Call for Proposals: Innovations in Life Sciences and Stakeholder and Agency Responses

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions on innovations in life sciences and stakeholder and agency responses for presentation at our Tenth Annual Health Law Symposium. The Symposium will take place at Loyola University Chicago School of Law on Friday, October 28, 2016 at 9:30am.

The Symposium will explore recent innovations in life sciences and responses by regulatory agencies including FDA, FTC, and DOJ as well as stakeholder responses and recommended next steps for policy and regulatory reforms.

A range of topics will be considered, including but not limited to gene editing, mobile health,
cybersecurity, personalized/precision medicine, 3-D printing technologies, Cancer Moonshot 2020, biosimilars and interchangeable biologics, and vaccine development and incentives (e.g., Zika).

Submission Information: Those interested in participating, please send a 1000-word abstract to  health-law at luc.edu by May 31, 2016. Authors will be notified of decisions no later than June 15, 2016. If your abstract is selected, a full paper will be due by January 6, 2017.

Covered expenses: Hotel, travel, ground transportation, three provided meals.

Questions: E-mail questions to health-law@luc.edu Continue reading

James Hodge on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week’s guest was James G. Hodge, Jr., JD, LLM, Professor of Public Health Law and Ethics and Director of the Public Health Law and Policy Program at the Sandra Day O’Connor College of Law, Arizona State University. Through scholarship, teaching, and applied projects, Professor Hodge delves into multiple areas of health law, public health law, global health law, ethics, and human rights.

Our lightning round this week focused on drug prices. Nic analyzed a California referendum proposal and the general potential of state drug price cap laws. Frank noted that New York’s Medicaid program and private insurers now must take a much more humane approach with respect to state-of-the-art treatment for Hepatitis C.

Our conversation with James focused on his recent work addressing the Zika virus. We covered topics ranging from the genetic modification of mosquitoes to the Puerto Rico financial crisis, and legal interventions ranging from budget requests to quarantines to price controls for condoms and mosquito repellent.

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 RadioTunein 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

NPRM Symposium: Your Privacy or Your Life – Human Research Subjects and the Great Healthdata Giveaway

Part One of Seven-Part Blog Series by Guest Blogger Patrick Taylor

The recent Apple-FBI controversy has highlighted the fact that our government, obligated to protect our privacy in some contexts, actively undermines it in others. The same internal conflict of interest is responsible, at least in part, for the U.S. government’s recent proposal to revise longstanding regulations to protect people who participate in research.

The proposals emerged last September, 2015, and were hailed as the first major reworking of the regulations in several decades, four years after an Advance Notice of Proposed Rulemaking buried somewhat different approaches to the same desired adverse privacy effects in a tome of hundreds of pages. It’s a safe bet that few if any members of the public not professionally involved ever read them. The feds gave themselves four years to consider and devise the current proposal, but they gave the public about four months to consider it and with no evident structured interaction with public opinion. Continue reading

State Drug Price Cap Laws: How Do They Work?

Two weeks ago, I blogged here about various state bills designed to encourage transparency in the pharmaceutical industry, by requiring companies to disclose information about their research & development costs, marketing expenses, and prices charged to different purchasers. In that post, I glossed over the state initiatives to cap drug prices directly, but as these initiatives have been more recently in the news, I want to focus on them here and ask a basic question: can someone explain to me how they would work?

Let’s back up. Two states, California and Ohio, are considering ballot initiatives that propose to cap what drug manufacturers can charge to public payers in the state (such as Medicaid).  The texts of the initiatives are nearly identical, with a few state-specific differences in the enumeration of entities eligible to pay the capped price.  As clearly stated in a comprehensive POLITICO article earlier this week by Nancy Cook and Sarah Karlin-Smith, the initiatives “would require the state to pay no more for prescription drugs than the U.S. Department of Veterans Affairs — one of the few federal agencies allowed to negotiate drug prices.”

We can and should debate whether price caps like these are a good idea, as a policy matter, and the Cook & Karlin-Smith piece canvasses a number of the arguments on both sides.  But first, we should be clear that the laws we’re enacting can actually accomplish their intended purpose.  And if they can’t, we should acknowledge that publicly.  I see at least two primary obstacles to the implementation of these price cap initiatives, and since they’ve largely been absent from the public discussion, it’s useful to state them explicitly.

