New CBO Analysis: Cutting Subsidies Would Backfire on Trump

By Wendy Netter Epstein 

The cost-sharing reduction payments are an essential component of the ACA.  These payments reduce out-of-pocket costs for lower income enrollees so that individuals can actually use their insurance coverage and not be prevented from seeking care because of a high deductible or a copay they can’t afford.  President Trump has been threatening since he took office to end these payments.  And there is at least some possibility that he has the authority to do (see House v. Price).

Politically speaking, Trump’s goal in threatening to end these payments is either to hasten what he sees as the inevitable demise of Obamacare—or at least to use the threat of ending the payments to hold the feet to the fire of those who have resisted “repeal and replace.”  Either way, Democrats have widely condemned Trump’s threats and the instability they cause in the market. Continue reading

Biobanks as Konwledge Institutions – Seminar 11/3 at the University of Copenhagen

Biobanks as Knowledge Institutions

“Global Genes –Local Concerns” Seminar with Prof. Michael Madison (University of Pittsburgh, U.S.)

Join us at the University of Copenhagen on November 3rd, 2017 to discuss the legal implications of “Biobanks as Knowledge Institutions” with Professor Michael Madison. 

Abstract

The presentation characterizes the material and immaterial attributes of biobanks as knowledge resources, and it characterizes the broader questions that they pose as resource governance questions rather than as questions solely of law or of public policy. Biobanks are knowledge institutions. Professor Madison argues that despite the varied and diverse nature of biobanks today (indeed, precisely because of their diversity), their social and scientific importance dictates the need for a robust program of research of a comparative nature to identify shared features that contribute to their success (where they succeed) and features that likely contribute to problems or even failure. Both their importance and the associated governance challenges have only grown larger and more complex as biobanks meet the era of data science. In that regard Professor Madison points to emerging scholarly literature that focuses on governance challenges of material and data in biobank contexts, which builds on a knowledge commons governance framework. He concludes by suggesting directions for future work. Continue reading

Petrie-Flom Panelists Contribute to new Guiding Framework for Designing and Implementing Serious Illness Programs

By Mark Sterling

As part of the Project on Advanced Care and Health Policy, the Petrie-Flom Center hosted two convenings on Critical Pathways to Improved Care for Serious Illness.  Through roundtable discussions and working sessions at these convenings, expert panelists reviewed innovative programs designed for the aging population with chronic illnesses, focusing on those with declining function and complex care needs.  These convenings contributed to the development of a framework to guide healthcare providers in developing and scaling programs to deliver high quality care to individuals with serious illness, which is of increased importance given the growth of this population and the development of alternative payment models.  The convenings were held in March and June, and the panelists, agendas, slide decks, and related program materials remain available on the Petrie-Flom website (Session 1 & Session 2).

C-TAC, which collaborates with Petrie-Flom on the Project on Advanced Care and Health Policy, now has published a Report, Toward a Serious Illness Program Design and Implementation Framework, to help providers develop, replicate, and scale programs across a variety of serious illness populations and settings.  The Report’s Framework provides steps to allow healthcare organizations to assess evidence-based options for each facet of care model design and implementation.  As noted in the Report, the Framework is designed to:

  • Inform serious illness program development, replication, and scaling;
  • Integrate with care model payment design;
  • Inform care model and proforma simulator development;
  • Inform other aspects of design and development such as policy, standardized measurement, and regulatory analysis.

Continue reading

Introducing new blogger Wendy Netter Epstein

Wendy Netter Epstein is joining Bill of Health as a regular contributor.

epstein-hi-res-blogProfessor Epstein is a Visiting Associate Professor at the University Chicago Law School, and an Associate Professor of Law and Faculty Director of the Jaharis Health Law Institute at the DePaul University College of Law.  She is a graduate of Harvard Law School, where she was editor-in-chief of the Journal of Law, Medicine & Ethics, Recent Developments. Prior to starting her academic career, Professor Epstein was a partner in commercial litigation at Kirkland & Ellis LLP, concentrating on health industry clients.  Professor Epstein’s teaching and research interests focus on health care law and policy, contracts, and commercial law.  Her work takes an interdisciplinary approach, applying both law and economics and behavioral science principles to problems negatively impacting vulnerable parties.  In 2017, Professor Epstein won both the University-wide and law school Excellence in Teaching Awards at DePaul University.

Representative publications:

Welcome, Wendy!

