The Week in Health Law

Our annual Back To School Special returns in time for a new semester. In this first part we welcome TWIHL Allstars Nick Bagley, Micah Berman, Glenn Cohen, Nicole Huberfeld. Our conversations covered a lot of ground including CSR payments, House v. Price, gene editing, the Trump administration’s approach to regulation, healthcare federalism, and the future of waivers under CMS’s new management.

A deep dive into pharmaceutical patent protection and its intersection with the FDA new drug approval process. We touch on molecular drugs, biosimilars, data 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.

Two of the nation’s leading researchers into prescription drug costs join us for an in-depth exploration of the reasons for our high and increasing drug bill and a critical analysis of some of the investment, transparency, value, and outcomes-based metrics being used to determine “fair” prescription drug costs.

Our guest this week is Wendy Netter Epstein, who is Associate Professor of Law at DePaul University, and Faculty Director of DePaul's Jaharis Health Law Institute. Her teaching and research interests focus on health care law and policy, contracts, and commercial law. Professor Epstein has won Excellence in Teaching Awards from both DePaul University and the College of Law. We discussed some of her research on contract law and health care, including "The Health Insurer Nudge." The lightning round this week included a discussion of institutional liability, and divergent paths for antitrust (the Obama/Trump emphasis on professions and occupational licensure, or the Better Deal focus on mergers). Recalling our conversations with Guian McKee and Jessica Mantel, we also discussed the macroeconomic impact of health care institutions. Obamacare certainly helped Detroit, but Dan Diamond worries that the Cleveland Clinic (and many other hospitals) are not providing levels of community benefit high enough to justify their tax exemption.

On another international episode of the Pod we chat with Claudia Pagliari, Senior Lecturer in Primary Care and Informatics and Director of Global eHealth at Edinburgh University in the UK. A psychologist by training she is an internationally recognized expert in health informatics. Our broad-ranging discussion touched on digital technology for health sector governance in low and middle income countries, drug advertising rules, DTC genetic tests, medical app curation, and transatlantic perspectives on data sharing.

Frank and Nic internalize their travel issues and try to get to grips with some of the recent stories from healthcare land. Among the stories we discuss are UK Information Commissioner’s report on the Royal Free - Google DeepMind trial, US-EU competition policy (another Google case), a class action in Alaska involving a DTC genetic service that is butting heads with a very strongly worded state statute, the opioid crisis seen through a litigation lens, and our latest thoughts, rants, and questions about health reform/repeal including the latest on the three-legged stool and cost-sharing subsidies. Finally, and with great trepidation we raise the wise of single-payer care only to uncover a new policy position taken by one of your hosts!

Two very special guests and the Pod’s first power couple interview. Leslie and John Francis join us to discuss their new book “Privacy: What Everyone Needs to Know” published by Oxford University Press. 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.

University of California law professor Michelle Goodwin joins us for a detailed discussion about the increasingly adverse relationship between women and the state. Increasingly, pregnancy is being policed by an array of oppressive state laws, many of which are being used in contexts far removed from their legislative intent. Our conversation includes a detailed look at the abortion cases and their limitations. We end with a disturbing narrative about under age marriages in the U.S., often in circumstances that otherwise would be statutory rape.

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 activities.

Perhaps we should have called it “We Should Have Quit Will We Were Ahead!” In any event, a 100th show doesn't come around every week (or even every 8.5 days), and we wanted to express our thanks to all our guests and listeners while reflecting (hence the self-indulgence) on the journey so far.

Wendy Parmet, Matthews Distinguished University Professor of Law at Northeastern University and one of the great figures in contemporary health law & public health law and policy joins us to discuss her new book, co-authored with Patricia Illingworth, The Health of Newcomers: Immigration, Health Policy, and the Case for Global Solidarity, New York University Press (2017). This is a far-reaching piece of work looking at 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.

We welcome LeHigh University political scientist Laura Katz Olson who discusses Medicaid’s survival and it’s less than successful track record as a model for universal healthcare. Her latest book, “Elder Care Journey: A View from the Front Lines” offers both a compelling narrative and an opportunity to assess our current system of long-term care from both theoretical and personal perspectives. Among the questions we ponder: Why do system design, implementation, and legal structures conspire to increase the burdens on family caregivers, and how do those issues impact access?

With help from our good friend Nathan Cortez from SMU School of Law we take a detailed look at the American Health Care Act. In addition to coming to grips with some of its complex provisions we discussed how it will fare in the Senate. Here Professor Cohen’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!

We are joined by Robert K. Smoldt, Chief Administrative Officer emeritus of Mayo Clinic and Associate Director of the Arizona State University Healthcare Delivery and Policy Program. The topics discussed are alternate payment systems including pay for value. We do a deep dive into P4V, elicit comparisons with healthcare in Japan, and ponder integrated care models.

Khiara Bridges, Professor of Law and Professor of Anthropology at Boston University joins us for an in-depth discussion of her new book “The Poverty of Privacy Rights.” The book takes a highly critical look at how Medicaid recipients are treated and whether they are left with any (or any meaningful) privacy rights.