Thursday, March 19, 2015
Cross Posted from Health Affairs Blog
Health care lawyers justifiably ignored the 2012 Obama administration consumer privacy framework because it expressly and broadly exempted entities subject to HIPAA, stating “To avoid creating duplicative regulatory burdens, the Administration supports exempting companies from consumer data privacy legislation to the extent that their activities are subject to existing Federal data privacy laws.”
In contrast, the administration’s 2015 draft bill, the Consumer Privacy Bill of Rights Act, though based on that framework, substantially affects health care entities, including those subject to HIPAA, and so demands more attention in the health law community.
Tuesday, March 17, 2015
The IU Robert H. McKinney School of Law's Hall Center for Law and Health and Indiana Health Law Review Annual Symposium will be held on Friday, March 27, 2015. This year's topic is: Medical Myths: Exploring Effectiveness, Misinformation and Scientific Rigor.
Keynote by Aaron E. Carroll, MD, MS., well known physician and author (& blogger).
Other speakers include David Hyman, Norm Tabler, Ross Silverman, Doug Blanke, Kristin Madison, Paul Helft, Tim McBride and David Orentlicher. Lunch keynote by Matthew R. Gutwein, JD. President and CEO, Health and Hospital Corporation of Marion County.
More information here.
Thursday, March 12, 2015
This week Lindsay Wiley joins us to discuss "New Public Health" and we debate the value and validity of wellness plans.
Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale
Wednesday, March 11, 2015
Duquesne University School of Law invites applications for a visiting assistant professor for the 2015-2016 academic year. Although the appointment is only a one-year, non-tenure-track appointment with a 9-month contract, if the law school has an opening for the 2016-2017 academic year, either for a visitor or for a tenure-track position, the visiting assistant professor will be entitled to apply. Teaching and scholarship responsibilities will focus on the area of Health Care (e.g., Health Law, Health Care Organization & Finance, Health Care Fraud & Abuse) with other areas of the teaching and scholarship package subject to negotiation. Applicants should have superior academic credentials and a record, or the promise, of excellence in teaching and legal scholarship, preferably in the area for which the appointment is sought. Previous teaching and practical experience is desirable. Entry-level applicants may demonstrate scholarly promise by publications in scholarly journals or scholarly works in progress.
Interested candidates should submit a letter of interest and a curriculum vitae to apply.interfolio.com/28805. We especially encourage applications from racial minorities, women, and others who would enrich the diversity of our academic community.
The position remains open until March 31, 2015.
Monday, March 9, 2015
With the future of the Affordable Care Act in doubt after last week’s hearing before the U.S. Supreme Court, Republican lawmakers are busily preparing back-up legislation. New options should not be necessary—the government should prevail against those challenging its interpretation of the Act’s premium subsidy provisions. But it is prudent to consider alternatives in the event that the Court rules against the government.
While most of the ideas being floated would do little to bring health care insurance to the uninsured, there is an option that really could expand access to coverage while also containing health care spending. And it could be attractive to Republicans and Democrats alike on Capitol Hill.
Thursday, March 5, 2015
This week Abigail Moncrieff joins us to discuss the King v. Burwell oral arguments, the story behind the amicus brief she authored, and what it was like to hear Justice Kennedy talk about the issue she raised.
Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us at @nicolasterry @FrankPasquale
Wednesday, March 4, 2015
Oral arguments ran over an hour in King v. Burwell today (transcript available here). As many are aware, the question in this case involves whether the IRS appropriately interpreted the ACA to authorize tax credits for insurance policies purchased on both state-based and federally-based health insurance exchanges. The plaintiffs claimed that the IRS has acted illegally in providing tax credits through federally-run exchanges, and if they are successful, the IRS will immediately cease offering subsidies to individuals who have purchased health insurance in federally-run exchanges.
Reading oral arguments is always less satisfying than hearing or witnessing them, but reading the tea leaves is still irresistible when justices appear to reveal their positions. For example, Justices Kagan, Sotomayor, Ginsburg, and Breyer appeared to agree with the arguments put forth by the United States. Justices Scalia and Alito appeared to agree with Mr. Carvin and the plaintiffs, though Justice Alito appeared open to some of statutory answers being provided by Solicitor General Verrilli toward the end of his argument. The Chief Justice was almost silent during the oral arguments, and Justice Kennedy raised his favorite topic, federalism, and whether Carvin's interpretation of the ACA can lead to unprecedented coercion of the states, raising a fatal constitutional consequence for what should otherwise be an exercise in legislative interpretation.
