Sunday, July 27, 2014
HealthLawProf Blog would like to thank our June guest bloggers Associate Dean and Professor Alicia Ouellette, Professor Erin Fuse Brown, Professor Seema Mohapatra, and Professor Wendy Mariner. Here is a short recap of their posts:
Associate Dean and Professor Alicia Ouellette posted the following: Legal Issue or Culture War: Conversion Therapy in the Courts and Beyond, The World Cup and Health: If You Can’t Stand the Heat, Don’t Play in Manaus, Sterilization in the California Prisons and the Medicaid Rules: Under and Over Protecting Women
Professor Erin Fuse Brown posted the following: IPAB May Be A Super-Independent Agency, But It Is Constitutional, Hospitals Using ACA to Justify Cuts in Charity Care, The Health Implications of Piketty’s Inequality, The Hidden Costs of Narrow Networks
Professor Seema Mohapatra posted the following: The Soda War Continues, Tennessee’s Criminalization of Drug Use by Pregnant Women, E-Cigs and Advertising, Genetic Testing of College and Professional Athletes-Legal? Required?, Facial Recognition Technology, Genetic Diseases, and Privacy
Professor Wendy Mariner posted the following: Who Has Jurisdiction Over Sugary Drinks?, Take Care of Your Health at Penn State... Or What?, Hobby Lobby – Part 1: Five Supreme Court Justices Write Corporate Fiction, Hobby Lobby – Part 2: Do Religions Get Their Own Facts?
HealthLawProf Blog is pleased to post the following introduction to a very interesting Symposium published by the North Carolina Law Review entitled "Health Care Decisions in the New Era of Health Care Reform:"
Optimal decision making in health care often proves challenging. Health care providers often confront multiple treatments for each condition with limited evidence as to which interventions work best; moreover, treatment decisions can implicate questions of ethics and personal values that may not be answerable by clinical expertise alone. Fragmented delivery systems lead to insufficient coordination among providers in managing patients’ overall care. Patients face significant informational disadvantage not only in dealing with clinical information, but also in making choices regarding health care insurance coverage. Payers must make reimbursement and coverage decisions with incomplete information about the value and cost effectiveness of many treatments. Governmental officials must make complex regulatory decisions in managing a health care system with seemingly endless demand, escalating costs, and limited resources.
Saturday, July 26, 2014
Having spent a good part of my career focused on research ethics issues, I have read with interest the reports and fallout about Facebook’s “emotional contagion” experiment. It’s not often that you get an example of research gone awry that affects so many.
If you’ve missed this story, here’s the nutshell version: in 2012, Facebook conducted an experiment involving some 700,000 of its users to determine whether manipulating their newsfeeds to show items with more positive or negative words would affect their emotions. (Facebook is always sorting – via algorithms – users’ newsfeeds; this just used a different algorithm to do so.) The hypothesis was that if a user viewed more positive messages, their posts would contain more positive words and vice versa. The news feeds were manipulated for a week, and the study found an effect, although a small one. The study was published on June 17th in the Proceedings of the National Academy of Science.
An early post from our Guest Blogger of the Month for September, Professor Diana Winters:
Legal commentators have spent a lot of time this week sparring over statutory interpretation and the contrasting readings of the ACA by the Halbig and King courts. The potential consequences of these cases demonstrate just how high the stakes of this enterprise can be.
With less fanfare, the Second Circuit decided a case yesterday that may too have large consequences for the health and welfare of the public. In NRDC v. EPA, the court reversed a district court’s decision to require FDA to hold hearings on the withdrawal of approval for the use of two antibiotics—penicillin and tetracyclines—in animal feed. This issue has enormous public health consequences, but the consequences of this case extend beyond antibiotic use, to agency practice in general. The opinion sanctions egregious agency delay and a tremendous lacuna in decision making.