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

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!twihl 5x5

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, and 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.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

Housing Equity Week in Review

Here is our weekly round-up of developments from the world of housing law and health. For the week of August 7-14, 2017:

  • HUD released its “Worst Case Housing Needs” report to Congress providing national data and analysis of the problems facing low-income renting families. CityLab offers a summary of the report here.
  • Is California’s housing laws making its housing crisis worse? Natalie Delgadillo at Governing analyzes the impact of the 1985 Ellis Act, which allows landlords to mass-evict tenants in order to leave the rental business.
  • A new study from University of Hawaii researchers finds homelessness and inadequate housing are major causes of unnecessary hospitalizations. Read more.
  • HUD is inviting paper submissions for a symposium on housing and health. Submissions will be accepted through September 30. Full details here.
  • A new Colorado law requires landlords to give 21-days notice of rent increases and lease terminations, via HousingWire.
  • Amy Clark at the National Housing Conference offers an explanation of YIMBYism — “yes, in my backyard” — via NHC’s Open House blog.

Applications Due TODAY, 8/11! 2017-2018 Petrie-Flom Student Fellowship

PFC_Logo_300x300The Center and Student Fellowship

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website and check out profiles of some of our past Fellows in the PFC Spotlight.

Eligibility

The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs to wait until after their first year to apply. Continue reading

Erika Lietzan on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!twihl 5x5

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, biosimilarsdata 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.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

Petrie-Flom Student Fellowship Testimonial

Applications for the 2017-2018 Student Fellowship are due this Friday, August 11, so apply today! Full details here

By Shailin Thomas, 2016-2017 Petrie-Flom Student Fellow

The Petrie-Flom Center student fellowship was an incredible opportunity for me as a law student interested in health law and policy.  Not only did it give me a substantive legal foundation in health law, it also helped me hone my short- and long-form academic writing.  I can confidently say that I am a better law student and a better legal scholar than I was a year ago, and that is largely the result of the skills and connections I developed through the Petrie-Flom student fellowship.

Of particular importance to me was the mentorship provided to student fellows.  The faculty members that mentor student fellows are some of the most thoughtful voices in health law scholarship.  At every step of the fellowship process, the mentors are there to offer guidance — from tips for writing more engaging blogposts to advice on finding a journal to publish the fellowship paper. A large part of being a lawyer is formulating and showcasing your thoughts in the most compelling, persuasive ways possible, and the Petrie-Flom fellowship advisers are experts at increasing the impact of legal and academic work.  The ability to form strong relationships with these prominent health law academics, while getting their input and feedback on my writing, has put me in a much better position to launch my legal career. Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from the characteristics of expanded access programs, to the association of the priority review voucher with neglected tropical disease drug and vaccine development, to the use of surrogate outcomes in oncology. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bonnie RJ, Kesselheim AS, Clark DJ. Both Urgency and Balance Needed in Addressing Opioid Epidemic: A Report from the National Academies of Sciences, Engineering, and Medicine. 2017 Jul 13. [E-pub ahead of print]
  2. Fralick M, Avorn J, Kesselheim AS. The Price of Crossing the Border for Medications. N Engl J Med. 2017;377(4):311-313.
  3. Hwang TJ, Kesselheim AS, Sarpatwari A. Value-Based Pricing and State Reform of Prescription Drug Costs. 2017 Jul 10. [E-pub ahead of print]
  4. Jain N, Hwang TJ, Franklin JM, Kesselheim AS. Association of the Priority Review Voucher with Neglected Tropical Disease Drug and Vaccine Development. 2017;318(4):388-389.
  5. Kemp R, Prasad V. Surrogate Endpoints in Oncology: When Are They Acceptable for Regulatory and Clinical Decisions, and Are They Currently Overused? BMC Med. 2017;15(1):134.
  6. Miller JE, Ross JS, Moch KI, Caplan AL. Characterizing Expanded Access and Compassionate Use Programs for Experimental Drugs. BMC Res Notes. 2017;10(1):350.
  7. Phillips AT, Desai NR, Krumholz HM, Zou CX, Miller JE, Ross JS. Association of the FDA Amendment Act with Trial Registration, Publication, and Outcome Reporting. 2017;18(1):333.

