Listen to Frank Pasquale, Nicolas Terry and their guests discuss the most pressing issues in Health Law & Policy.
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Frank Pasquale is Professor of Law at the University of Maryland Francis King Carey School of Law in Baltimore. Contact him on twitter: @FrankPasquale
Nicolas Terry is the Hall Render Professor of Law & Executive Director, Hall Center for Law and Health at Indiana University Robert H. McKinney School of Law in Indianapolis. Contact him on twitter: @nicolasterry
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We welcome Jacob Sherkow, a law professor at the Innovation Center for Law and Technology, at New York Law School, with affiliations at Columbia University and the University of Copenhagen's Center for Advanced Studies in Biomedical Innovation Law. Jacob teaches a variety of courses related to intellectual property. His research focuses on how scientific developments, especially in the biosciences, affect patent law and litigation.
Jacob is a prolific scholar, the author of over two dozen articles on these and related topics in both traditional law reviews and scientific journals. (The latest include "Cancer's IP," a vital policy intervention.) A scholar capable of both "big picture" and very fine-grained analysis, he is a great guide for bridging the worlds of health care law & policy, and intellectual property. Our conversation begins with an excellent CRISPR primer before traversing some fascinating questions about gene-editing patent litigation around the world, licensing issues, and the broader array of regulatory issues generated by such emerging technologies.
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.
Seton Hall Law Professor Carl Coleman leads our deep dive into human subjects research, the revised common rule, and the future of data and biospecimen use. We discuss the reasons for the continued delays of the revised common rule, and debate some of its merits. We also add some comparative perspective as we explore researchers' objections to aspects of both the original and revised rules. Carl has previously written on "rationalizing risk assessment" in research, and brings a wealth of experience to the discussion.
Carl has served as Bioethics and Law Adviser at the World Health Organization (WHO) in Geneva, Switzerland, where he was one of the primary authors of the report, Ethical Considerations in Developing a Public Health Response to Pandemic Influenza. He has contributed to WHO reports on capacity building for research ethics committees, ethical issues in tuberculosis prevention, care, and control, research ethics in epidemic response efforts, standards and operational guidance for research ethics committees, and key issues in global health ethics. From 2010-2013, Carl was a member of the Secretary's Advisory Committee on Human Research Protections (SACHRP), which is charged with providing expert advice to the Office for Human Research Protections of the U.S. Department of Health and Human Services.
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 cutting edge research on the relationship between reimbursement systems and healthcare price and cost issues.
Our conversation includes some compelling “lightning” stories, including wellness plans, Maryland's potential state mandate, 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.
On that last topic: past show guests Aaron Kesselheim and Ameet Sarpatwari will be speaking at Maryland Law on March 8th, along with other health policy superstars; more details to come!
This week features 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. Paul digs deep, exposing a byzantine non-system of care for the elderly and disabled. (This week's episode complements our earlier engagements with eldercare in the work of political scientist Laura Katz Olson (Episode 98) and law professor Allison Hoffman (Episode 73)).
Paul offers a nuanced and multifaceted program for improving the lives of both the disabled in need of care, and the workers who provide that care. Paul argues that the expansion of the role of direct care workers, including more and better training for them, “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.
Paul Osterman is the Nanyang Technological University Professor of Human Resources and Management at the MIT Sloan School of Management as well as a member of MIT’s Department of Urban Planning. His research concerns changes in work organization within companies, career patterns and processes within firms, economic development, urban poverty, and public policy surrounding skills training and employment programs.
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!
This week features 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 almost-gone 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.
Frank also mentions Centene as a potential kingpin of further health care consolidation, and his testimony before Congress on Nov. 30. TWIHL may well be the only podcast on earth to have both co-hosts before the House Energy & Commerce Committee the same year. So be sure to subscribe! And Frank welcomes AALS attendees to a panel on health law in San Diego on January 4. "From Obamacare to Trumpcare: The Future of American Healthcare" will be 10:30am - 12:00pm at the San Diego Marriott Hotel & Marina, Pacific Ballroom 22, North Tower/Level 1.
This week features another return visit from Leo Beletsky, our friend and Northeastern University School of Law professor. Leo is a fearless critic of misguided approaches to the opioid crisis. 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.
We briefly mentioned Frank's talk in Berlin at the Friedrich Ebert Stiftung (the think tank of Germany's Social Democratic Party) discussing the interaction of black hat search engine optimization and addiction rehab referral.
Our lightning round discussed the latest legislative attacks on the ACA (this time through a potential individual mandate repeal), as well as some additional health policy issues.
Renowned hematologist-oncologist, researcher, and writer Vinay Prasad joins us to discuss his views on modern clinical and research practice. A prolific scholar, Prasad has been upending conventional wisdom for years. We discuss the effectiveness (or not) of cancer screening, a more realistic take on the cancer moonshot, and continual conflicts of interest issues in medicine. Be sure to follow Vinay on Twitter @VinayPrasad82.
We welcome Loyola University Chicago Professor Spencer Weber Waller, who brings his extraordinary acumen on both competition and consumer law issues to bear on healthcare markets in today's episode. Our discussion centers on Professor Waller’s recent essay on health care antitrust. The key issue is whether healthcare antitrust is (or should be) another example of healthcare exceptionalism, or whether transubstantive principles should govern.
Our discussion ranges from competing models of antitrust theory to remedies and enforcement and healthcare “snowflakes"--unique situations that merit exceptional treatment. The ultimate issue is whether antitrust authorities should continue to try to create markets in health care, or should accept a public utility model of regulation closer to the approach of most other advanced industrial democracies.
First off, an urgent appeal: please consider donating to chef José Andrés, who is feeding tens of thousands of victims of Hurricane Maria in Puerto Rico. Donation link is here.
We have a particularly brainy episode this week, as we host Amanda Pustilnik, a Professor of Law at the University of Maryland whose research includes work on models of mind in criminal law, evidentiary issues presented by neuroscientific work on memory, and the role of pain in different legal domains. Amanda has also served as a Senior Fellow in Law & Neuroscience of the Center for Law, Brain & Behavior at Massachusetts General Hospital. She recently co-authored the Nature article "Brain imaging tests for chronic pain: medical, legal and ethical issues and recommendations." She also organized a 2015 symposium here on Bill of Health, titled "Pain on the Brain." Amanda is a recognized leader in the emerging area of Neuroscience and the Law. Our conversation includes a primer on the area and a discussion of criminal responsibility 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. We also covered other health news. Links include: 1) an ongoing public health disaster in Puerto Rico, 2) the imploding Iowa ACA exchanges (and Iowa's withdrawal of a waiver proposal that would have gutted the ACA there), 3) are AHPs the Trump University of health insurance?, and 4) sequelae of the opioid epidemic: HIV and hepatitis C.
Listen here, and be sure to rate the show on iTunes!
This week's guest is 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."
This week we are joined by R. Alta Charo, the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin at Madison. Alta has also has served on the faculty of the UW Masters in Biotechnology Studies program and the Dept. of Medical History and Bioethics at the School of Medicine & Public Health at the University of Wisconsin.
Alta has written for JAMA and NEJM on stem-cell tourism (and its lessons for gene editing), among many other topics, applying her expertise on law & medical technology to a wide array of cutting edge controversies. Our conversation focuses on risk perception and reality in areas ranging from CRISPR-Cas9 (the breakthrough gene-editing technique) to teen pregnancy and reproductive health services. A distinguished scholar and top-level advisor to government and NGOs, Alta offers invaluable insights on a rapidly changing technological and political landscape.
Adam Gaffney, physician, writer, public health researcher, and healthcare advocate joins us to discuss the “right to health” in all its manifestations, and the slow crawl of U.S. healthcare toward 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, with a brief mention of zombie repeal and replace efforts and Senate HELP's September 12th bipartisan exchange stabilization hearing. (Frank was also in the Senate that day, but at a different hearing.)
Adam W. Gaffney is Instructor in Medicine at Harvard Medical School, and a staff physician at the Division of Pulmonary and Critical Care Medicine at the Cambridge Health Alliance (CHA), an organization with a longstanding commitment to community health and the health of the underserved. He is author of To Heal Humankind: The Right to Health in History (Routledge, 2017).
Episode 112: Activating the FDA, with Lewis Grossman
We talk with Lewis A. Grossman, a professor of law at American University and Of Counsel at Covington & Burling. Lewis is on sabbatical during academic year 2017-18, serving as a Law and Public Affairs (LAPA) Fellow at Princeton University. He teaches and writes in the areas of American legal history, food and drug law, health law, and civil procedure. He has also been a Visiting Professor of Law at Cornell Law School.
Our Lightning Round touches on nursing home arbitration (resources here, here, and here), the decline in the number of FDA warning letters, EEOC wellness program regulation, single payer, and the resilience of the exchanges.
Our conversation with Lewis focused on the history of empowered patients and American health libertarianism. Activists played a major role, as his fascinating article AIDS Activists, FDA Regulation, and the Amendment of America’s Drug Constitution shows.