The University of Pittsburgh School of Law invites applications for a full-time faculty position at the rank of Assistant, Associate or Full Clinical Professor to teach in and direct the School’s Health Law Clinic. While this position is not in the tenure stream, it is part of a system of contracts progressing to renewable long-term contracts. The position will begin on July 1, 2015.
The Clinic’s primary mission is to provide an experiential learning opportunity for our students, while also providing legal services to low-income individuals involved in health-related litigation or advocacy. Duties of the Clinical Professor include classroom teaching, including the possibility of teaching doctrinal courses; supervision of second- and third-year law students as they represent clients and participate in community projects; administrative duties relating to the Health Law Clinic; community outreach and fundraising; and participation in faculty governance of the School of Law. The candidate hired for the position will have the opportunity to shape the future direction of the Clinic. Therefore, all candidates should be prepared to present a vision of the type of clinic that they would hope to implement. Examples might include a medical-legal partnership, a clinic focusing primarily on representation of applicants for disability benefits in Medicaid or Social Security administrative hearings, or other focused areas of representation or advocacy.
Qualifications include admission to practice in Pennsylvania or willingness to seek admission to the Pennsylvania bar; substantial experience in the field of health law and, preferably, clinical pedagogy; excellent supervisory and communication skills; the ability to work effectively with students, clients, and other constituents; and an interest in developing clinical experiences for students in the Health Law Clinic within a community that supports interdisciplinary collaboration and innovative teaching opportunities.
To apply, please submit a letter of interest, resume, and list of two or three references to Professor Ben Bratman, Chair, Clinical Appointments Committee, at email@example.com. Write “Health Law Clinic Application” in the subject line of the email. The deadline for applications is September 4, 2014.
The University of Pittsburgh is an Affirmative Action/Equal Opportunity Employer and values equality of opportunity, human dignity, and diversity. Recruitment is subject to approval by the University’s Provost.
Friday, July 25, 2014
Like the recent Supreme Court decision in Hobby Lobby, the D.C. Circuit’s ruling earlier this week in Halbig v. Burwell is being hailed by conservatives and bemoaned by liberals as a death knell for Obamacare. Unlike the decision in Hobby Lobby, however the D.C. Circuit’s ruling is not the end of the matter, and many liberals are finding hope in the ruling of the 4th Circuit the same day, the probability of an en banc hearing in the D.C. Circuit, and the ultimate possibility of a favorable Supreme Court decision. In an earlier post in HealthLawProf, I decided to take seriously the possibility of damage control from a limited reading of Hobby Lobby. It is pretty much universally agreed—and I believe correctly—that it is not possible to do similar damage control by giving a limited reading to Halbig v. Burwell. If the ruling stands, that tax subsidies are not available to people purchasing coverage through the exchanges in the states that are letting the federal government do the work, many important other provisions of the ACA will be untenable, including the penalties for large employers not offering insurance whose employees receive subsidies and likely the individual mandate itself. But I think it is possible to undermine Halbig in a way not generally recognized by the liberal critics who argue (correctly) that the statutory provision at issue is ambiguous: argue that the jurisprudence of the majority opinion in Halbig is internally inconsistent. Here’s how.
Under D.C. Circuit precedent, the court must “uphold an agency action unless we find it to be ‘arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.’” So, the question for the court was whether the IRS rule permitting individuals purchasing insurance through federally-run exchanges was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law. In concluding that it was, Judge Griffith’s opinion for the court reasoned that it was not in accordance with law. That is, Judge Griffith found that there was no ambiguity in the relevant provision of ACA that permitted the IRS to interpret the statute as it did. Here's where much of the criticism takes him on. But there’s more to say.
In reaching the conclusion that the statutory language is not ambiguous, Judge Griffith purported to rely on a literalist approach to statutory interpretation. But he did not in fact rely consistently on such an approach—nor could he have done so. The problem is that in order to formulate the literalist question to answer, Judge Griffith had to resolve several issues in a manner that was not literalist at all.
