Leo Beletsky on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we interviewed Leo Beletsky, Associate Professor of Law and Health Sciences at Northeastern University. Leo utilizes empirical and theoretical approaches to analyze how legal mechanisms can help curb substance abuse, prevent the spread of HIV and other infectious diseases and improve patient care. By highlighting discrepancies between black letter law and its real-world implementation, he also examines the relationship between police practices, public health outcomes and human rights of vulnerable groups.

We had plenty of opportunity to apply Leo’s expertise to the topic we focused on this week: opioid addiction. Recent studies have demonstrated a rapidly rising rate of opioid abuse, with troubling consequences for individuals and communities. This drug use has also attracted a host of legal responses, which Leo has expertly dissected in past work (including some recent studies here).

Our lightning round featured discussions of recent research on income and life expectancy, the emerging natural experiment in Kentucky on Medicaid rollback, and insurer mergers.

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

Virginia’s Proposed Lethal Injection Secrecy Law

By Elizabeth Guo

On Monday, Governor Terry McAuliffe of Virginia proposed a significant change to the Virginia legislature’s bill to replace lethal injection with electrocution in death penalty cases. Instead of allowing electrocution, the amendment would give greater authority to the Department of Corrections (DOC) for procuring and making lethal injection drugs. Under the proposed amendments, the DOC could contract with a pharmacy to compound drugs necessary to carry out lethal injection. The amendments would also keep the names of drug suppliers and compounders secret by exempting the information from the Freedom of Information Act. Also, the names would not be discoverable “in any civil proceeding unless good cause is shown.”

States with capital punishment are increasingly resorting to state secrecy laws as they are finding it harder to procure the lethal injection drugs they need. At least fourteen states have passed or tried to pass rules keeping the names of lethal injection suppliers confidential. Some states, such as Georgia, define information about the drugs and equipment used in an execution as a “confidential state secret” so that the public prisoners and even courts are prevented from viewing the information. Other states, including Oklahoma, do not designate this information as a state secret but nonetheless, make the information unavailable through litigation. A few states allow litigants to discover the information through litigation, but the state does not need to make the information publicly available.

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Pharmaceutical Transparency Bills: Targeting Disclosures Purposefully

On Monday, the Massachusetts Joint Committee on Health Care Financing held a hearing on Senate bill 1048, which would require pharmaceutical companies to report to the state a range of information on their research & development costs, marketing and advertising costs, and prices charged to a number of different purchasers.  The hearing, recapped by the Boston Globe and Gloucester Times (among others), went as expected, with industry executives opposing the bill and health insurers, consumer advocates, and others testifying in support.

Massachusetts is not the only state considering a transparency bill.  At least ten other states, including California, North Carolina, Oregon, and Virginia have all drafted bills that would advance similar goals.  These bills do differ in their details.  As just one example, each state would require disclosure from a different set of drugs and companies.  Massachusetts would only require disclosure of costs and pricing for the top twenty selling drugs in the state (where the list is based around a set of criteria including but not limited to cost), California, Oregon, and Virginia would require disclosure for any drug whose wholesale cost is $10,000 or more per year (in California, this includes over 900 drugs), and North Carolina’s bill is framed around classes of drugs, rather than prices.

It is no accident that these bills have been developed in the wake of Martin Shkreli, Valeant Pharmaceuticals, and other drug pricing scandals.  Patients and policymakers are seizing this moment to take action against the drug industry.  Forcing companies to disclose their R&D costs, advertising costs, and pricing practices is seen as a step in the right direction against these secretive companies.  In this blog post, I want to focus on just one of many interesting issues raised by these bills: what and who are they useful for, and how can we target the required disclosures to best achieve those ends?  More specifically, I’m not interested in transparency for transparency’s sake.  Disclosure rules (like nutrition labels, for instance) can and should be used to help people make better decisions than they would’ve otherwise made.