We talk with legal scholar and journalist Dr. Julia Powles. At Cambridge, Julia was associated with the Centre for Law, Medicine and Life Sciences and Centre for Intellectual Property and Information Law, and a Research Associate of the Faculty and Computer Laboratory. She is now a Research Fellow at Cornell Tech and NYU Law School, in New York City.
Julia has done some deep dives into dubious methods of data acquisition by Google, focusing on Google subsidiary Deep Mind’s NHS data grab. Our conversation starts with Hal Hodson's 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 All-Stars Erin Fuse Brown, Zack 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.
Our annual Back To School Special returns in time for a new semester. In this first part we welcome TWIHL all-stars 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. Our guests on Twitter include @MicahLBerman, @CohenProf, and @nicholas_bagley.
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, 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, 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.
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 guests this week are 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, and Aaron S. Kesselheim, MPH, MD, JD, Associate Professor of Medicine at Harvard Medical School, and Research Associate at Harvard's T.H. Chan School of Public Health.
During the program, Frank mentioned the book-in-progress Infection: The Health Crisis in the Developing World and What We Should Do About It, by William W. Fisher III and Talha Syed, in the context of a discussion of drug importation, reflecting concerns he expressed in a 2009 article.
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 (including in Zimbabwe), DTC genetic tests and informed choice, medical app curation, and transatlantic perspectives on data sharing.
Speaking of curation--aside from her prolific, far-ranging, and insightful scholarship, Claudia also aggregates a great deal of interesting perspectives on digital health & society, theory, design, policy, evaluation, innovation, ethics, on Twitter at @EeHRN. Be sure to follow her there!
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 the 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.
As for Google DeepMind, we start with a discussion of how Google DeepMind trial failed to comply with data protection law. We discuss Google's larger problems with the EU Competition and Franks’s response to US skepticism about the case.
In cyberhealth, we take on an Alaskan class action against a genetic testing lab,and the latest ransomware attack.
Our opioid epidemic coverage continues: the White House opioid crisis commission missed the due date for preliminary report, and Oklahoma sued opioid drugmakers, while New Hampshire pressed an epidemic probe. Meanwhile, a not-so-enlightened Ohio legislator has proposed a "3 opioid overdoses and you’re out" eliminationist policy with some potential EMTALA implications. Meanwhile, the new administration is pursuing a struthious strategy reminiscent of Harper.
Finally, the main event: health reform/deform/repeal. Leaving aside the clear tax cut paid for by Medicaid evisceration… where are the policies? The bottom line appears to be that many architects of GOP health policy don’t believe in Medicaid as an entitlement, or perhaps even that the healthy should be in the same pool as the sick--especially given the growing popularity of the Cruz option to stratify risk pools.
We discuss how the predictable death spirals resulting from such policies may have a "squeeze the balloon" quality: under the cost-shift hydraulic, the uninsured may reduce hospital margins, leading them to raise prices for the still-insured. If that occurs, the end-effect of the GOP plan may be to shift more of the cost of care from the top 1%, to those in employer-sponsored insurance. Given obviously inadequate funding for risk pools under current proposed legislation, the insurers of last resort will be crowdfunding or bankruptcy courts.
Meanwhile, Medicaid cuts will hurt schools so badly that even red-state school leaders in rural areas are venting frustrations. They say Medicaid funding cuts would hamper their ability to serve low-income and special education students. Of course, we can predict the likely policy response from DC: slash "unfunded mandates" to serve the disabled. Ironically, the rural core of the current reigning coalition may be hurt the most.
As the Overton Window, wall, and house in health care policy have been drafted to Oz by the Trump tornado, it looks like the the biggest winner in the current health-care debate is single-payer. Some links compare its popularity to that of McConnellcare, and to various state efforts at reform.
Finally, and with great trepidation we raise the wisdom of single-payer care only to uncover a new policy position taken by one of your hosts, who worried about a different kind of "death spiral" in 2013.
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!
This week, University of California Law Professor Michele Bratcher Goodwin offers a detailed and insightful analysis of an increasingly adversarial relationship between women and the state. In a series of articles, Goodwin has demonstrated that 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. She asks in "The Pregnancy Penalty," "If a woman is fourteen times more likely to die during pregnancy and childbirth than terminating a pregnancy through a legal abortion, why do some lawmakers resist support for contraception and seek to criminalize abortions?" Today's podcast includes many troubling answers, rooted in historical and social theoretical analysis.
Our conversation includes a detailed look at leading abortion cases and their limitations. We end with a disturbing narrative about under-age marriages in the US, often in circumstances that otherwise would be statutory rape. Goodwin describes the failed institutions that have made underage marriage a global problem.
Michele Goodwin is a Chancellor’s Professor at the University of California, Irvine with appointments at the School of Law; Program in Public Health; Department of Criminology, Law, & Society; Department of Gender and Sexuality Studies; and Stem Cell Research Center. Her publications include five books and over 80 articles and book chapters on law’s regulation of the human body, including civil and criminal regulation of pregnancy and reproduction, reproductive technologies, human trafficking (for organs, sex, and marriage), and tissue and organ transplantation.
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.
This week, we celebrate Episode 100! Like Episode 1 from 2015, it's just Nic & Frank--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's reflections on the political economy of health automation (inter alia). Enjoy!
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 Solidarity, a 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.
Our guest this week is Laura Katz Olson, Professor of Political Science at Lehigh University. Laura is the author of eight books, including The Politics of Medicaid and Elder Care Journey. Olson has published widely in the field of aging, health care and women’s studies, her articles addressing such topics as Medicaid, Medicare, long-term care of the elderly, pensions, Social Security and problems experienced by older women. She has been a Scholar at the Social Security Administration, a Gerontological Fellow and a Fulbright Scholar. She is also on the editorial board of the Journal of Aging Studies and New Political Science.
Our conversation first focused on recent developments in federal health policy, including slashing cuts to Medicaid in proposed budgets. We then discussed Elder Care Journey, an insightful mix of Laura's personal experience seeking long term care for her mother, and her connection of that experience to failures in US policy on aging. The personal is indeed political, and Laura connects negative experiences ranging from quotidian frustration to alarming neglect, to a set of health laws and policies that fails to offer adequate support to dementia patients and their caregivers.
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.
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. Robert has been involved in healthcare administration for over 30 years — both with the U.S. Air Force and Mayo. Mr. Smoldt joined Mayo in 1972, and he has worked in a variety of administrative positions in both medical and surgical departments. Prior to his CAO role, he served as chair of the Department of Planning and Public Affairs.
The topics discussed with Robert are alternate payment systems, including pay for value. We do a deep dive into P4P (pay for performance) and P4V (pay for value), elicit comparisons with healthcare in Japan, and ponder integrated care models and the future of health policy.
We also discussed "provider-specific benchmarks that reward improvement rather than the level of performance," and several other unintended consequences of Advanced Payment Models (APMs). We're sure you will find Robert's edifying insights a vital part of top-level dialogue on the future of health care finance.
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. Khiara's unique combination of social science research and legal analysis builds on her prior work in Reproducing Race, an ethnography of pregnancy and birth at a large New York City public hospital, which explored the role of race in the medical setting. A contribution to anthropology, privacy law scholarship, and critical race theory, Bridges' work should inform high level academic and policy debates about data collection, analysis, and use.
Brown University School of Public Health researcher and teacher Elizabeth Tobin-Tyler joins us for a far-reaching conversation about social determinants of health. In particular, we discuss medico-legal partnerships and their role in filling unmet legal needs that are themselves increasingly recognized as social determinants. We discuss issues framed by Professor Tobin-Tyler’s scholarship such as professionalism, conflicts of interest, funding, and medico-legal education.
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.
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.
Our guest this week is Craig Garthwaite, Associate Professor of Strategy and the Co-Director of the Health Enterprise Management Program (HEMA) at the Kellogg School of Management at Northwestern University. An applied microeconomist, Craig has published research on how changes in law and policy affect the health and biopharmaceutical sectors.
After a quick review of the AHCA collapse's aftermath, we discussed why the rate of increase of health care spending has been declining. We covered his 2012 article, "The Doctor Might See You Now: The Supply Side of Public Health Insurance Expansions," and looked at the nonprofit hospital as "insurer of last resort" when other forms of financing care are not available. We closed with some dystopian speculation: what if Trump predictions of ACA's "collapsing" become a self-fulfilling prophecy?
As the highly unstable health policy landscape approaches Inception-level complexity, be sure to follow Craig's blogging at Code Red, where he and David Dranove offer economic perspectives on the US health care system.
This week's conversation featured Northeastern University School of Law Professor, Andrea Matwyshyn. In addition to her appointment on the law faculty, she is a professor of computer science (by courtesy), and co-director of the law school’s Center for Law, Innovation, and Creativity (CLIC).
An expert on cybersecurity and healthcare, Andrea helped us understand the changing approaches of federal regulatory agencies. We discussed the range of cybersecurity threats, from the science fictional to the all-too-factual scourge of ransomware. We also covered the continued threats from the Internet of Health Things and how the market and policymakers must find ways to reward developers for producing safe and secure code. We ended with a brief discussion (unlikely to be our last) of Blockchain as a security model, given current enthusiasm for algorithmic data management and smart contracts in the health policy space.
