Wednesday, October 22, 2014
Cross-posted from Bill of Health
The enormity of the tragedy in West Africa remains hard to appreciate even as Ebola begins to migrate into developed countries. In the U.S. mindless panic stoked by the 24 hour news cycle and fear-mongering politicians are not the only familiar phenomena. In important ways our “Ebola crisis” is only tangentially related to a malicious virus and has much more to do with the state of our health care system. Consider the following “Ebola issues”
- Ebola has been marked by uncertainty as to federal and state responsibilities for infectious disease policy, prevention and reaction. Sadly, first impressions have been confirmed by the appointment of an Ebola “czar”, a sure sign that various branches of government have not been playing well together. Such regulatory fragmentation and lack of coordination is not new. Health care is our most regulated industry emanating from a bewildering array of legislation and regulation enforced by innumerable and frequently dysfunctional federal and state agencies.
- That lack of coordination has been replicated at the local level between agencies and healthcare institutions and between multiple institutions. Regional or local planning appears to be missing or only reactive. In a post-Katrina, post-swine flu world it seems extraordinary that there were not cogent plans waiting to be executed. Of course “There are only four in the U.S. with special isolation units designed to contain biohazards like Ebola” but why weren’t there plans to utilize them? Even now how many localities have a plan to handle, say, a major outbreak by using a centralized, tertiary care facility?
- We don’t know exactly what happened at Texas Health Presbyterian Hospital in Dallas (although some reports are now quite detailed). At the least there are suspicions of fragmentation and lack of coordination within the hospital. That shouldn’t be a surprise. In too many healthcare institutions inadequate systems, lack of teamwork, ambiguity at hand-offs, etc., stubbornly remain part of the narrative.
- In Dallas one or several healthcare workers made a mistake. And, if it is true that Thomas Duncan’s blood was transported through the hospital’s pneumatic tube system, so did the facility. It is now 15 years since the publication of To Err is Human. How can it be that preventable adverse events are now the number 3 killer in the U.S. after heart disease and cancer? Just last week a major hospital in Los Angeles recently suspended elective surgeries after an outbreak of surgical infections. Why would we believe that such institutions could handle a case or two of Ebola?
- Press reports suggest that affected healthcare institutions had either inadequate protocols in place to combat a contact virus like Ebola or that protocols were not properly implemented or followed. Thankfully, the CDC now seems to be working hard to provided updated protocols and guidance. Yet, overall, many healthcare system stakeholders treat protocols or clinical practice guidelines as optional. The Affordable Care Act’s section 3501 mandate to AHRQ has never looked more vital.
- The tragedy of Thomas Duncan’s death was almost instantly overshadowed by a blame game. Someone or something must have been responsible—the CDC, doctors, nurses, the victim, even technology. Once again the urging of the IoM in To Err to concentrate on system and process reform and move away from individual blame seems to have been ignored. Notwithstanding, because we lack any sensible alternative compensation system some healthcare institutions or workers, maybe even airlines could face liability claims and in some cases an OSHA investigation.
- Even seasoned observers of the culture of blame in healthcare likely were surprised to see the Dallas hospital throw their electronic health records system under the proverbial bus. As David Blumenthal later noted the problem in Dallas was “humanware, not the software,” but also reflected on how “providers’ unhappiness with EHRs reflects profound underlying dysfunctions in our health care system.” Sadly that instinctive criticism of the facility’s EHR illustrates a dislike of HIT in hospitals caused by underperforming technologies and poor integration into clinical workflows. Further the general failure of the meaningful use subsidies to improve interoperability does not bode well for tracking patients during large outbreaks, or supplying CDC with good data to plug into its predictive analytics models.