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The Zubik Supplemental Briefs: The Objectors Push for Second-Class Coverage, With a Smile

Photo: Supreme Court rally

Tim Ritz/Americans United for Separation of Church and State

By Gregory M. Lipper

The first set of supplemental briefs in Zubik v. Burwell is in. The government seems willing to accept a modified version of the Court’s proposed compromise—if it means that the Court will halt the neverending legal challenges to the contraceptive-coverage regulations. The religious objectors, however, merely purport to accept the Court’s proposal; in practice, they are standing by their insistance that affected women should be forced to seek and obtain second-class, contraception-only policies that will sever their reproductive care from the rest of their healthcare. And they reserve the right to use the political process to oppose the creation of even those second-class plans.

Recall that the Court proposed a modified version of the government’s accommodation. The Court proposed that rather than provide separate written notice in order to become exempt from the coverage regulations, objectors coud simply “inform their insurance company that they do not want their health plan to include contraceptive coverage of the type to which they object on religious grounds”; at that point, and as contemplated by the existing accommodation, the insurance companies “would separately notify petitioners’ employees that the insurance company will provide cost-free contraceptive coverage, and that such coverage is not paid for by petitioners and is not provided through petitioners’ health plan.” (If you want more detail, here’s my earlier coverage of the Court’s order.) Continue reading

What we know about how the structure of Marketplaces and Medicaid expansion affect enrollment

By Emma Sandoe

It is fairly obvious that states that expanded Medicaid saw greater enrollment in Medicaid after the opening of the Health Insurance Marketplaces in October 2013 than states that did not expand. CMS has been releasing monthly reports that indicate just that.

This also corresponds to the reductions in uninsurance. States that expanded Medicaid clearly have seen greater reductions in uninsurance than states that elected not to expand. The US Census Bureau recently posted the maps below in their blog “Research Matters.” Here is a map of the uninsurance reductions:

With the exceptions of states like Massachusetts that have already high levels of Medicaid expansion, it’s clear which states have chosen to expand Medicaid and which ones have not, but if you need the context, here is a map of states that have expanded Medicaid:

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Compulsory Arbitration Clause in Nursing Home Agreements: The NAF Saga Continues

By Alex Stein

As I reported a year ago, the National Arbitration Forum (NAF) was a designated arbitrator in thousands of nursing home agreements. When a nursing home resident complained about medical malpractice or other mistreatment, her complaint had to be arbitrated before NAF and according to NAF’s rules. If the resident or her successors were to sue the nursing home in court, the court would have to stay the proceeding and compel arbitration, as mandated by Section 2 of the Federal Arbitration Act (FAA) that deems written arbitration agreements “valid, irrevocable, and enforceable.”

Six and a half years ago, things have changed dramatically. In July 2009, the Minnesota Attorney General filed a complaint against NAF and related entities, accusing them of violations of the Minnesota Prevention of Consumer Fraud Act. The complaint alleged that NAF held itself out to the public as an independent arbitration company, while at the same time working against consumers’ interests and that it “earns revenue when it convinces companies to place mandatory predispute arbitration agreements in their customer agreements and then to appoint the Forum to arbitrate any future disputes.” Shortly thereafter, the parties entered into a consent judgment under which NAF agreed that it would not administer, process, or participate in any consumer arbitration filed on or after July 24, 2009.

Based on caselaw that followed this judgment, I estimated that the judgment effectively annulled the arbitration clause in thousands of agreements between nursing homes and residents. See, e.g., Riley v. Extendicare Health Facilities, Inc., 826 N.W.2d 398 (Wis.App. 2012); Estate of Cooper v. Evangelical Lutheran Good Samaritan Soc., 2013 WL 4526274 (N.M.App. 2013); Miller v. GGNSC Atlanta, 746 S.E.2d 680 (Ga.App. 2013); Sunbridge Retirement Care Associates v. Smith, 757 S.E.2d 157 (Ga.App. 2014).