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Implied Certification and the Problem of Interpretation Under the False Claims Act

by Joan H. Krause

[Cross-posted from Hamilton and Griffin On Rights]

In a recent post, I explained the contours of the False Claims Act (FCA) implied certification theory of falsity, the subject of the recent Supreme Court argument in Universal Health Services v. United States(UHS). In this post, I will address an issue largely overlooked by most commentators: the potential for differing interpretations of what is required by the underlying Medicare and Medicaid provisions that form the basis for the certification.

Recent years have seen an expansion of FCA cases from “factually false” misrepresentations to those involving “legally false” claims, where items or services were provided but the claimant also violated an underlying legal requirement. For example, UHS involves an allegation that the defendant clinic violated the FCA because, by submitting a claim for payment under MassHealth, it implicitly certified that it was in compliance with all relevant Massachusetts regulations – including the staffing and supervision requirements it later was found to have violated.

Courts have taken two broad approaches to defining the universe of regulatory provisions with which certification will be implied. Some courts, notably the Second Circuit in Mikes v. Straus, 274 F.3d 687 (2d Cir. 2001), limit the theory to violations of statutes or regulations clearly identified as conditions of payment. Other courts, such as the First Circuit in UHS, instead ask whether the claimant “knowingly represented compliance with a material precondition of payment,” which need not be “expressly designated.” The tests may sound similar, but differ both theoretically and functionally. First, defining implied certification by reference to “materiality” is curious in light of the fact that, since 2009, materiality has been an express – and distinct – element of the FCA false records provision in 31 US.C. § 3729(a)(1)(B). Yet implied certification cases such as UHS usually arise under the false claims provision in § 3729(a)(1)(A), which Congress did not amend to require materiality.

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Looking Towards 2030 in Patient Safety

There is a clear need for those charged with patient safety policy making to prepare for the future and to take account of emerging trends. This would be so in any commercial or professional organisation. These issues were addressed in the context of patient safety at the recent,Patient Safety Global Action Summit held in March 2016 in London. The conference was designed to mirror the discussions contained in the report  by NIHR (National Institute for Health Research), Patient Safety Translational Research Centre at Imperial College London and The Imperial College NHS Trust on the priorities and direction that the patient safety movement should follow going towards 2030.

There is a lot that is excellent in this report  which is very rich in analysis and detail. Lots of deep thinking about patient safety issues with interesting and novel ideas expressed on nearly every page.

Emerging threats to patient safety

In the report, in chapter one, it is acknowledged that there are many existing issues at the root of patient harm that have yet to be solved. Also that unfortunately trends in healthcare are likely to increase the risks to safety. The report focuses on four emerging trends: Continue reading

Amicus brief in Amicus v. Sequenom: Why the U.S. Supreme Court should grant the petition for a writ of certiorari

I am happy to announce that on April 20th the New York attorney Robert M. Schwartz and I have filed an amicus brief at the US Supreme Court with Berkeley-based Andrew J. Dhuey as Counsel of Record. The brief, which was signed by 10 prominent  European and Australian Law Professors as amici curiae, adds a European perspective to the many amicus briefs that have been submitted in support of Sequenom’s petition for certiorari to the United States Supreme Court. Sequenom’s petition in Case No. 15-1182 was filed on March 21, 2016 and seeks review of the Federal Circuit’s controversial decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, reh’g denied, 809 F.3d 1282 (Fed. Cir. 2015). The case concerns the revocation of Sequenom’s patent claims directed to inventive methods of genetic testing by detecting and amplifying paternally inherited fetal cell-free DNA (cffDNA) from maternal blood and plasma. Before the development of this highly beneficial, non-invasive prenatal diagnostic test, patients were placed at higher risk and maternal plasma was routinely discarded as waste. Distinguishing this case from previous Supreme Court decisions and highlighting the mitigating effects of other patentability requirements, we fear that the Federal Circuit’s overly rigid approach to claims eligibility decision might jeopardize the development of new therapies in an increasingly important area of modern medicine.