Two Views About the Gene Editing ‘Breakthrough’ that Are Not Getting Enough Attention (IMHO)

As has now been well-covered in the news, Nature just published a paper from Mitalipov’s lab at the Oregon Health and Science University that used CRISPR/Cas 9 gene editing to correct the MYBPC3 mutation associated with hypertrophic cardiomyopathy — a heart muscle disease that affects 1 in 500 people. The more impressive element of the story is that by doing the alteration simultaneous with the sperm fertilizing the egg (not after fertilization) they were able to avoid the mosaicism that problematized early attempts in China — in mosaicism not all cells are repaired due to failure in the editing. The media coverage thus far, sadly but predictably, has focused on the soundbite of “designer babies” and “hope and hype” (indeed as my friend Hank Greely has suggested perhaps “overhype”.) These are worthy narratives to tell, to be sure, but here are two other narratives that I think are not getting the air time they deserve:

(1) The Importance of Genetic Ties: This use of CRISPR/Cas 9, as with most reproductive technologies, are attempts to allow those with disease-causing genes or other obstacles to reproduce genetically to do so. Investment and development of these technologies reifies the importance of genetic ties, as opposed to the kinds of ties associated with adoption, step-parenting, etc. It confuses a right to be a genetic parent, with a right to be a parent. We might have one right or both, but we should be clear they are different rights claims. Françoise Baylis has written eloquently about this issue in the context of In Vitro Gemetogenesis, and others (myself included) have mused on what claims the infertile have on society to have the state pay for these kinds of technologies instead of adopting. The National Academies report on gene editing suggested that clinical use of gene editing to eliminate disease be restricted to cases where there is an “absence of reasonable alternatives,” but does not take a position on when adoption is a reasonable alternative. Of course, in the U.S. at least, adoption is not easy and not available for everyone and there are a ton of interesting normative questions I have gestured at (including whether it matters for “reasonability” whether the child is of a certain age, race, or lacks developmental delay).

(2) The Importance of Embryo Sparing: A different alternative to gene editing in some cases is to fertilize large numbers of embryos and engage in preimplantation genetic diagnosis to eliminate those embryos that carry the disease-causing genes. There is a lot of obstacles to doing this: the fact that women may not retrieve enough eggs to do this, the cost (physical and financial) of repeated egg retrievals and PGD, the fact that this may not work for all genetic problems, etc. But one problem that vexes some is that this results in the destruction of large numbers of embryos (“discard” is sometimes used as the euphemism). Gene editing may be a solve for this problem. The Mitalipov group in their Nature paper have a line to this effect, “When only one parent carries a heterozygous mutation, 50% of the embryos should be mutation-free and available for transfer, while the remaining carrier embryos are discarded. Gene correction would rescue mutant embryos, increase the number of embryos available for transfer and ultimately improve pregnancy rate” (emphasis mine). This raises to me a very interesting question: some religious conservatives have tended to oppose both attempts to transform the human genome & embryo destruction (especially in the stem cell debate context). Could gene editing offer an olive branch to them as an alternative to the “greater evil” of routine PGD plus discard? Does it matter that to get to a place where we could achieve this we would have to actually destroy numerous embryos to perfect the research? (The Mitalipov embryos were not implanted, it seems under current U.S.  law that they could not be/) Is the right way to think about this consequentialist — destroy some embryos today to develop embryo sparing technologies to save many more tomorrow — or is this a case of complicity where the wrongfulness of the basic research taints what comes later?

Ameet Sarpatwari and Aaron Kesselheim on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!twihl 5x5

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. Ameet Sarpatwari is 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 is PORTAL Director and 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.

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 Apple Podcasts, listen at Stitcher Radio Tunein, or 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

Dissecting the Charlie Gard Case

The judicial decision to allow mechanical life support to be removed from the British infant, Charlie Gard, has been roundly condemned by some sources.  The infant’s distraught mother lamented that the parents had been allowed “no control” over their child’s life and death.  Demonstrators, calling themselves “Charlie’s army,” assembled near the courthouse crying “shame” at the court’s failure to sustain a preservable human life.  Conservative commentators condemned the “unwarranted” governmental interference with parents’ child-rearing prerogatives.  They wondered why the parents weren’t permitted to transport the infant, at their own expense, from London to New York to try an experimental medication being offered by a Columbia physician.  Another conservative source accused the National Health Service of taking Charlie prisoner, contending that the British health service feared being shown up by American free enterprise medicine if Charlie were treated in New York.

