Friday, October 3, 2014
Sharona Hoffman, Citizen Science: The Law and Ethics of Public Access to Medical Big Data, Berkeley Tech. L. J. (Forthcoming).
Tsachi Keren-Paz, Injuries from Unforeseeable Risks Which Advance Medical Knowledge – A Restitution-Based Justification for Strict Liability, 29 Eur. J. of Tort L. 3 (2014).
Thursday, October 2, 2014
Guest Blogger Professor Erin Fuse Brown: Surprise! The Doctors at Your In-Network Hospital are Out-of-Network
Nick Bagley has written a great post at the Incidental Economist responding to Elisabeth Rosenthal’s recent article in the NY Times on out-of-network emergency physician billing. This phenomenon arises when a patient goes to an in-network hospital, but the physicians staffing the emergency room are out-of-network. As a result, patients get balance-billed by the out-of-network physicians for large amounts that are not subject to their deductible or out-of-pocket limits. I wanted to pile on to the moral outrage and add some thoughts about legal solutions.
This week several groups called for the resignation of FDA Commissioner Dr. Margaret Hamburg in a letter to HHS secretary Sylvia Burwell. Why? Because of the agency’s stance on opioid drugs, as reflected in their statement, “preventing prescription opioid abuse and ensuring that patients have access to appropriate treatments for pain are both top public health priorities for the FDA.” Keep in mind, the agency has not been idle on the issue of preventing untimely deaths related to opioids. For example, hydrocodone products were recently rescheduled from schedule III to schedule II and the Risk Evaluation Mitigation Strategy (REMS) program was instituted last year. But in the fog of moral panic in response to untimely opioid related deaths, there is little room for moderate stances that factor the wellbeing of all patients in public policy.
The warning by the Centers for Medicare and Medicaid Services (CMS) last week that up to 115,000 people might lose their health insurance under the Affordable Care Act (ACA) unless they can send proof of their citizenship or immigration status was more than a bit ironic. After spending much of the year and millions of dollars trying to boost participation in the exchanges, CMS is now trying to reduce participation. In so doing, it will likely exclude many young, healthy adults, just the type of people that the exchanges need to succeed
The reason for the exclusion lies with the heated politics of immigration, and our ambivalent approach to providing immigrants with health care. Although the ACA’s critics have lambasted the law on many accounts, when the Act was first debated in Congress no charge – not even death panels! -- was made more heatedly or drew more attention than the claim that the Act would cover illegal immigrants. It was that charge, after all, that Representative Joe Wilson referred to when he shouted “You lie!” during the President’s speech to a joint session of Congress.
Wednesday, September 24, 2014
Under HIPAA, patients' spouses and other family members have certain rights to access health information. In an important guidance document in the wake of United States v. Windsor, the Office for Civil Rights (OCR) at HHS has clarified that "spouse" under HIPAA refers to legally married same-sex spouses, even if the individual is receiving services in a jurisdiction not recognizing same-sex marriage.
This guidance deals with several specific provisions of HIPAA. First is the definition of "family member" in 45 CFR 160.103, added in the omnibus rule-making for the HITECH Act and GINA. This definition applies to both the HIPAA security and the HIPAA privacy rules. It provides that relatives by "marriage" are to be treated the same as relatives by consanguinity and that spouses are first-degree relatives. According to the guidance, "spouse" includes "individuals who are in a legally valid same-sex marriage sanctioned by a state, territory, or foreign jurisdiction (as long as, as to marriages performed in a foreign jurisdiction, a U.S. jurisdiction would also recognize the marriage)." In addition, "marriage" includes "both same-sex and opposite-sex marriages" and "family member" includes "dependents of those marriages." These definitions hold whether or not an individual lives in a jurisdiction recognizing same sex marriage and whether or not the individual is receiving health care services in a jurisdiction recognizing same sex marriage.
