Thursday, May 22, 2014
E. H. Morreim, Dumping the 'Anti-Dumping' Law: Why EMTALA Is (Largely) Unconstitutional and Why It Matters, 5 Minn. J. L. Sci. & Tech 211 (2014).
Nav Persaud, Thom Ringer, Trudo Lemmens, How Can Journals Respond to Threats of Libel Litigation, 11 PLOS Medicine 1 (2014).
Valerie Gutmann Koch, A Private Right of Action for Informed Consent in Research,45 Seton Hall L. R. __ (2015).
Glenn Cohen, What (If Anything) Is Wrong with Human Enhancement? What (If Anything) Is Right with It?, 49 Tulsa L. Rev 645 (2014).
Julian James Zuba Polaris, Principles Over Principals? How Innovation Affects the Agency Relationship in Medical and Legal Practice, Yale J. of Health Policy, Law, and Ethics (Forthcoming).
Tracy D Gunter, Can We Trust Consumers with Their Brains? Popular Cognitive Neuroscience, Brain Images, Self-Help and the Consumer, Indiana Health L. Rev. (Forthcoming).
Trudo Lemmens, The Markingson Case and the Ethics of Institutional Proceduralism, 11 Bioethical Inquiry 11 (2014).
Bert-Jaap Koops, The Role of Framing and Metaphor in the Therapy versus Enhancement Argument, Pisa U. Press 35 (2013).
Jenna Feldman, Medical Malpractice Liability and Accountability: Potential Legal Ramifications and Solutions for Florida ACOs, U. of Miami L. Rev. (Forthcoming).
Mahmood Moosazadeh, Mahtab Movahednia, Nima Movahednia, Mohammadreza Amiresmaili, Iraj Aghaei, Determining the Frequency of Defensive Medicine Among General Practitioners in Southeast Iran, 2 Int. J. Health Policy Manag. 119 (2014).
Donald H. Stone, The Dangers of Psychotropic Medication for Mentally Ill Children: Where is the Child's Voice in Consenting to Medication? An Empirical Study, 23 Temple Pol. & Civ. Rts. L. Rev. 121 (2013).
Jeffrey W. Sheehan, Late Fathers' Later Children: Reconceiving the Limits of Survivor's Benefits in Response to Death-Defying Reproductive Technology, 15 Vand. J. Ent. & Tech. L. 983 (2013).
Charles Maimela, Professional Medical Malpractice: Legal Liability of the Plastic Surgeon, 76 J. of Contemp. Roman-Dutch L. 589 (2013).
Jonathan R. Montgomery, Caroline Jones, Hazel Biggs, Hidden Law‐Making in the Province of Medical Jurisprudence, 77 The Modern L. Rev., 343 (2014).
Wednesday, May 21, 2014
Guest Blogger Professor John Jacobi: Ensuring Successful Reform Follow-Through, Part 2: Affordability
Health reform is an ongoing project. In my last post, I noted that the success of ACA enrollment frees up some bandwidth to grapple with other outstanding implementation tasks – tasks that are vital to supporting the goals of the Affordable Care Act. I tried to focus on issues with a short- or medium-term horizon, and which could be tackled largely by state or private-sector actors – that is, without change in federal law. In this post, I’ll talk about affordability (the first “A” in the ACA). First, the good; then, the problems; finally, some potential solutions.
Almost five million new Medicaid enrollees, of course, have affordable care. There are indications that Medicaid expansion will gradually come, in some form, in many red states, including Indiana, which is proposing what sounds like a mash-up of the Basic Health Plan and an 1115 waiver. Beyond Medicaid, several affordability provisions support access in private insurance:
- Modified community rating, with 3:1 ratio limit.
- Abolition of most annual/lifetime limits on coverage.
- Annual out-of-pocket limit of $6,350/individual and $12,700/family (2014).
- Actuarial value requirements for QHPs.
- No cost-sharing for preventive care.
Low-income purchasers on the exchanges have additional protections:
- Premium support, limiting the effective cost of coverage for people at or below 400% of FPL to 2% to 9.5% of income.
- Further reductions in out-of-pocket caps by two-thirds for those at or below 200% of FPL, by one-half for those at or below 300% of FPL, and by one-third for those at or below 400% of FPL.
- Reductions in cost sharing (point-of-care copayments and deductibles) for those below 250% of FPL, raising the actuarial value of their coverage to as high as 94%.