Joined by Michigan University School of Law Professor Nicholas Bagley, an expert on health law and federalism, we discussed “Federalism and the End of Obamacare,” his recent and extremely thoughtful Yale Law Journal essay. We also talked about the risk corridor payments litigation and wondered whether the insurers will ever get paid. And the ever-popular topic of the CBO came up, as Nick dashed Secretary Price's hopes of regulating his way to a better score. Be sure to check out Nick's work at The Incidental Economist, and SSRN.
This week's guest on TWIHL is Ann Marie Marciarille, a professor of law at the University of Missouri-Kansas City (UMKC) Law School. We discuss a brand range of topics, including the post-NFIB Medicaid “gamble,” the concept of the cost-shifting hydraulic, our less-than-rigorous mechanisms for dealing with infectious diseases, the long-tail of the Actavis case, and what happens when your inhaler stops working in the Portuguese Azores (and what that tells us about our drug distribution and pricing models).
Ann Marie has long researched and written on health care regulation and finance, with a particular interest in health care reform. Her articles on Medicaid and health care federalism are important guides to the ACA (and post-ACA) landscape of equity, access, and experimentalism in health policy.
Before joining UMKC, Ann Marie had a long career as health law attorney, including 10 years as a health care antitrust prosecutor for the California Attorney General’s office, and several years as a legal services attorney specializing in health care matters. Her ability to unify both the practitioner and scholarly perspective was evident in our discussions of topics ranging from Medicaid expansion to international drug pricing comparisons. Be sure to follow her blog, Missouri State of Mind, for more scholarship and commentary on vital topics in health law and policy.
This week we welcome Lydia Nicholas, a Senior Researcher in Nesta’s Collective Intelligence team, who is exploring new forms of knowledge production and problem solving that are emerging from the collaboration of networked publics, institutions and organizations. We focused our discussion on the use and abuse of health data. Lydia is based in the UK, where some recent incidents involving data (including the care.data controversy and Deep Mind's analysis of records to develop AI diagnostic capacities) have focused discussion on data collection, analysis, and use.
Lydia’s work looks at how minds, systems and technologies come together to perform better at cognitive challenges with particular focus on health and patient organisations. Before joining Nesta Lydia worked as a researcher across technology sectors, with particular focus on medical and biological information. She has an MSc in Digital Anthropology and has researched public understanding of Big Data and data collection practices. This expertise enriched our discussion of the quantified self and emerging practices of the "quantified self," as well as the "metric power" accumulated by those with access to information. Be sure to follow Lydia on Twitter @lydnicholas for more news and views on data ethics and policy.
This week features Diana R. H. Winters and Joanna Sax, law professors at Indiana School of Law and California Western School of Law. We discussed how food regulation differs from drugs, devices, supplements, and other goods and services. We also addressed whether there would be a less regulated model going forward after the 21st Century Cures Act and GOP dominance of all three branches of federal government, and most statehouses. GMOs were a frequent topic of conversation, and we concluded with a discussion of the top things practitioners, law students, and law professors should know about food law.
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.
We had a broad-reaching discussion on ACA repeal/replacement/repair and the increasingly likely restructuring of Medicaid. We delve deep into Medicaid policy, block grants, and what we know about “innovative” expansion models.
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.
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.
This week features Professor Erin C. Fuse Brown of Georgia State University's College of Law. We discussed her fascinating work on the law & policy of consumer protection in health care, including the new article "Consumer Financial Protection in Health Care."
Our discussion centered on surprise medical bills (including balance billing),“inscrutable price opacity,” and medical debt collection. This is a difficult area and one that implementers of the ACA have only begun to confront. Looking forward, our consensus was that this increasingly will become the province of “bifurcated” state laws passed under the specter of ERISA preemption--which could leave those in self-insured plans at the mercy of their employers.
For a thoughtful perspective on cutting edge efforts to protect patients from surprise bills and opaque billing, there is no better resource. And be sure to check out her SSRN Page for other important work on ongoing efforts to bend the cost curve in health care and assure more universal access to care.
We welcome University of Missouri-Columbia law professor Sam Halabi, who brings a wealth of academic and practical experience to the podcast. He is interested in corporate governance and regulation at both national and international levels. He has edited (with Lawrence O. Gostin and Jeffrey S. Crowley) Global Management of Infectious Disease after Ebola (Oxford University Press, 2017) and his book, Intellectual Property and the New International Economic Order: Knowledge, Exploitation, and Resistance is scheduled for publication by Cambridge University Press in 2018.
We discussed Sam's article Selling Hospice (among others). Listeners may also be interested in a WaPo series on hospice care. The lightning round focused on past guest Allison Hoffman's recent post on the seismic shift in the health policy landscape, the 21st Century Cures Act, new SAMHSA rules, and an OCR resolution agreement.
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.
Episode 80 is our irreverent but also quite serious annual survey of who or what has been nice or naughty in health law and policy during the last year. Our experts make some great picks and dig deep into the underlying policy coal and candy. Plus, of course, our “surprise” bonus round as we pick who we would like to welcome singing carols outside our homes! Enormous thanks to our guests:
Elizabeth Weeks Leonard
And a very happy holiday season to all our listeners. See you in '17!
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."
We are joined by UNC law professor Richard Saver, who presents his new research on the Sunshine Law that was part of the ACA. His findings are fascinating, and inevitably led to a broader discussion of the worth of transparency-based regulation.
We mentioned the work of many past show guests, including Charles Ornstein's great project on "Dollars for Doctors" at ProPublica, Kristin Madison's analysis of how information-based regulation works, Nathan Cortez on agency publicity, and Bill Sage's work on disclosure as a regulatory strategy. Frank asked some questions based on an article on big data in medicine, and his book The Black Box Society. And some final thoughts from danah boyd, offered in another context: transparency is not enough, and transparency ≠ accountability.
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.
Our guest this week is Jill A. Fisher, Ph.D., Associate Professor of Social Medicine at UNC-Chapel Hill. Jill is a social scientist with a Ph.D. in Science and Technology Studies from Rensselaer Polytechnic Institute and expertise in medical sociology. Her research interests include social studies of the pharmaceutical industry, clinical trials, political economy, healthcare and social inequalities, and research ethics.
Our lightning round discussed Timothy Jost's go-to piece on the election, "Day One And Beyond: What Trump’s Election Means For The ACA." Sarah Kliff also writes on four routes to repeal.
For 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 Contracts, Negotiation 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).
Our discussion with Russell focused on his article, Relative Value Health Insurance. We discussed the benefits and drawbacks of tiering in health care, and how consumers' price sensitivity could promote more valuable care plans.
Our guest this week is Larry Singer, Professor of Law and Director of the Beazley Institute for Health Law and Policy at Loyola University Chicago. Professor Singer is a nationally recognized expert on legal and strategic issues surrounding the organization of health care institutions. He has served as chair of a national health care system, and a board member of various charitable organizations. He has been inducted as a Fellow in the Institute of Medicine of Chicago.
For the lightning round, Nic covered a European decision on personally identifiable data, a Becker’s piece on MACRA agonistes, a critical take in JAMA on AI diagnostics, and an Indiana case concerning the chargemaster’s role in billing disputes. Frank addressed a Harvard Study on unaffordable cost sharing as a tool of discrimination, the trend toward polypharmacy, and counter-efforts to reduce excessive prescriptions. He also mentioned battles over pharmacist provider status and Medicaid’s equal access provision.
Our discussion with Larry focused on trade-offs now clearing emerging out of ACA implementation: more people have insurance, but Medicaid is in crisis in many states. Larry also discussed how stratified coverage options accelerate inequalities among hospitals and health care systems.
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.
Our guest this week is Lisa C. Ikemoto, the Martin Luther King, Jr. Professor of Law at UC Davis Law School. Lisa has written on specimen management, stem cell research, and many other topics in bioethics and health law and policy.
Our conversation included Lisa's important insights on ways that race and gender mediate access to and impacts of biomedical technology use and health care. Her recent work addresses reproductive tourism, the ways in which human gamete use links the fertility and biotechnology industries, and the privatizing effects of informed consent. Lisa is a Bioethics Associate of the U.C. Davis Health System Bioethics Program, and a Faculty Associate of the U.C. Davis Center for Science and Innovation Studies.
Our guest this week is Paul A. Lombardo, Regents’ Professor and Bobby Lee Cook Professor of Law at Georgia State University. Paul has written articles and books a wide array of topics in health law, medico-legal history, and bioethics. His books include: Three Generations, No Imbeciles: Eugenics, the Supreme Court and Buck v. Bell (2008) and A Century of Eugenics in America: From the Indiana Experiment to the Human Genome Era (2011). From 2011-2016, he was a senior advisor to the Presidential Commission for the Study of Bioethical Issues. He has also served on the Board of Directors of the ASBH.
We focused on two issues: eugenics and psychometrics. Frank related some of Paul’s landmark work on genetic selection to current debates on polygenic scoring--including the Dalton Conley provocation “What if Tinder Showed Your IQ”? Frank also related Lombardo’s work on the psycograph to a symposium led by Amanda Pustilnik on pain measurement (including Frank's post on algometry). It’s a free-wheeling discussion marred only by the absence of Nic--the first time in history Terry was stopped from joining the pod. But don’t worry, he’ll be back for the next episode!