Thursday, July 24, 2014
Cross-posted from Bill of Health
Sutter Health v. Superior Court, 2014 WL 3589699 (Cal. App. 2014), is a medical data breach class action case that raises questions beyond the specifics of the Californian Confidentiality of Medical Information Act.
The stakes were high in Sutter — under the California statute medical data breach claims trigger (or should trigger!) nominal damages at $1000 per patient. Here four million records were stolen.
Plaintiffs’ first argued the defendant breached a section prohibiting unconsented-to disclosure. The not unreasonable response from the court was that this provision required an affirmative act of disclosure by the defendant which was not satisfied by a theft.
A second statutory provision argued by the plaintiffs looked like a winner. This section provided, “Every provider of health care … who creates, maintains, preserves, stores, abandons, destroys, or disposes of medical information shall do so in a manner that preserves the confidentiality of the information contained therein.”
Over at Balkinization, Abbe Gluck, Neil Siegel, and Joey Fishkin have excellent posts on what's wrong with the Halbig majority. Abbe's is especially important given that the majority wrongly agreed with the complainants that the exchange is some kind of cooperative federlism program. It's not.
Wednesday, July 23, 2014
This has been cross-posted for a more general audience at ACSblog. Though it contains more background than most healthlawprof readers will need, analysis comes after the jump.
The D.C. Circuit held in Halbig v. Burwell that the IRS cannot provide tax credits to individuals who purchase private health insurance in states with federally-run insurance exchanges, potentially depriving millions of middle and low income Americans access to affordable health insurance. Improbably, while the blogosphere lit up, the Fourth Circuit held in King v. Burwell that the IRS properly interpreted the Affordable Care Act (ACA) to provide tax credits in all exchanges whether run by a state or the federal government. Members of the Obama Administration immediately declared they will seek rehearing by the D.C. Circuit en banc. The standard of review for petitions for rehearing is rigorous, but given the importance of the case, and the new circuit split, rehearing is conceivable. Further, it is not unreasonable to anticipate that the Supreme Court ultimately will grant a petition for certiorari in either or both of these cases. If it is upheld, Halbig could be the most damaging decision in the ACA litigation wars yet. For those not mired in the details of the ACA and its ongoing legal challenges, here’s why.
The ACA attempts to create near-universal insurance coverage by making Americans insurable and by commanding insurers to play by uniform rules. The ACA was created because, in 2008, one in five Americans did not have health insurance coverage. To make this number tangible, imagine everyone you know with blue eyes… and now imagine they do not have health insurance. That’s how many were uncovered, and the lack of coverage was just about that random too. In the United States, if you don’t have health insurance, you don’t have access to consistent healthcare. The ACA has clear goals, but it is a muddy scrum of legislative drafting that never underwent a conference committee process, and that imprecision has facilitated the litigation in these cases.
To avoid adverse selection (the problem of free riding), the ACA requires Americans to carry minimum essential coverage or face a tax penalty (upheld in NFIB v. Sebelius); however, if insurance premiums would cost more than 8% of an individual’s income, then no tax penalty will be assessed. To facilitate health insurance coverage, the ACA created health insurance exchanges, also called marketplaces, where individuals and small groups can purchase health insurance that provides standardized benefits without exclusions for preexisting conditions and other disequalizing prohibitions. People who earn 100-400% of the federal poverty level are eligible for federal tax credits that assist in paying premiums for private insurance on the exchanges (“premium assistance tax credits,” codified at 26 U.S.C. 36B), increasing substantially the number of people who can afford to purchase private health insurance.
States were given a choice to create exchanges with federal funding under ACA section 1311, and if they opted not to, then the federal government would create “such” exchange in the state under ACA section 1321. Sixteen states and D.C. created their own exchanges before January 1, 2014, so currently two-thirds of states have federally-run exchanges. This landscape is shifting slightly as some states’ exchanges fail and they move to federal mechanisms, while other states are still eyeballing the federal money available until 2015. What matters here is that the majority of exchanges were federally-run on the day that Halbig was decided.
