Death Spirals…to the Rescue!

We’ve heard a lot about “death spirals” and how they could stand in the way of the Affordable Care Act’s goal of a functioning individual health insurance marketplace.  Seth Chandler has an interesting blog devoted to the subject, “ACA Death Spiral.”  And those who have been following King v. Burwell, the Supreme Court’s latest ACA case, have been predicting that a ruling against the government there would be disastrous because it would only exacerbate the “death spiral” threat to individual health insurance markets.  (See a sum-up of such predictions here.)

But could death spirals save the ACA?  According to a fascinating amicus brief filed in the King case by a number of interest groups and co-signed by several prominent law professors and Bill of Health contributors (I understand that Abigail Moncrieff is the driving force behind the brief, joined by Allison Hoffman, Sharona Hoffman, Russell Korobkin, Joan Krause, Stephen Marks,  Kevin Outterson, and Theodore Ruger), the answer might be yes.  The argument boils down to “death spirals to the rescue.”  (Here is a copy: 14-114 bsac JALSA.)

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Global Health Impact and Access to Essential Medicines

By Nicole Hassoun, The Global Health Impact Project

Ebola is ravaging parts of Africa, yet it is not the worst health problem facing people in the region. Millions more are infected with and die every year from diseases like malaria, TB, and HIV/AIDS because they cannot access the essential medicines they need. To change this, we need to understand where we are succeeding in combating these diseases, and where we need to focus our efforts. Until now, this information has been sorely lacking.

Fortunately, the beta for a new Global Health Impact index has just launched that can help us address the access to medicines problem (check out: global-health-impact.org). Using the index, you can see the impact of the drugs for HIV, malaria, and TB in each country in the world. You can also get a sense for the overall impact we are having on the different diseases in the model. Finally, one can see drugs’ impacts by originator company. Continue reading

Are Egg Donors like Miners and Boxers?

By Dov Fox

The U.S. tax court has just issued its long-awaited decision in Perez v. Commissioner, 144 T.C. No. 4 (Jan. 22, 2015). (Hat tip to Richard Carpenter, who represented Perez.) The case decided whether the $20,000 a woman called Nichelle Perez received to provide her eggs is, for IRS purposes, taxable income, or, instead, recovery for physical damages, which would make that payment tax-free. An introduction to this case is available in my earlier Bill of Health post: Can you be taxed for selling your eggs?, and at greater length in last year’s Taxing Eggs: A Mini Symposium, over at the Faculty Lounge. And the opinion cites thoughtful articles by Professors Kim Krawiec, Bridget Crawford, and Lisa Milot.)

The legal question presented was whether the payments Perez received are tax-exempt “damages” under Section 104 of the Internal Revenue Code. The court held they did not, and thus could be taxed. Judge Holmes observed that the contracts had characterized those payments as consideration for pain and suffering rather than the eggs themselves. He explained that “the injury here, as painful as it was to Perez, was exactly within the scope of the medical procedures to which she contractually consented.” Accordingly, “the payments were made not to compensate her for some unwanted invasion against her bodily integrity but to compensate her for services rendered.” Despite the pain and danger Perez incurred through the process of egg retrieval, Judge Holmes affirmed that “the money she received was not ‘damages’” because “she voluntarily signed a contract to be paid to endure” those risks. I’d be interested to learn whether readers find persuasive the Court’s provocative analogies to egg “donation”: Continue reading

Raising the King v. Burwell Stakes

By Nicolas Terry

Today, the Washington Post ran an interview with Laurence Tribe about the King v. Burwell subsidy litigation (recall that oral arguments are scheduled for March 4). Tribe speculated that Chief Justice Roberts will once again be the swing vote, as he was in Nat’l Fed. of Independent Bus. v. Sebelius. Tribe seems to predict another pragmatic Roberts opinion (and one that might bring Justice Kennedy along), finding the subsidy provisions are at worse ambiguous and that the executive is owed deference as argued by the eminently reasonable Nick Bagley.