Against this estimation, the Arkansas Supreme Court has recently ruled that the arbitration clause in nursing home agreements is enforceable conditional on the substitution of NAF by a different arbitrator. The new arbitrator, the Court held, will decide the parties’ dispute by applying the NAF procedural code for arbitration. Courtyard Gardens Health and Rehabilitation, LLC v. Arnold, — S.W.3d —- (Ark. 2016). Continue reading

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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Our return guest this week is Wendy Parmet, Matthews Distinguished University Professor of Law, Professor of Public Policy and Urban Affairs, Director of the Program on Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support at Northeastern University School of Law.  Professor Parmet is a leading voice internationally on cutting edge issues in public health.

In the opening, lightning round, Nic and Frank discussed:
1) Zubik v. Burwell, and the long line of First Amendment cases in the area.
2) The FTC’s new interactive tool for mobile apps.
3) The Part 2 proposed rule, and AMIA’s comment.
4) In the series Frontiers in the Financialization of Health Care, mortgages for expensive treatments, and crowdfunded funerals.

Our focus on Flint, Michigan this week featured Wendy’s insightful work on solidarity in bioethics, and “invisible victims” of public health failures. We also discussed the Docs v. Glocks saga, and the limits of regulation of professional speech.

And finally, attention all listeners: Northeastern will be hosting a conference on the future of public health law this Friday, and Wendy’s book “Welcoming Newcomers” will be out this Fall!

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

Malpractice, Apologies and the Statute of Limitations in Federally Qualified Health Centers

By Alex Stein

Two months ago, the Seventh Circuit has delivered another important decision with regard to medical malpractice actions filed against federally qualified health centers. Blanche v. United States, 811 F.3d 953 (7th Cir. 2016). See also Arteaga v. United States, 711 F.3d 828 (7th Cir. 2013), and Sanchez v. United States, 740 F.3d 47 (1st Cir. 2014), discussed here.

Such actions can only be filed in federal courts pursuant to the Federal Tort Claims Act (FTCA), but patients and – worse – their attorneys are often unaware of this fact. As a result, by the time they properly file a suit, the FTCA’s two-year limitations period expires and the patient’s cause of action against the United States becomes time barred. See 28 U.S.C. § 2401(b). I call this problem “FTCA’s Trap for the Unwary.” To salvage the suit, the patient can petition for equitable tolling, but her chances of being granted equitable tolling are slim (in courts that still interpret the FTCA’s limitations provision as jurisdictional, those chances do not even exist). Continue reading

Monday, 4/11, HLS Health Law Workshop with Nathan Cortez

HLS Health Law Workshop: Nathan Cortez

April 11, 2016, 5-7 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Download the Presentation: “Regulation by Database”

Nathan Cortez is Associate Dean for Research and Associate Professor in Dedman School of Law at Southern Methodist University. He teaches and writes in the areas of health law, administrative law, and FDA law.  His research focuses on emerging markets in health care and biotechnology. He has become one of the world’s leading legal scholars on medical tourism, patient mobility, and cross-border health insurance.

His research also addresses mobile health technologies, how to regulate innovations that disrupt static regulatory regimes, the First Amendment restraints on FDA regulation (including FDA’s graphic tobacco warnings), immigration federalism, and alternative modes of regulation.

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 March. The selections feature topics ranging from the characteristics and follow-up of post-marketing studies or conditionally authorized medicines in the European Union; to changes in prescription drug, over the counter drug, and dietary supplement use among older adults in the United States; to an assessment of the logic of Amarin’s off-label promotion of Vascepa. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Hey SP, Kesselheim AS. An Uninformative Truth: The Logic of Amarin’s Off-Label Promotion. PLoS Med. 2016 Mar 15;13(3):e1001978.
  2. Hoekman J, Klamer TT, Mantel-Teeuwisse AK, Leufkens HG, De Bruin ML. Characteristics and follow-up of post-marketing studies of conditionally authorised medicines in the EU. Br J Clin Pharmacol. 2016 Mar 18. [Epub ahead of print].
  3. Kapczynski A. Free Speech and Pharmaceutical Regulation-Fishy Business. JAMA Intern Med. 2016 Mar 1;176(3):295-6.
  4. Massey PR, Wang R, Prasad V, Bates SE, Fojo T. Assessing the Eventual Publication of Clinical Trial Abstracts Submitted to a Large Annual Oncology Meeting. 2016 Mar;21(3):261-8.
  5. Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC. Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011. JAMA Intern Med. 2016 Mar 21. [Epub ahead of print]
  6. Yeh JS, Sarpatwari A, Kesselheim AS. Ethical and Practical Considerations in Removing Black Box Warnings from Drug Labels. Drug Saf. 2016 Mar 21. [Epub ahead of print]

