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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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.

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.

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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Two new publications on “European patent strategies under the UPCA” and on “Synthetic Biology & Intellectual Property Rights”

I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2)  “Synthetic Biology & Intellectual Property Rights”:

1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published  in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.

Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.

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Concussion laws lead to increase in health care utilization

By Christine Baugh

Between 2009 and 2014 all U.S. States and the District of Columbia implemented concussion legislation. Generally modeled after Washington State’s Zachery Lystedt Law, most of these statutes require that youth and adolescent athletes are provided with information about concussions prior to sports participation, that they are removed from play if they are suspected of having sustained a concussion, and that they receive clearance from a medical professional prior to returning to sports participation. One of the main purposes of the Zachery Lystedt Law, and presumably those laws modeled after it, is to prevent the catastrophic neurological injury that can occur when a youth athlete returns to play too quickly following a concussion.

Gibson and colleagues recently published their study “Analyzing the effect of state legislation on health care utilization for children with concussion,” in JAMA Pediatrics. This study compared concussion care utilization for adolescents age 12 to 18 in states with and without concussion legislation using an insurance claims database. After controlling for potentially confounding factors such as median income and number of insured individuals per state, Gibson et al. found that states that had implemented concussion legislation had increased concussion care utilization (92% increase) compared to those without legislation (75% increase). The increases in care utilization were driven primarily by increases in visits to the doctor’s office and to a neurologist, not through increases in emergency department care, which the authors described as encouraging.

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FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part II)

The FDA’s public workshop on their draft guidance framework for the regulation of laboratory-developed tests (LDTs) continued yesterday, featuring sessions on three additional issues: 1) notification and adverse event reporting, 2) public procedures for classification and prioritization, and 3) quality system regulation.

Many issues that had been raised during Thursday’s sessions reappeared in the context of these new subjects.  Commenters considered whether and when laboratories should be able to submit one (rather than many) LDT notifications and/or registrations, the relationship between clinical use and risk classification, and the need to be sensitive to the diversity of LDTs and their providers in formulating the final guidelines.  Other, more legal aspects were also raised again, including concerns about redundancy between FDA regulations and those already promulgated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, whether the FDA possesses the legal authority to regulate most LDTs, and whether the FDA is required to proceed by notice-and-comment rulemaking rather than acting through the guidance process.  (Litigation is almost certain to arise on these last two topics, about which I’ll have more to say in future posts.)

But I want to briefly highlight one theme that cropped up on both days more frequently than I had anticipated: the role of insurers and insurance reimbursement.  Panelists considered whether insurers or other payers should have a seat at the table when advisory committees are convened to classify and prioritize LDTs for review.  They discussed the effect of FDA approval on insurance coverage, debating whether the proposed regulations would increase or decrease access to FDA-approved LDTs.  But most importantly (at least in my view), they explicitly considered the way in which increased FDA regulation would combine with decreasing insurance reimbursement to decrease incentives for innovation in diagnostic testing.

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Check out the latest news from the Petrie-Flom Center!

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Happy New Year! Check out the January 9th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

Featured in this edition:

Harvard Law School 2013-05-03 Petrie-Flom Center Food ConferenceOutbreak: Developing New Medical Products for Epidemics, A lecture by Peter Hutt                                Thursday, January 15, 2015, 12:30 PM                         Hauser Hall 102, 1575 Massachusetts Avenue, Cambridge, MA

The recent outbreak of Ebola has called attention to the substantial difficulties associated with developing and testing new products for time-sensitive epidemics. What are the legal, ethical, and economic barriers to getting essential treatments and preventative measures from the lab into the hands of patients – and how can they be overcome?

Please join the Petrie-Flom Center for a discussion of these issues by Peter Barton Hutt, Partner at Covington & Burling, LLP, and Lecturer on Law at HLS. Rachel Sachs, Petrie-Flom Center Academic Fellow, will respond.

For more on news and events at Petrie-Flom, see the full newsletter.

FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part I)

Over the past several months, I’ve been blogging (here, here, and here) about the FDA’s recent forays into regulating laboratory-developed tests (LDTs).  Since the release of the draft guidance framework in October, serious arguments have been made on opposing sides of the issue, and industry groups have made additional moves in opposition to the proposed regulation.  And now, today (and tomorrow), the FDA is holding a public workshop on their draft guidance framework, focusing on a wide range of issues.

Today’s workshop featured sessions on three main issues: 1) labeling considerations, 2) clinical validity and intended use, and 3) categories for continued enforcement discretion.  Many commenters simply presented the unique concerns of their organization and urged the FDA to consider them in finalizing the guidelines, which was helpful when it did seem as if the draft guidance may have insufficiently considered the needs of a particular set of laboratories, such as public health laboratories that focus on testing for infectious diseases like Ebola and chikungunya (about which I’ve also blogged, here and here).

More helpful, though (at least in my view), were the comments of those who sought to provide concrete recommendations for the FDA on the basis of 1) the policy concerns they saw underlying the guidance and 2) the practical effects of implementation that they foresaw.  I’ll illustrate with an example, which hopefully will display the complexity inherent in even the simplest questions that the FDA must answer here.

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Cost Containment and Cost Shifting

By David Orentlicher
[Cross-posted at Health Law Profs.]