This protection is real and substantial – a tremendous improvement from the pre-ACA days when, as chronicled by Melissa Jacoby, Teresa Sullivan, Elizabeth Warren and others, medical debt played a large part in personal bankruptcy filings, and, significantly, the majority of those filing with medical debt were insured.
Tuesday, May 20, 2014
The ABA/AHLA program on Antitrust in Health Care this week included extensive analyses of recent challenges to provider mergers and other aspects of concentration and market power. Douglas Ross (Davis Wright Tremaine), Roxane Busey (Baker & McKenzie), and I presented a “Year in Review” analysis of significant case law and regulatory developments affecting competition in the health care sector (including a Jaryndyce v. Jaryndyce award to the case that seems to keep popping up in every annual program we do: this year’s winner by acclamation was the West Penn/UPMC/Highmark saga). Several items that may be of particular interest:
Dan Kessler discussed his empirical study, published in this month’s issue of Health Affairs, concerning the price and spending effects of hospital-physician integration. The key finding of the paper is that increases in the market share of hospitals that own physician practices leads to higher prices and spending. As discussed in my last post, antitrust authorities are paying closer attention to hospital acquisitions of physician practices, something they have ignored in the past. However, the FTC’s recent successful challenge to such an acquisition did not take on the important issue of the vertical aspects of the consolidation at issue. Another finding (though far less robust) by Kessler and his co-authors indicated that increases in market share of hospitals that had joint ventures with physicians (such as PHOs) have lower rates of admission, a result that supports the potential efficacy of ACOs.
How will exchanges affect competition? Some 23 states have seen co-ops enter their markets through the exchanges and there is some evidence that the exchange may facilitate new entry. Recall that during the run up to the ACA many called for adding a public option insurance plan to each health care exchange. The argument was that the individual insurance markets around the country were so concentrated throughout the country that consumers would not benefit from competitive markets in the exchanges. Congress chose not to add the public plans presumably on the assumption that the incentives of serving millions of new customers would incentive new entry. How has that worked out? A recent Kaiser Family Foundation study provided interesting results. It found significantly increased competition in two big states that organized their own exchanges. In New York, the Herfindahl Index (the measure commonly used to assess concentration in antitrust cases) for the individual insurance market declined from 1641 to 1197. In California, the HHI declined from 3052 to 2418. Interestingly, both states have adopted an “active purchaser” approach to their exchanges; that is, the exchanges negotiate up front with plans before they are allowed to sell their products on the exchange. Less encouraging was the result in some other states. Connecticut’s individual insurance market has less competition in its exchanges than it had prior to the ACA. Further some rural states or parts thereof have only one insurer participating in their exchanges.
Many medical providers learn about the law the way kids learn about sex – whispers with friends, internet message boards, and media depictions of the most dramatic and unrealistic kind. And while both medical schools and junior high schools offer some type of formal education, it is quite limited, especially as compared to the information these students collect through other, less reputable, sources. As a result, many medical providers go into practice with a dark cloud over their heads – the “scared straight” model of legal education, if you will.
We’ve heard a lot about the practice of defensive medicine – ordering more tests and procedures than are medically necessary in an effort to protect oneself from potential liability. But fear of liability manifests itself in other, less dramatic, ways as well – for example, in overly-restrictive interpretations of HIPAA requirements that make it difficult for patients and their care providers to access needed medical information. In reality, however, much of the fear of liability experienced by medical professionals is unfounded.
Every physician is afraid of being sued, and rightly so. According to a 2011 study in the New England Journal of Medicine, between 75% and 99% of physicians had faced a malpractice claim by the time they reached the age of 65. With rates like these, physicians must accept the fact that under our current system of litigation, someday, somehow, they are likely to be on the receiving end of lawsuit. Other professions, like engineering and architecture, face this problem as well. And without diminishing the incredible inconvenience, expense, and (perhaps most significantly) stress and mental anguish that result from being named in a lawsuit, I think it’s important that medical providers have a more realistic perspective of how likely lawsuits against them are to succeed.
Guest Blogger Associate Professor Jonathan Todres: Incorporating Experiential Learning in Health Law Courses
As law schools continue to contemplate curricular reforms, health law courses offer a particularly rich area for exploration. Employers increasingly want new graduates to be “practice ready.” Setting aside the larger debates on legal education, I believe that the breadth of health law creates opportunities to foster the development of students’ skills for many types of law practice. Though clinics at many schools are an obvious space for that development, doctrinal courses can offer significant opportunities.