Treasury Targets Corporate Inversion, Pfizer-Allergan Deal Falls Through

By Dalia Deak

The Treasury Department published regulations on Monday that took aim at corporate inversions – and, they hit their mark. Two days later, the merger of pharmaceutical giants Pfizer and Allergan, the largest planned inversion in history of the pharmaceutical industry, fell through.

The temporary and proposed regulations put forth on Monday make it more difficult for U.S.-parented multinational groups to change their tax residence to a low-tax country. This practice, the Treasury noted, is typically not to grow the underlying business or pursue other commercial benefits that may arise, but primarily to reduce their taxes. Companies will often follow up corporate inversions with another tactic—earnings stripping. This is where the company will seek to further minimize U.S. taxes by paying deductible interest to the new foreign parent or its affiliates in the low-tax country.

Specifically, the regulations attempt to curb inversions and earnings stripping by doing the following:

  • Limiting inversions by disregarding foreign parent stock attributable to certain prior inversions or acquisitions of US companies (under section 7874);
  • Targeting transactions that increase related-party debt that does not finance new investment in the US (under section 385); and
  • Allowing the IRS on audit to divide a purported debt instrument into part debt and part stock (under section 385).

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Webcast: Dennis on Precision Medicine and Cancer Pathology

The Regulatory Science Series at University of Arizona

presents

Eslie Dennis, MD,
Vice President and Head Global Medical Affairs Ventana Medical Systems, Inc., a member of Roche Group

speaking on 

“Cancer, Pathology, and Precision Medicine:  Virchow Revisited Through Grogan’s Lens”

Available live at 3PM Eastern Apr 6 and archived at https://goo.gl/NGEBPt

Academic Immersion

Editor’s Note: The Petrie-Flom Center is now accepting applications for Student Fellowships for the 2016-2017. See our website for more information about applying! 

Last week, the New England Journal of Medicine published a Perspectives article describing the “Immersion Day” it holds for its board members. On the Immersion Day, participants don scrubs and shadow front line employees across various parts of the hospital – this might include attending ICU rounds or observing a surgery. The day gives board members the opportunity to meet and engage with staff in a meaningful way as they go about their jobs, painting a vivid picture of the issues and concerns that arise on paper in the board room. In its third year, the program is a resounding success, garnering rave reviews from the trustees. In fact, the hospital has now created an Immersion Day for state policymakers.

Having worked as a clinician before moving into policy and research, this piece resonated deeply with me. I have found my clinical experience to be essential and formative for how I view policy questions. In addition, as I approach the end of my year as a student fellow, I realized that this piece and the concept of immersion describes my experience with the Petrie-Flom Center. Continue reading

From Chance to Choice to Court

[Cross-posted from the Huffington Post Blog]

By Dov Fox

It used to be that whether you got the child you wanted — or one you hadn’t planned on — was left to cosmic fate or the randomness of reproductive biology. Now, new powers of reproductive medicine and technology promise to deliver us from the vagaries of the natural lottery.

The likes of voluntary sterilization and embryo screening give people who can afford them greater measures of control over procreation. Except, that is, when reproductive professionals make mistakes that frustrate efforts to pursue or avoid pregnancy or parenthood.

When, for example — just a few recent cases — a pharmacist fills a woman’s birth control prescription with prenatal vitamins. Or when a fertility clinic implants embryos carrying the hereditary disease that a couple underwent in vitro fertilization (IVF) to screen out. Just this week comes another report of losing IVF embryos.