This 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!
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.
This week we welcome David Barton Smith, Emeritus Professor at Temple University and Adjunct Professor in the Department of Health Policy and Management in the Dornsife School of Public Health at Drexel University.
David is a prolific author. He won the 1995 Robert Wood Johnson Health Policy Research Investigator Award for research on the history and legacy of the racial segregation of health care and continues to lecture widely on this topic.
We discussed his most recent book, The Power to Heal: Civil Rights, Medicare and the Struggle to Transform America’s Health System (Vanderbilt Press, 2016), which has already received the Goldberg Prize for the best book in the area of medicine this year. David is a compelling storyteller, explaining how civil rights leaders in the 1960s leveraged Medicare funding into successful desegregation initiatives.
David's work here is also inspiring a companion documentary supported by NEH, which will tentatively air on PBS stations later this year in celebration of the 50th Anniversary of the implementation of Medicare.
For the lightning round, Nic discussed new developments regarding the ACA and women's health, while Frank talked about the new profession of patient advocates, and renewed concern over black boxed code in medical devices.
Our 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.
In our third and final Back to School Special, Nic Terry discusses Chanko v. ABC and recent HHS-OCR enforcement. Nick Bagley discusses House vs. Burwell and the 3Rs of health insurance. Elizabeth Weeks Leonard discusses the 60 day rule, increased civil penalties and Escobar.
Nic focused on health privacy in his discussion, leading off with the fascinating (if tragic) case of Chanko v. ABC (which involved the broadcasting a patient’s death on a television program). He also explained the important NY-Presbyterian Resolution Agreement and the Advocate Health Care Resolution Agreement.
Liz covered some complex developments in health care fraud and abuse regarding reporting of overpayments. She also explained recent inflation adjustments to civil monetary penalties.
In addition to discussing lawsuits by health insurers over nonpayment of certain funds that appeared to be promised by the ACA, Nick also analyzed yet another of the ACA’s seemingly endless string of legal challenges: House v. Burwell, which refused to infer an appropriation in the ACA for Section 1402 reimbursements to insurers.
Many thanks to Nick, Liz, and our other BTSS experts!
It’s our second TWIHL Back to School Special (BTSS)! And you’ll see why we love acronyms so much once you hear Frank’s discussion of MACRA’s Merit-based Incentive Payment System (MIPS) and Advanced Payment Models (APMs). For an introduction to MACRA, check out resources linked to here and here and here.
We are pleased to have two great returning guests for this BTSS: Leo Beletsky discusses the opiate crisis and the curative but unfunded mandate. Erin Fusee Brown discusses Universal health Services v. U.S., ex rel. Escobar, the case that may launch a thousand (or more) false claims litigations.
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.
Our guests this week are Matthew Penn, Director of the Public Health Law Program within CDC’s Office for State, Tribal, Local and Territorial Support, and Ross Silverman from Indiana University. Matthew leads a team of public health advisors and analysts in supporting practitioners and policy makers at the state, tribal, local, and territorial levels through the development of practical, law-centered tools and legal preparedness to address public health priorities. Ross is Professor of Health Policy and Management at the Indiana University Richard M. Fairbanks School of Public Health at IUPUI, and holds a secondary appointment as Professor of Public Health Law at the Indiana University Robert H. McKinney School of Law. Ross serves numerous leadership positions in the field of public health law, including as a mentor in the Robert Wood Johnson Foundation/Georgia State University Future of Public Health Law Education: Faculty Fellowship Program, as a member of the American Public Health Association Action Board, and as past chair of the American Public Health Association Law Section.
Some topics discussed by the guests include a Transdisciplinary Approach to Public Health Law: The Emerging Practice of Legal Epidemiology, a Morbidity and Mortality Weekly Report (MMWR) (State and Territorial Ebola Screening, Monitoring, and Movement Policy Statements — United States, August 31, 2015), and The Electronic Health Records Toolkit: Improving Your Access to Electronic Health Records During Outbreaks of Healthcare-associated Infections.
In the lightning round, Frank and Nic discussed the growing cost of catastrophic coverage in Medicare Part D, and how a Procrustean health care system can fail the obese. They also covered the new hospital star ratings, developments in off-label promotion and corporate criminal liability, and disturbing new revelations about the manifest inadequacies of many narrow networks on the exchanges.
Our guest this week is Jon Mark Hirshon, M.D., M.P.H., Ph.D., an Associate Professor in the Department of Emergency Medicine and in the Department of Epidemiology and Public Health at the University of Maryland School of Medicine. Jon Mark is also on the board of the American College of Emergency Physicians, and is an internationally recognized expert on acute care. His teams have trained approximately 900 physicians from countries in the Middle East in topics ranging from clinical care of trauma patients to disaster preparedness to research methods.
Our lightning round featured discussions of an issue brief, "How Has the Affordable Care Act Affected Health Insurers' Financial Performance?," as well as a news story on some insurers' dissatisfaction with the ACA. While health costs may increase GDP, they are hurting some insurers' bottom lines. On the health IT front, we focused on ransomware and non-covered entities' data. And continuing our wellness coverage, we mentioned employers' new enthusiasm for mobile monitoring of employees' mental health--what Rachel Emma Silverman's twitter feed has jokingly called "#textualhealing."
During his interview, Jon Mark focused on policy issues in acute care. He discussed a lawsuit filed by the American College of Emergency Physicians against the federal government reflecting ACEP's concerns about reimbursement. Jon Mark also described the many challenges now facing emergency departments, ranging from narrow networks that fail to fairly compensate care, to user-unfriendly IT systems. Jon Mark also offered practical solutions for increasing access to acute care--an urgent policy concern given America's dismal overall grades for access to emergency care.
Our guest this week is Mehrsa Baradaran, J. Alton Hosch Associate Professor of Law at the University of Georgia. Author of the acclaimed book How the Other Half Banks, Baradaran described the increasingly difficult financial landscape for poorer Americans. We discussed the impact of inequality and financial exclusion on many aspects of health care finance, including providers' collections policies, hospital-as-lender models, and high-deductible health plans. Baradaran offers many important insights on how new financial realities affect both monetary flows and consumer protection in health care.
This week our guest is Professor Deborah Lupton, one of the world's leading digital sociologists. Her new book, The Quantified Self, is the basis of most of our discussion--and it has fascinating lessons for health care lawyers, providers, and patients.
Deborah joined the University of Canberra in early 2014 as a Centenary Research Professor associated with the News & Media Research Centre in the Faculty of Arts & Design. Her research and teaching is multidisciplinary, incorporating sociology, media and communication and cultural studies. Deborah has previously held academic appointments at the University of Sydney, Charles Sturt University and the University of Western Sydney.
Deborah is the author of 15 books and over 150 journal articles and book chapters on topics including the social and cultural dimensions of: medicine and public health; risk; the body; parenting cultures; digital sociology; food; obesity politics; and the emotions. She is an advocate of using social media for academic research and engagement, including Twitter (@DALupton) and her blog This Sociological Life.
Those interested in further exploring the social theory of digital selfhood may be interested in Frank's piece, The Algorithmic Self. And for some forward-thinking reflections on new technologies of digital health, check out Nic's recent post at Health Affairs on hearing aids and regualtory arbitrage.
This week we spoke with Rachel E. Sachs, who will join the faculty of the Washington University in St. Louis School of Law in Fall 2016. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health.
We focused on Rachel's work on drug pricing and innovation for global health. As part of a broader academic agenda for developing access to knowledge, Rachel's work illuminates the many trade-offs involved in optimizing innovation law. She has also illuminated the importance of "innovation beyond IP," and the importance of legal synergies in accelerating or impeding innovation.
Fresh from ASLME's Health Law Professors' Conference in Boston: a special TWIHL! Pharmalot's Ed Silverman joins a cavalcade of past show guests (Rachel Sachs, Ross Silverman, and Nicholas Bagley) for a conversation about social media and health law, scholarship, and policy.
Some of the works cited: Mark Carrigan, Social Media for Academics; Tressie McMillan Cottom, Microcelebrity and the Tenure Track; Tressie McMillan Cottom, When Marginality Meets Academic Microcelebrity; UW Stout, Rubrics for Assessing Social Media Contributions; Wiley, Altmetrics
And thanks to the audience for great questions!
This week we talked with Henry T. ("Hank") Greely, who has many positions and offices at Stanford University: Edelman Johnson Professor of Law; Director, Center for Law and the Biosciences; Professor (by courtesy) of Genetics, Stanford School of Medicine; Chair, Steering Committee of the Center for Biomedical Ethics; and Director, Stanford Program in Neuroscience and Society.
We focused our discussion on Hank's just-released book, The End of Sex and the Future of Human Reproduction. Having chaired California’s Human Stem Cell Research Advisory Committee and served on the Advisory Council of the NIH’s National Institute for General Medical Sciences, Hank has been an important voice in bioethics for decades. Be sure to listen to the podcast and read the book for a uniquely insightful perspective on the new challenges to ethics and social order posed by emerging reproductive technologies.