- Of course once the blame game starts almost anything can be criticized and HIPAA has long carried a large target on its back. In the case of the Ebola patients in Dallas HIPAA apparently is simultaneously both too leaky and insufficiently transparent. However, at the moment there seems little need to dispense with our general rules protecting patients’ confidential information. Public health authorities already have access to the PHI they need. And, if there was to a major Ebola outbreak such that the President declared a public health emergency the HHS Secretary can waive some HIPAA rules for hospitals that have instituted an emergency protocol. On a related note the Americans with Disabilities Act (ADA) imposes some privacy-like requirements, for example by limiting the amount of information that can be required of an employee and placing limitations on requiring medical examinations.
In short almost every issue raised so far is not Ebola (or even pandemic) specific but further evidence that the Affordable Care Act was only a baby step towards righting our health care ship. As my colleague Fran Quigley observed about the ongoing catastrophe in Africa, “functioning health systems have proved elusive for the world’s poor.” But here we should be able to do better.
Friday, October 17, 2014
The announcement by Apple and Facebook that they will cover the costs of egg freezing predictably provoked some controversy—predictably because it involves reproduction and also because too many people do not trust women to make reproductive decisions.
Interestingly, the challenge to women’s autonomy can come from both sides of the political spectrum, as has happened with several assisted reproductive technologies. Scholars on the left criticized surrogate motherhood on the ground that surrogates were exploited by the couple intending to raise the child, and other new reproductive technologies are criticized on the grounds that women will feel obligated to use them rather than free to use them. Indeed, this concern about coercion drives some of the objections to egg freezing.
Some women freeze their eggs because they face infertility from cancer chemotherapy; other women may not have found a life partner and want to suspend their biological clock until that time comes.
But some observers worry that with the option of egg freezing, some women will succumb to the pressures of the workplace and choose egg freezing not because they really want to but because they feel that have to. After all, if a woman can delay procreation and put in long hours at the office, why shouldn’t she do so? Employers might think that women who forgo egg freezing are not really committed to their jobs.
These concerns are legitimate, but are people too willing to invoke them? Egg freezing is not a simple procedure, nor is its success a certainty. Even if covered by insurance, women are not likely to choose egg freezing lightly. We should worry that egg freezing critics may be too ready to question the decision making capacity of women contemplating their reproductive choices.
Thursday, October 16, 2014
Kara Loewentheil, Satanists, Scott Walker, & Contraception: A Partial Account of Hobby Lobby's Implications for State Law, 9 Harvard L. & Pol'y Rev. (Forthcoming, 2015).
Seema Mohapatra, Use of Facial Recognition Technology for Medical Purposes: Do Our Current Laws Protect Health Privacy?, Pepperdine L. Rev. (Forthcoming).
Emma Cave, Competence and Authority: Adolescent Treatment Refusals for Physical and Mental Health Conditions, 8 Contemp. Soc. Sci.92 (2013).
Guest Blogger Research Fellow and Lecturer in Law Tara A. Ragone: Experimenting with Transparency and Decision Support to Inform Health Plan Selection
As we prepare for the second open enrollment period for the health insurance marketplaces to begin in just over one month, transparency offers a potential means of empowering consumers to make better decisions regarding the health plans they choose.
Some states are making strides in this area. The New Hampshire Insurance Department was an early leader on the transparency front, creating a website called NH HealthCost in 2005 to provide information on the costs of medical services based on claims data collected from the state’s insurers and stored as part of the Comprehensive Health Care Information System. Although the site was down for months earlier this year because of problems encountered when it changed vendors, it is back up and running and promises that “significant changes” are in store. Currently, however, it only offers data on the costs of a few dozen medical services, such as MRIs, CT scans, ultrasounds, X-rays, colonoscopies, and emergency room visits.
HealthLawProf Blog is very pleased to welcome the second of our bloggers for the month of October, Research Fellow and Lecturer in Law Tara A. Ragone. The following is her short bio:
Tara Adams Ragone joined the Center for Health & Pharmaceutical Law & Policy as a Research Fellow and Lecturer in Law in 2011. Her research and writing for the Center focus on implementation of health care reform, accountable care organizations, health care access, prescription drug abuse, and issues related to the representation of health care professionals. Ms. Ragone also developed and teaches a health law skills course that explores substantive law and skills specific to three common health law practice settings. She also advises the health law moot court team and regularly contributes to Seton Hall Law’s Health Reform Watch blog.
