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

By Nicolas Terry and Frank Pasquale

Listen here!

twihl 5x5

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

Rawlsian Questions about CRISPR Gene Editing

By Kelly Dhru

We worship perfection because we can’t have it; if we had it, we would reject it. Perfection is inhuman, because humanity is imperfect. – Fernando Pessoa, The Book of Disquiet.

Pessoa may have had an “I told you so!” moment looking at the ethical debates over CRISPR-Cas9, which is the technology that has made the alteration of genomes easier. As we march towards fundamentally altering the code that governs our bodies, it is this very walk towards perfection that seems to scare us.

To start with, not enough can be said about the importance of CRISPR-Cas9, which is one of the most important scientific advances of our times. Because of this technology, we are now looking at the ability to combat some previously “incurable” genetic disorders. This technology is also opening up doors to tackle malaria, Zika and dengue fever in innovative ways and to potentially find a cure for cancer. Continue reading

Sovereign Immunity Protects State-Owned Hospitals and Medical Personnel Against Malpractice Suits

By Alex Stein

Pike v. Hagaman, — S.E.2d —- 2016 WL 3097727 (Va. 2016), is a must-read for anyone interested in medical malpractice and health law. This new decision of the Virginia Supreme Court grants state-owned hospitals and their personnel categorical sovereign-immunity protection against medical malpractice suits. Continue reading

Policy Surveillance: A Vital Public Health Practice Comes of Age

In a new article published today in the Journal of Health Politics, Policy and Law, Scott Burris, Laura Hitchcock, Jennifer Ibrahim, Matthew Penn and Tara Ramanathan make the case for the practice of policy surveillance to improve public health.

Though widely used, legal “treatments” for public health promotion and protection are too often applied to large populations without timely evaluation or even systematic monitoring. When we implement programmatic interventions in health, we demand evaluation. We should demand no less for legal interventions.

Policy surveillance can help end the inconsistent treatment law receives in public health research and practice. Policy surveillance is the systematic, scientific collection and coding of important laws of public health significance. Continue reading

Still Seeking Contraceptive Compromise After Zubik v. Burwell

[Crossposted from RegBlog]

By Allison Hoffman

Zubik v. Burwell was this year’s Affordable Care Act (ACA) appearance on the Supreme Court stage. Consolidated with six other cases, Zubik challenged the ACA requirement that group health plans and health insurance issuers must provide free coverage of preventative services, including all contraceptive methods approved by the U.S. Food and Drug Administration (FDA).

Some religious groups believe that the use of some or all contraceptives is morally wrong. In response, the initial preventive services regulation exempted houses of worship, such as churches, from the requirement altogether. For religious nonprofit organizations, such as universities and hospitals, later regulations created an accommodation that enabled employees to receive coverage for contraceptives without the employer having to provide it.

Even though the U.S. Department of Health and Human Services (HHS) has tried to make it easy for nonprofit organizations to receive the accommodation, it still requires those organizations, unlike churches and other houses of worship, to ask for it affirmatively through a process of self-certification. Continue reading

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

By Nicolas Terry and Frank Pasquale

Listen here!

twihl 5x5

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!

twihl 5x5

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

Please, Boston Nonprofit Hospitals, Can’t You Join Forces Instead Of Competing?

[Crosspost that originally appeared on WBUR’s CommonHealth]

By Michael Anne Kyle and Lauren Taylor

Here in Boston, cooperation between health care providers is a fraught issue.

Competition is fierce among local, not-for-profit teaching hospitals, and the idea of collaboration brings to mind collusion, mergers and monopolies.

Unfortunately, these concerns may be keeping Boston hospitals from pursuing cost-effective strategies to meet federal tax-exemption requirements and improve community health. Over the next year, each of Boston’s 12 hospitals will have to conduct a community health needs assessment (CHNA) to retain their tax-free status. New requirements in the Affordable Care Act specifically encourage collaboration between hospitals and with other health care agencies, such as public health departments.