Tuesday, July 22, 2014
With two federal courts of appeals coming to different conclusions on the most recent challenge to the Affordable Care Act, we should not be surprised that the judges have split along partisan lines.
By a 2-1 vote, the U.S. Court of Appeals for the D.C. Circuit held that subsidies for the purchase of health care insurance are available only on state-run exchanges, while the U.S. Court of Appeals for the Fourth Circuit held 3-0 that subsidies for the purchase of health care insurance are available on both state-run and federally-operated exchanges.
The two judges ruling against the Obama administration were appointed by Republican presidents while the four judges ruling in favor of the Obama administration were appointed by Democratic presidents.
Monday, July 21, 2014
The New York Times reports on complaints by consumers about limitations on their access to physicians and hospitals. According to the story, insurers have restricted their provider networks to contain costs, while misleading their customers about the extent of the restrictions.
Without more information, one cannot draw firm conclusions about the problems. We cannot tell the extent to which insurers are acting badly, nor can we tell how much we are seeing the same backlash as in the 1990's when managed care organizations tried to contain costs by limiting their provider networks.
But the reports are not surprising. Limiting patient choice can be an important way to reduce costs. However, it is a politically unpopular way to do so. Hence, we often are told by candidates and elected officials that their health care reform will promote the three C's--greater coverage, lower costs, and broad choice.
It will be important to see how much the public tolerates restrictions on choice. It may make a big difference on whether the health insurance exchange premiums remain favorable.
Wednesday, July 16, 2014
David H. Kaye, 'Open to Dispute': CODIS STR Loci as Private Medical Information, Forensic Mag. (2014).
Rita Barnett-Rose, Informed Consent, Psychotropic Medications, and a Prescribing Physician’s Duty to Disclose Safer Alternative Treatments, 16 DePaul J. Health Care L. 67 (2014).
William A. Woodruff, Evidence of Lies and Rules of Evidence: The Admissibility of fMRI-Based Expert Opinion on Witness Truthfulness, N. Carolina J. of L. & Tech. (Forthcoming).
AALS Section on Law, Medicine & Health Care
Works-in-Progress for New Law School Teachers
AALS Annual Meeting, Washington, DC
Saturday, January 3, 2015
The AALS Section on Law, Medicine and Health Care is pleased to announce a Call for Papers for a special Works-in-Progress for New Law School Teachers Program. The Section will run the Program from 5:15 to 6:30 p.m. on Saturday, January 3, at the AALS 2015 Annual Meeting in Washington, DC.
This program will bring together junior and senior health law scholars for a lively discussion of the junior scholar's’ works-in-progress. Junior health law scholars will submit papers that they expect to submit in the spring 2015 law review submission cycle. After they briefly present their papers in a concurrent roundtable setting, senior scholars will provide oral comments and critiques. This new program presents an opportunity for the audience to hear cutting edge health law scholarship by recent members of the academy.
We will limit our selection to two or three papers.
Thursday, July 10, 2014
Riding in to work this morning, I heard an NPR story on raw milk, and it struck me once again that public health may be a victim of its own success.
I understand the appeal of knowing where your food is coming from. I remember how excited my nieces were to get ice cream at a local dairy and visit the cows that we assumed provided the milk for our treat. (They may not have.) But while most Americans could benefit from a better understanding of where of food comes from (including understanding it does not come in packages), there are reasons to be leery about returning to a day before pasteurization.
A 1943 article in the British Medical Journal estimates there were 65,000 deaths attributable to tuberculosis from raw milk in England and Wales between 1912 and 1937. This total does not include deaths from other causes associated with drinking raw milk. While there have been only two reported deaths from raw milk in the United States from 1998-2011, the Centers for Disease Control and Prevention reports that thousands have become ill as a result of drinking raw milk. Children, the elderly, pregnant women, and people with weakened immune systems are more susceptible to illness from raw milk.