This week we talked with George J. Annas, Chairman of the Bioethics & Human Rights Department, and William Fairfield Warren Distinguished Professor, at Boston University. George's work is legendary among health policy experts; a 1998 tribute from Jay Katz gives some sense of its breadth and depth. Having reviewed numerous works, Katz states:
"I have barely conveyed the richness of George Annas' observations on the ambiguities in motivations and actions that persist in current research practices. The many recommendations he makes, should be of valuable assistance to those interested in reforming current rules governing research on humans. Plagued by Dreams...reveal[s] another facet of George Annas' personality: His commitment to public advocacy. He values scholarship but he also wants it to have an impact on shaping institutions and health care policies...In the many settings in which I have encountered George Annas over the years, I have admired his boldness, intellect, compassion and moral vigor."
Our conversation had the theme "paternalism & its critics," based on articles George had recently authored (or co-authored with last week's guest, Wendy Mariner) on informed consent, genomics, and sugary drinks.
A special TWIHL episode with analysis of the new EEOC regulations under the ADA and GINA on Employer Wellness Plans. Nic is joined by Professor Wendy Mariner. Professor Mariner is the Edward R. Utley Professor of Health Law at Boston University School of Public Health, Professor of Law at Boston University School of Law, Professor at Boston University School of Medicine, and Co-Director of the J.D.-M.P.H. joint degree program, and a member of the faculty of the Center for Health Law, Ethics and Human Rights at BUSPH. Professor Mariner’s research focuses on laws governing health risks, including social and personal responsibility for risk creation, health insurance systems, implementation of the Affordable Care Act, ERISA, health information privacy, and population health policy.
Our discussion concentrated on the ADA regulation and examined how the agency responded to comments (including ours), the concept of voluntariness, the status of EEOC v. Flambeau, Inc., data protection (including issues raised when employers research the health of their employees), and the policy flaws in the wellness space.
This week we interviewed Elizabeth Sepper, Associate Professor of Law at Washington University. Elizabeth's work explores the interaction of morality, professional ethics, and law in health care and insurance. She has written extensively on conscientious refusals to provide reproductive and end-of-life healthcare In recent work, Elizabeth has argued that, in resisting compliance with antidiscrimination laws, pharmacy regulations, and insurance mandates (most prominently, the Affordable Care Act’s contraceptive mandate), businesses make claims more reminiscent of market libertarianism than of religious freedom.
Our conversation covered many aspects of conscience claims by contemporary health providers. Our timing was perfect, since HHS just finalized a rule on one of Elizabeth's areas of expertise: prohibitions on discrimination based on race, color, national origin, sex, age or disability. Elizabeth weighed in on the rule and its implications for the future of health care.
This week we interviewed Christina S. Ho, Associate Professor of Law at Rutgers University. Christina worked on the Domestic Policy Council at the White House and later led Senator Hillary Rodham Clinton’s health legislative staff.
In our lightning round, we discussed an important new study on medical errors as a leading cause of death in the United States. We also addressed the news of Google's access to health data in Britain, and ongoing controversies at HSCIC (now rebranded NHS Digital).
We asked Christina about her cutting edge work on the Chinese health care system, the right to health care, and comparative health law generally.While China only spends about 5.5% of GDP on health care, almost 50% of the spending is on pharmaceuticals. Christina offers an insightful look at the past, present, and likely near future of Chinese health reforms.
This week's guest was James G. Hodge, Jr., JD, LLM, Professor of Public Health Law and Ethics and Director of the Public Health Law and Policy Program at the Sandra Day O’Connor College of Law, Arizona State University. Through scholarship, teaching, and applied projects, Professor Hodge delves into multiple areas of health law, public health law, global health law, ethics, and human rights.
Our lightning round this week focused on drug prices. Nic analyzed a California referendum proposal and the general potential of state drug price cap laws. Frank noted that New York's Medicaid program and private insurers now must take a much more humane approach with respect to state-of-the-art treatment for Hepatitis C.
Our conversation with James focused on his recent work addressing the Zika virus. We covered topics ranging from the genetic modification of mosquitoes to the Puerto Rico financial crisis, and legal interventions ranging from budget requests to quarantines to price controls for condoms and mosquito repellent.
This week we talked with Heather H. Howard, Lecturer in Public Affairs at Princeton University and Director of the State Health Reform Assistance Network. She served as New Jersey's Commissioner of Health and Senior Services from 2008-2010, overseeing a cabinet-level agency with a budget of $3.5 billion and staff of 1,700 responsible for public health services, regulation of health care institutions, senior services, and health care policy and research.
Our lightning round "closed the loop" on some prior stories. Nic noted a big fine against a hospital which may end ER reality shows (or at least raise the price of their insurance policies), and a smaller action from OCR with a simple message: covered entities need to complete their BAAs! Prior show guest Nicholas Bagley offered an administrative end run around Gobeille. We also discussed the kaleidoscopic complexity of modern insurance markets.
Our conversation with Heather touched on her past, present, and future work on ACA 1332 waivers. If you care about innovation in state health policy, this podcast is for you.
This week we interviewed Leo Beletsky, Associate Professor of Law and Health Sciences at Northeastern University. Leo utilizes empirical and theoretical approaches to analyze how legal mechanisms can help curb substance abuse, prevent the spread of HIV and other infectious diseases and improve patient care. By highlighting discrepancies between black letter law and its real-world implementation, he also examines the relationship between police practices, public health outcomes and human rights of vulnerable groups.
We had plenty of opportunity to apply Leo's expertise to the topic we focused on this week: opioid addiction. Recent studies have demonstrated a rapidly rising rate of opioid abuse, with troubling consequences for individuals and communities. This drug use has also attracted a host of legal responses, which Leo has expertly dissected in past work (including some recent studies here).
Our lightning round featured discussions of recent research on income and life expectancy, the emerging natural experiment in Kentucky on Medicaid rollback, and insurer mergers.
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.
In the opening, lightning round, Nic and Frank discussed:
1) Zubik v. Burwell, and the long line of First Amendment cases in the area.
2) The FTC's new interactive tool for mobile apps.
3) The Part 2 proposed rule, and AMIA's comment.
4) In the series Frontiers in the Financialization of Health Care, mortgages for expensive treatments, and crowdfunded funerals.
Our focus on Flint, Michigan this week featured Wendy's insightful work on solidarity in bioethics, and "invisible victims" of public health failures. We also discussed the Docs v. Glocks saga, and the limits of regulation of professional speech.
And finally, attention all listeners: Northeastern will be hosting a conference on the future of public health law this Friday, and Wendy's book "Welcoming Newcomers" will be out this Fall!
This week we interviewed Christopher Robertson, a professor and associate dean at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute.
We mainly discussed Robertson's new book with past TWIHL guest Aaron Kesselheim, Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law. The book is a tour de force collection of approaches to improving our knowledge of optimal medical, legal, and forensic practices.
We also discussed some of Robertson's recent contributions to insurance law and policy, including Scaling Cost-Sharing to Wages: How Employers Can Reduce Health Spending and Provide Greater Economic Security, as well as A Randomized Experiment of the Split Benefit Health Insurance Reform to Reduce High-Cost, Low-Value Consumption. The latter work, combined with Episode 47's discussion with Mark Hall about employer-based exchanges, may well signal a gradual transition toward defined contribution (rather than defined benefit) health insurance plans.
This week we talked with prolific health law scholar Mark Hall, Director of the Health Law and Policy Program and Fred D. & Elizabeth L. Turnage Professor of Law at Wake Forest University School of Law. Mark has authored or edited twenty books, including Making Medical Spending Decisions (Oxford University Press), and Health Care Law and Ethics (Aspen). He is currently engaged in research in the areas of heath care reform, access to care by the uninsured, and insurance regulation.
We discussed Mark's articles:
Medicaid Expansion Costs in North Carolina: A Frank Discussion
Evaluating the Affordable Care Act: The Eye of the Beholder,
Private Health Insurance Exchanges for Employers: Issues for Regulators and Public Policy
The "private exchanges" discussion in particular will be of deep interest to those concerned about the broader cultural effects of the ACA on health insurance management.
This week features Professor Erin C. Fuse Brown of Georgia State University's College of Law (a previous guest on episodes 5 and 22!). We discussed her fascinating work on the law & policy of health care pricing, including work on cost-control and consolidation (with Jaime S. King). Be sure to check out her SSRN Page for other important work on ongoing efforts to bend the cost curve in health care and assure more universal access to care.
This week we talked with Associate Professor Efthimi Parasidis, who holds a joint appointment with The Ohio State University Moritz College of Law and the College of Public Health, and is a faculty affiliate of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy.The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.
We started the podcast with a discussion of SCOTUS's latest ERISA preemption case, Gobeille. We then moved on to HHS's proposed rule on EHR certification. (For background on the latter topic, see Frank's "Private Certifiers & Deputies in US Health Care."). Finally, a big congratulations to Nic on his invitation to the White House's recent Precision Medicine Initiative.