Even though Tribe wouldn’t label Roberts as a consequentialist, he does believe that the pragmatic Roberts would be influenced by the impact on the States, the disruption of insurance markets, and the consequences for the newly insured. If the Chief wants more data on those issues he could do no better than to consult two excellent reports from the Urban Institute. The first estimates that a declaration that the subsidies are invalid “would increase the number of uninsured in 34 states by 8.2 million people… and eliminate $28.8 billion in tax credits and cost-sharing reductions in 2016 ($340 billion over 10 years) for 9.3 million people.” Perhaps as important, the Urban Institute’s model also predicts general turmoil in private, non-group insurance markets as the young and healthy would disproportionately drop coverage, causing a predicted 35% increases in premiums.

The second and most recent brief from the Urban Institute begins to put faces on those who will suffer: “Over 60 percent of those who would become uninsured are white, non-Hispanic and over 60 percent would reside in the South. More than half of adults have a high school education or less, and 80 percent are working.”

The executive shouldn’t need such help given the ACA’s clear intent as to how the federal and state exchanges were meant to function. But, if a dose of pragmatism is required to secure a majority of the Court, the stakes couldn’t be any clearer.

Should patients be able to limit doctor access to medical records?

by Vadim Shteyler 

The growing accessibility of Electronic Health Records (EHRs) across hospitals and practitioners raises new concerns about patient privacy. Before EHRs, patients had control over how much information they shared with each healthcare provider. Receiving patient information from other practitioners has required a signed consent form specifying the information patients are comfortable sharing (e.g., radiological studies, mental health history, sexual history, etc.). And hospitalists have been expected to request the minimal necessary information to provide good care. With growing networks and increasing compatibility across EHRs, more providers now have access to information without the patients’ express permission or even awareness.

Recent works published in the Journal of General Internal Medicine reported the results of a study that designed and recorded patient and provider experiences with a patient-controlled EHR (in which patients chose which providers could access which data in their medical records). A preliminary survey showed that, before the study, only 10 percent of patients had access to their medical records. Half of surveyed patients did not know what information their EHR contained. However, all patients wanted access to their EHRs. Meanwhile, another study reported that only one-third of physicians thought patients should have EHR access. Continue reading

Recommended Reading: New Empirical Analysis of False Claims Act Whistleblower Litigation

By Kate Greenwood
[Cross-posted at Health Reform Watch]

Late last year, the Columbia Law Review published David Freeman Engstrom’s Private Enforcement’s Pathways: Lessons from Qui Tam Litigation, the fourth in a series of articles Professor Engstrom has written on the growth and evolution of qui tam litigation. (My colleague Associate Dean Kathleen Boozang wrote about the first three at Jotwell, here.) Private Enforcement’s Pathways, like the articles that precede it, brings a welcome dose of data and empirical analysis to a controversial area of the law, the debate over which has at times generated more heat than light.

Professor Engstrom’s analysis rests on a database he built containing information on the roughly 6,000 unsealed FCA cases that have concluded in a litigated judgments or settlement since 1986. In response to Freedom of Information Act requests, the Department of Justice provided information on the judicial district in which each case was filed, the date that DOJ decided whether or not to join each case, and the outcome of each case (including the amount, if any, that the government recovered and the whistleblower’s share of that recovery). DOJ also provided the date of filing for the 3,000 cases filed since 1986 that remain under seal, as well as for the 6,000 unsealed cases. From PACER, Professor Engstrom retrieved information on the parties, law firms, and individual lawyers involved in each unsealed case.

Based on his analysis of the data, Professor Engstrom “largely rejects widespread claims that qui tam litigation is in the midst of an inefficient ‘explosion’ of enforcement effort, or … that qui tam enforcement activity has ‘lurched’ from one extreme to the other in response to a changing litigation environment.” Instead, he notes, “the data suggest a steady maturation of the regime.” Professor Engstrom also concludes that although “mean recoveries have roughly doubled since 2000 (and nearly quadrupled since 1990) … a substantial portion of this growth is attributable to a handful of especially large settlements of $500 million or more … most of them against pharmaceutical companies[.]” This, of course, is small comfort for pharmaceutical companies. Pharmaceutical and medical device companies complain that the size of the recoveries, combined with the threat of exclusion from participation in federal healthcare programs, mean that, in FCA cases brought against them, the whistleblower and the government hold all of the cards.