Because in 2014 in the United States we infrequently see children die from infectious disease, it is easier to make a decision that risks infectious disease. In earlier generations, most people knew someone – a family member or a friend – who had been injured or died from infectious disease. Reports of polio would leave public swimming pools empty in the summer heat. Worldwide diarrhea still kills 760,000 children under the age of 5 each year, and measles remains one of the leading causes of death among young children. In the United States, access to antibiotics and vaccines have thankfully made such experiences a rarity. But as our collective memory of what those public health successes have achieved dims, we may ignore what public health has to tell us about our current risks.
HealthLawProf Blog extends a big welcome to our guest blogger for the month of July, Professor Leslie W. Wolf:
Leslie E. Wolf is Professor of Law at Georgia State University’s College of Law and Director of the College’s Center for Law, Health & Society. She has taught courses on medical liability, human subjects research, public health law, HIV/AIDS and the law, and bioethics. Professor Wolf came to GSU from the University of California, San Francisco, where she taught medical ethics and research ethics and also served on several research oversight committees. She has been both a Greenwall Fellow and a Greenwall Faculty Scholar.
Professor Wolf conducts research in a variety of areas in health and public health law and ethics, with a particular focus on research ethics. She has received funding for her research from the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Greenwall Foundation. This research includes projects on conflicts of interests, research with stored biological materials, Certificates of Confidentiality, IRB web guidance, and HIV-related laws and policies. She also has served on the Centers for Disease Control and Prevention’s Ethics Subcommittee to the Advisory Committee to the Director (2008-2012), as a peer reviewer for federal research programs, and has been an invited presenter to various government agencies
Wednesday, July 9, 2014
State reluctance to fund Medicaid programs adequately is an endemic problem for recipients, especially those who are dual eligibles or who rely on Medicaid for services to enable them to continue to live in the community. Yet despite the ACA’s laudable goals of expanding Medicaid and coordinating Medicaid services in the interests of improved care, states continue to constrain their Medicaid programs either directly by specifying the choice of providers or indirectly by discouraging provider participation by low reimbursement rates. Several recent challenges to the impact of these cost control efforts on assisted living services for people with disabilities are worth following.
First, Idaho providers of supported living services brought suit in 2009 challenging the Idaho legislature’s failure to appropriate sufficient funds. The state’s rate-setting study had recommended a substantial increase in funds, but the legislature did not approve the increase. The district court granted summary judgment to the providers and the 9th Circuit affirmed in a very brief opinion in April 2014. The district court’s reasoning, upheld by the 9th Circuit, was that the Medicaid Act requires state rates to be “‘consistent with efficiency, economy, and quality of care and … sufficient to enlist enough providers’ to meet the need for care and services in the geographic area. 42 U.S.C. § 1396a(a)(30).” Exceptional Child Center v. Armstrong , 2014 WL 1328379 (April 14, unpublished). Purely budgetary reasons such as those cited by Idaho do not suffice to meet this standard. Last week, Idaho appealed the 9th Circuit decision to the Supreme Court.
Second, independent living centers in Southern California have brought suit challenging California’s method for enrolling dual eligibles into managed care programs. Such efforts, touted as improving care coordination, come under criticisms that they are instead merely methods of cost control that will result in the loss of essential services. The plaintiffs are Communities Actively Living Independent & Free, the Westside Center for Independent Living, and Southern California Rehabilitation Services, Inc.; they seek to enjoin what they contend is California’s confusing notice to dual eligible about their impending reenrollment and how to opt out of it. Westside Center for Independent Living vs. California Department of Health Care Services, Cal. Civil No. 34-2014-080001884 (filed July 2, 2014).
I’ll post updates, if and when available.
Monday, July 7, 2014
I write this post with more than a little trepidation; I’m as unhappy as anyone about what the Court made of the Religious Freedom Restoration Act last week. Nonetheless, given the current state of play, I’ve tried to see whether there are any ways to try to limit the damage.