The second provision treated in the guidance is 45 CFR §164.510(b), the section of the Privacy Rule governing when individuals must be given an opportunity to agree or object to uses or disclosures of protected health information. This standard permits disclosure to family members of information directly relevant to the family member's involvement in a patient's care, with certain limitations. It also permits disclosure of information needed to inform family members of the patient's location, general condition, or death, again with limitations. If the patient is available and competent, they must agree to or be given an opportunity to object to the disclosure, or the provider must reasonably infer that they do not object. An example is a family member picking up a prescription for another family member.
The third provision to which the guidance applies is 45 CFR §164.502(a)(5)(i), the provision that prohibits health plans, other than issuers of long-term care policies, from using or disclosing genetic information for underwriting purposes. Such plans may not use information about family members' genetic tests or the manifestation of disease in family members to make underwriting decisions. Here, too, "family member" encompasses same-sex spouses on the same basis as opposite sex spouses.
The HIPAA privacy rule also contains provisions regarding rights of personal representatives. In general, the structure of the rule is to defer to state law regarding who counts as a patient's personal representative. Many states have surrogate decision making statutes authorizing a prioritized list of others to make decisions for patients lacking decision making capacity; typical priority lists begin with the holder of the patient's power of attorney for health care, the patient's guardian if any, and then the patient's spouse. These provisions are a matter of state law, however, and not part of the Privacy Rule itself. Many states also provide that personal representatives have the same rights as patients themselves with respect to health information, although some states now have advance directive statutes that invite patients to specify rights of their personal representatives to access health information. The guidance indicates that OCR is planning to issue "further clarification" or a notice of proposed rulemaking regarding same sex spouses as personal representatives. Stay tuned.
Saturday, September 20, 2014
CREIGHTON UNIVERSITY SCHOOL OF LAW invites applications for a lateral tenured or tenure-track professor in health care law to join our faculty in Fall 2015. Applicants should have significant academic or practice experience in the business side of health care (e.g., the financing and regulation of health care, including but not limited to the Affordable Care Act). Creighton University has seven health care schools on its campus, as well as a College of Arts and Sciences and a College of Business, and the Law School is particularly interested in establishing interdisciplinary programs with those schools for non-JD as well as JD students. Candidates with experience in developing such programs are especially encouraged to apply. Candidates should have excellent academic credentials and a proven record of (or demonstrated potential for) outstanding classroom teaching and scholarship.
Katherine A Curnow, Information, Power and Relationships: Minimising Barriers to Access to Justice for End of Life Disputes, 25 Australasian Disp. Resol. J. 137 (2014).
Ali Sunyaev, Tobias Dehling, Patrick L. Taylor, Kenneth D. Mandl, Availability and Quality of Mobile Health App Privacy Policies, J. of the Am. Med. Informatics Ass'n (2014).
Guest Blogger Associate Professor Diana R.H. Winters: So Much, But Yet Not Enough - The Administration’s Plan to Combat Antibiotic Resistance
Yesterday was a big day in the fight against antibiotic resistance. The White House released an Executive Order and a National Strategy document on Combating Antibiotic-Resistant Bacteria, the President’s Council of Advisors on Science and Technology (PCAST) released a report on antibiotic resistance, and the National Institutes of Health and the Biomedical Advanced Research and Development Authority announced a $20 million prize for developing tests to identify highly resistant infections. Kevin Outterson at The Incidental Economist, Food Safety News, and the New York Times provide a good summary of these developments.
It is clear that the administration recognizes the grave threat posed by antibiotic resistance and that it intends to make combating this danger a national priority. Its approach is broad—the National Strategy includes a “Guiding Principle” that “[d]etecting and controlling antibiotic resistance requires the adoption of a ‘One-Health’ approach to disease surveillance that recognizes that resistance can arise in humans, animals, and the environment,” and the strategy pays much attention to the role of antibiotics in food production. One main objective of the strategy is to eliminate the use of medically important antibiotics at subtherapeutic levels for growth promotion (the practice of feeding animals antibiotics to make them fatter, not to make them well).