We argue that doing one, citywide CHNA presents a rare opportunity for high-value, low-commitment coordination among Boston hospitals. Continue reading

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

By Ameet Sarpatwari 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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of July. The selections feature topics ranging from the reporting of clinical trial subgroup effects in top medical journals, to an assessment of generic drug approvals since the 1984 Hatch-Waxman Act, to the impact of proposed Medicare Part D reforms on cancer drugs. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Gabler NB, Duan N, Raneses E, Suttner L, Ciarametaro M, Cooney E, Dubois RW, Halpern SD, Kravitz RL. No improvement in the reporting of clinical trial subgroup effects in high-impact general medical journals. Trials. 2016;17(1):320.
  2. Gagne JJ, Han X, Hennessy S, Leonard CE, Chrischilles EA, Carnahan RM, Wang SV, Fuller C, Iyer A, Katcoff H, Woodworth TS, Archdeacon P, Meyer TE, Schneeweiss S, Toh S. Successful comparison of US Food and Drug Administration Sentinel analysis tools to traditional approaches in quantifying a known drug-adverse event association. Clin Pharmacol Ther. 2016 Jul 14. [Epub ahead of print].
  3. Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016 Jul 18. [Epub ahead of print].
  4. Haffner ME. The history of orphan drug regulation – US and Beyond. Clin Pharmacol Ther. 2016 Jul 9. [Epub ahead of print].
  5. Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of postmarketing studies of conditionally authorized medicines in the EU. Br J Clin Pharmacol. 2016;82(1):213-26.
  6. Luo J, Kesselheim AS. Protecting Pharmaceutical Patents and Test Data: How the Trans-Pacific Partnership Agreement Could Affect Access to Medicines in the US and Abroad. AMA J Ethics. 2016;18(7):727-35.
  7. Mailankody S, Prasad V. Implications of Proposed Medicare Reforms to Counteract High Cancer Drug Prices. JAMA. 2016;316(3):271-2.
  8. van Staa TP, Goldacre B, Buchan I, Smeeth L. Big health data: the need to earn public trust. BMJ. 2016 Jul 14;354:i3636.

Child safeguarding: the National Health Service (NHS) can do much better

By John Tingle

Our children are our future and we need to look after them well. There is however a lot of evidence to suggest that we are failing our children in a number of key health areas. UNICEF in a report put the UK in 16th position – below Slovenia, the Czech Republic and Portugal – in a league table of child well-being in the world’s richest countries. The report considers five dimensions of children’s lives – material well-being, health and safety, education, behaviours and risks, and housing and environment – as well as children’s subjective well-being.

There are a number of health and other child well-being challenges for the UK to meet. The UNICEF report provides some useful context from which to view the recently published Care Quality Commission (CQC) report on the arrangements for child safeguarding and healthcare for looked after children in England.The CQC is the independent regulator of health and social care in England.Whilst the report does contain some positive findings, when read as a whole, these seem subsumed by the large number of negative findings, some of which are very worrying. Continue reading

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

By Nicolas Terry and Frank Pasquale

Listen here!

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

CALL FOR ABSTRACTS! 2017 Annual Conference, “Transparency in Health & Health Care: Legal & Ethical Possibilities & Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

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

Introducing a new global antibiotic R&D partnership

Yesterday US HHS announced a new global partnership to fund pre-clinical antibiotic R&D, coordinated by the Boston University School of Law. The partnership is known as CARB-X, which is the abbreviation for the Combating Antibiotic-Resistant Bacteria (CARB) Biopharmaceutical Accelerator.  CARB-X is the culmination of one key part of the US National Action Plan on antibiotic resistance.  Background paper in Nature Reviews Drug Discovery.

Under the grant, BU Law will coordinate more than $350 million in new funds for R&D over the next five years, in partnership with BARDA, NIAID, the Wellcome Trust, the AMR Centre, MassBio, the California Life Sciences Institute and the Broad Institute at Harvard and MIT.  Kevin Outterson is the PI and Executive Director of CARB-X.