This Supreme Court term has featured a striking number of unanimous decisions. What has drawn unanimity in these cases has been the narrow basis on which they were decided. Commentators have praised Justice Roberts for his political skills in bringing the Court together—demonstrating that at least one branch of government remains functional and shoring up claims to judicial legitimacy. Other observers note, however, that the unanimity is only skin deep—and point to the cases in which the Court divided 5-4 as symptomatic. So suppose we perform a thought experiment on one of the most divisive decisions of this term, Hobby Lobby. How could the decision have been narrowed? How should it have been narrowed? Such an examination is invited by Justice Alito’s statement that the Court’s holding is “very specific.” It is also invited by Justice Kennedy’s concurrence, which opens with the assertion that the Court’s opinion “does not have the breadth and sweep ascribed to it by the respectful and powerful dissent. Finally and disturbingly, it is also invited by the observation that the Court has quite quickly, in the case involving Wheaton College, opened wide one of the apparently narrow doors.
Wednesday, July 2, 2014
Recruitment for Public Health Law faculty at University of South Florida Department of Health Policy & Management
University of South Florida – College of Public Health
Department of Health Policy & Management
Assistant/Associate Professor #18604
The Department of Health Policy and Management at the University of South Florida is recruiting for two faculty positions. We welcome applicants from a broad range of interests in health policy and management.
The University of South Florida is a metropolitan institution located in Tampa, Florida. USF offers comprehensive programs in public health, medicine, pharmacy, nursing, allied health sciences, business, engineering, arts and sciences, education, social work, and creative arts. USF offers unique opportunities for collaboration and research with institutions in Latin America and the Caribbean. The Tampa Bay area is a dynamic and growing metropolitan area of over two million residents that offers a wide range of cultural, artistic, athletic, and recreational activities, excellent public schools, close proximity to Gulf of Mexico beaches and an affordable cost of living.
Daniel Patrick Moynihan famously said, “Everyone is entitled to his own opinion, but not to his own facts.” When it comes to federal law, however, some people with religious beliefs may indeed be entitled to their own facts. The U.S. Supreme Court’s interpretation of the Religious Freedom Restoration Act (RFRA) in Burwell v. Hobby Lobby Stores, Inc. certainly leaves this impression. By allowing the corporations and their owners to determine what counts as a substantial burden on their “exercise of religion,” the five Justices in the majority appear to have removed that question from judicial review. This has serious implications for future claims that RFRA excuses corporations from complying with neutral and generally applicable federal laws.
Having decided that corporations can exercise the beliefs of their owners (or considering corporations and owners as one and the same – see Part 1 of this blog), and having assumed that the government has a compelling interest in women’s health and equality, Justice Alito’s opinion for the majority addressed whether HHS regulations (including all FDA approved contraceptives and services among the required preventive services that must be covered without cost-sharing) substantially burdened the corporations’ or owners’ exercise of religion under RFRA.
Tuesday, July 1, 2014
Call for Papers: Unbefriended Elderly: Making Medical Treatment Decisions for Patients without Surrogates
AALS Joint Program
Section on Aging and the Law ● Section on Law, Medicine, and Health Care
2015 AALS Annual Meeting in Washington, D.C.
January 3, 2015 from 3:30 to 5:15 p.m.
The AALS Section on Aging and the Law and the AALS Section on Law, Medicine, and Health Care are sponsoring a joint program at the January 2015 Annual Meeting. The program will consider many of the issues faced by elders, doctors, and the health care and social services systems when making medical treatment decisions for those incapacitated patients and residents who have no reasonably available legally authorized decision maker.
There are three confirmed panelists for this program:
(1) Ellen Fox, MD, former Chief Officer for Ethics in Health Care, U.S. Department of
(2) Professor Lawrence A. Frolik, University of Pittsburgh School of Law
(3) Erica Wood, JD, Assistant Director, ABA Commission on Law and Aging