HealthLawProf Blog is very pleased to welcome the first of our bloggers for the month of October, Professor Jean Macchiaroli Eggen. The following is her short bio:
Jean Macchiaroli Eggen is Distinguished Professor of Law at Widener’s Delaware campus. Professor Eggen specializes in toxic torts, torts ,and civil procedure. After joining the law faculty of Widener in 1986, she became one of the first legal academics to develop the new discipline of toxic torts and introduce it into the legal curriculum of a law school.
Distinguished Professor Eggen received an A.B. from Connecticut College and an M.A. from Michigan State University, and was a Ph.D. Candidate (ABD) at the University of Michigan. She received a J.D., magna cum laude, from Syracuse University College of Law, where she served as Editor-in-Chief of the Syracuse Law Review, held the prestigious Syracuse University Graduate Fellowship, and received awards for published writing. Following law school, Professor Eggen worked as a tort and environmental litigation attorney at the law firm of Bond, Schoeneck & King in Syracuse, New York. She is admitted to practice in New York.
Wednesday, October 15, 2014
Cross-posted from Bill of Health
Recent speculation about healthcare disruption seems to have moved away from HIT to mHealth (discussed here). Apple has fueled this trend with its launch of sensor-laden iPhones and the new Apple Watch, iOS 8’s Health app and the HealthKit API framework. The future, we are told, is in mHealth provided by our phones and wearables notwithstanding that we have yet to solve data protection and other issues associated with the new devices.
Over the last few days leaks have suggested that web behemoths Facebook and Google may have their own takes on the future of healthcare. Reuters reports that Facebook is doing, lets face it, what you would expect—creating online “support communities” for patients with similar conditions and diseases.and creating “preventative care” applications. Now, Engadget reports that Google is testing a new service that offers chats with doctors when a user searches for symptoms. The service seems related to Google Healthcare Helpouts, a video telemedicine platform that launched a year ago to some on-line speculation about healthcare disruption but which today seems limited to a small number of mostly non-physician therapists, family counsellors, coaches or other advisors.
The twitter (@nicolasterry) chatter this morning speculated on how Google would comply with HIPAA if such a service exists. But, of course, Google is not a HIPAA covered entity. On the other hand, the doctor offering to chat with the patient presumably is. As with Healthcare Helpouts, therefore, Google likely will be the doctor’s business associate (“Helpouts providers can enter into a BAA with Google when they create a listing on Helpouts”). Obviously we will need more information to assess such a relationship. While some Google services seem to offer HIPAA compliance not all do. At the moment it is unclear the extent that Helpouts, its chat function and the storage of any data generated would comply with both the privacy and security rules.
Some of the more interesting questions about this new service concern state not federal law. If Google follows its Helpouts model it will require credentialing of the doctors providing the services raising the specter of actions for negligent credentialing against Google.
However, it is the doctors involved that seem to face the greatest legal jeopardy. There is one outlier on the moribund-looking Google Healthcare Helpouts roll, the One Medical Group that offers state specific medical consultations to its current members. Note those closely worded limitations. Therein lies the problem. State law is going to throw several barriers in the way of the new Google service. First, opening that chat window is also going to open a physician-patient relationship with all the legal (and ethical) implicationsthat follow. Second, some states will require all the information collected during the encounter to be documented in the patient’s medical record. Most importantly, however, it would seem hard for Helpout doctors to argue that chat encounters are anything but the “practice of medicine.” State medical boards and their regulations are astoundingly sensitive to doctors practicing across state lines or treating patients out of their physical presence.