In addition to the size of False Claims Act recoveries, Professor Engstrom explains, critics contend that the FCA’s qui tam regime has led to companies being targeted for “arguable, gray-area misconduct” and for “relatively minor regulatory infractions,” the implication being that these are suits that the government would not otherwise bring. Professor Engstrom’s addresses these contentions, about the nature of the cases being brought, in the second half of his article. Because they prove more difficult to evaluate empirically, he augments his number crunching with three case studies, two of which—the Medicare drug pricing cases and the healthcare kickback and self-referral cases—involve life sciences companies as defendants. While acknowledging that his analysis “plainly falls short of a definitive showing that qui tam litigation has or has not evaded meaningful public control,” Professor Engstrom finds some evidence of a tendency among qui tam enforcers to take advantage of legislative inertia and the DOJ’s increasingly hands-off approach to “push legal mandates down interpretive pathways they would not travel with purely public enforcement.”

Professor Engstrom’s discussion of the potentially changing nature of FCA cases was particularly interesting to me, because I have followed with interest the debate over constitutional and other issues raised by the ban on off-label drug and device promotion and its enforcement via the False Claims Act. Life sciences companies contend that the ban off-label promotion is an example of a gray area that has been exploited by qui tam relators, with sub-optimal results. While the DOJ’s heavy involvement in these cases makes it hard to complain about a lack of public control, companies argue that the way that the ban has been defined through FCA litigation fails to comport with congressional intent. The industry has repeatedly asked the Food and Drug Administration to weigh in, via regulation or guidance, on the contours of the ban, perhaps in the belief that the FDA will track what they believe the intent of Congress to have been more closely than the DOJ has. The FDA has responded by issuing a number of new and newly-revised draft guidances, with further action promised.

Professor Engstrom’s article provides a very helpful frame for understanding the complex interplay between the life sciences industry and its private and public enforcers. Its value goes well beyond that, though, and I recommend it to anyone interested in the “longstanding debate about the merits and demerits of private enforcement of public law and the complex relationship between litigation and democracy.”

Worth Reading This Week

By Nicolas Terry

2014: A Great Year for Orphan Drugs

By Emily Largent

In America, an orphan disease or condition is defined by law as one that affects fewer than 200,000 people.  Six to seven-thousand different rare diseases have been identified, and new rare diseases are regularly described in the medical literature.  Many of these are conditions for which few or no drugs are available.  The Orphan Drug Act of 1983 sought to counterbalance market forces and spur orphan drug development by offering pharmaceutical companies a variety of incentives, including market exclusivity, tax credits, and research grants.  The act has resulted in many drugs for rare diseases coming to market and many more coming down the research pipeline. 

I have previously written about the ethics of allocating scarce resources, e.g., through insurance plans, to pay for orphan drugs.  Therefore, it is with great interest that I recently noted that 17 of the 41 novel new drugs that FDA approved in 2014 (i.e., 41%) were approved to treat rare diseases.  Examples include Impavido, which treats leishmaniasis, and Sylvant, which treats multicentric Castleman’s Disease, a disorder similar to lymphoma.  A complete list of the 2014 novel new orphan drugs can be found here. Continue reading

Caps, Settlements, and Chutzpah under California’s Medical Malpractice Law

By Alex Stein

A recent California Supreme Court decision, Rashidi v. Moser, — P.3d —- (Cal. 2014), must be read by anyone interested in medical malpractice and in torts generally.

