Tuesday, August 5, 2014
Guest Blogger Visiting Assistant Professor Valerie Gutmann Koch - FDA Announces Plans to Regulate LDTs (But What About DTC Genetic Tests?)
Oversight of direct-to-consumer (DTC) genetic tests and laboratory developed tests (LDTs) in general has garnered increasing attention in the media. Most recently, on July 31, pursuant to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA), the FDA notified Congress that it intends to issue draft guidance for the oversight of LDTs – diagnostic tests (including genetic tests and tests for rare conditions) developed and performed by a single laboratory. The FDASIA requires the FDA to provide at least 60 days’ notice before publishing any draft guidance on the regulation of LDTs.
FDA’s decision to exercise its jurisdiction over LDTs as medical devices has been discussed and even expected for almost a decade. In June 2013 FDA Commissioner Margaret Hamburg called for more active FDA regulation of LDTs, stating that the Agency’s risk-based framework for regulating such tests was under development. Hamburg noted that the FDA has discretion in overseeing certain LDTs as devices. Although historically “they were relatively simple, low-risk tests performed on a few patients being evaluated by physicians at the same facility as the lab,” she explained that they now warrant oversight because they have become “more sophisticated and complex.”
HealthLawProf Blog is very pleased to welcome the second of our bloggers for the month of August, Visiting Assistant Professor Valerie Gutmann Koch. The following is her short bio:
Valerie Gutmann Koch is Visiting Assistant Professor at IIT Chicago-Kent College of Law and Lecturer in Law, Medicine, and Ethics at the MacLean Center for Clinical Medical Ethics at the University of Chicago. She also serves as Special Advisor to the New York State Task Force on Life and the Law, the state’s bioethics commission; she previously served as the Senior Attorney to the Task Force. Professor Koch's research interests focus on the issues arising at the intersection of law, medicine, and ethics, with a focus on emerging technologies in medicine and science and the legal challenges they pose. Previously, she practiced in the IP litigation practice at Kirkland & Ellis LLP. Professor Koch received her Juris Doctor from Harvard Law School, and she graduated magna cum laude with an A.B. from Princeton University's Woodrow Wilson School of International Affairs and Public Policy. Her recent research can be found on SSRN.
I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.
The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.
But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.
HealthLawProf Blog extends a big welcome to one of our guest bloggers for the month of August, Associate Dean and Associate Professor Joanna K. Sax:
Joanna Sax is an Associate Professor of law, the Associate Dean for Research and Faculty Development, and the co-Director of the Institute of Health Law Studies at California Western School of Law. Professor Sax has a J.D. Ph.D. from the University of Pennsylvania. Her Ph.D. is in Cell and Molecular Biology. Professor Sax combines her background in biomedical science and her legal education to focus on ways to incentivize the advancement of science. She also has expertise in the policies of the Food and Drug Administration; although she focuses on the food side. Professor Sax joined the faculty at California Western School of Law in 2009. She teaches Contracts, Trusts & Estates and a seminar entitled Law, Science & Medicine.
Thursday, July 31, 2014
On July 29, 2014, the U.S. Court of Appeals for the Fifth Circuit issued an as-applied ruling in a case involving Mississippi’s statute requiring that all physicians affiliated with a Jackson clinic providing abortion services have admitting and staff privileges at local hospitals. All local hospitals were unwilling to grant privileges to two of the clinic’s physicians who were involved most directly in abortion services because of the nature of their practices. Had the state’s statute been enforced, the clinic—Mississippi’s only facility offering abortion services—would have been ordered to close.
Mississippi’s argument was that ordering the clinic to close would not impose an undue burden on Mississippi women’s constitutional rights because women would be able to travel to nearby states for abortion services. The Fifth Circuit reasoned to the contrary: “Mississippi may not shift its obligation to respect the established constitutional rights of its citizens to another state. Such a proposal would not only place an undue burden on the exercise of the constitutional right, but would also disregard a state's obligation under the principle of federalism—applicable to all fifty states—to accept the burden of the non-delegable duty of protecting the established federal constitutional rights of its own citizens.” Jackson Women’s Health Organization v. Currier, 2014 WL 3730467 (July 29, 2014).
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