Tim Jost on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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

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

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

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Naughty or Nice 2016? on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Here it is! Naughty or Nice 2016?, 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: Glenn CohenNicole HuberfeldElizabeth Weeks LeonardJessica Roberts, and Lindsay Wiley.

And a very happy holiday season to all our listeners. See you in ’17!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Zack Buck on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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

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

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Richard Saver on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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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.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Jordan Paradise on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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

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

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

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Jill Fisher on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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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.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Russell Korobkin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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

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

Larry Singer on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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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.

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Allison Hoffman on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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

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

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

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Lisa Ikemoto on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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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.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Paul Lombardo on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Subscribe to TWIHL here! 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. Continue reading

Melinda Buntin on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

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

By Nicolas Terry and Frank Pasquale

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

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

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

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

David Barton Smith on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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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.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Ameet Sarpatwari on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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

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

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

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Back to School Special Part 3 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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It’s that time of year again–the TWIHL Back to School Specials (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.

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!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Back to School Special Part 2 on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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It’s that time of year again–the TWIHL Back to School Specials (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 is our second episode, 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 also pleased to have two great returning guests for this BTSS: Leo Beletsky discusses the opiate crisis and the curative but unfunded mandateErin Fusee Brown discusses Universal health Services v. U.S., ex rel. Escobar, the case that may launch a thousand (or more) false claims litigations.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

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

By Nicolas Terry and Frank Pasquale

Listen here!

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

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

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

CDC’s Matthew Penn Plus Ross Silverman on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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twihl 5x5Our guests this week are Matthew PennDirector 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.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

FitBits Be Free: General Wellness Products Are Not (Generally) Medical Devices

By Nicolas Terry

The FDA has issued a final guidance on low risk wellness devices, and it is refreshingly clear. Rather than applying regulatory discretion as we have seen in the medical app space, the agency has made a broader decision (all usual caveats about non-binding guidances aside) not to even examine large swathes of wellness products to determine whether they are Section 201(h) devices. As such, this guidance more closely resembles the 2013 guidance that declared Personal Sound Amplification Products (PSAPs) not to be medical devices (aka hearing aids).

The FDA approach to defining excluded products breaks no new ground. First, they must be intended for only general wellness use and, second, present a low risk. As to the former, FDA has evolved its approach to referencing specific diseases or conditions. Make no such reference and your product will sail through as a general wellness product. Thus, claims to promote relaxation, to boost self-esteem, to manage sleep patterns, etc., are clearly exempt. On the other hand, the agency will clearly regulate products that claim to treat or diagnose specific conditions. Continue reading