So this really is a case of caveat doctor. There are enough legal issues here for a law school exam (bonus points for any discussion of Google and the corporate practice of medicine) suggesting an abundance of caution. In part, that is a shame. We are still dismally far from providing low cost, 24×7 convenient access to medical advice and services and just-in-time medical services triggered by a symptoms search seems an attractive innovation. On the other hand, like clinics in retail stores or urgent care centersGoogle’s medical chat seems more likely to increase fragmentation than solve it and, in the process, risk some medical licenses.
Saturday, October 11, 2014
The SEALS 2015 meeting is at the Boca Raton Resort & Club in Boca Raton, Florida, from July 27 to Aug. 2, 2015. In past years, we have collected expressions of interest in health law programming, helped facilitate groupings into panels and discussion groups and were successful in creating a workshop of a few days of sequential programming to make travel and attendance easier.
If you are interested in participating, please enter your thoughts on this form by October 15. After the 15th, I will share the submissions and we can organize for submission through the SEALS system by Oct 31. Hopefully, we can consolidate the health law offerings into a workshop day or two sequential days like 2013 and 2014. The SEALS guidelines about submission types can be viewed here if you would like more information about the rules that apply to panels and discussion groups.
You are absolutely welcome to propose directly through the SEALS site instead or if you have done so already, feel free to let me know so we can include you in this process. Of course, please let me know if you have any questions.
Kelly K. Dineen, JD, RN, PhD(c)
Assistant Professor of Health Law & Ethics
Albert Gnaegi Center for Health Care Ethics &
Saint Louis University School of Law
Center for Health Law Studies
Michele Goodwin, Fetal Protection Laws: Moral Panic and the New Constitutional Battlefront, 102 Cal. L. Rev. 781 (2014).
Julie Tannenbaum, The Promise and Peril of the Pharmacological Enhancer Modafinil, 28 Bioethics 436 (2014).
Jonathan Pugh, Embryos, the Principle of Proportionality, and the Shaky Ground of Moral Respect, 28 Bioethics 420 (2014).
Paul Fronstin, M. Christopher Roebuck, Quality of Health Care After Adopting a Full-Replacement, High-Deductible Health Plan With a Health Savings Account: A Five-Year Study 404 EBRI Issue Brief 4 (2014).
Steve Calandrillo, Chryssa V. Deliganis, In Vitro Fertilization and the Law: How Legal and Regulatory Neglect Compromised a Medical Breakthrough, Ariz. L. Rev. (Forthcoming, 2015).
James G. Hodge, The Changing Nature and Scope of Public Health Emergencies in Response to Annual Flu, 11 Biosecurity & Bioterrorism: Biodefense Strategy, Practice, & Sci. 142 (2014).
Thaddeus Mason Pope, Legal Briefing: Brain Death and Total Brain Failure, 25 J. of Clinical Ethics 245 (2014).
Marc A. Rodwin, Compensating Pharmaceutical Injuries in the Absence of Fault. 62 Food & Drug L. J. 448 (2014).
Marc A Rodwin, Justin Silverman, Why the Medical Malpractice Crisis Persists Even When Malpractice Insurance Premiums Fall, 25 Health Matrix, (Forthcoming, 2015).
Zack Buck, Breaking the Fever: A New Construct for Regulating Overtreatment, 48 U.C. Davis Law Review (Forthcoming, 2015).
Thursday, October 9, 2014
While controversial among some ethics experts, uterus transplantation has been performed several times, most commonly in Sweden. A few weeks ago, a mother for the first time gave birth to a baby gestated in a transplanted uterus.
Should we worry about uterus transplants? Transplanting life-extending organs, like hearts, livers, lungs and kidneys, has become well-accepted, but observers have raised additional questions about transplantation for life-enhancing body parts like faces and hands. As long as transplant recipients have their new organs, they must take drugs to prevent their immune systems from rejecting the transplanted organs. The risks can be substantial. For example, the immunosuppressive drugs put people at an increased risk of cancer. It is one thing to assume health risks for the possibility of a longer life, but are the risks of being a transplant recipient justified by improvements in the quality of life?
