical developments in health policy.

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 Radio, Tunein 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

Rebecca Dresser on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week features Professor Rebecca Dresser of Washington University. She is the author of Silent Partners: Human Subjects and Research Ethics (Oxford University Press, 2016) and When Science Offers Salvation: Patient Advocacy and Research Ethics (Oxford University Press, 2001), along with many other insightful articles on bioethics and law. Our discussion focused on Silent Partners, including Rebecca’s work’s relevance to current debates on research ethics and informed consent.

Rebecca is a past member of the President’s Council on Bioethics and National Institutes of Health Recombinant DNA Advisory Board. She is a prolific speaker and panelist at national and international symposia, conferences, and workshops on such topics as bioethics and cancer; advance treatment directives; stem cell research; biomedical research policy; and human cloning.

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 Radio, Tunein 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

Tim Jost on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we are honored to have a conversation with Professor Tim Jost from Washington & Lee School of Law. Jost, one of our most prolific scholars and astute commentators, not to mention the rock around which the Health Affairs blog is built, looks back at the successes and failures of the ACA, speculates on some of the reasons for its rocky road, and looks ahead to repeal and replacement.

Jost’s posts at Health Affairs are more urgent than ever as the uncertainty around ACA repeal/replace/delay intensifies. While his work on consumer-directed health care is particularly relevant to today’s policy environment, he has also proposed reforms to strengthen the ACA.

For some notes on items we discussed: Frank mentioned an analysis of Tom Price’s plan to replace the ACA, focusing on the plan to “block grant $1 billion dollars a year for four years (or $2.2 million per Congressional District per year) to help states fund high risk pools.” Jost mentioned a Commonwealth Fund report suggesting that amount is not even within two orders of magnitude of the true cost of such pools (at least $100 billion). But at least some people will truly benefit from ACA repeal: the 400 highest-income households each “would get an average tax cut of about $7 million a year,” according to CBPP.

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 Radio, Tunein 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

Zack Buck on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week’s podcast features conversation with University of Tennessee Professor Zack Buck. His recent research suggests an interesting fiduciary approach to dealing with the problem of over-treatment and also ponders the best way to deal with the “financial toxicity” that results from related phenomena.

Zack’s work is archived at SSRN. He has creatively approached the problem of overtreatment in a series of articles, focusing on ways that health care finance and regulation can be reformed in order to better calibrate incentives for optimal care. His work includes “Furthering the Fiduciary Metaphor” and “Caring Too Much: Misapplying the False Claims Act to Target Overtreatment.”

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 Radio, Tunein 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

Jordan Paradise on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Loyola Chicago law professor Jordan Paradise joins us to discuss some of her recent work in life sciences law. Jordan’s recent interests span nanotechnology, synthetic biology, precision medicine, gene editing, and electronic cigarettes.  Her publications have appeared in both peer-reviewed and legal publications.

We start with a review of some of the regulatory issues involving e-cigarettes, and discuss the 2016 FDA regulations. We then move into a discussion of FDA regulation of biologics and biosimilars and Jordan explains naming and substitution issues.

Jordan’s recent publications include research on how the FDA could regulate e-cigarettes, strategic misuse of risk evaluation and mitigation strategies (REMS), and cutting edge developments in the law of biosimilars.

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 Radio, Tunein 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

Russell Korobkin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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twihl 5x5For our Diamond Podcast, our guest is Russell Korobkin, Vice Dean and Richard C. Maxwell Professor of Law at UCLA School of Law, where he teaches ContractsNegotiation and Health Care Law. Russell has published more than 50 law journal articles in the fields of behavioral law and economics, negotiation and alternative dispute resolution, contract law, the health care law and stem cell research, and has also published several books.

In the lightning round, Nic focused on the AARP’s challenge to wellness programs, and further empirical research on the Oregon experiment. Frank discussed news coverage of past guest Ameet Sarpatwari’s work, and a study on the use of scribes to promote better data gathering and analysis (and relieve physician burnout). Continue reading

Allison Hoffman on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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We start with a special request to TWIHL listeners this week: please consider donating to Partners in Health’s Haitian hurricane relief efforts. It’s always a good time to donate to PIH.org, but especially now, in the wake of apocalyptic levels of destruction. In the southwest peninsula, over one million people are cut off from food, clean water, and medical care.

Our guest this week is Allison Hoffman, Professor of Law at UCLA School of Law and an expert in health care law and policy.  Professor Hoffman’s work examines the Affordable Care Act, Medicare and retiree healthcare expenses, and long-term care.  We discussed Allison’s recent work on long-term care, including the soon-to-be-published piece “Reimagining the Risk of Long-Term Care,” in the Yale Journal of Health Policy, Law, and Ethics. This is a particularly important topic in the wake of the collapse of the CLASS Act–an infrequently-lamented but very important shortcoming of the ACA.