We tried to cover the range of Efthimi's latest publications and research, but it was difficult! The discussion ranged from empirical research on "natural food" labeling (and its First Amendment implications), research ethics regarding cognitive enhancement of soldiers, the future of pharmacovigilance, and the diversity of views of vaccine objectors. Hop over to his SSRN page to see his work on these and other topics.
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.
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 Act, The Difficulty Accommodating Healthcare Workers, Withdrawn Accommodations, and The New ADA Backlash. The show includes both background on the ADA's purpose and initial reception, as well as up-to-date analysis of its present application.
This week we interviewed Dayna Matthew, Professor of Law ad the University of Colorado Law School. Professor Matthew brings an interdisciplinary approach to the study of health law. She holds a joint appointment at the Colorado School of Public Health and is co-founder of the Colorado Health Equity Project, a medical legal partnership whose mission is to remove barriers to good health for low income clients by providing legal representation, research, and policy advocacy.
We discussed her excellent new book, Just Medicine: A Cure for Racial Inequality in American Health Care. The book discusses shocking disparities in US health care treatment and outcomes, and proposes a bold agenda for addressing them. Laws like the ACA and even the CRA (as presently written) are not capable of addressing present manifestations of bias (both inside and outside formal health care institutions). Professor Matthew develops the Biased Care Model as a core contributions to advance understanding of health and health care disparities. She also proposes concrete legislative changes, discussed on the show, to counteract biased care.
This week we interviewed Charles Ornstein, a senior reporter for ProPublica covering health care and the pharmaceutical industry. ProPublica has been at the cutting edge of technology, health, and privacy reporting, and Ornstein's work there has exposed both the personal narratives and hard data behind an American epidemic of privacy violations. We cover some of his recent hits in this conversation, and reflect on what it would take to see an effective health privacy regime in the US. HITECH geeks will love the discussion of "accounting of disclosures" at the end.
This week featured Deven McGraw, Deputy Director for Health Information Privacy at the U.S. Department of Health and Human Services' Office for Civil Rights. Deven has been an influential figure in health law for years, both as a partner at Manatt, Phelps & Phillips, LLP (and co-chair of its Privacy and Data Security practice) and as head of CDT's Health Privacy Project.
Our lightning round featured Nick's takes on a recent certificate of need case, a JAMA article on high-deductible plans, and superbugs on duodenoscopes. Frank covered the NY Times's blockbuster article on drug shortages, and Politico's data-driven angle on Biden's "cancer moonshot."
We then focused on Deven's work, covering many topics in health privacy and security. OCR hopes that its recent guidance on access to health records will empower patients. Cloud computing and the "internet of health things" are huge concerns. OCR is innovatively offering FAQ pages for developers and others on the frontlines of health care's technological advance, and welcomes their (and your) questions!
This week we welcomed Jessica L. Roberts, Director of the Health Law & Policy Institute and Associate Professor of Law at the University of Houston. In 2015, she received the university-wide Teaching Excellence Award and the Provost’s Certificate of Excellence. Professor Roberts was named a 2018 Greenwall Faculty Scholar in Bioethics. Her research focuses on the intersection of health law and antidiscrimination law.
We started the program with a brief discussion of topics in the news, including the actuality of single-payer care in Britain and the possibility of Medicare-for-All in the US. Nic brought us up to date on Postmarket Management of Cybersecurity in Medical Devices, a guidance issued by the FDA. Frank brought up some ACA hiccups, including employees’ (failed) resistance to expanding wellness programs, and the rather startling statistic that 56% of Humana’s in-network hospitals have no in-network emergency physicians.
Jessica then led our discussion of her article (with Nicole Huberfeld), Health Care and the Myth of Self-Reliance, and her article (with Elizabeth Weeks Leonard) What Is and Isn’t Healthism. Each article addresses deep issues of distributive justice theory and anti-discrimination principles, as well as practical problems confronting HR and compliance departments.
This week, we interviewed Guian McKee, an Associate Professor of Public Policy at the University of Virginia. Guian received a Ph.D. in American history at the University of California, Berkeley in May 2002. His research interests include U.S. social policy history and urban history. He is the author of The Problem of Jobs: Liberalism, Race, and Deindustrialization in Philadelphia, published in November 2008 by the University of Chicago Press. He also recently published an article on the political economy of health in Baltimore.
Nic and Frank began with a discussion of the FTC's Big Data report. We also discussed developments in Medicaid policy in Kentucky and other states, and the politicization of meaningful use.
Our discussion with Guian questioned some conventional narratives about health care costs. Frank discussed the hidden costs of health care cost-cutting, and Guian confirmed that "med and eds" have been at the center of many urban policy proposals in the wake of deindustrialization. Nic and Guian discussed the importance of addressing overutilization. And the conversation ended on a hopeful note about automation complementing, rather than replacing, human professionals.
This week we interviewed Professor Mary Crossley of the University of Pittsburgh School of Law. Professor Crossley's research has focused on issues of inequality in the financing and delivery of health care, encompassing topics ranging from an exploration of potential legal remedies for physician bias in medical treatment, to an examination of how recent trends in health insurance coverage function to discriminate against unhealthy people.
We focused on the "community benefit standard" for federal nonprofit status for hospitals. The ACA has imposed new requirements in this domain, including a Community Health Needs Assessment (CHNA). CHNA's might spur hospitals to do more to address health disparities and improve quality.
In our lightning round, we discussed four recent developments in health law:
1) Final rule issued by HHS with respect to HIPAA law enforcement exceptions related to reporting of "mental health prohibitors" for gun ownership to background check database.
2) Proposed changes to meaningful use in legislation introduced by Rob Portman.
3) Charles Ornstein's great work at ProPublica on HIPAA violations.
4) Massive bills still dog even insured patients.
In a special Holiday-themed show reviewing the year in Health Law & Policy Nic welcomed Nicole Huberfeld, the Ashland-Spears Distinguished Research Professor of Law at the University of Kentucky College of Law, Nicholas Bagley, Professor of Law at the University of Michigan, and honorary ‘Nic’ Elizabeth Weeks Leonard, J. Alton Hosch Professor of Law at the University of Georgia.
The ‘naughty or nice’ round included discussion of the declining numbers of the uninsured, King v. Burwell, Armstrong v. Exceptional Child Center, Gobeille v. Liberty Mutual Insurance Company, Chief Justice Roberts, Senator Marco Rubio, and FTC cases LabMD, POM Wonderful, Wyndham & North Carolina Board of Dental Examiners.
Our ‘Happy New Year’ round included the House of Representatives ACA lawsuit, Universal Health Services v. United States ex rel. Escobar, the MMA 2003 non-interference clause, health care prices, and Whole Woman’s Health v. Cole.
Finally, our ‘carolers-of-choice’ were Justice Scalia, Donald Trump, Jimmy Fallon and the FLOTUS with the MOSTEST.
We’ll be back in the New Year. Happy Holidays Dear Listeners!
This week we talked with Robert I. Field, Professor of Law at Drexel University. Robert is also a professor of health management and policy at Drexel's Dornsife School of Public Health, a lecturer in health care management at the Wharton School of the University of Pennsylvania, and a senior fellow of Penn’s Leonard Davis Institute of Health Economics. He is the author of "Mother of Invention: How the Government Created 'Free-Market' Health Care," which presents a historical overview of government programs in creating and maintaining the health care system and places health reform in the context of an ongoing evolutionary process. He is also the author of "Health Care Regulation in America: Complexity, Confrontation and Compromise," a comprehensive overview of health care regulation.
We discussed a number of recent developments surrounding the ACA, including the most recent judicial challenges (and their potential to congeal into an emerging ACA SCOTUS jurisprudence) and legislative attacks. We discussed mainstream health economists' zeal for the Cadillac tax, despite such thin evidence it will actually raise wages. We closed with a discussion of one theme from Robert's book: what the US health care sector would look like if there were dramatic reductions in government support and regulation.
This week we interviewed Anna Laakmann, Associate Professor of Law at Lewis & Clark Law School. Anna’s teaching and scholarship focus on biomedical innovation policy. Before she entered the legal academy, Laakmann was manager of technology development and commercialization at a medical research institute outside Philadelphia, where she evaluated the patentability and commercial potential of scientific discoveries, managed patent prosecution, and negotiated license agreements with biopharmaceutical companies.
Nic and Frank led off with discussion of the LabMD appeal, an NPR story on the NPRM (see Episode 32), and an opinion on the disposition of frozen embryos--a topic of some interest to bioethics scholars.
Anna then led the discussion of her work on regulatory property and liability for clinical innovation. Listeners interested in the coordination of conflicting sets of laws regulating innovation may also find the work of scholars at the two "Innovation Law Beyond IP" conferences at Yale of interest.
This week we interviewed W. Nicholson Price, an Assistant Professor at the University of New Hampshire School of Law with a J.D. and Ph.D. (Biological Sciences) from Columbia University. Nicholson's work on both IP and health care covers a wide array of important issues and was recently featured in a New York Times article.