Wednesday, October 8, 2014
As NPR reported yesterday, voters in Colorado and Oregon will decide next month whether foods with genetically-modified (GM) ingredients should be identified as such with labeling. And why not? More information usually is better, and many people care very much whether they are purchasing GM foods. Moreover, it is common for the government to protect consumers by requiring disclosures of information. Thus, sellers of securities must tell us relevant information about their companies, and sellers of food must tell us relevant information about the nutritional content of their products.
Nevertheless, there often are good reasons to reject state-mandated disclosures of information to consumers. Sometimes, the government requires the provision of inaccurate information, as when states require doctors to tell pregnant women that abortions result in a higher risk of breast cancer or suicide. At other times, the government mandates ideological speech, compelling individuals to promote the state’s viewpoint. Accordingly, the First Amendment should prevent government from requiring the disclosure of false or misleading information or of ideological messages. (For discussion of abortion and compelled speech, see this forthcoming article.)
What about GM labeling? Is this similar to requiring country-of-origin labeling for meat and produce, a policy upheld by the D.C. Circuit earlier this year? GM labeling likely will mislead more than inform. Many people harbor concerns about genetic modification that are not justified by reality. In particular, as the NPR report indicated, researchers have not found any risks to health from eating GM foods. Indeed, genetic modification can promote better health, as when crops are fortified with essential vitamins or other nutrients. For very good reasons, GM foods run throughout the food supply, whether from traditional forms of breeding or modern laboratory techniques. Thus, the American Association for the Advancement of Science has concluded that GM labeling “can only serve to mislead and falsely alarm consumers.”
[cross-posted at PrawfsBlawg and orentlicher.tumblr.com]
Tuesday, October 7, 2014
Guest Blogger Assistant Professor Jennifer A. Brobst and Keegan Warren-Clem, Esq.: Why Health Law Should Take The Lead In Addressing Secondary Traumatic Stress Among Attorneys And Judges
Health law need not focus externally on clients only, but should embrace the medical and mental health needs of its own at-risk practitioners. While more has been discussed with regard to addiction, depression and suicide in the legal profession, primarily relegated to Lawyer Assistance Program CLEs, there is a growing awareness of the need to include traumatic stress in the discussion of serious mental health concerns facing attorneys. The last two decades have presented important gains in psychological research and understanding of traumatic stress, research which the legal profession should be embracing to improve the well-being of its own practitioners.
While some attorneys are directly exposed to traumatic and shocking events in the course of their representation, such as a violent assault in a courtroom or witnessing a client suicide, more often attorneys are repeatedly exposed to clients who themselves have been exposed to trauma. Some legal areas of practice are more susceptible to this exposure and its attendant risk of secondary traumatic stress, including, for example, immigration law, criminal law, poverty law, family law, domestic violence law, mental health and disability law, and the law of child abuse and neglect. Unfortunately, the legal profession is one of the last to examine itself with respect to risks of traumatic stress, where law enforcement, medicine, EMS, psychology and social work have all engaged in a much more extensive examination over the past several decades to ameliorate and prevent professional secondary traumatic stress (see Brobst 2014 below).
Monday, October 6, 2014
If you are a health law professor attending the January 2015 AALS Annual Meeting in Washington, DC, there is robust programming in our area of teaching and scholarship. There are at least six distinct health law events summarized below.
In addition, please consider serving as a commentator as part of a new “Works in Progress for New Law Teachers” program by the Section on Law, Medicine and Health Care. This Saturday evening session is comprised of three separate concurrent roundtables with the junior authors identified below. If you can participate, please contact chair-elect Thaddeus Pope (firstname.lastname@example.org).
Tsachi Keren-Paz, Alicia El Haj, Liability versus Innovation: The Legal Case for Regenerative Medicine, Tissue Engineering (2014).