This line of questioning is worth considering for a moment. Readers are probably aware that the doctrine of coercion was merely a theory until the Court breathed life into it in NFIB v. Sebelius. In that decision, the Court held that the ACA's Medicaid expansion was unconstitutionally coercive because states, in the plurality's view, had to choose between expanding Medicaid to childless, non-elderly adults or losing all of their Medicaid funding. But, the structure of Medicaid is quite different from the structure of the exchanges. If a state rejects Medicaid funding, then that state has no Medicaid program within its borders - this form of cooperative federalism facilitated the coercion analysis in NFIB, because the states successfully argued that they could not realistically leave the program. The exchanges, on the other hand, epitomize 'backstop federalism' - if a state rejected funding to create a state-based exchange, then the federal government would step in (and it did).
Initially, it was unclear what Justice Kennedy was pursuing in his federalism questioning, because he seemed to indicate that he perceived the Medicaid-style federalism at work in the exchanges. He later clarified, however, that he was concerned about the ramifications of the challengers' theory, that Congress intended to deny subsidies in states that refused to establish exchanges, thereby obliquely and opaquely threatening states by refusing to offer tax credits to their citizens. Not only is this interpretation of the ACA plainly wrong, but it would also create a bizarre conditional spending situation where the states did not know they were being threatened until long after they decided to reject federal policy. Justice Kennedy indicated that this reading of the statute would result in a "serious constitutional problem" that should be avoided, and he is right. But, he was also skeptical about the actual language of the statute, so the U.S. cannot yet breathe easy.
One additional observation for now - the impact on health insurance access will be even greater than the parties discussed. If the IRS ends subsidies for insurance policies purchased through the federal exchange, the current tally indicates that approximately 8 million people will lose the subsidies that make insurance affordable for them. While they will not be subject to a tax penalty for failure to carry health insurance, they also will not be able to afford health insurance. That is immediately clear. But, the ripples will be greater than the 8 million, because some states that have obtained waivers to expand Medicaid are placing their newly eligible Medicaid populations into the exchanges. If the exchanges experience a death spiral due to increased premiums and loss of covered lives in the risk pool, then the exchanges become a very unstable way to provide Medicaid coverage and likely become unaffordable for states. Demonstration waivers are supposed to be budget neutral, which would become impossible in plans like Arkansas' if the plaintiffs win this case. Further, low-income individuals tend to churn between Medicaid and private insurance coverage - but if the insurance offered through federal exchanges is not subsidized, then they will churn into uninsured status, thereby increasing dramatically the number of lives affected by this decision.
Of course, if the Court upholds the IRS interpretation of the ACA, then we can all go back to waiting for the next challenge to come along.
Monday, March 2, 2015
Leslie P. Francis, Patient Registries: Patient Consent When Children Become Adults, 7 St Louis U. J. of Health L. & Pol'y 389 (2014).
Alicia J. Paller, Are You My Mother? Why Mitochondrial DNA Transfers Require States to Rework Traditional, Two-Person Legal Parentage Frameworks, 33 Biotechnology L. Report 193 (2014).
Thursday, February 26, 2015
For anyone interested, this is a fantastic symposium, bringing together academics, practitioners, and disability advocates.