The Setting

Charlie Gard was born on August 4, 2016, suffering from a rare genetic disease called mitochondrial DNA depletion syndrome (MDDS).  MDDS seriously affected Charlie’s brain and muscles, leaving him without ability to hear, see, cry, move his arms or legs, or breathe without a mechanical ventilator.  On October 11, 2016, Charlie was admitted to Great Ormond Street Hospital (GOSH) where he was continuously treated until just before his death in a hospice in July 2017.

In early January 2017, the GOSH clinicians had been willing to import and administer an experimental drug (nucleoside powder) touted by a N.Y. physician, Dr. Michio Hirano.  Nucleoside treatment had been used by Dr. Hirano for a different mitochondrial mutation (TK2), not MDDS.  However, before nucleoside treatment could be initiated, Charlie experienced brain seizures causing even more brain damage – leaving no signs of upper brain activity necessary for responsiveness and interaction with an environment.  GOSH’s staff then concluded that there was no meaningful chance that nucleoside treatment could help Charlie.  In February 2017, GOSH applied for a judicial order declaring that withdrawal of the ventilator would be in Charlie’s best interests (to shorten the pain and suffering that Charlie was probably experiencing) and therefore would be lawful.
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The State of Care in Mental Health Services in England 2014-2017

By John Tingle

The Care Quality Commission (CQC) is the independent regulator of health and adult social care in England. They have recently published a report of inspections on specialist mental health services. The  report is very thorough and detailed and reveals both good and bad practices. When reading the report however the poor practices identified eclipse the good ones.

Patient safety concerns

Concerns about patient safety are a constant and overarching theme in the report. The CQC biggest concern in this care area is patient safety:

“For both NHS and independent mental health services overall, and for eight of the 11 core services, safe was the key question that we most often rated as requires improvement or inadequate. At 31 May 2017, 36% of NHS core services and 34% of independent core services were rated as requires improvement for safe; a further 4% of NHS core services and 5% of independent core services were rated as inadequate for safe “(29).

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Call For Abstracts! Beyond Disadvantage: Disability, Law, and Bioethics – PFC’s 2018 Annual Conference

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1973).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

disability-law-bioethics_slideHistorically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood. Continue reading

OK, Now What? Health Care Reform Next Steps

By Carmel Shachar

The latest push to repeal at least some aspects of the Affordable Care Act (ACA) died late into Thursday, July 27, 2017 when John McCain (R-AZ) joined Lisa Murkowski (R-AK) and Susan Collins (R-ME) to vote against a much stripped down repeal bill.  This dramatic moment has been replayed over and over again by health policy wonks and on cable TV.  However, now that we have all “watched the show” a pressing question is unavoidable: What happens next?

Next Steps for Congress

The failure to pass repeal and replace (in the form of the Better Care Reconciliation Act), complete repeal (in a variation of the Obamacare Repeal Reconciliation Act), or skinny repeal (in the form of the Health Care Freedom Act), suggests that Congress may have to resort to something previously considered unthinkable: bipartisan action.  Indeed, soon after Senate Republicans failed to pass a health care bill, Senate Democratic leader Chuck Schumer (R-NY), stated that “[o]n health care, I hope we can work together to make the system better in a bipartisan way.” Continue reading

Is There a Fourth Amendment Expectation of Privacy in Prescription Records? According to the Utah District Court, Maybe Not

It might come as a surprise to many in the United States that they may have no Fourth Amendment reasonable expectation of privacy in their physicians’ records when their physicians transfer these records to state agencies under state public health laws. Yet on July 27, the federal district court for the state of Utah said exactly this for records of controlled substance prescriptions—and perhaps for medical records more generally. (United States Department of Justice, Drug Enforcement Administration v. Utah Department of Commerce, 2017 WL 3189868 (D. Utah July 27)). Patients should know that their physicians are required by law to make reports of these prescriptions to state health departments, the court said. Because patients should know about these reports, they have no expectation of privacy in them as far as the Fourth Amendment is concerned.  And, so, warrantless searches by the Drug Enforcement Administration (DEA) are constitutionally permissible at least so far as the district of Utah is concerned.  Physicians are by law required to make many kinds of reports to state agencies: abuse, various infectious diseases, possible instances of bioterrorism, tumors, abortions, birth defects—and, in most states, controlled substance prescriptions.  The Utah court’s reasoning potentially throws into question the extent to which any of these reports may receive Fourth Amendment protection.