With Harvard professors protesting their increased responsibility for health care costs, we are seeing just the most visible aspect of the recurring cycle described in “Tragic Choices.” As Guido Calabresi and Philip Bobbitt observed in that book, society tries to defuse societal conflict by hiding its rationing choices through implicit forms of rationing. Thus, for example, health care insurers relied on managed care organizations in the 1990’s to contain health care costs with the premise that managed care would preserve health care access and quality while squeezing the fat out of the health care system.

But after a time, the public realizes what’s going on and rebels against the implicit rationing policy. Hence, managed care’s effective cost containment strategies, such as limited networks of physicians or primary care gatekeeping, were dumped, and health care costs began to climb again.

What did health care insurers turn to after abandoning serious managed care? Shifting more of the costs of health care to patients through higher deductibles and higher copayments. Insurers didn’t need to identify limits on their coverage because individuals would respond to their higher out-of-pocket costs by hesitating to seek care. Costs would be contained by “market forces” rather than rationing. But the Harvard professors and other Americans are now rebelling against the shifting-of-costs policy, just as Calabresi and Bobbitt predicted in 1978. (Indeed, they even included the shifting of costs as an example of an implicit rationing strategy.) Continue reading

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

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital/Harvard Medical School reviews the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the abstracts/summaries for papers identified from December. The selections feature topics ranging from access to clinical trials data, to pharmacy-based interventions to reduce primary medication non-adherence, to the impact of out-of-pocket spending caps on the non-elderly with private group health insurance. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bonini S, Eichler HG, Wathion N, Rasi G. Transparency and the European Medicines Agency—sharing of clinical trial data. N Engl J Med. 2014 Dec 25;371(26):2452-2455.
  2. Fischer MA, Choudhry NK, Bykov K, Brill G, Bopp G, Wurst AM, Shrank WH. Pharmacy-based interventions to reduce primary medication nonadherence to cardiovascular medications. Med Care. 2014 Dec;52(12):1050-1054.
  3. Kesselheim AS, Huybrechts KF, Choudhry NK, Fulchino LA, Isaman DL, Kowal MK, Brennan TA. Prescription Drug Insurance Coverage and Patient Health Outcomes: A Systematic Review. Am J Public Health. 2014 Dec 18:e1-e14. [Epub ahead of print]

  4. Nissen SE. Commentary: Confidentiality of interim trial data-The emerging crisis. Clin Trials. 2014 Dec 18. [Epub ahead of print]

  5. Notenboom K, Beers E, van Riet-Nales DA, Egberts TC, Leufkens HG, Jansen PA, Bouvy ML. Practical Problems with Medication Use that Older People Experience: A Qualitative Study. J Am Geriatr Soc. 2014 Dec;62(12):2339-2344.

  6. Riggs KR, Buttorff C, Alexander GC. Impact of Out-of-Pocket Spending Caps on Financial Burden of those with Group Health Insurance. J Gen Intern Med. 2014 Dec 4. [Epub ahead of print]

  7. Zarin DA, Tse T, Sheehan J. The Proposed Rule for U.S. Clinical Trial Registration and Results Submission.N Engl J Med. 2014 Dec 24. [Epub ahead of print]

A Right to Die? The M.D. Case Before the Argentine Supreme Court

by Martín Hevia

In 2015, the Argentine Supreme Court is to hear a case involving the right to die, death with dignity, and informed consent. Because of a car accident in the Province of Neuquén, M.D., the patient, has been in a permanent, irreversible, vegetative state for 18 years. His sisters and curators have requested the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way.

This will not be the first time that the Supreme Court hears a case of death with dignity. In 2012, the Court heard the case of Albarracini Nieves, who was unconscious when admitted to a hospital in Buenos Aires. The physicians established that a blood transfusion was necessary. But, as Albarracini belonged to the cult “Jehovah’s Witnesses”, he had had made a statement before a public notary in 2008 where he expressed he would not accept any blood transfusions even if his life were in danger. His father requested a cautionary measure that would order the transfusion to be practiced. The first instance court admitted the solicited measure, considering that although Albarracini had expressed that he refused an eventual transfusion, he was not “in a condition to make decisions with full discernment.”The case then reached the Supreme Court, which argued that there were no reasons to doubt over the current validity of Albarracini’s expression of will and that there was no evidence that he would not have considered the significance of his decision.The Court argued that “…this Court has clearly established that Article 19 of the National Constitution grants the sphere of freedom, within which he can freely adopt fundamental decisions about himself without any State or third parties interference, as long as those decisions do not violate third parties’ rights.”The Court stated that“The possibility of accepting or refusing a specific treatment, or selecting an alternative form of treatment, is part of self-determination and personal autonomy; that patients have the right to choose options according to their own values or points of view, even when they may seem irrational or imprudent, and that free choice must be respected.”

The M.D. case is different in that it is difficult to prove the patient’s will – unlike in the Albarracini Nieves case – because there is not a patient’s written statement on whether it is appropriate for him to continue or not certain medical treatment to keep him alive. The Superior Court of Justice of the Province of Neuquén has decided on the case invoking the 2009 Patients´ Rights Act: according to this law, the sisters have standing to grant informed consent in the name of their brother.

The Supreme Court and Argentine lower courts have interpreted the National Constitution and concluded that it grants patients a wide range of autonomous choice as regards their autonomy, reflected in their right to refuse medical treatment.  On that basis, the Supreme Court will probably confirm the decision of the lower court.