Month: April 2016

Leo Beletsky on ‘The Week in Health Law’ Podcast

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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 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

Virginia’s Proposed Lethal Injection Secrecy Law

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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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Reproduction Gone Awry

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The Daily Journal published an op-ed article by Blogger and University of San Diego (USD) School of Law Associate Professor of Law Dov Fox titled, “Reproduction Gone Awry.”

In his article, Fox points to last month’s lawsuit against a Beverly Hills fertility clinic — the same one sued by Sofia Vergara’s ex in a dispute over control of frozen embryos — arguing it would be a mistake to write it off as another aberration. The clinic is accused of having negligently destroyed the only seven frozen embryos that a Sherman Oaks woman created using her donor-fertilized eggs.

The article argues that high-tech procreation goes largely unregulated makes these mistakes more common than you might think. A comprehensive study by Johns Hopkins University of U.S. fertility clinics found that more than one in five report errors in diagnosing, labeling and handling genetic samples or embryos. See “Genetic testing of embryos: practices and perspectives of US in vitro fertilization clinics” (2008).

Mistakes like these can also frustrate efforts to avoid parenthood or to have children who are born healthy. Fox refers to one recent case in which a pharmacist filled birth control prescriptions with prenatal vitamins.

Fox goes on to state that the victims of such transgressions have little recourse under the law and they almost always lose in court. Contract claims can’t vindicate patient interests where providers, despite their negligence, haven’t broken any specific promises. Like all doctors, reproductive specialists are careful to avoid guaranteeing particular results of their care. And they usually insist that patients waive liability for even implied breaches of contract.

Moreover, Fox also argues that ordinary medical malpractice won’t work either because patients in the reproductive context don’t sustain bodily intrusion or impairment beyond the treatment they agreed to. Nor can recovery for economic setbacks or emotional distress capture the deepest injury at stake. Indeed, it is one our law doesn’t recognize: namely, having been robbed of the ability to determine the conditions under which to become pregnant or have children.

Read the full article online. 

Pharmaceutical Transparency Bills: Targeting Disclosures Purposefully

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By Rachel Sachs

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

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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.) Read More

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

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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

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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). Read More

‘The Week in Health Law’ Podcast

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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 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

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

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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). Read More