Saturday, May 11, 2013
Remembering the Bad Old Days of HIV/AIDS Exceptionalism--and How News from Kansas, an HBO Documentary, and Dancing with the Stars Can Teach Students To See it When it Happens Again
The controversy in Kansas over Sub HB 2183, which was passed into law on April 17th, 2013, puts me in mind of how difficult it is to explain the period of time when "aids specific" laws emerged. My purpose in highlighting this situation is not to get deeply involved in Kansas law or politics. It is pull together some material that may be helpful for teaching public health law to students unaware of the lessons we have learned from the laws proposed, and passed, specifically in response to the emergence of HIV/AIDS during the 1980’s. Without an understanding of the fear and panic that accompanied a disease for which there was no test, no treatment, no vaccine and which quickly killed young, healthy people within months of starting symptoms, it is easy to minimize the risk of such a thing happening today.
What Happened in Kansas
As I understand it, Sub HB 2183 was presented as a statute similar to those in almost every state intended to protect first responders and others who face occupational exposure to infectious
diseases and pathogens. It gives the State’s Department of Health the authority to develop a mechanism for mandatory testing or even isolation of the person who is the possible source of infection
if he is unable to give consent or if no surrogate decision maker can be found. Time is of the essence in these situations and the goal is to provide prophylactic treatment as soon as possible—not to stigmatize the source of infection.
One of the effects of Sub HB 2183 was to eliminate a bill passed in 1986 which specifically prohibited the State from quarantining individuals based on a diagnosis of HIV/AIDS. This led to concerns that people living with HIV/AIDS in Kansas would no longer be protected. Ann Gotlib explains these concerns, and their historical context, clearly in IJFAB-the International Journal of Feminist Approaches to Bioethics.
In an open letter to concerned citizens, the Secretary of Kansas’ Department of Health & Environment explained that “This bill was never about isolation or quarantine related to persons with HIV infection.” Instead, the bill “provides the authority for the secretary…to adopt administrative regulations for prevention and control of HIV in addition to the other specified infectious diseases under current law.” He continues to explain that the Bill reflects an attempt to modernize an old statute from that era, KS 65001, that specifically prohibits the state from quarantining or isolating individuals diagnosed with HIV/AIDS.
Without getting in to Kansas politics and law any deeper, KS 65001 is indeed is a good example of an “AIDS specific” law of that era in that it prohibits the State from quarantining individuals based on a diagnosis of HIV/AIDS. Indeed, according to the Kansas Equality Coalition, the Bill passed based on a compromise that involved creating “a list of diseases ‘not’ subject to quarantine, and to include HIV/AIDS in that list.”
What Kansas Can Teach
Public Health Students Today
Whatever the motivation for the legislation or its effect on
the citizens of Kansas, the controversy deserves attention and study just as would thediscovery of a “living fossil.” It gives us direct access to studying the past.
For anyone else looking for ways to bring that time alive, here are a few words about my experience
Thursday, May 9, 2013
Among the many states with Republican governors balking at taking federal money for the ACA Medicaid expansion, a few such as Arkansas and Ohio are exploring a compromise with HHS: use Medicaid expansion money to purchase coverage through health exchanges for people whose income level (up to 138% of poverty) qualifies for the expansion. The proposals are modeled on the use of Medicaid funds to purchase employer-provided insurance for people who qualify for Medicaid and cannot afford their employers’ insurance. But the strategy is fraught with peril.
According to a Kaiser Family Foundation issue brief, two problems with the premium assistance proposals are paramount: whether they will provide the levels and types of coverage that Medicaid would provide and whether they will turn out to be more expensive than direct expansion of Medicaid coverage would be.
With respect to levels of coverage, current premium assistance programs require states to provide “wrap-around” coverage for gaps between Medicaid and employer-provided insurance. The essential benefit package required for plans offered through exchanges are benchmarked to existing plans in their respective states. Thus there will be considerable differences among the states in plans offered through the exchanges. Needed wrap-around coverage will vary accordingly. States such as Ohio, however, are seeking to negotiate with HHS to obtain waivers for the wraparound requirements and threatening to reject the Medicaid expansion if they are not given flexibility.
With respect to cost, programs must demonstrate cost effectiveness in the sense that they provide the same levels of coverage (including wrap around) for equivalent costs. According to the Kaiser issue brief, difficulties on this score may also be significant. Premium assistance programs to date have been fairly small and focused on populations where cost-savings can be expected. On the other hand, an advantage may be allowing families to purchase the same insurance for all family members.
At the recent tenBroek symposium, disability rights advocates voiced particular concern about the prospect that HHS might consider granting states waivers for wraparound coverage. Coverage for home health services, durable medical equipment, or longterm care may be particularly important for people with disabilities but not included in essential benefit packages offered through exchanges. If HHS does agree to flexibility in wraparound coverage, important safety net benefits may be lost despite expansion of Medicaid coverage.
