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.
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 (email@example.com).
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.
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.