2015 Jacobus tenBroek Disability Law Symposium
The ADA at Fifty: The Future of Disability Law and the Right to Live in the World
March 26-27, 2015
National Federation of the Blind Jernigan Institute
Join leading disability rights advocates from throughout the United States in celebration of the Americans with Disabilities Act by looking ahead to the next twenty-five years. The 2015 Jacobus tenBroek Disability Law Symposium will consist of plenary sessions and workshops facilitated by distinguished law professors, practitioners, and advocates who will discuss topics such as: the future of disability, how to enable the participation of people with disabilities in court proceedings, the unique challenges faced by criminal suspects and offenders with intellectual and developmental disabilities, and a vision for the next twenty-five years to improve and augment the ADA, Rehabilitation Act, and IDEA. Presenters include:
- Peter Blanck, University Professor and Chairman, Burton Blatt Institute, Syracuse University
- Chief Judge Richard S. Brown, Wisconsin Court of Appeals
- Leigh Ann Davis, Program Manager, National Center on Criminal Justice and Disability, The Arc
- Robert Dinerstein, Professor of Law, American University Washington College of Law
- David Ferleger, Esquire, Law Office of David Ferleger
- Beverly Frantz, Criminal Justice and Sexuality Project Director, Institute on Disabilities, Temple University
- Daniel F. Goldstein, Partner, Brown, Goldstein and Levy
- Christine M. Griffin, Executive Director, Disability Law Center of Massachusetts
- Arlene S. Kanter; Bond, Schoeneck, and King Distinguished Professor; Syracuse University College of Law
- Marc Maurer, Immediate Past President, National Federation of the Blind
- Arlene B. Mayerson, Directing Attorney, Disability Rights Education and Defense Fund
- Ari Ne'eman, Co-founder and President, Autistic Self Advocacy Network
- Laurence Paradis, Executive Director and Co-director of Litigation, Disability Rights Advocates
- Mark Riccobono, President, National Federation of the Blind
- Howard A. Rosenblum, Chief Executive Officer, National Association of the Deaf
- Fredric K. Schroeder, Research Professor, San Diego State University Research Foundation; First Vice President, World Blind Union
- Anita Silvers, Professor and Chair of Philosophy, San Francisco State University
- Christopher Slobogin; Milton R. Underwood Chair in Law; Director, Criminal Justice Program, Vanderbilt University Law School; Affiliate Professor of Psychiatry; Vanderbilt University School of Medicine
- Judge Richard B. Teitelman, Supreme Court of Missouri
- Kathryn Walker, Criminal Justice Fellow, The Arc
- Michael Waterstone, Visiting Professor of Law, Northwestern University School of Law; J. Howard Ziemann Fellow and Professor of Law, Loyola Law School Los Angeles
To view the agenda, or for more information about the symposium, hotel accommodations, and symposium sponsorship opportunities, please visit https://nfb.org/law-symposium.
Registration fee: $175
Student registration fee: $25
You can register online by going to: https://nfb.org/civicrm/event/register?reset=1&id=49.
You may also download from the symposium website a registration form to mail or fax.
Documentation for CLE credits will be provided.
For additional information, contact:
Lou Ann Blake, JD
Law Symposium Coordinator
National Federation of the Blind
200 East Wells Street
at Jernigan Place
Baltimore, Maryland 21230
Telephone: 410-659-9314, ext. 2221
Tuesday, February 24, 2015
Frank Pasquale and Nicolas Terry are pleased to announce The Week in Health Law Podcast. We (and our guests) enjoy a commuting-length discussion about some of the more thorny issues in Health Law & Policy.
This week, a special treat, as we are joined by Nicole Huberfeld to discuss Medicaid expansion (as well as Google health searches and bending the safety curve).
Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us @nicolasterry @FrankPasquale
Doctors Conducting Peer Review Can Recover Compensatory and Punitive Damages for Confidentiality Violations
Hat tip to Alex Stein for the following post:
The Supreme Court of New Mexico has recently delivered an important decision protecting peer reviewers’ statutory entitlement to confidentiality. Yedidag v. Roswell Clinic Corp., — P.3d —- (N.M. 2015), 2015 WL 691333. The Court ruled that peer reviewers can sue violators of their confidentiality right and recover compensatory and even punitive damages. This ruling applied the common law criteria for identifying statutory violations as a breach of contract. Based on those criteria, the Court categorized peer reviewers as members of the class protected by the peer review statute, who deserve remedies for violations of their confidentiality right. The Court also estimated that the criminal penalty imposed by the statute on the right’s violators was too lenient to discourage violations. The Court projected that allowing peer reviewers to sue violators will compensate for the resulting shortfall in deterrence. As a conceptual matter, the Court decided that peer reviewers’ confidentiality entitlement is a “mandatory rule of law incorporated into physician-reviewer employment contracts.”
This decision was followed by a ruling against the hospital that terminated the employment of a doctor for “verbally attacking” a colleague at a peer review meeting. The alleged “verbal attack” included tough questions that addressed the colleague’s removal of one malignant tumor from a deceased patient’s colon, instead of two. The hospital perceived these questions as “unprofessional conduct” that justified the doctor’s termination, but the Court profoundly disagreed. The Court decided that the doctor’s questions – even if uncivilized – were privileged, and that it was not within the hospital’s rights to use them (or any other confidential peer review information) as a reason for firing him. Based on that decision, the Court affirmed the jury’s verdict obligating the hospital to pay the doctor compensatory and punitive damages. The Court’s decision relied on several academic works that included Katharine Van Tassel’s important study of the peer review mechanism.
Cross posted from Bill of Health.
Thursday, February 19, 2015
David Orentlicher, Employer-Based Health Care Insurance: Not So Exceptional after All, 36 U. Ark. Little Rock L. Rev. (2014).