Nic led off with a tour de force analysis of the recent LabMD decision by an ALJ at the FTC, challenging apocalyptic post-mortems of the case in light of Wyndham & extant FTC common law. Frank riffed on Tim Jost's recent Health Affairs post on deductibles and legislative rulemaking and called for a bit more service journalism at the New York Times when it covers health and education finance.
We then discussed black box medicine and the new challenges posed to both health and patent law by opaque predictive analytics. Consider, for instance, the challenge in even describing such practices for "written description" purposes. Nicholson offered a big picture view on the relative value of patent and trade secrecy law in incentivizing innovation here.
This week we welcomed back Brietta R. Clark, Associate Dean for Faculty and Professor of Law at Loyola Law School in Los Angeles. Brie is an expert on health care law and inequality. Her research focuses on the structural defects and biases that create inequity in our health care delivery and financing systems, and the role that law and government regulators play in ensuring equitable access to health care resources.
We began the show with our "lightning round" by discussing a Kentucky Supreme Court case limiting nursing home arbitration agreements in some scenarios. (Interested readers should check out Nic's prophetic article on malpractice arbitration, and later work citing it.) We briefly mentioned the contraceptive cases granted cert this term, and hope to return to them in a later episode.
Brie offered an illuminating tour of leading Medicaid Managed Care initiatives. She also explained how the recent surge of enrollments have been handled in the states. Brie offered a compelling vision for Medicaid reform (ala New York's FIDA program and other waivers) promoting the triple aim, but also warned that some waivers may be going too far. Let's hope Brie's excellent research (one example here) guides policymakers in the future.
This week we are joined by Glenn Cohen, Professor of Law at Harvard Law School and Faculty Director of Harvard's Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, and Holly Fernandez Lynch, Executive Director of the PFC and member of the Secretary's Advisory Committee on Human Research Protections (SACHRP), at the U.S. Department of Health and Human Services.
We discussed the NPRM on the Common Rule, summarized here and here. (Comments are due by December 7th.) Holly and Glenn offered perspectives on the nature and purpose of the proposed revision, and the bioethical aims it served, with a particular focus on the advancement of research. Frank focused on the practical implications for designing consent procedures for learning health care systems. Nic commented on the regulatory complexity arising out of the interaction of HIPAA and HSR protections of data. Podcast listeners will find themes in this episode also engaged in our conversations with Deirdre Madden and Michelle Meyer.
This week we interview Christy Ford Chapin, author of Ensuring America’s Health: The Public Creation of the Corporate Health Insurance System (Cambridge University Press, 2015). Chapin is an assistant professor of twentieth-century political history at the University of Maryland, Baltimore County, and a visiting scholar at Johns Hopkins. Her interests include political, business, and economic history as well as capitalism studies. Chapin has won numerous wards including a Miller Center for Public Affairs Fellowship and a John E. Rovensky Fellowship in American Business and Economic History.
Our discussion's themes included "everything old is new again:" it turns out that many au courant cost-cutting ideas were part of health policy discourse in the 1960s, 50s, and even 40s. We also explored the validity of the conventional wisdom on the rise of employer-sponsored insurance. And we considered what health policy might look like, if it were better informed by history.
Our first international episode features Professor Deirdre Madden, a leading bioethicist and expert on health law at University College Cork. Professor Madden was author of the Report on Post-Mortem Practice and Procedure (2005) and Chairperson of the Commission on Patient Safety and Quality Assurance which published its Report, entitled Building a Culture of Patient Safety, in July 2008. She recently co-authored an overview of the national laws on electronic health records in the EU Member States.
We opened with a discussion of some current trends in health law, including the EU/US Safe Harbour's invalidation and recent developments in meaningful use. We then moved on to research regulation, with a brief mention of the US NPRM and more in-depth discussion of biobanking. Deirdre's discussion of the Guthrie Cards in Ireland should be of great interest to those following developments in newborn screening and tissue storage in the US.
This episode features Scott Burris, who is a Professor of Law at Temple Law School, where he directs the Center for Health Law, Policy and Practice, and the Robert Wood Johnson Foundation’s Research on Policy and Law program. He is also a Professor in Temple’s School of Public Health.
We discussed Scott's extraordinary work at the National Coordinating Center for Policies for Action, the Policy Surveillance Program, and the Public Health Law Research National Program Office.
Public health law tracking and assessment tools are meant to subject policymaking to rigorous, data-driven studies of comparative effectiveness and cost-benefit analysis. Consider, for example, recent controversies regarding the overall effect of helmet laws. Scott discussed the methodological questions raised by such assessments and law tracking, and new directions for public health law.
This week we interviewed Kirk J. Nahra, Partner at Wiley Rein. As his firm website notes, he "was named as the Co-Chair of the Confidentiality, Privacy, and Security Workgroup, a panel of government and private sector privacy and security experts advising the American Health Information Community (AHIC) on privacy and security issues arising from health information technology," and has also "been named an expert practitioner by the Guide to the Leading US Healthcare Lawyers, a leading health care lawyer by The Best Lawyers in America directory and one of the leading privacy “hired guns” by Computerworld."
We discussed HITECH, HIPAA, health data outside the HIPAA zone, and the future of health privacy. We also briefly mentioned emerging threats to the US/EU Safe Harbor framework.
This week we discussed Medicare payment policies, the social determinants of health, and changing delivery models with Professor Jessica Lind Mantel, Assistant Professor & Co-Director of the Health Law & Policy Institute at the University of Houston Law Center. Some of Professor Mantel's many excellent articles on health law & policy are available here.
This week's podcast features Aaron S. Kesselheim, MPH, MD, JD, Associate Professor of Medicine, Harvard Medical School, and Research Associate at the Department of Health Policy and Management at Harvard's T.H. Chan School of Public Health. Aaron is a prolific and insightful scholar whose work has influenced policy makers globally.
To start the show, Nic and Frank discussed a new study of ACOs, proposed budget cuts for AHRQ, worry over unintended consequences of readmission penalties, and EHR gag clauses (and developer codes of conduct).
Aaron covered many topics, including:
1) Kim Kardashian's FDA feud over stealth marketing of an anti-nausea drug.
2) An FDA guidance on social media marketing.
3) New FDA Commissioner nominated.
4) Addressing high drug prices, including the case of Sovaldi.
Our 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. We discussed:
1) The right to health, as applied to immigrants.
2) Public health as collective action.
3) Regulation of e-cigarettes.
For show openers, Frank discussed insurers' major rate increases, and industry consolidation. Nic covered a report on the Ebola incident in Texas in 2014, and an interesting new study on insurance and utilization.
We welcome guest Ryan Abbott to discuss some important recent developments including FTC v. Wyndham and the Amarin Pharma off-label use case. Check out the Duke article Professor Abbott authored with Ian Ayres suggesting improved models for dealing with unapproved uses.
For more on the collision course between the expansion of the First Amendment and the FDA's regulatory mission, listensers may want to consult:
Kyle Thompson, The Changing Landscape of the Commercial Speech Doctrine and FDA Advertising Regulation: Off-Label Marketing in the Wake of Sorrell v. IMS.
Bill Vodra et al., The Food and Drug Administration’s Evolving Regulation of Press Releases: Limits and Challenges.
Nathan Cortez, Do Graphic Tobacco Warnings Violate the First Amendment?
Wendy Parmet, The First Amendment Meets Public Health Again — The US AID Case.
Nic welcomes studio guests law professor Barbara Evans & bioethicist Eric Meslin. The primary topic is the future of research and its regulation leading to a broad-ranging discussion that includes the future of the FDA, emerging research models, and how consent & autonomy fit into this changing ecosystem. Eric mentioned an interesting article by Neal Lane and you should check out some excellent contributions by Barbara dealing with the FDA and Genomic Tests and other regulatory issues.
Our first "special" and it is special. We asked some wonderful health lawyers what were the compelling additions to this Fall's health law curriculum. The answers are diverse and fascinating. In alphabetical order we were deligted to hear from:
Micah Berman PBS Unnatural Causes
Erin Fuse Brown Physician Self-Referral Updates (STARK)
Glenn Cohen Egg freezing and egg banking: empowerment and alienation in assisted reproduction
Brietta Clark Pickup v. Brown
Nicole Huberfeld Armstrong v Exceptional Child Center Inc.
Elizabeth Weeks Leonard King v. Burwell
Frank Pasquale Narrow Networks
Ross Silverman Should childhood vaccination against measles be a mandatory requirement for attending school? Yes
Norman G. Tabler, Jr. Can an Arbitrator Rule Against a Hospital for Not Violating the Anti-Kickback Statute?
Nicolas Terry North Carolina State Board of Dental Examiners v. Federal Trade Commission
Our guest this week was Professor Micah Berman, who holds a joint appointment with The Ohio State University Moritz College of Law and the College of Public Health. We discussed FDA regulation of tobacco, First Amendment challenges to certain public health regulation, and the future of tobacco regulation. Articles and cases mentioned in the episode include:
Berman on manipulative marketing.
Berman on raising the tobacco sales age.
The Chamber of Commerce's challenges to anti-smoking laws.
The "docs & Glocks" case (Wollschlaeger) on physicians asking about gun ownership.
Capturing Social and Behavioral Domains in Electronic Health Records.