This decision involved a very serious incident of medical malpractice. A patient underwent surgery to stop severe nosebleed. His doctor ran a catheter through an artery in his leg up into his nose. Tiny particles were injected through the catheter to irreversibly block certain blood vessels. The particles, however, traveled to places other than the intended sites. As a result, when the patient awoke after the surgery he was permanently blind in one eye. He sued the doctor and the hospital for medical malpractice and the particles’ manufacturer for products liability. Subsequently, the patient settled with the particles’ manufacturer for $2,000,000 and with the hospital for another $350,000. The case went to trial against the doctor alone. Continue reading

Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?

A new blog post by Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen on the Health Affairs Blog:

Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.

This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.

Read the full post here, and register for the Third Annual Health Law Year in P/Review for free here.

Neuroimaging and the Law: Pitfalls

by Zachary Shapiro

While there is considerable enthusiasm for incorporating neuroimaging technologies in the courtroom, it must be balanced with an understanding of the very real limitations of available neuroimaging data at present. I will focus on the use and study of one such technology, functional magnetic resonance imaging (fMRI), to explore some of these limitations.

Many fMRI studies have small participant groups, which means that the data may lack the statistical power needed to allow generalization of results. There are several reasons for this. Even though fMRI machines have decreased in price, they are still expensive, and since the fMRI machine is very large, it requires specialized space in order to function. Conducting a scan is also quite time consuming. For these reasons many neuroimaging experiments utilize subject groups that were not selected due to concerns related to statistical power, but rather due to practical concerns such as how much scanning time, space, and money has been allocated to the experiment.

Furthermore, the size and technology of fMRI machines necessitates running experiments in a very particular way that could affect the outcomes. Because participants are required to lie still in a small space, there is a limit to what tasks and activities they can be expected to perform. It is impossible to assess the effects that lying still in a giant scanner may have on normal behavior, meaning that fMRI machines may not accurately tell us about the human brain under normal conditions. Experimental design is especially problematic if we want to bring fMRI experiments into a criminal legal context, as it is currently impossible to design an experiment that accurately recreates the dynamic conditions of stress that are likely to occur during the undertaking of a criminal action.

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Next Friday (1/30): Third Annual Health Law Year in P/Review

P-Review_2015_poster_with_borderJanuary 30, 2015 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East AB
1585 Massachusetts Avenue, Cambridge, MA

Please join us for the Third Annual Health Law Year in P/Review symposium, with leading experts discussing major developments during 2014 and what to watch out for in 2015. The discussion at this day long event will cover hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients.

The full agenda with speakers is available on our website.

Attendance is free and open to the public, but space is limited and registration is required. Please register here. Contact petrie-flom@law.harvard.edu with questions.

Federal Newborn Screening Law Emphasizes Informed Consent

Allison M. Whelan, J.D.
Senior Fellow, Center for Bioethics and Global Health Policy, University of Minnesota 
Guest Blogger

On December 18, 2014, President Obama signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act includes new timeliness and tracking measures to ensure newborn babies with deadly yet treatable disorders are diagnosed quickly. These changes responded to a Milwaukee Journal Sentinel investigation that found thousands of hospitals delayed sending babies’ blood samples to state labs.  A primary purpose of newborn screening is to detect disorders quickly, so any delays increase the risk of illness, disability, and even death.

Although a major reason for the Act’s amendments is to address these problematic delays, another important addition to the Act establishes a parental consent requirement before residual newborn blood spots (NBS) are used in federally-funded research. The Act directs the Department of Health and Human Services (HHS) to update the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to recognize federally-funded research on NBS as “human subjects” research. It also eliminates the ability of an institutional review board to waive informed consent requirements for NBS research.

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A “Money Blind” for Research into Maternal-Fetal Medication Risk?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

A week ago, the Food and Drug Administration announced the results of a review of the medical literature it conducted in response to “recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.” The literature, FDA determined, is inconclusive. FDA found that all of the studies had “potential limitations in their designs” and that “sometimes the accumulated studies on a topic contained conflicting results that prevented us from drawing reliable conclusions.” As a result, the FDA chose not to update its current recommendations. The agency emphasized, though, that the use of pain medication should be “carefully considered” by pregnant women and their physicians.