In my Public Health Law course, I incorporate two drafting exercises during the semester. Given the nature of topics we cover in the course (infectious disease outbreaks, tobacco, obesity, gun violence, bioterrorism, and others), the course lends itself to engaging students in legislative drafting exercises. These assignments further strengthen skills taught in other parts of the curriculum and foster the development of new skills. This week, I share a few observations from my teaching on the value of incorporating skills exercises into a doctrinal class.
Tuesday, May 13, 2014
Cross-posted from Bill of Health
A resident of Spain allegedly owed back taxes triggering attachment proceedings. The local newspaper published the details of an upcoming auction of his property in early 1998. At some point the issue was settled. However, the matter was not forgotten—the newspaper was online and a Google search of the gentleman’s name returned this history. He complained to the Spanish data protection agency (AEPD) that he had a right to have older, irrelevant information erased and that Google should remove the links. The AEPD agreed and Google sued for relief. The Spanish High Court referred the interpretation of the Data Directive (95/46) to the European Court of Justice in 2010 and in 2013 the Advocate-General issued an advisory opinion supportive of Google’s position. Somewhat surprisingly the European Court of Justice has now taken the opposite view (Case C‑131/12, Google Spain SL v. AEPD, May 13, 2014).
Several aspects of the judgment are noteworthy (such as the holding that a search engine is a data processor). However, the primary importance of the decision by Europe’s top court is that Article 12(b) of Directive 95/46 provides a right to data erasure or, as it is sometimes referred to, a right to be forgotten. In the words of the court:
[Unlawful data processing] may result not only from the fact that such data are inaccurate but, in particular, also from the fact that they are inadequate, irrelevant or excessive in relation to the purposes of the processing, that they are not kept up to date, or that they are kept for longer than is necessary unless they are required to be kept for historical, statistical or scientific purposes.
The practical implications not only for search engines but also for data brokers are considerable. Much of the profiling information stored in big data warehouses was originally collected for narrower purposes or for purposes or transactions that have now run their course.
In the context of health data protection in the U.S. I have argued that In order to sustain our traditionally strong protection for health information, big data needs to be reined in and prevented from creating data “proxies” for health information that exist outside of HIPAA-protected space. I have advocated two improved protections; first, enhanced protections should limit the data than brokers may collect, and second, data subjects should be provided a quasi-property right of erasure that “follows” that data. U.S. privacy advocates now have a major privacy “beacon” to invoke.
In Europe the court’s decision also may have major political ramifications. The draft data protection regulation that explicitly recognizes the right of erasure (as well as introducing other privacy rights) has been making robust progress through Europe’s political institutions, recently receiving the strong endorsement of the European Parliament. About the only serious hurdle in its path may be shifts in power resulting from the imminent European elections. Now, that the fourth branch of the EU government has interpreted existing law as already including that right, the new law may prove unstoppable.
Saturday, May 10, 2014
Guest Blogger Professor John V. Jacobi - Post-Enrollment: Ensuring Successful Follow-Through for Health Reform
Millions – including millions of the “young invincibles” – have been enrolled in the ACA’s private and public insurance programs. And a recent study by Sommers, Long, and Baicker in the Annals of Internal Medicine, suggests that this enrollment will save lives. That’s great news for all interested in progressive health reform. But there is a lot of work to be done to ensure that care follows coverage. In this and subsequent posts, I’ll point to key implementation issues that share two characteristics: First, they go beyond the very important enrollment issues. Second, although federal implementation and advocacy is vital, my issues can be addressed largely through state and local government or private parties.
But before that, let’s call it: 2014 enrollment in ACA-related care is a success. The numbers are quite compelling. Private plan enrollment totals a surprising 13 million. This includes the 8 million signing up through federal or state exchanges, and the additional 5 million signing up outside the exchanges with plans that must meet Qualified Health Plan standards and share a common risk pool with in-exchange plans. About 28% on-exchange, and 45% of off-exchange enrollees are in the important 18-34 age group. More good news? Insurers report that at least 4 out of 5 have already paid their first month’s premium. And an additional 4.8 million are newly enrolled in Medicaid and SCHIP.