Tuesday, September 16, 2014
Guest Blogger Assistant Professor Jennifer A. Brobst: Whether The Movement To Criminalize Revenge Porn Will Serve As An Effective Coercive Public Health Strategy
Revenge porn involves the attempt by an offender to harm another person’s reputation and wellbeing through the online posting and distribution of sexually explicit images of that other person without his or her consent. In a 2013 survey, approximately 10% of ex-partners have threatened to post sexually explicit images online, of which 60% have done so. Other research noted by the American Psychological Association, accompanying this survey, has indicated that more men than women currently report being victims of revenge porn, contrary to the public media focus on women as primary victims.
While existing voyeurism and invasion of privacy charges and causes of action address the taking of such images without a person’s consent, until recently there were civil but not criminal remedies for the distribution of sexual images without consent, such as private images taken together during a relationship or through sexting. According to the National Conference of State Legislatures, as of August 15, 2014, the following states enacted revenge porn criminal statutes in 2013 or 2014: Arizona, California, Colorado, Georgia, Hawai’i, Idaho, Maryland, New York, Pennsylvania, Utah, Virginia, and Wisconsin. At least sixteen other states have pending legislation to adopt similar provisions.
The University of Richmond Journal of Law & the Public Interest currently has five openings for articles for the two general issues of their volume. As a Journal that centers in large part on the Public Interest, the Journal will be happy to accept and review articles on a broad range of topics that affect citizens on a national level or in the Commonwealth of Virginia.
Guest Blogger Professor Wendy Parmet - King v. Governor of the State of New Jersey: Applying the First Amendment to Laws Regulating Physician Speech
Last week’s decision by the U.S. Court of Appeals for the Third Circuit in King v. Governor of the State of New Jersey, provides an insightful addition to the growing body of case law examining the clash between the state’s power to regulate clinical practice andfree speech.
Although the common law of informed consent arguably implicates the First Amendment rights of physicians and other health professionals, the conflict between the state’s power to regulate health care and free speech has become more apparent in recent years as state legislatures have increasingly enacted laws prescribing what physicians and other clinicians can and cannot say. Such laws are especially common with respect to abortion, but state legislatures have also required physicians to provide specific information about breast cancer treatments, or refrain from asking patients about gun ownership.
Carl E. Fisher, David L. Faigman, Paul S. Appelbaum, Toward a Jurisprudence of Psychiatric Evidence: Examining the Challenges of Reasoning from Group Data in Psychiatry to Individual Decisions in the Law, SSRN.
Katherine A. Curnow, Lisa C. Toohey, A Focus on Process: Procedures to Address Disputes About End of Life Decisions, 24 Australasian Disp. Resol. J. 45 (2013).
There was an article a couple of weeks ago in the New York Times about “engineered foods,” and how “a handful of high-tech start-ups are out to revolutionize the food system by engineering ‘meat’ and ‘eggs’ from pulverized plant compounds or cultured snippets of animal tissue.” The author discussed some of the business models, interviewed some of the entrepreneurs, and contemplated some of the implications of “Food 2.0.” The concerns she noted involved the nutritional impact of these foods, and the possibility of resource-intensive production.
But what sort of screening will these food products go through before they enter the food supply? How will FDA vet these new foodstuffs for toxicity or allergenic properties? It won’t. Manufacturers can self-affirm that food products are safe, based on their own studies, and market them on that basis with no prior FDA approval. This is the GRAS (generally recognized as safe) route to marketability. A manufacturer could also choose to submit to the formal food additive approval process, which is extremely time-consuming, but considering the breadth of the GRAS exception, they probably won’t. Many more GRAS notifications are filed per year than food additive petitions.
Thursday, September 11, 2014
Jennifer M. Jørgensen, Paula L. Hedley, Mickey Gjerris, Michael Christiansen, Ethical Issues Related to Screening for Preeclampsia, 28 Bioethics 360 (2014).
Thomas Jefferson School of Law
Announces the First Annual
Jameson Crane III Disability and the Law
The Crane Writing Competition is designed to encourage outstanding student scholarship at the intersection of law and medicine or law and the social sciences that promotes an understanding, furthers the development of legal rights and protections, and improves the lives of those with disabilities.