Tuesday, February 17, 2015
Penn Law Review Online is hosting a debate over King v. Burwell. Click the link to read more.
Ciara O'Connell, Litigating Reproductive Health Rights in the Inter-American System: What Does a Winning Case Look Like?, 16 Health & Hum. Rts. J. (2014).
Michael J. Malinowski, Throwing Dirt on Doctor Frankenstein's Grave: Access to Experimental Treatments at the End of Life, 65 Hastings L.J. 615 (2014).
Lauren B. Huddleston, Defining the Administration of Anesthesia: Just the Push of a Plunger?, 50 Wake Forest L. Rev. 2015.
Jordan Paradise, REMS as a Competitive Tactic: Is Big Pharma Hijacking Drug Access and Patient Safety?, Hous. J. of Health L. & Pol'y (Forthcoming 2015).
Kameshwari Sridhar, Inter Partes Review -- A New Frontier for Hatch-Waxman Generics vs Innovators Pharma Patent Battles: Recent Oracea Decision Sets the Pace! Does Inter Partes Review Signify a Death Knell for Pioneer Patents? -- With the Pioneer Pharma Prevailing in the Latest Hatch-Waxman Act Based PTAB Verdict on Oracea Patents!!!, IPFrontline, Intell. Prop. L. (2015).
Monday, February 16, 2015
The singular insight in global health is that absolute reductions in morbidity and premature morality are not robust indicators of success in the absence of equity. That is, we can achieve high levels of global health but still lag in justice. What would be truly transformative is to achieve both overall population health and fair distribution of the benefits—in other words, Global Health with Justice. What would global health with justice look like? That is the critical problem I explore in Global Health Law (Harvard University Press, 2014, Chinese Translation Forthcoming 2016). Before answering this pivotal question, consider contrasting narratives, showing how global health can exist in a state of inequality.
Global Health Narratives
Gates Foundation/ONE. The Living Proof: Real Lives, Real Progress campaign champions once unimaginable global health achievements. Success stories are pervasive, and with good reason. International assistance has skyrocketed, while child and maternal mortality has plummeted and millions are accessing treatment for HIV/AIDS. Polio eradication is on the horizon, with game-changing vaccines within reach for AIDS and malaria.
This narrative of success is true and inspiring, but also consider the voices of two young people living in poverty, abridged from, Global Health Law:
Namubiru (Gaba, Uganda). I live in a rowdy place, with no clean water, no good toilets or bathrooms. At night, the conditions worsen, with hardly any electricity. The mosquito noise fills up the place. Cockroaches move around me. My mother would help me with medication fees, but she is dying of AIDS. A lot of sexual violence happens to me. I want to get an education and a job. I am so sad. I need a new life.
Johnny (Blackfeet Tribal Reservation, Montana, USA). I start my day with a cup of Joe, then corral and break horses, and smoke a bowl of weed. My father snorts coke and gets drunk, taking my birthday money. He beats all the kids. When your family is broken due to drugs and alcohol everyone is hurt. What I mean is what little kids get to eat or not to eat, did they get the shoes or clothes they needed, it depends on whether adults do drugs. I want to shout, “when you do meth hey, don’t let your kids be here.” What about the kids?
Thursday, February 12, 2015
Sandra K. Prucka, Lester J. Arnold, John E. Brandt, Sandra Gilardi, Lea Harty, Feng Hong, Joanne Malia, David J. Pulford, An Update to Returning Genetic Research Results to Individuals: Perspectives of the Industry Pharmacogenomics Working Group, 29 Bioethics 82 (2015).
Wednesday, February 11, 2015
Kyle Brothers, Mark A. Rothstein, Ethical, Legal and Social Implications of Incorporating Personalized Medicine into Healthcare, 15 Future Med. 43 (2014).
Guy Kahane, Julian Savulescu, Normal Human Variation: Refocussing the Enhancement Debate, 29 Bioethics 133 (2015).
Carina Fourie, Moral Distress and Moral Conflict in Clinical Ethics, 29 Bioethics 91 (2015).
Christopher Wareham, Cecilia Nardini, Policy on Synthetic Biology: Deliberation, Probability, and the Precautionary Paradox, 29 Bioethics 118 (2015).
Monday, February 9, 2015
Cross-posted from Bill of Health
Given the increasing numbers of health data breaches, including this week’s announcement from Anthem (potentially exposing 80m records, mine included) a brief review of the subject may be appropriate.