Sustaining that success won’t be easy. As Henry Aaron describes in the current issue of the New England Journal of Medicine, the success of the ACA in the short term will be subject to “brutal political war.” Aaron also describes the legacy of the political war that led to crafting of the ACA as an incremental plan, rather than a comprehensive, coherent design. The practical problem, in Aaron’s words, is that:
[R]eform had to be built on the most complex, kludgy, and costly system on planet Earth. Multiple layers of health coverage – as a fringe benefit of private employment, as compensation for military service, as public charity for the poor, as public coverage for the elderly and disabled, and as a private commodity purchased by individuals in a remarkably dysfunctional market – overlap and intersect to pay for care through a bewildering variety of agents in a system that even experts seldom fully comprehend.
HealthLawProf Blog is very pleased to welcome the fourth and final of our guest bloggers for the month of May, Professor John V. Jacobi:
John Jacobi is the Dorothea Dix Professor of Health Law & Policy at Seton Hall Law School. He teaches, researches, and works in the areas of health care access, finance and delivery reform, as well as disability rights and mental health discrimination. He is the Faculty Director of the Seton Hall Law School Center for Health & Pharmaceutical Law & Policy. His research and scholarship in these areas is informed by participation as a board member of the Greater Newark Healthcare Coalition, a community-provider collaborative dedicated to integrating care for Medicaid recipients in Newark, New Jersey, and North Jersey Community Research Initiative, an HIV service and research organization. He participates in legislative and regulatory advocacy on behalf of low and moderate income residents. He has served as Senior Associate Counsel to the Governor of New Jersey, as Assistant to the Commissioner of the New Jersey Public Advocate, and as Gibbons Fellow in Public Interest and Constitutional Law. He is a summa cum laude graduate of the State University College of New York at Buffalo (Mathematics and Philosophy) and a magna cum laude graduate of Harvard Law School.
Thursday, May 8, 2014
Oklahoma’s botched execution of Clayton Lockett has brought increased attention to an issue that I have been concerned with for years – the increased “medicalization” of legally sanctioned executions, and, in particular, the role that medical professionals and the scientific community play in this process.
Until the 20th century, most executions were conducted publicly – execution was a communal ritual that served as a means of catharsis. But the American execution process has, over time, become less visible, and, as a consequence, subject to less public oversight. I believe that the movement of the capital punishment process “behind the curtain,” both literally and figuratively, should trouble death penalty opponents and supporters alike.
The standard lethal injection protocol used throughout the United States was developed in 1976 by Dr. Jay Chapman, Oklahoma’s state medical examiner, and Dr. Stanley Deutsch, chair of the Oklahoma Medical School anesthesiology department. Without testing or research, they settled on a three-drug protocol for executing prisoners – sodium thiopental, a short-acting barbiturate; pancuronium bromide, a paralytic; and potassium chloride, which stops the heart. Until recently, this was the combination used in every state.
Monday, May 5, 2014
Human trafficking inflicts significant physical, mental, and emotional harm on its victims. The health consequences are dramatic and, in some cases, even life threatening. Victims and survivors of human trafficking confront a range of health issues from physical injuries and sexually transmitted infections to PTSD, depression, anxiety and other illnesses.
Although human trafficking has received increased attention in recent years, responses to the problem remain rooted primarily in criminal justice frameworks. Law enforcement is necessary but not sufficient. Health care professionals can play a key role in addressing human trafficking.
Victims of human trafficking present at a wide range of health care facilities, including hospital emergency departments, community health centers, primary care clinics, school clinics, specialty clinics (e.g., obstetrics/gynecology, psychiatry), health department clinics, dental clinics, and other service providers. In an article on sex trafficking of children and adolescents published last month in the New England Journal of Medicine, Ellen Wright Clayton and I wrote that health care professionals can help identify at-risk and exploited youth, provide needed treatment to survivors, and ensure that these individuals are connected with appropriate services. These roles apply not only to assisting individuals trafficked into the sex trade but also in identifying and responding to labor trafficking victims. Recent research has reinforced the need to recognize and respond to all forms of trafficking. Labor trafficking, which frequently has been overlooked, implicates numerous industries and businesses, including hospitality and tourism, agriculture, construction, mining, fisheries, domestic service, hair and nail salons, and many others.
For a number years, beginning well before the enactment of the Affordable Care Act, hospitals around the country have been engaged in a land rush. The target has not been real estate, but doctors. The number of physicians employed by organizations associated with hospital systems now exceeds 50 percent and in some specialties like cardiology the figure may be over 75 percent. Much of the post-ACA hiring has involved primary care physicians, a phenomenon explained by the importance of nonspecialists in forming accountable care organizations and serving as the vehicle for referrals in the brave new world of integrated delivery and bundled payment.