While the bulk of the project funds pre-clinical R&D, we are also interested in the role of law, IP and other innovation incentives, using the unique dataset that CARB-X will generate.

Is Gaming the Transplant List an Ethical Dilemma?

NPR recently published a thought-provoking piece discussing an ethical dilemma doctors face when treating patients in need of organ transplants. Transplant list priority is designed to depend upon the relative sickness of patients, allocating organs to those who need them most. However, instead of lab results or other direct measures, the list uses the treatment a patient is receiving as a proxy for her condition. As a result, doctors have the ability to move their patients up the list by prescribing — or over-prescribing — more extreme and invasive treatments.

It’s understandable why this temptation exists — doctors go into medicine to heal, and I imagine it’s difficult to refrain from taking an action which could very well save a patient’s life. But should this be an ethical dilemma?

Bumping a patient up the transplant list could certainly save a life, but that life could come at the expense of another’s. The problem is that organ transplants are inherently zero-sum — if one patient goes up on the list, another must come down. If one person gets an organ, that means another doesn’t. Furthermore, over-treating to influence transplant priority has consequences that reach beyond any individual patient, potentially furthering inequality in the transplant system and contributing to unsustainable health care spending. Continue reading

Fighting the Next Pandemic: Airline Vaccine Screens

Whether it is Ebola, H1N1, the season flu, or the next nasty bug that we cannot yet even imagine, if we wanted to efficiently spread the disease, one could not do much better than packing several Flight routeshundred people into a cylinder for a few hours, while they eat, drink, defecate, and urinate.  Even more, to make sure that the disease cannot be contained in a particular locality, we could build thousands of those cylinders and move them rapidly from one place to another worldwide, remix the people, and put them back in the cylinders for return trips back to their homes, schools, and jobs.

We are (hopefully) not going to stop airline travel.  But we can make it a lot safer, by ensuring that almost everyone who boards these flights is vaccinated.  That’s the thesis of a new paper out this week.

Airlines carry two million people every day.  And, prior research has shown that airline travel is a vector of disease.  In fact, when the September 11 attacks caused airline travel to fall, seasonal flu diagnoses fell too.

The threat of pandemics is quite real, and more generally, the mortality and morbidity associated with infectious disease is a severe public health burden.  About 42,000 adults and 300 children die every year from vaccine-preventable disease.  New vaccines are on the horizon.

Arguably, airlines have market-based and liability-based reasons to begin screening passengers, whether for vaccinations generally or for particular ones during an outbreak.  Although the states have traditionally exercised the plenary power to mandate vaccinations, and have primarily focused on children in schools, the U.S. federal government also has substantial untapped power to regulate in this domain as well.

Learning from mistakes in the NHS: a special report by the Parliamentary and Health Service Ombudsman (PHSO) into how the NHS failed to investigate properly the death of a three-year-old child.

By John Tingle

In the UK where health is concerned money is a particularly poor compensator for the loss of a limb, faculty or even a family member. In my experience patients who have suffered adverse health incidents, negligence, more often than not, are not primarily motivated by obtaining monetary compensation. They seek in the main an explanation of what occurred and why, an apology and an assurance that what happened will not happen to anybody else; that lessons have been learned.

The NHS (National Health Service) for decades has been unable to provide a satisfactory complaints and patient adverse incident investigation service which provides these outcomes generally. More often than not patients have to resort to complaining or beginning litigation in order to find out what happened and why and the process that they have to embark on can alienate them even more as they soon hit major and seemingly unsurmountable obstacles. The NHS maintains a defensive and blame ridden culture when errors happen as the terrible events of Mid Staffordshire revealed.

The report Continue reading

DUE AUGUST 5: Call for Apps – Petrie-Flom Center Harvard Grad Student Fellowship

THE PETRIE-FLOM CENTER

STUDENT FELLOWSHIP PROGRAM, 2016-2017

CALL FOR APPLICATIONS 

The 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.

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 at Harvard to wait until after their first year to apply.

Requirements. All student fellows will have the following responsibilities: Continue reading