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Introducing New Executive Co-Editor and Contributor Carmel Shachar

shachar_peopleCarmel Shachar, the Executive Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, will being joining Bill of Health as both executive co-editor and regular contributor. Carmel’s scholarship focuses on law and health policy, in particular the regulation of access to care for vulnerable individuals, health care anti-discrimination law and policy, and the use of all-payer claims databases in health care research.

Before coming to the Petrie-Flom Center, Carmel was previously a Clinical Instructor on Law at the Center for Health Law and Policy Innovation at Harvard Law School (CHLPI), where she helped lead CHLPI’s access to care and Affordable Care Act implementation work. During her time at CHLPI, Carmel focused on analyzing and translating health policy issues and opportunities for a broad range of audiences, including many federal and state-level health policy coalitions. She also coordinated and led a major multi-state initiative to document discriminatory benefit designs on the health insurance Marketplaces. Carmel previously practiced health care law at Ropes & Gray, LLP in Boston, Massachusetts. Carmel currently serves on the board of the Fishing Partnership Support Services as well as on the Institutional Animal Care and Use Committee of Boston University. Carmel graduated cum laude from Harvard Law School, where she was a student fellow at the Petrie-Flom Center, and the Harvard T. H. Chan School of Public Health.

Please join us in welcoming Carmel to Bill of Health!

Prime Health: Should Amazon Purchase a Hospital Chain?

Cross-posted from Medium.

By Nicolas Terry

The devotees of digital health and disruption recently lit up the Internet after reports that Amazon had deployed a secret health tech team codenamed 1492 (presumably a reference to healthcare visionary Columbus). The real surprise would be if Amazon did not have such a team in place. Other tech companies, Alphabet, Apple, IBM, Samsung, et al, understand that, while a latecomer to technologies, future healthcare will be data-driven and that there will be multiple opportunities to sell cloud storage, analytics services, and immodestly-priced wearables.

But, let’s pose a far more interesting question. What if Amazon decided to go beyond participating in upstart digital health with its interest in wellness, and took a swing at traditional healthcare and sickness? What, in other words, if Amazon purchased a hospital chain or network? Let’s assume that “1492” is the internal code name for Prime Health. On its face, the idea of what only a few years ago was just an online bookseller entering the healthcare field seems ridiculous. After all, healthcare is more complicated by several orders of magnitude than any other industry. Also, healthcare is particularly hard for outsiders to disrupt due to intrinsic market failures, overarching structural issues, the illiquidity of healthcare data, provider and patient heterogeneity, underperforming HIT technologies, third-party reimbursement, and so on. Saliently, healthcare is not about warehousing hard goods and distributing them with AI-based logistics. Rather, healthcare is all about bricks-and mortar facilities, services more that goods, face-to-face interactions, neighborhoods, customer needs that cannot be left to “spoil,” and a “last mile” problem that is incredibly hard to solve with technology. In other words, it’s quite like selling groceries. However, here’s the thing, Amazon recently purchased the upscale grocery chain Whole Foods for $13.4 Billion! Continue reading

Obamacare as Superstatute

By Abbe R. Gluck

I am have always been a partial skeptic about Eskridge and Ferejohn’s “superstatute” theory—their groundbreaking argument that certain statutes are special because they transform and entrench norms beyond the rights embodied in the statute itself. Some of my resistance stems from how hard it has been for scholars to identify and reach consensus on which statutes, apart from Eskridge and Ferejohn’s paradigm example of the Civil Rights Act (which beautifully fits the theory), fit the bill. (The other part of my resistance comes from dissatisfaction with the doctrinal implications of their theory.)

But since last October, Eskridge and Ferejohn have been paramount in my mind and I may need to eat some crow. It has been impossible to watch the past eight months of debate and drama over the Affordable Care Act without thinking of superstatute theory. I have nearly finished an article making that case, but given this week’s events, I could not resist putting the idea out there sooner.

The ACA seems to clearly satisfy the threshold criteria of superstatute theory. It has survived (several) election cycles, including a change in Administration. It has survived more political contestation than any statute in modern memory, including not only the 50 times Congress tried to repeal it under Obama and the four other, more serious, attempts that we just saw; but also four years’ worth of sabotage by Congress to starve to death with lack of funding. It also has survived not one, but two, high profile showdowns in the U.S. Supreme Court that had the potential to take the entire statute down (NFIB and King), and other important challenges to discrete aspects of the law (e.g., Hobby Lobby). Continue reading