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Additional Troubles for Theranos

By Katherine Kwong

The onslaught of bad news for Theranos, the start-up laboratory services company plagued with troubles since last October, continued this week with a new round of reports and press coverage. First, on March 28, the Journal of Clinical Investigation published an article that found that Theranos’ tests tended to produce more irregular results than those of two other laboratory services companies. Then, on March 31, an inspection report by the Centers for Medicare and Medicaid Services was released, revealing numerous problems at Theranos that led to quality control problems, possibly leading to inaccurate test results for patients. The article and report both raise additional questions about Theranos’ claims and long-term viability – a steep letdown from early hype about the company, which promised to revolutionize the laboratory testing industry. The story of Theranos’ troubles highlights how scientific flaws and regulatory mishaps can lead to serious problems for companies seeking to innovate in the health sciences space.

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Monday, 4/4, HLS Health Law Workshop with Nicolas Terry

HLS Health Law Workshop: Nicolas Terry

April 4, 2016 5:00 – 7:00 PM
Hauser Hall 105
Harvard Law School, 1575 Massachusetts Ave., Cambridge, MA 02138

Download the Presentation: “Regulatory Disruption and Arbitrage in Healthcare Data Protection”

Nicolas P. Terry is the Hall Render Professor of Law at the Indiana University Robert H. McKinney School of Law. He serves as Executive Director of the Hall Center for Law and Health. Professor Terry teaches Torts, Products Liability, Health Information Technology, Law & Science, and Health Care Quality.

Educated at Kingston University and the University of Cambridge, Professor Terry began his academic career as a member of the law faculty of the University of Exeter in England. He has served as a Senior Fellow at Melbourne Law School and held visiting faculty positions at the law schools of Santa Clara University, the University of Missouri-Columbia, Washington University, and the University of Iowa. From 2000-08, Professor Terry served as co-director of Saint Louis University’s Center for Health Law Studies. From 2008-10, Terry served as the School of Law’s Senior Associate Dean.

Professor Terry’s research interests lie primarily at the intersection of medicine, law, and information technology. He is a permanent blogger at the HealthLawProf Blog and at Harvard Law School’s Bill of Health.  Professor Terry is also is the co-presenter of the “The Week in Health Law” podcast.

“Hijacking, evidently, is this year’s broccoli”

By Gregory M. Lipper

Linda Greenhouse has another must-read column about the Supreme Court contraception cases, and she predicts that the religious objectors will reject the compromise proposed by the Court in Tuesday’s order requesting supplemental briefing:

Would opt-out-without-notice serve just as well? If women would still get their coverage, probably it would. Will the religious interests resist taking “yes” for an answer, as they have from the beginning of this litigation?

Probably they will, because they are after bigger game: getting the Supreme Court to interpret the Religious Freedom Restoration Act to mean anything they say it means.

Relatedly, I discussed (along with Jeffrey Rosen and Michael Moreland) both the Zubik oral argument and supplemental-briefing order, on the National Constitution Center’s We the People podcast; you can listen here.

Greg Lipper (@theglipper) is Senior Litigation Counsel at Americans United for Separation of Church and State.

‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

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This week we interviewed Christopher Robertson, a professor and associate dean at the James E. Rogers College of Law, University of Arizona, and affiliated faculty with the Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology at Harvard. Robertson also leads the Regulatory Science program, a partnership with the Arizona Health Sciences Center and the Critical Path Institute.

We mainly discussed Robertson’s new book with past TWIHL guest Aaron Kesselheim, Blinding as a Solution to Bias:  Strengthening Biomedical Science, Forensic Science, and Law. The book is a tour de force collection of approaches to improving our knowledge of optimal medical, legal, and forensic practices.

We also discussed some of Robertson’s recent contributions to insurance law and policy, including Scaling Cost-Sharing to Wages: How Employers Can Reduce Health Spending and Provide Greater Economic Security, as well as A Randomized Experiment of the Split Benefit Health Insurance Reform to Reduce High-Cost, Low-Value Consumption. The latter work, combined with Episode 47’s discussion with Mark Hall about employer-based exchanges, may well signal a gradual transition toward defined contribution (rather than defined benefit) health insurance plans.