The fiscal case for the land rush is not exactly clear, at least in the short run. The median loss for hospitals employing a physician in 2012 was $176,463 and Moody’s considers physician employment “a principal driver of hospitals’ margin pressure.” However, many hospitals, fearful of being left out and losing revenues from referrals, lab work and profitable specialty service lines, are eagerly buying up physician practices. Likewise physicians are also consolidating, especially in the form of large, single-specialty groups.
What have the antitrust enforcers had to say about physician consolidation? Until recently, not much. In fact, neither the FTC or DOJ had ever litigated a physician merger case and only a handful of states had done so. However, in 2012 the FTC signaled its interest in the issue, challenging and settling by consent decree a hospital’s acquisition of two competing cardiology practices in Reno, Nevada. Somewhat controversial was the FTC’s decision not to insist on undoing the acquisitions (which enabled the hospital to employ 88 percent of the cardiologists in the market), but instead only requiring that a number of physicians be released from their non-compete agreements, presumably freeing them to practice independently or affiliate with another hospital.
Sunday, May 4, 2014
HealthLawProf Blog is excited to welcome the third of our four guest bloggers for May, Professor Nadia Sawicki:
Professor Sawicki is a faculty member at Loyola University Chicago School of Law's Beazley Institute for Health Law and Policy. Her current research focuses on issues relating to informed consent, particularly inreproductive and end-of-life care contexts; government speech in the public health arena; and professional discipline by state medical boards. An expert in both health law and bioethics, she is drawn to areas of conflict between law and ethics - including the government's use of persuasion, physicians' professional responsibilities when they act on behalf of the state, conscientious objection by medical providers, and the law's recognition of rights to recovery for invasion of contested interest.
HealthLawProf Blog extends a warm welcome to the second of our four guest bloggers for May, Professor Jonathan Todres:
Jonathan Todres is Associate Professor of Law at Georgia State University College of Law. He researches and writes on a range of issues related to children’s rights and child wellbeing. His current research focuses in particular on trafficking and related forms of exploitation of children, economic and social rights issues, and legal and cultural constructs of childhood. Jonathan serves as a regular advisor to non-governmental organizations working on children’s rights issues. He also served recently on an Institute of Medicine and National Research Council study committee on commercial sexual exploitation and sex trafficking of minors in the United States (the committee published its final report in September 2013). He received his B.A. (International Development) from Clark University and his J.D. from Columbia Law School and served as a U.S. Peace Corps volunteer in Thailand. You may view his research on his SSRN page: http://ssrn.com/author=239725
HealthLawProf Blog is very pleased to welcome the first of our four guest bloggers for the month of May, Professor Thomas (Tim) Greany:
Professor Greaney is Chester A. Myers Professor of Law and Director of the Center for Health Law Studies at Saint Louis University School of Law. He is co-author of the nation’s leading health law casebook, Health Law: Cases, Materials and Problems (7th edition) and a Treatise and Hornbook on health law, the new edition of which will be published in the Fall. He has published over 60 articles and chapters concerning antitrust law and health care law and policy and has testified on these issues before the Judiciary Committee of the House of Representatives and Federal Trade Commission.
Before joining the Saint Louis University faculty, he served as an Assistant Chief in the Department of Justice Antitrust Division, supervising health care antitrust litigation. He has also been a Fulbright Fellow studying European Community competition law in Brussels, Belgium; and has been a visiting scholar at Université Paris Dauphine, Paris, France, Seton Hall University, and the University of Minnesota. Professor Greaney was named as Jay Healy Health Law Professor of the Year by the American Society of Law, Medicine and Ethics in 2007.
Professor Greaney received his B.A magna cum laude from Wesleyan University and his J.D. from Harvard Law School.
Perhaps it’s because reading stories about behavioral economics makes me feel better about the irrational things I do on a regular basis, but it seems that stories and research reports about the potential value of behavioral economics for health policy and public health are appearing with increasing frequency. I don’t claim to be a highly sophisticated consumer of this literature, nor do I claim to have rigorously tracked the frequency of references to behavioral economics in the health literature. (But apparently I have been reading enough empirical scholarship that I know an author is expected to state caveats about her findings.)
