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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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