At the federal level both the Security Rule and the Breach Notification Rule are in play. In large part the Security Rule requires covered entities and their business associates to base their security precautions on risk assessment. Required precautions include administrative, physical, and technical safeguards. Many of these are required, for example unique user identities for access and tracking. Some precautions, however, are only “addressable.”
This latter is the case with data encryption, defined in the Security Rule as “the use of an algorithmic process to transform data into a form in which there is a low probability of assigning meaning without use of a confidential process or key.” In practical terms data may need to be encrypted end-to-end (during transmittal) or while stored (at rest). Being only ‘addressable,’ the question whether to encrypt stored data depends on the data custodian’s assessment whether that technology “is a reasonable and appropriate safeguard in its environment, when analyzed with reference to the likely contribution to protecting electronic protected health information.” If the risk assessment goes against encryption that decision must be documented and a reasonable and appropriate alternative safeguard implemented.
Saturday, February 7, 2015
In a much-awaited decision, the Canadian Supreme Court on Friday held that Canada's statutes criminalizing aiding suicide violated the Canadian Charter. The decision in Carter v. Canada is being widely hailed by advocates of the legal permissibility of the practice and decried by disability advocates. I'm writing this post to call people's attention to some noteworthy aspects of the decision--I am most emphatically not taking sides in this blog post (although I do have a view).
The decision in Carter was under Sect. 7 of the Canadian Charter, which reads: "Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice." Briefly, the Court thought that the violation of the right to life is that that criminalization might force people to take their lives earlier than they wish to in order to avoid suffering. The violation of liberty is that people have a right to make decisions concerning their bodily integrity. And leaving people to intolerable suffering violates the security of the person.
Importantly, the decision is not limited to cases of terminal illness. It extends its reasoning to anyone in "intolerable suffering as the result of illness, disease, or disability." But the Court also said that Canada has an interest in protecting the vulnerable that could justify statutory limits on aid in dying. The difficulty with the existing statutes was that they are a complete ban, and thus in the view of the Court not proportional to the state's legitimate goal. Here, the Court cited evidence from other jurisdictions that statutes permitting aid in dying, with appropriate safeguards, have not resulted in evidence of abuse.
In one respect, the decision is a narrow one, because it simply holds that the criminal statutes (prohibiting aiding and abetting a suicide and prohibiting self-consent to the taking of one's life) violate the Charter. The Court left the current prohibitions in place for one year, to allow Parliament to construct a statute that would pass constitutional muster. It will be fascinating to see what Parliament does in response to the decision, especially with respect to crafting safeguards that are appropriately proportional to the goal of protecting people from abuse.
Friday, February 6, 2015
Jamie R. Abrams, The Illusion of Autonomy in Women's Medical Decision-Making, 42 Fla. St. U. L. Rev. (2015).
Andra le Roux-Kemp, Elsie Burger, Shaken Baby Syndrome: A South African Medico-Legal Perspective, 17 Potchefstroom Electronic L. J. 1287 (2014).
Paddy Rawlinson, Vijay Kumar Yadavendu, Foreign Bodies: The New Victims of Unethical Experimentation, 54 The Howard J. of Crim. Just. 8 (2015).
Hannah Alsgaard, Rural Incentive Programs for Legal and Medical Professionals: A Comparative Analysis, 59 S.D. L. Rev. 585 (2014).
Wednesday, February 4, 2015
Guest Blogger Professor Lawrence O. Gostin - Science, Choice, and Parental Rights in Conflict: The Vaccination Debates
The values of public health, personal choice, and parental rights have collided in an intense debate over mandatory vaccinations. Senator Rand Paul argued that parents have the right to choose: “The state doesn’t own your children. Parents own the children.” The overwhelming weight of science supports the safety and effectiveness of immunizations. Parental choice also does not extend to decisions that impose risks on the community. While libertarian values stress autonomy to make self-regarding decisions, it does not give license to place harm others. But if an individual’s right ends at the point that its exercise jeopardizes the safety of others, then why do states allow parents to opt out of vaccinations? The reason boils down to overbroad exemptions granted by many states. The Constitution doesn’t require states to grant exemptions, but lobbying by a minority of parents has resulted in a tragedy of the commons.
First some background. Vaccine preventable diseases are on the rise—diphtheria, pertussis, tetanus, measles, mumps, and rubella. Parents are delaying or selectively administering vital immunizations for their children, often opting out entirely. The CDC declared measles eliminated in 2000. But in 2014, the United States recorded a record number of cases—644 cases from 27 states, more than three-fold higher than any previous year. In January, a measles outbreak started at Disneyland, diffusing to 14 states, re-igniting the immunization debates.