The Week in Health Law

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. By the way, watch out for a future post by Frank at the LPE Blog on Trumpcare's transformation of Medicaid. His latest health care post there was titled "The Epicycles of Health Care Market Design: Time for a Paradigm Shift in Health Policy." Also of interest this week: the ethics of fake operations; the UK's Minister of Loneliness; and Covered California covers the coverage roller coaster, as does Vox.

We welcome back our good friend Zack Buck, Professor of Law and Wilkinson Junior Research Professor at the University of Tennessee College of Law. He teaches bioethics and public health, torts, health care finance and organization, health care regulation and quality, and fraud and abuse. He is producing really interesting scholarship relating to our seemingly ever-present and intractable healthcare price and cost issues. Our conversation includes some compelling “lightning” stories, including wellness plans, the Health Affairs retirement of the great Tim Jost, and Medicaid work requirements. Then Zack demonstrated his true mettle, answering questions about MACRA/MIPS, value bundle reimbursement models, and state law attempts to reel in drug costs.

Frank and I welcome labor economist Paul Osterman, Professor of Human Resources and Management at the MIT Sloan School of Management. His most recent book is “Who Will Care For Us: Long Term Care and the Long Term Workforce,” which is the basis for our discussion. He argues that the expansion of the role of direct care workers “will save the system money, both by obtaining better health outcomes—thereby reducing visits to emergency rooms, hospitals, and nursing homes—and by shifting some tasks to lower-paid occupations.” Our discussion covers the demographics of care workers, scope of practice issues, the role of Medicare and Medicaid, possible technological innovations, and quality regulation.

We welcome back one of our most popular guests, Northeastern School of Law professor Andrea Matwyshyn. Our conversation combines some reflections on the past year, events of the last week, and a deep dive into some of the issues that healthcare AI raises and must face going forward.

A welcome return to the pod by Boston University health law professor Wendy Mariner. The three of us present an expanded “lighting round.” We discuss the end of the individual mandate, Murray-Alexander, deficit hawks targeting Medicare, the ramifications of the CVS-Aetna merger, the CMS Guidance on the contraceptive services opt-out, and a new health security settlement out of California.

Another return visit from Leo Beletsky, our friend and Northeastern University School of Law professor. Beletsky is a fearless critic of the more obvious “solutions” to the opioid crisis such as incarceration. His take is far more nuanced, using a public health frame to understand the crisis and employing evidence-based analysis to determine appropriate responses. Our wide-ranging conversation included analysis of attempts to combat crisis though law enforcement and interdiction, the inapplicability of the “vector” epidemic frame to opioids, and primary, secondary, and tertiary public health interventions.

Renowned hematologist-oncologist, researcher, and writer Vinay Prasad joins us to discuss his sternly-held views on modern clinical and research practice. We discuss the effectiveness (or not) of cancer screening, a more realistic take on the cancer moonshot, and the continual conflicts of interest issues in medicine-issues that maybe are not solvable with transparency laws.

We welcome Loyola University Chicago Professor Spencer Waller who brings his antitrust skills to bear on competition in healthcare markets. Our discussion centers on Professor Waller’s recent essay, available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2819543. The key issue is whether healthcare antitrust is (or should be) another example of healthcare exceptionalism or transubstantive. Our discussion ranges from competing models of antitrust theory to remedies and enforcement and healthcare “snowflakes.”

We welcome University of Maryland scholar Amanda Pustilnik, a recognized leader in the emerging area of Neuroscience and the law. Our conversation includes a primer on the area and a discussion of the more import areas, including criminal reasonability and the measurement of chronic pain. Our lightning round concentrates on the current proposals and counter proposals surrounding the workings of the insurance exchanges and we take a close look at Iowa’s challenging individual insurance market.

Back from a short hiatus we greet Michelle M. Mello, Professor of Law and of Health Research & Policy at Stanford University. She is the author of more than 150 articles and book chapters on the medical malpractice system, medical errors and patient safety, research ethics, regulation of pharmaceuticals, legal interventions to combat obesity and noncommunicable disease, and other topics. Our conversation focused on her recent work on medical apologies, communication-and-resolution programs, overlapping surgery (which refers to operations performed by the same primary surgeon such that the start of one surgery overlaps with the end of another), reconciliation after medical injury, and the influence of the malpractice environment on care patterns. The lightning round featured a tour of the many facets of synthetic ACA repeal: CHIP delay, health budget slashing, zombie reconciliation, marketing budget cuts, inexplicable "maintenance" efforts that bring down HealthCare.gov for 12 hours a day at peak sign up periods, the Trump EO on association health plans, and the suspension of CSR payments. As Nancy LeTourneau reports, “synthetic repeal won’t be scored by CBO and has tossed aside any attempt to replace the law. That means that the results could be even more disastrous for the American people.”

We take advantage of a very special opportunity to talk with Alta Charo, Professor of Law and Bioethics at the University of Wisconsin at Madison. Topics ranged from ethical and regulatory perspectives on CRISPR-Cas9 gene-editing, to the Trump administration's manifestly counter-productive ending of the Teen Pregnancy Prevention Program, to the politicization of reproductive “science” by Trump appointees to HHS.

Adam Gaffney, physician, writer, public health researcher, and healthcare advocate joint us to discuss the “right to health” in all its manifestations and the slow crawl of U.S. healthcare to universalism and single-payer. It’s a broad-ranging discussion, touching on law, human rights, political discourse, and economics. A brief “lightning” round focuses on the exposure of Facebook’s ethos and healthcare consolidation and concentration.

American University Washington College of Law Professor Lewis Grossman joins us to discuss his fascinating article “AIDS Activists, FDA Regulation, and the Amendment of America’s Drug Constitution.” Prior to that discussion our Lightning Round touches on nursing home arbitration, the decline in the number of FDA warning letters, the EEOC Wellness regulation, single payer, and the resilience of the exchanges.

We talk with legal scholar-journalist Julia Powles who has done some deep dives into the world of Alphabet’s Deep Mind’s relationship with NHS data. Our conversation starts with Julia’s collaborator, Hal Hodson, and his reporting on Deep Mind for the New Scientist. Julia explains the findings of the Information Commissioner and the subtle intersection of the Data Protection Act 1998 and the “boot out” to the Caldicott Guidelines. The relevance to the U.S. is confirmed with discussions of the “first mover” advantages in establishing data market power, the problems associated with the privatization of public health data, and the “transparency paradox” associated with big data companies.

Our annual Back To School Special returns in time for a new semester. In this second part we welcome TWIHL Allstars Erin Fuse Brown, Zack Buck, and Jessica Roberts. In this part, topics 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 choose of the past seven months.