As most Bill of Health readers know, the US Supreme Court has in a recent series of cases (i.e. the combined effect of Bilski, Prometheus, Myriad and Alice) barred the patent eligibility for many genetic inventions as “products and processes of nature”. In Sequenom the CAFC interpreted these to mean – in essence- that “laws of nature” had to be entirely eliminated from the test of patent eligibility under §101 of the Patent laws. Should this interpretation be institutionalized it will contravene the tests for exclusions and exceptions under the EPC, arguably contradict longstanding US treaty policy and disrupt international patent harmonization. More importantly, we fear that the broader impact of such an restrictive interpretation may have grave consequences for a sustainable global drug delivery system, which should involve both public and private actors.

Although we believe that patents will remain the backbone of the industry, we acknowledge in our brief that  there are certain areas of biomedical innovations, such as antibiotics and orphan drugs, where the patent system does not work particularly well. We further recognize that both in Europe and in the US concerns have been raised about overly pre-emptive patents scope, but these are addressed at different levels. In contrast to Europe, the CAFC has interpreted the uncodified exception as part of a “threshold test” for patent-eligibility applied before other patentability requirements can be assessed. A strict and coherent application of these requirements, however, would invalidate overly-broad patent claims, while also permitting, well-defined, narrower claims on diagnostic technology. In our view, the current approach conflates the patent eligibility test with issues that can be more sensibly addressed within a strict and coherent assessment of novelty, non-obviousness and sufficient disclosure criteria or at the post-grant level. We believe that, the Federal Circuit’s threshold test has not sufficiently considered the manner in which today’s statutory requirements have developed in both the U.S. and Europe to address policy rationales for patentability exceptions. To entirely transplant those issues into the patent eligibility assessment would categorically close the patentability door on many well-defined and beneficial inventions that deserve patent protection. In absence of sufficient public involvement and appropriate alternative incentives we risk that the wells driving technological progress run dry and that companies engage in business strategies, such as increased reliance on trade secrecy, that are not necessarily beneficial for our innovation system.

Accordingly, we urge the Supreme Court to clarify a patent eligibility test in line with its longstanding jurisprudence and in harmony with international and European law.

If the CAFC’s restrictive interpretation should prevail, however, I believe that it will be crucial to swiftly optimize the framework for PPPs, alternative innovation incentives and regulatory exclusivities on an international level to allow for greater flexibilities and encompass further technological areas, such as biomedical diagnostics. Article 39 of the TRIPS agreement should provide sufficient leeway for such changes, but the pros and cons of such alternative approaches would have to be carefully considered.

The Amici curiae have no stake in the parties or in the outcome of the case. A full list of the Amici is appended at the end of the brief.

 

Heather Howard on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we talked with Heather H. Howard, Lecturer in Public Affairs at Princeton University and Director of the State Health Reform Assistance Network. She served as New Jersey’s Commissioner of Health and Senior Services from 2008-2010, overseeing a cabinet-level agency with a budget of $3.5 billion and staff of 1,700 responsible for public health services, regulation of health care institutions, senior services, and health care policy and research.

Our lightning round “closed the loop” on some prior stories. Nic noted a big fine against a hospital which may end ER reality shows (or at least raise the price of their insurance policies), and a smaller action from OCR with a simple message: covered entities need to complete their BAAs! Prior show guest Nicholas Bagley offered an administrative end run around Gobeille. We also discussed the kaleidoscopic complexity of modern insurance markets.

Our conversation with Heather touched on her pastpresent, and future work on ACA 1332 waivers. If you care about innovation in state health policy, this podcast is for you.

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 RadioTunein 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

CPC+: Opportunities and Challenges for Primary Care Transformation

In recent days there has been a lot of action around CMS’ Comprehensive Primary Care Initiative (CPCI). First, the next phase of the program was announced, expanding the program in size and scope. Several days later, an evaluation of the first two years of the initiative was published in the New England Journal of Medicine.

The original CPCI demonstration began in October 2012 and included 502 practices in seven regions (states or smaller areas within states). The regions were determined largely by payer interest, as commercial and state health insurance plans are essential partners in this multi-payer model. The CPCI involves risk-stratified care management fees for participating practices and the possibility of sharing in net savings to Medicare (if any). In turn, the practices must invest in practice redesign around: access and continuity, chronic disease management, risk-stratified care management, patient and caregiver engagement, and care coordination across a patient’s providers, e.g., managing care transitions and ensuring close communication and collaboration.