In any event, three items that I’ve read recently have me pondering the value of this literature.
In April, a Robert Wood Johnson Foundation-sponsored research program with the long-winded name “Applying Behavioral Economics to Perplexing Health and Health Care Challenges” issued a Progress Report on the results of studies in its initial funding cycle. The program (which explicitly cites to Richard Thaler and Cass Sunstein’s 2008 book Nudge: Improving Decisions about Health, Wealth, and Happiness) looks for solid evidence that behavioral economics techniques can in fact have a positive effect on health-related behaviors. Although RWJF finds behavioral economics approaches sufficiently promising to fund research investigating them, the recent Progress Report was no pep rally. It stated that the results of the Round 1 studies have been mixed, in terms of finding that behavioral economics-inspired interventions can successfully lead to positive changes in health-related behavior. Notwithstanding these mixed results, the program’s director reported being encouraged, since the point of funding this research is to learn what sorts of “choice architecture” interventions actually influence behavior and why.
I was flipping through the most recent issue of Fertility & Sterility, the journal put out by the American Society for Reproductive Medicine (ASRM), when I came across an ad for the Fairfax EggBank. One of the largest sperm banks in the country has apparently expanded into the egg banking business. The ad was yet another reminder how constantly evolving technology raises new legal questions and sometimes resolves old ones.
Back in 2007, when I began assisting fertility doctors with their consent forms, I recall considering the special language that would be necessary to address egg freezing, as it was still considered experimental at the time. No more. In 2013, the ASRM released a “Practice Committee Opinion” declaring that oocyte cryopreservation would no longer be considered experimental. With advances in the oocyte cryopreservation technique (using vitrification—a quick-freezing process), the rates of success for those using frozen eggs were comparable to those using fresh.
How does the establishment of egg freezing as an accepted practice change the legal landscape for individuals and couples using assisted reproduction? Until now, most patients using assisted reproduction have been offered the option of embryo cryopreservation. The fate of unused embryos maintained in storage has posed dilemmas for patients and, in some cases, has led to litigation when couples divorce. I have discussed the issues raised in these cases in depth in two recent articles, Embryo Disposition, Divorce & Family Law Contracting: A Model For Enforceability and Embryo Disposition And Divorce: Why Clinic Consent Forms Are Not The Answer. Although legal theories have varied, courts have shied away from allowing one party to later use the embryos without the other’s consent.
Saturday, May 3, 2014
I'm a guest over at prawfsblog this month--come visit-and my posting today was about why law professors should be interested in Sen. Elizabeth Warren's new memoir. You can read the whole pitch below--it includes that it's a funny, warm, well-written and interesting account of a remarkably successful career. I also noted how important her efforts at fixing student loan debt are as a platform on which to build needed change in higher education. Finally, she has very interesting things to say about balancing work and family as well as going beyond the classroom to help the individuals affected by the law she studied. At a recent executive board meeting of the AALS Section on Law, Medicine and Health Care, current chair Dr. Ani Satz noted that there are not many mechanisms for recognizing that kind of service. (side note--consider yourself warmly invited to the terrific panels our chair elect, Dr. Thad Pope, has organized for us to present and co-sponsor, more information to come).
But for a health prof audience, I'd also point out that she discusses her empirical work (with a team of top social scientists--she didn't do the math herself) that finally demonstrated the major flaw in our employer based health insurance system. Medical bills turned out to be the leading cause of bankruptcy--and very often among families already insured. Either their insurance was inadequate (maybe we should get these folks together with the people who are upset they can't keep their "old" plans) or, worse, their illness meant they could no longer work. Whether the debt came directly from medical bills or from using credit cards and home equity loans to pay the bills--the results were equally catastrophic.
That this actually happens--that medical bills are a leading cause of bankruptcy--is as far as I know not currently disputed. But I'd be remiss in this context not to point out that as part of the opposition research arising from her running to Senate-the Breitbart blog has made available a series of angry accusations from the 1990's of misconduct about that study.
It will be a while before we see if the Affordble Care Act is going to do much to fix this problem--and predictions are mixed. See this as opposed to this. There's a federal study finding bankruptcies down in Massachusetts following Romneycare. Common sense suggests that changes like no exclusions for pre-existing conditions and the lift of lifetime caps will make things better (for people with plans bound by those provisions).
But although certainly not usually described as such, Sen. Warren is, if not a Health Law Prof, certainly one whose work is very important to us.