Rebecca J. Cook, Joanna N. Erdman, Bernard Dickens, Abortion Law in Transnational Perspective: Cases and Controversies - Introduction, Pa. Stud. in Hum. Rts. Series (2014).
Melissa Hamilton, The Reliability of Assault Victims’ Immediate Accounts: Evidence from Trauma Studies, 26 Stanford L. & Pol'y Rev. (Forthcoming, 2015).
Shane P McNamee, The Regulatory and Liability Implications of Nano-Scale Drug Delivery in the Human Body, 11 Nanotechnology L. & Bus. (2014).
Brian S. Clarke, Coming Out in the Classroom: Law Professors, Law Students and Depression, J. of Legal Educ. (Forthcoming).
HealthLawProf Blog would like to thank our wonderful August and September guest bloggers, Associate Dean and Associate Professor Joanna K. Sax, Visiting Assistant Professor Valerie Gutmann Koch, Assistant Professor Jennifer A. Brobst, Professor Wendy Parmet, Associate Professor Diana R.H. Winters, Assistant Professor Kelly Dineen. Here is a short recap of their posts:
Visiting Assistant Professor Valerie Gutmann Koch posted the following: FDA Announces Plans to Regulate LDTs (But What About DTC Genetic Tests?), Ventilator Allocation in a Pandemic, How an Obligation to Return Research Results Is (and Should be) Changing the Investigator-Participant Relationship, and Bioethics Fact and Fiction in Lifetime’s The Lottery.
Assistant Professor Jennifer A. Brobst posted the following: The Global Ebola Health Crisis – Counteracting The Western Media’s Privilege And Prejudice In The Classroom, A Lesser Right to Die for Pregnant Women, and Whether The Movement To Criminalize Revenge Porn Will Serve As An Effective Coercive Public Health Strategy.
Professor Wendy Parmet posted the following: Ebola and the Return of Quarantine, Defining Public Health Emergencies, King v. Governor of the State of New Jersey: Applying the First Amendment to Laws Regulating Physician Speech, and Expelling Immigrants from the Exchanges.
Associate Professor Diana R.H. Winters posted the following: Designing policy interventions in the context of obesity—what we can learn from the effects of cigarette taxes on children’s health, Questioning Quorn, and So Much, But Yet Not Enough - The Administration’s Plan to Combat Antibiotic Resistance.
Saturday, October 4, 2014
Touro Law School’s Law Review is currently working on a written symposium issue on the subject of “Conflict Management in Healthcare.” The Law Review is looking to have this published in early 2015.
Manuscripts have already been submitted by academicians and practitioners who work in the area of dispute resolution and, more uniquely, in the prevention of legal conflicts within and between health care entities. Examples include the use of pre-dispute clauses requiring ADR in lieu of litigation, and the prediction and avoidance of the risk of disputes through the construction of agreements and the organic documents of organizations.
Friday, October 3, 2014
With a highly troublesome reading of the U.S. Supreme Court's opinion in Planned Parenthood v. Casey, the U.S. Court of Appeals for the Fifth Circuit managed to uphold a statute that has closed many abortion clinics in Texas, at least for the time being. The statute requires abortion clinics to meet standards for ambulatory surgery clinics, and the costs of doing so are unaffordable for the majority of abortion clinics. According to the New York Times,
Thirteen clinics whose facilities do not meet the new standards were to be closed overnight, leaving Texas — a state with 5.4 million women of reproductive age, ranking second in the country — with eight abortion providers, all in Houston, Austin and two other metropolitan regions. No abortion facilities will be open west or south of San Antonio.
At issue was whether the statute imposes an "undue burden" on pregnant women seeking an abortion in Texas and is therefore unconstitutional. The district court found an undue burden because some women will have to travel 500 miles to reach an abortion clinic and therefore incur a substantial hardship from the increased time and expense of the travel. The women will have problems with child care, transportation, and getting time off from work.
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.