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REGISTER NOW! 2016 Annual Conference: Big Data, Health Law, and Bioethics

Close-up of fiber optic cables

2016 Annual Conference:
Big Data, Health Law, and Bioethics
May 6, 2016
Wasserstein Hall, Milstein East ABC
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data).

Defined as such, health care has become one of the key emerging use cases for big data. For example, Fitbit and Apple’s ResearchKit can provide researchers access to vast stores of biometric data on users from which to test hypotheses on nutrition, fitness, disease progression, treatment success, and the like. The Centers for Medicare & Medicaid Services (CMS) have vast stores of billing data that can be mined to promote high value care and prevent fraud; the same is true of private health insurers.  And hospitals have attempted to reduce re-admission rates by targeting patients that predictive algorithms indicate are at highest risk based on analysis of available data collected from existing patient records. Continue reading

Implied Certification and the Quest for Fraud that “Counts” Under the False Claims Act

By Joan H. Krause

[Cross-posted from Hamilton and Griffin on Rights]

Sometimes, we lie when we speak; other times, we lie when we don’t. Striking the right balance is the essence of the Universal Health Services (UHS) case recently argued before the Supreme Court, which challenged the applicability of the False Claims Act (FCA) to situations in which a claimant falsely “implies” compliance with underlying regulatory requirements.

UHS was brought by the parents of a young woman who died after receiving Medicaid-covered (MassHealth) mental health treatment from a clinic that did not satisfy state licensing and supervision regulations. The parents alleged that the claims for payment were fraudulent because they implicitly represented that the clinic was in full compliance with relevant state requirements. The district court dismissed the suit, finding that the staffing and supervision regulations were not “conditions of payment” whose violation would render subsequent claims false under the FCA. The First Circuit reversed, focusing instead on whether UHS had “knowingly represented compliance with a material precondition of payment.” Noting that preconditions need not be “expressly designated,” the court identified a set of regulations that, read together, appeared to limit MassHealth payment to properly supervised care. While such a fact-intensive dispute might at first appear an unlikely candidate for certiorari, UHS was one of several such “implied certification” opinions issued by the federal appellate courts in 2015. Perhaps because of its emotionally compelling facts – the other cases involved, inter alia, the recruitment practices of a for-profit college and a military contractor that falsified marksmanship scores – UHS was chosen as the vehicle to resolve a growing circuit split. Continue reading

Variability of US State Workplace Wellness Program Laws

A team of researchers led by Jennifer Pomeranz, JD, MPH, Clinical Assistant Professor of the College of Global Public Health at New York University, have released a new set of resources that detail characteristics of laws related to workplace wellness programs and identify trends in these laws across the United States: interactive maps for public and private employers at LawAtlas.org and a paper published in the American Journal of Public Health.

Workplace Wellness Program Laws in US

A few key findings:

  • Thirty-three states and the District of Columbia have laws related to workplace wellness programs.
  • Four states (Georgia, Indiana, Maine and Massachusetts) provide tax incentives for work place wellness programs.
  • State laws addressed public and private employers differently, for example, five states permit rewards (e.g., discounts, rebates and waivers) by public employers, whereas 16 states expressly permit positive rewards for participation in programs by private employers.

The research was funded by the Robert Wood Johnson Foundation’s Public Health Law Research Program.

Fraudulent Concealment by Nonfeasance as an Exception to the Statute of Repose

By Alex Stein

As a general rule, malpractice suits against physicians and hospitals must be filed within the repose period that starts running on the day of the alleged malpractice. Expiration of that period kills the plaintiff’s suit regardless of whether she was able to file it on time. Unlike statutes of limitations, this absolute time-bar does not depend on the accrual of the plaintiff’s cause of action nor is it subject to the discovery rule and equitable tolling. Typically, states recognize only one exception to the statute of repose: fraudulent concealment. Under that exception, when a negligent doctor or hospital intentionally gives the aggrieved patient (or her successor) false or misleading information about the treatment, the patient (or her successor) becomes entitled to toll the repose period until she becomes aware of the true facts. Many courts have ruled that this exception was only available to plaintiffs who could establish affirmative misrepresentation on the part of the doctor or the hospital. According to these decisions, fraud capable of tolling the repose period could only be committed by misfeasance, that is, by active conduct rather than by failure to disclose the relevant facts. More recent court decisions, however, obliterate the omission-commission distinction in the context of fraudulent concealment by doctors and hospitals: see, e.g., DeLuna v. Burciaga, 857 N.E.2d 229, 245-46 (Ill. 2006).