This week featured Professor Elizabeth Weeks Leonard of the University of Georgia. Professor Weeks is a prolific scholar and insightful analyst of all things CMS reimbursement-related. Professor Weeks Leonard begins the podcast with an overview of fraud and abuse law. We then discuss some notable particulars, including the "Two Midnights Rule," "reverse false claims," and Recovery Audit Contractors.
This week we discussed the law of genetic privacy (and health data in general) with Ifeoma Ajunwa, a law professor at UDC and researcher with Microsoft Research. GINA was big news last month as a "landmark case" resulted in a verdict of "$2.25 million to two men whose employer tested their DNA."
Ajunwa's original, compelling work on GINA includes this article on genetics & civil rights. Ajunwa's scholarly agenda on disparate impact and genetics also got a boost in late June when the Supreme Court affirmed the disparate impact theory by ruling "that the Texas housing department had violated the Fair Housing Act, and engaged in racial discrimination, by putting too much subsidized housing in predominantly black urban neighborhoods, and too little in white suburban neighborhoods."
We also briefly discussed the dangers of large-scale genetics databases, a topic Ajunwa coordinated a New York Times debate on.
Completing our coverage of King v. Burwell with some great analysis from guest Wendy Mariner. Abigail Moncrieff's article is Understanding the Failure of Health- Care Exceptionalism in the Supreme Court’s Obamacare Decision, 142 CHEST 559, 559-60 (2012). The RWJ report on Narrow Networks is here, and Abbie Gluck's SCOTUSblog post is here.
A special, alas Frank-less edition, with some first impressions on the Supreme Court decision in King v. Burwell. Thanks so much to guest Nicole Huberfeld for her perceptive analysis.
We are joined this week by Nicholas Bagley, Assistant Professor of Law at the University of Michigan and blogger at The Incidental Economist. We start with a few reflections on the King v. Burwell tea leaves, and then address Professor Bagley's fascinating new article on health care as a public calling. Our final segment discusses the future import of big data and trade law for health policy.
Sources mentioned in our conversation included:
1. Dose of Competition Report.
2. EU Data Protection Developments.
3. Trade treaties and access to health.
4. On economists who believe health care could or should consumer over 20% of the GDP of a productive economy: Baumol and Cutler.
This week we are joined by Leslie Francis for a wide-ranging discussion of Privacy, Big Data and EU Law. Check out some of Leslie's publications here and here. Leslie is Associate Dean for Faculty Research & Development at the College of Law at the University of Utah, and a Distinguished Professor in both Law and Philosophy.
This week, we are joined by Kristin M. Madison, Professor of Law and Health Sciences at Northeastern University. Kristin has been a thought leader on health policy in several areas, including data stewardship and health economics.
We discussed Kristin's recent Health Affairs post on wellness programs, as well as interoperability initiatives.
This week's episode featured our first return guest, Professor Nicole Huberfeld. Her draft on the Universality of Medicaid at 50 is highly recommended. Nicole is one of America's premier legal academics specializing in the complexities of federal-state collaboration and conflict in health care.
We discussed ongoing controversies in US health care federalism,and several cases, including Armstrong v. Exceptional Child Center. For a critical take on Armstrong, here is the post by Steve Vladeck we mentioned during the discussion.
One theme of the episode was brinksmanship: just how far either the states or federal government would go to "get their way" in disputes over the implementation of Medicaid or the ACA. Florida Governor Rick Scott's recent plan for financing health care budgets by taxing hospital profits was one of many examples discussed.
This week we are joined by William M. Sage, James R. Dougherty Chair for Faculty Excellence at the University of Texas School of Law. Professor Sage has both J.D. and M.D. degrees, served as Vice Provost for Health Affairs at UT from 2006-13, and is one of the leading voices in American health policy on information policy in health care and the improvement of health care delivery systems.
Our discussion started with the recent Amarin case, regarding First Amendment limits on the FDA's authority to limit truthful statements. We also addressed Tibbs v. Bunnell and N.C. Board of Dental Examiners v. FTC. Professor Sage's recent work on Upstream Health Law and Assembled Products informed all three discussions.
This week we are joined by Glenn Cohen, Professor of Law at Harvard Law School and Faculty Director of Harvard's Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics. Glenn's extensive record of publications includes the recent Patients with Passports, The Constitution & Rights Not to Procreate, My Body, My Bank, and Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy.
We were eager to hear Glenn's views on several bioethical dilemmas recently in the news, including a controversy over Nepalese surrogate mothers and Chinese scientists' genetic modification of human embryos.
We also discussed the legal implications of the spread of the 1099 economy into health care, focusing on start-up Honor's aspiration to "Uber-ize" home health care. For podcasted background on home health care, this episode of the Diane Rehm show may be of interest.
We are joined by Nathan Cortez, Associate Dean for Research and the Adelfa Botello Callejo Endowed Professor of Law in Leadership and Latino Studies at Southern Methodist University. Nathan has published cutting edge articles on mHealth in NEJM and law reviews, and is a global thought leader on mHealth regulation.
Our discussion also touched on the larger conflicts between medicine as a highly regulated domain, and deregulatory trends in information law generally. Listeners may be interested in this background material:
Dissenting Statement of Commissioner Maureen K. Ohlhausen (in case relating to a mole analysis app).
George Annas on 23andme and the FDA.
[Warning: Graphic material]: Figure1 as the Instagram of Physicians.
We are joined by Michelle Meyer, Professor and Director of Bioethics Policy in the Union Graduate College–Icahn School of Medicine at Mount Sinai Bioethics Program. Michelle is a noted authority on Public Health Ethics and Bioethics.
We primarily discussed the ethics of digital experimentation, with an eye to controversies over Facebook and OkCupid. For more background, see James Grimmelmann's aggregation.
We are joined by Thad Pope, one of the country's leading scholars on end of life issues. He is professor of law and director of the Health Law Institute at Hamline Law. He curates a particularly useful web site, Medical Futility & Non-Beneficial Treatment Cases, at ThaddeusPope.com and authors the Medical Futility Blog. He joins us to discuss VSED (some background here) and Assisted Suicide. His scholarship on the topic includes papers here and here. The BC case he discussed is here. In addition we discuss regulation of dietary supplements and the problem of agency capture and the HHS-ONC Report on HIT Information Blocking and a recent FTC letter to ONC.
We are joined by Professor Mark Rothstein, the Herbert F. Boehl Chair of Law and Medicine and the Founding Director of the Institute for Bioethics, Health Policy and Law at the University of Louisville School of Medicine. One of his recent papers concerns Ethical Issues in Big Data Health Research. We discuss that as well as Apple's ResearchKit (See Nic's blog post at Bill of Rights) and the Administration's proposed Privacy Bill of Rights (See Nic's blog post at Health Affairs).
This week features Professsor Ross D. Silverman, JD, MPH. He is Professor of Health Policy and Management at the Indiana University Richard M. Fairbanks School of Public Health at IUPUI, and holds a secondary appointment as Professor of Public Health Law at the Indiana University Robert H. McKinney School of Law.
After Nic's update on the doc fix bill, the discussion centered on vaccination policy. Silverman, a national expert on the topic, just published pertinent work in the New England Journal of Medicine. Silverman also discussed recent emergency public health measures in response to an HIV outbreak in rural Indiana.
This week features Professor Erin C. Fuse Brown of Georgia State University's College of Law. We discuss her fascinating work on the law & policy of health care pricing, which includes:
Irrational Hospital Pricing
It's a hot topic, given Elisabeth Rosenthal's NY Times series on excessive, surprising, and worrisome health pricing practices.
This week's episode features Professor Lindsay F. Wiley of the American University School of Law. Wiley has written cutting edge scholarship on wellness programs, including:
Access to Health Care as an Incentive for Healthy Behavior? An Assessment of the Affordable Care Act's Personal Responsibility for Wellness Reforms
Health Law as Social Justice
Shame, Blame, and the Emerging Law of Obesity Control
We lead off our discussion this week with a recent article by Lewis, Khanna, and Montrose, Employers Should Disband Employee Weight Control Programs.
This week's episode features a discussion of oral argument in King v. Burwell, the latest legal challenge to PPACA to reach the Supreme Court.
We are joined by Professor Abigail Moncrieff of the Boston University School of Law, a leading expert on the law & policy of federalism, and constitutional law. Her work includes:
Cost-Benefit Federalism: Reconciling Collective Action Federalism and Libertarian Federalism in the Obamacare Litigation and Beyond
The Positive Case for Centralization in Healthcare Regulation: The Federalism Failures of the ACA
This week's episode featured Professor Nicole Huberfeld. Her draft on the Universality of Medicaid at 50 is highly recommended.
FP, NT, and NH discussed the new Google/Mayo Clinic initiative on health searches. Check out Search Engine Land for ongoing coverage.
And all discussed the ongoing effort to reduce hospital-acquired infections (HACs) and reduce medical errors, including this Blumenthal/Squire report.
FDA, Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff
Nicolas Terry, Time for a Healthcare Data Breach Review?
New York Attorney General Targets Supplements at Major Retailers
Nursing Home Compare 3.0