With millions of new enrollees poised to enter the Medicaid program in 2014, Medicaid's remedy quandry will become a more pressing issue. The Medicaid Act contains no obvious remedy for Medicaid providers or Medicaid beneficiaries when states fail to deliver the healthcare promised by the Medicaid Act. For years, the default private right of action was Section 1983, but when Gonzaga University v. Doe was decided in 2002, lower federal courts interpreted the decision as a new limit on § 1983 actions for many sections of the Medicaid Act, which I wrote about here.
The narrowing scope of 1983 rights of action has led to the Supremacy Clause cause of action that was at issue in Douglas v. Independent Living Center last term, and that question almost certainly will make its way back to the Supreme Court. In fact, states have been trying to get the Court to further restrict, even terminate, 1983 actions for Medicaid, though so far the petitions for certiorari have been denied. (Very recently, the Court denied Indiana such a petition, which was a bit of a surprise to Court observers.)
Nevertheless, stay on the alert. The Court is hearing a section 1983 case in the October 2013 term, and it could be an opportunity for the Roberts Court to pick up where Gonzaga left off. The case is Madigan v. Levin, and it involves use of § 1983 to bypass the limited remedies available in the ADEA. The Court could issue a limited decision in the case by simply determining that the ADEA's remedial scheme is comprehensive and leaves no room for additional age discrimination related claims. Or, Madigan could open the door to an articulation of this Court's interpretive take on 1983 that would very likely reject a broader swath of 1983 claims.
Tuesday, May 7, 2013
Guest Bloggers Mary Ann Chirba and Alice A. Noble - Medical Malpractice, the Affordable Care Act and State Provider Shield Laws: More Myth than Necessity?
Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.
In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: http://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].
In April, the governor of Georgia signed H.B. 499 [link: http://www.legis.ga.gov/legislation/en-US/display/20132014/HB/499] into law, becoming the first state to pass legislation based on the AMA model act.
This came on the heels of a Medical Association of Georgia Advocacy Brief [link: http://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]
It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.
The intersection of federal standards and state personal injury litigation against a regulated industry is nothing new. It has long played a role, for instance, in product liability claims ranging from medical drugs and devices to motor vehicles. The literature is already quite deep as to whether federal regulations preempt state requirements or have evidentiary value at trial, and we will not add to it today. What is of particular interest with the Georgia law and, therefore, will be the focus of this discussion is: (1) why the ACA has fueled concerns of expanded malpractice liability, and (2) whether the Georgia law achieves any real gains in shielding physicians or other health care providers from malpractice liability beyond what already exists under state law.
Put simply, we consider: why was the Georgia law passed, and does it really accomplish anything?
Publication of Symposium Issue - Capacity, Conflict, and Change: Elder Law and Estate Planning Themes in an Aging World
The 2012-13 Symposium Issue of the Penn State Law Review Capacity, Conflict, and Change: Elder Law and Estate Planning Themes in an Aging World is now available on-line. This Symposium Issue arose out of collaboration between two sections of the Association of American Law Schools (AALS) for the Annual Meeting in January 2013. The leadership of the Section on Trusts and Estates and the Section on Aging and the Law called for a dialogue among law faculty members who teach, research and write in these and related fields, with a special eye to the demographics of population aging. This Symposium Issue is a collection of the formal papers that arose out of this dialogue.
Monday, May 6, 2013
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This year's Petrie-Flom Conference was devoted to the FDA in the 21st Century. If the distribution of conference papers is any harbinger, it appears likely that food is and will continue to play a diminishing role in the agency's future. Out of the two days of panels, only ONE was devoted to food. Moreover, the dependence of the FDA on user fees for any funding increases can only be expected to swell the sections of the agency devoted to drugs and devices while food regulation languishes--the Food Safety Modernization Act (FSMA) notwithstanding. Obesity, it seems, is a medical (or public health) problem, not a food problem. In general, however, the conference was a wonderful confluence of FDA history, FDA policy, and FDA possibilities. I strongly urge blog readers to check out the liveblogging from the conference (on the link above in this paragraph, as well as the conference recording when it appears).
For readers of this blog, one of the more relevant discussions concerned transparency in clinical trial data. Trudo Lemmens called attention to the just-issued interim ruling of the General Court of the EU regarding document release by the European Medicines Agency (EMA). Two pharmaceutical manufacturers, AbbVie and InterMune, challenged the EMA's decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications. The EMA's decisions to release were taken in accordance with its 2010 access-to-documents policy. This access policy aims to protect the privacy of individual data while allowing independent scrutiny of the results of clinical trials; the EMA has announced that it will continue the policy for other document requests not at issue in the interim ruling.
Worth reading on the subject of transparency more generally is Lemmens' recent article in JMLE on human rights and pharmaceutical knowledge governance. In the article, Lemmens argues that pharmaceutical companies' control over knowledge production is a significant global public health problem. Viewing the issue in human rights terms can prioritize it on the public policy agenda and blunt restrictions on information access based in trade obligations and trade secrets. Lemmens bases the human rights argument in the human right to health which, he contends, creates obligations for states to implement determinants of the right to health, including information. Lemmens also suggests grounding in the right to life for production of important safety information. Privacy is invoked on the other side of data transparency--as indeed it was during the discussions at Petrie Flom. In response, Lemmens notes the irony of invoking protection of individuals in one dimension--privacy--against protection of individuals in another dimension--health and safety. As a solution, he suggests that the apparent impasse should be transcended by models "based on meaningful citizen involvement in public health-oriented science." Lemmens also defends establishment on an international framework for sharing clinical trial safety and effectiveness data, given the global structure of pharmaceutical research today.