One of the reports that triggered the FDA’s review was no doubt this study, published in JAMA in April 2014, which found an association between prenatal exposure to acetaminophen and a higher risk of developing attention deficit hyperactivity disorder. The study led to headlines like Acetaminophen Use While Pregnant Leads to ADHD, Study Says and Mom’s Tylenol Use, Dad’s Age Are Latest Suspects on ADHD Front. At the New York Times’ Motherlode, KJ Dell’Antonia wrote: “If there is a pregnant woman out there willing to take Tylenol after reading this research — or just the associated headlines — I’d be surprised.” But there are serious risks associated with other pain medications, too. Tylenol has long been considered a relatively safe option. Even white-knuckling it is not risk free. As the FDA pointed out in its announcement, untreated severe and persistent pain increases the change that a pregnant woman will develop anxiety, depression, and high blood pressure.

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Pregnancy in the Ebola Epidemic – An update

By Kelsey Berry

A few weeks ago, I posted on this blog a discussion of an ethical dilemma in the treatment of Ebola-infected pregnant women in West Africa. I wanted to follow-up with two brief updates concerning Ebola and pregnancy in West Africa.

First, Medecins Sans Frontieres has opened the first care center specializing in treatment for Ebola-infected pregnant women in Sierra Leone. The care center will have 80 beds once it is fully operational and at present has one patient under care. In my last post I called for greater investigation into the reasons underlying higher mortality rates among Ebola-infected pregnant women, claiming that the causes of disparate outcomes in various population groups may be important to determine the justifiability of outcome-driven resource allocation. The new care center is ideally positioned to investigate and perhaps parse out biological, practice based, and institutional factors contributing to the disparity. There are some remaining questions – for instance, will capacity be reserved solely for pregnant women or other infected individuals seeking care? Further, we have already seen that MSF is investing resources in caring for a population for whom survival rates are nearly zero in the current Ebola epidemic; will continued commitment to treating this population depend upon observed changes in survival rates or other outcomes; or will the mere provision of care continue to justify the center if outcomes don’t improve measurably? This is a development I will continue to follow.

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Worth Reading This Week

By Nicolas Terry

Upcoming Event (1/29): A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015, 12: 00 PM

Wasserstein Hall, Milstein West B                               Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

This event is free and open to the public. Lunch will be served.

Efthimios Parasidis is Associate Professor at The Ohio State University Moritz College of Law and holds a joint appointment with the College of Public Health. He is an inaugural member of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy. He has published in leading law reviews and health policy journals, is co-authoring a casebook, and has a book under contract with Oxford University Press. The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

The lecture will be followed by an audience question and answer session moderated by Jacob Gersen, Professor of Law at Harvard Law School and Director of the Food Law Lab.

Cosponsored by the Food Law Lab and the Harvard Food Law and Policy Clinic at Harvard Law School.

A Chief Privacy Officer’s Take on the Chanko Case

Earlier this month, Charles Ornstein explored a New York City family’s charge that their privacy was violated by a local hospital and a reality television show in ProPublica. More specifically, he details how the death of one Mr. Mark Chanko was filmed at NY Presbyterian Hospital without the family’s consent, and then nationally aired on ABC’s NY MED over a year later. Mr. Chanko’s face was blurred for viewers but he remained recognizable to family and friends who watched the show. Since the broadcast, the family has pursued legal action through several New York courts with little success thus far.

The piece has already been commented upon by several smart people, most recently Kay Lazar of the Boston Globe. Just one day after Ornstein’s piece went to press, the Dean of Harvard Medical School Jeffrey Flier (@jflier) tweeted “How could this be allowed to happen?” only to be informed by the Chair of Surgery at Boston Medical Center, Gerard Doherty, (@GerardDoherty4) that three Harvard-affiliated hospitals are in fact currently hosting camera crews for a similar series. The ensuing conversation reminded me just how limited a platform Twitter is for tricky conversations about health care law and ethics. So I did what any self-respecting millennial would do – I went home for the holidays and asked my mom to help me understand what the internet couldn’t.

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