May 3, 2014 in Affordable Care Act, Blog, Consumers, Coverage, Employer-Sponsored Insurance, Health Care Reform, Insurance, PPACA, Proposed Legislation, Reform, Research, Research Ethics, State Initiatives, Workforce | Permalink | Comments (0) | TrackBack (0)
Wednesday, April 30, 2014
When people think about patent litigation they think about patent owners, they think about savvy technological competitors – they do not think about patients. For sure, everyone realizes that patients have strong interests in patented products, such as drugs or medical tests. And all agree that the goal of the patent system is to encourage innovation and eventually benefit patients. But, no one thinks of patients as active players in the patent playfield.
It is time to change the way we view patent litigation. In my article: The Rise of the End User in Patent Litigation, which is forthcoming in the Boston College Law Review, I show that end users are playing an increasingly growing role in patent litigation. End users are those who use patented technologies for personal consumption or in business. End users do not manufacture or sell patented technologies. Patients are prominent among these end users.
Patients were among the plaintiffs suing to invalidate Myriad Genetics’ patents on several breast cancer genetic mutations in order to increase public access to the genetic tests. The tests at that time cost around $3000. The Supreme Court decided the case – Association for Molecular Genetics v. Myriad Genetics – in 2013. Patients also repeatedly challenge settlement agreements -- called pay for delay agreements – between manufacturers of patented drugs and generic manufacturers. Under these agreements, patented drug manufacturers compensate generic manufacturers not to enter the market to the detriment of patients who now cannot benefit from lower priced drugs. And, in another example, a group of Fabry disease patients asked the National Institute of Health (”NIH”) to use its march-in power to grant licenses to other producers to address manufacturing problems at the patent owner’s facilities that caused a shortage of the patented drug. When the NIH refused the patients filed suit for damages against the patent owner and others in federal court.
My article shows that end users, including patients, are unique players in the patent playfield. First, they lack the technological expertise that is critical in patent cases, where showing patent invalidity or non-infringement depends on sophisticated technological understanding of the patented invention and any competitive products. Second, they are usually unaware of the existence of the patented technology until later in the life of the patent, when the technology achieves mainstream adoption. Because of that they are limited in their ability to use the less expensive Patent Office procedures in lieu of litigation. Third, they are usually (although not in cases of patients of chronic diseases) one-time players and would prefer to settle with patent owners than endure the exorbitant costs of patent litigation.
Since patients, like other end users of patented technologies, are uniquely situated, they tend to be at a disadvantage compared to the traditional players of the patent playfield – the patent owner and her competitors. My article argues for the need for procedural reforms to place patients, among other end users, on equal footing in patent litigation. For more on ways to address the imbalance – see my follow up post.
-Guest Blogger Gaia Bernstein
[cross posted on Health Reform Watch]
Tuesday, April 29, 2014
All of those efforts to persuade people to authorize postmortem organ donation seem to be paying off. Whether one gives consent when renewing a driver's license or by signing up at Donate Life America, the results are impressive. In 2012, 45 percent of American adults were included in state organ donation registries, and 40 percent of organ donations after death came from these "designated donors." That's a more than doubling of the 19 percent rate of designated donors among posthumous organ donors in 2007.
But the increase in donor designation has not translated into a meaningful increase in organ transplantation. There were 22,053 transplants from 8,085 deceased donors in 2007 and 22,187 transplants from 8,143 deceased donors in 2012.
Why hasn't donor designation translated into more organs? Is it because organ procurement organizations would have obtained consent from family members anyway for individuals who registered for donation? A survey of organ procurement organizations suggests strong agreement between registered donors and their families. Or maybe family wishes matter more than the decedent's wishes despite legal rules that recognize the priority of the decedent's wishes. Or perhaps other factors are hiding the effect of donor designation. Maybe it's too soon to see an effect from donor designation. It will be interesting to see how the data play out over the next few years.
[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]
Saturday, April 26, 2014
Yaniv Heled, On Patenting Human Organisms or How the Abortion Wars Feed into the Ownership Fallacy, 36 Cardozo Law Review __ (2014).
David Orentlicher, The Future of the Affordable Care Act: Protecting Economic Health More than Physical Health?, 51 Houston L. Rev. 1057 (2014).
Glenn Cohen, Make it Work!: Breyer on Patents in the Life Sciences,128 Harvard L. Rev. 55 (2014).