The Ohio State University Moritz College of Law Welcomes New Health Law Faculty Members Micah Berman and Efthimios Parasidis
The Ohio State University Moritz College of Law welcomes two new health law faculty members, Professors Micah Berman and Efthimios Parasidis. A big Ohio welcome to both!
Here are their short bios:
Micah Berman’s expertise is in public health law and policy. He will hold a joint appointment at Ohio State’s College of Public Health and at Moritz. Berman most recently was an associate professor at New England Law in Boston, where he founded and directed the Center for Public Health and Tobacco Policy. In addition to working on tobacco-control issues at the centers in Boston and Columbus, Berman contributed to similar initiatives as a senior advisor for the Food and Drug Administration (FDA). He has published his scholarship in a number of leading publications, including American Journal of Law & Medicine (forthcoming), Brooklyn Law Review, and American Journal of Public Health.
Berman graduated with distinction from Stanford Law School and received a Bachelor of Arts, summa cum laude, from Brandeis University. He previously was a trial attorney with the U.S. Department of Justice’s National Criminal Enforcement Section, Antitrust Division and a litigation associate at Stinson Morrison Hecker LLP in St. Louis, Missouri.
Efthimios Parasidis has spent a career studying biotechnology, bioethics, intellectual property, and related areas. He is an assistant professor of law at St. Louis University School of Law – one of the nation’s leading health law programs – and has served on the Law and Policy Workgroup of the Missouri Health Connection, which is responsible for creating Missouri’s health information exchange. As a co-principal investigator with researchers from the National Institutes of Health, his recent research includes analyzing the policies of the top 200 research institutions in the U.S. to see what compensation they provide for participants injured in a research study. His scholarship has been published in top journals, including Ohio State Law Journal, Connecticut Law Review, Wisconsin Law Review, and Tulane Law Review.
Parasidis holds a bachelor’s degree from The College of New Jersey, a master’s degree in bioethics from the University of Pennsylvania Perelman School of Medicine, and a J.D. from the University of Pennsylvania Law School. He was an associate at Jones Day and Dickstein Shapiro LLP in New York City. He also worked for the Office of the New York State Attorney General; co-founded Global Health Outcomes Inc., a health care research and analytics firm; and is a co-inventor on a patent application related to health information technology and comparative effectiveness research. Parasidis was also a Fulbright Fellow in Greece.
Sunday, May 5, 2013
Professor Alice A. Noble is a Senior Lecturer in the Legal Studies Program at Brandeis University and Adjunct Lecturer at Brandeis University’s The Heller School and Boston College Law School. She holds a law degree from Villanova University School of Law and a Master of Public Health degree from Harvard School of Public Health. In addition to teaching at Boston College Law School and Brandeis University, she has taught numerous courses at Harvard School of Public Health and Tufts Medical School. Courses taught include Genetics, Law, and Social Policy, Health Law and Ethics, Health Law and Policy, Advanced Legal Writing, Law and Public Health, Managed Care Law and Regulation, among others. She has practiced personal injury and medical malpractice defense litigation, has conducted funded research on health policy issues, and was a fellow in medical ethics at Harvard Medical School and a Senior Researcher at The American Society of Law, Medicine & Ethics. She has a number of peer-reviewed publications on topics such as medical malpractice, managed care, and hospital law. She is a contributor to the Health Affairs Blog. Alice has been an invited speaker on various matters, including national health care reform. Along with Professor Mary Ann Chirba and Attorney Michael Madigan, Alice is a co-author of the forthcoming Health Care Reform: Law and Practice (Matthew Bender--LexisNexis, 2013).
Professor Mary Ann Chirba holds a J.D. from Boston College Law School, a D.Sc. and M.P.H. in Health Policy from the Harvard School of Public Health, and a B.A. in Biology from Colgate University. She is a Professor at Boston College Law School where her courses have included Comparative Health Law, Legal Reasoning, Health Care Law and Policy I and II, Advocacy Writing, and Product Liability Law. At the Harvard School of Public Health, Professor Chirba has taught courses on FDA Law, Pharmaceutical Product Safety, “The Tobacco Wars,” Current Developments in Health Law, Managed Care Law & Regulation, and Medical Malpractice & Risk Management. Her research interests focus broadly on how law and regulation can promote or impede desired health outcomes, with a particular emphasis on the regulation of medical drugs and devices, emerging federal and state regulations and international guidelines for adult stem cell therapies, and federal and state health care reform efforts. She is a co-author of the forthcoming treatise entitled Health Care Reform: Law and Practice (Matthew Bender 2013).