Cleveland-Marshall College of Law
Journal of Law and Health
You are invited to submit an Article for possible inclusion in the Journal of Law & Health’s Annual Symposium: The Social, Ethical, and Legal Consequences of Sports-Related Brain Injuries. The Journal of Law & Health is a student-run publication dedicated to publishing innovative articles that offer diverse perspectives on the intersection between law, health, and medicine.
What makes a public health threat an emergency? In this week’s New England Journal of Medicine, Rebecca Haffajee, Michelle M. Mello and I ask this question in connection with Massachusetts Governor Deval Patrick’s decision last spring to declare the opioid-addiction epidemic a “public health emergency.” In our Perspective we do not question the seriousness of the opioid-addiction problem; or the specific policies Patrick implemented. Rather, we ask whether the epidemic warranted the invocation of emergency powers.
In the years since 9/11, in the name of public health legal preparedness, public health officials and scholars have focused much attention on the need for so-called emergency laws to strengthen the response to a public health emergency. Although the exact parameters of emergency laws vary, they typically allow for the suspension of some or most ordinary legal procedures and protections. Thus when an emergency is declared, the rules of the legal system are suspended. Executives can take action without awaiting legislative approval, or following the typical administrative process. Judicial review may also be significantly curtailed. As my co-authors and I discuss, this has enormous costs, not only on the individuals and entities whose interests are affected, but on the credibility of public health officials who must ultimately depend on the public’s trust. If the public comes to believe that declarations are issued too easily, its support for public health may diminish. In addition, in the absence of legislative and judicial checks, executive powers may easily be turned against vulnerable populations, as they have been too often in history.
This week, at Southern Illinois University School of Law, our annual Grayson Distinguished Lecture in health law featured Texas family law attorney Jessica Hall Janicek. Janicek successfully represented the family of Marlise Muñoz, who petitioned the state court in January 2014 to force the hospital to remove bodily sustaining devices after Ms. Muñoz collapsed and became brain dead while 14 weeks pregnant. Muñoz, a paramedic, had had a clear oral advance directive, choosing to opt out of life sustaining measures. However, the state hospital asserted through the District Attorney that Texas law would override her wishes and keep her body on a ventilator in the interests of saving the life of the fetus. At least 12 states have similar strict provisions overriding women’s advance directives if they are pregnant, regardless of whether the fetus is viable or if it will cause her unendurable pain or additional harm (i.e., Alabama, Idaho, Indiana, Kansas, Kentucky, Michigan, Missouri, South Carolina, Texas, Utah, Washington, and Wisconsin). Most other states, including Illinois, override a woman’s clear choice to decline life sustaining measures if she is alive and pregnant and the fetus has a probability of viability, following the Uniform Rights of the Terminally Ill Act. Maryland, New Jersey and Vermont stand out as the three which expressly permit pregnant women to control whether and how they wish to use life sustaining treatment in an advance directive.
The St. Louis Police Department (SLPD), which is geographically and jurisdictionally distinct from Ferguson and St. Louis County, has a relatively new chief of police who, in the wake of the events in Ferguson, acknowledged the legitimacy of citizens’ concerns about police interactions and a commitment to restoring communication and trust. Chief Dotson has consistently embraced a progressive stance on police operations, even in the face of strong resistance to maintain the status quo. Less than two months ago, he welcomed the new SLPD headquarters by emphasizing the value of modernizing the department’s infrastructure and practices. His repeated message: “It costs more to live in the past, than it does to invest in the future.”
Seema K. Shah, Piercing the Veil: The Limits of Brain Death as a Legal Fiction, U. of Mich. J. of L. Reform (Forthcoming).
Anna Lindblad, Niels Lynöe, Niklas Juth, End‐Of‐Life Decisions and the Reinvented Rule of Double Effect: A Critical Analysis, 28 Bioethics 368 (2014).
Eline M. Bunnik, A. Cecile J.W. Janssens, Maartje Schermer, Informed Consent in Direct‐To‐Consumer Personal Genome Testing: The Outline of a Model between Specific and Generic Consent, 28 Bioethics 343 (2014).
Douglas Mackay, Standard of Care, Professional Obligations, and Distributive Justice, 28 Bioethics 352 (2014).