Our lightning round was a veritable derecho of regulatory detail, addressing the Teladoc case, arbitration travails in nursing homes (and a rule designed to end some of them), HHS guidance on HIPAA and cloud computing, ONCHIT on data blocking, the politics of physicians, and Kansas’s asset verification debacle.

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 Radio, Tunein 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

Melinda Buntin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5This week we welcome Melinda J. Beeuwkes Buntin, Chair of the Department of Health Policy at Vanderbilt University’s School of Medicine. She previously served as Deputy Assistant Director for Health at the Congressional Budget Office (CBO), and worked at the Office of the National Coordinator for Health IT. At RAND, Melinda served as deputy director of RAND Health’s Economics, Financing, and Organization Program and co-director of the Bing Center for Health Economics. Her research at RAND focused on insurance benefit design, provider payment, and the care use and needs of the elderly. For the lightning round, Nic discussed technological improvement of decisionmaking, both for consumers and doctors. Nic also covered CMS’s rejection of Ohio’s request for a new section 1115 demonstration (which would have charged “premiums, regardless of income, to the 600,000 individuals in Ohio’s new adult group, as well as hundreds of thousands of low income parents, foster care youth, and beneficiaries with breast and cervical cancer”). Frank offered a counterintuitive look at the EpiPen and the present technocrat rage to privatize the VA. During the conversation, we covered some topics in CBO modeling, including Melinda’s recent paper on changes in spending by age of beneficiary. Frank mentioned some general concerns about CBO’s modeling raised by Federal Reserve economists, the GAO, Tim Westmoreland (in 2008 and 2007), Maggie Mahar, Timothy Jost, and Bruce Vladeck. We look forward to more conversations on the nature of health cost projections!

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 Radio, Tunein 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

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J. B. Silvers on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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We welcomed J. B. Silvers to the podcast this week. J. B. is the John R. Mannix Medical Mutual of Ohio Professor of Health Care Finance, and Professor of Banking and Finance, at the Weatherhead School of Management, with a joint appointment in the Case Western Reserve University School of Medicine.

We asked J. B. many questions about the state of the ACA, hospitals’ adaptation to the rapidly changing policy environment, and ongoing worries about a death spiral on the exchanges. He offered refreshing and insightful perspectives on a range of live controversies in health care finance.

J. B. has served on committees at the National Academies and several national and state commissions. Until recently, he was a board member (12 years) and treasurer of the Joint Committee on Accreditation of Healthcare Organizations (TJC/JCAHO) and a board member of SummaCare Insurance Company (14 years). For seven years Silvers was a commissioner on the Prospective Payment Assessment Commission (now MedPAC) advising Congress on Medicare payment. From 1997 to 2000, while on leave, he served as President and CEO of QualChoice Health Plan and Insurance Company. He currently is vice chair of the board at MetroHealth Medical Center.

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 Radio, Tunein 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

Ameet Sarpatwari on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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twihl 5x5Our guest this week is Ameet Sarpatwari, an Instructor in Medicine at Harvard Medical School and an Associate Epidemiologist at Brigham and Women’s Hospital based in the Program On Regulation, Therapeutics, And Law (PORTAL) within the Division of Pharmacoepidemiology and Pharmacoeconomics. Ameet’s research focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes. He is currently examining the public health implications of variation in state drug product selection laws, the risk of re-identification under HIPAA pathways for data sharing for post-approval drug research, and the comparative safety and effectiveness of biosimilars.In the lightning round, Nic addressed the Notice Act and ongoing controversy over hospitals’ use of “observation status” to dodge readmissions penalties and game reimbursements. We also mentioned the strange politics of bill naming. (One also wonders what exactly vulnerable patients are supposed to do once they receive notice that they could soon be hit by huge bills.)

Nic also covered the FTC’s reversal of an ALJ’s judgment in LabMD, the case that keeps on giving. Frank riffed on an article “Medicaid Expansion’s New Cost Estimate Isn’t Alarming,” from the CBPP, and expressed some skepticism as to the degree to which episode payment models would assure better pay for hospital care.

Our conversation with Ameet focused on his many articles on counter-detailing, medical research ethics, the opioid crisis, and large firms’ misues of the FDA’s regulatory system. Links to all are available at his website.

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 Radio, Tunein 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

Back to School Special Part 1 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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It’s that time of year again–the TWIHL Back to School Special (BTSS)! We’ve rounded up experts from across the health law academy to discuss what they see as the most important new developments over the past year in health law, and how to integrate them into the health law curriculum. We’ll have three installments of the BTSS; this episode is the first.

This episode features three scholars at the cutting edge of contemporary health law. Allison Hoffman discusses Gobeille v. Liberty Mutual Insurance and Zubik v. Burwell–and offers big picture commentary on the ways employer-sponsored insurance create unique dilemmas for American law. Nicole Huberfeld discusses Whole Women’s Health v. Hellerstedt and Medicaid expansion. Abbe Gluck describes a new “book course” approach to teaching health law, and the importance of health law perspectives in constitutional law and federal courts courses.

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 Radio, Tunein 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