A recent decision of Michigan’s Court of Appeals, In re Estate of Doyle, 2016 WL 857204 (Mich.App.2016), continues this trend. Continue reading

LGBT Backlash Legislation and the Politics of Biology

By Maayan Sudai

Of the many responses to the monumental victory of the gay marriage movement in Obergefell v. Hodges in 2015, one was a backlash of legislative proposals submitted by conservative groups. A popular target was the regulation of sex-segregated public spaces like bathrooms, schools, etc. – also called “bathroom bills” – in TexasFloridaKentucky, and other states. The anti-LGBT bills are meant to either block the extension of anti-discrimination protections that could accommodate free use of sex-segregated public spaces, or strictly ban Transgender people from entering public bathrooms that fit their self-identified gender.

In South Dakota, failed bill HB1008 would have made it illegal for schools to provide accommodations for Transgender students and would have required every public bathroom, shower, or locker room be “designated for and used only by students of the same biological sex.” The bill did not pass, as Governor Dennis Daugaard vetoed it last March, affirming the authority of local municipalities to determine their own standards. Nevertheless, a few weeks later a similar bill was passed in North Carolina. The new law, also known as HB2 or the “Charlotte Bill” (more formally: “Public Facilities Privacy and Security Act”) came as a response to a local non-discrimination ordinance issued by the Charlotte City Council which provided protections and accommodation to the LGBT community in public bathrooms. HB2 affectively repealed the Charlotte ordinance, and restricted the ability of other cities in the state to expand equality measures beyond the standard determined by HB2.[1] Rich Schragger said that HB2 is “thus an anti-LGBT law masked as an anti-discrimination provision.”

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What do doctors know about FDA drug approval standards and the breakthrough therapy designation? Less than we’d hope.

By Dalia Deak

A study published this week in JAMA examined how much physicians know about FDA approval standards for new drugs and the breakthrough therapy designation. The investigators found major gaps in understanding with regard to both issues, despite intuitive beliefs to the contrary.

For the study, Kesselheim et al. conducted a national survey of board-certified internists and specialists. They selected a random sample of 300 clinically active internists and 900 specialists in endocrinology, hematology, and infectious diseases from the American Board of Internal Medicine’s diplomate list. Of the 1,148 physicians contacted, 692 physicians, or 60%, responded.

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Proposed CMS Sanctions Threaten Theranos’ Future

By Katherine Kwong

The news for blood testing company Theranos has gotten even worse since this blog’s last discussion of the company’s woes. Despite the company’s statements at the end of March that it would correct all of the issues CMS had found, new reports have emerged that Theranos’ California lab may see its federal license revoked. Additionally, Theranos’ founder, Elizabeth Holmes, and Theranos’ president, Sunny Balwani, may be banned from owning or operating any testing laboratories for two years. These potential sanctions have been proposed after regulators concluded Theranos has failed to adequately address concerns raised about its tests by the Centers for Medicare and Medicaid Services (CMS).

How did Theranos get to this point? Continue reading

Monday, 4/18, HLS Health Law Workshop with Robert Cook-Deegan

April 18, 2016, 5-7 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

The materials for the presentation, “Mining the Genomic Data Mountain: Legal and Policy Challenges,” can be downloaded here.

Robert Cook-Deegan is a research professor in the Sanford School of Public Policy at Duke University, with secondary appointments in Internal Medicine (School of Medicine), and Biology (Trinity College of Arts & Sciences). He was the founding director for Genome Ethics, Law & Policy in Duke’s Institute for Genome Sciences & Policy from July 2002 through December 2012.  He is the author of The Gene Wars: Science, Politics, and the Human Genome and an author on over 250 articles.

Dr. Cook-Deegan’s areas of expertise include genomics and intellectual property, history of genomics, global health, science and health policy, and health research policy. His current research focuses on policy implications of genomics, bioethics, intellectual property, and innovation.