Friday, May 17, 2013
Evidenced Based Practice: When will Law Catch up with Medicine?
Two widely reported studies this week about bed rest for women at risk of preterm delivery and reduction of salt consumption in order to promote heart health highlight two things we don’t think about enough—that a lot of standard medical practices are without any foundation in science and a lot of legal ones probably are too. However, medicine has more and more taken the public health approach of examining the practices of individual doctors to see how effective they actually are in the general population. For example, it is old news that prescribing bed rest to pregnant women at risk of preterm delivery is not effective. But what this Obstetrics & Gynecology study found that “activity restriction”, such as quitting work, is still prescribed to one at three women at risk for preterm delivery. The accompanying “Bed Rest in Pregnancy: Time to Put the Issue to Rest” makes an ethical argument that continuing to prescribe bed rest in the absence of evidence of its effectiveness violates the principles of autonomy and beneficence.
The Institute of Medicine just issued this report Sodium Intake in Populations: Assessment of Evidence “found no consistent evidence to support an association between sodium intake and either a beneficial or adverse effect on most direct health outcomes other than some CVD outcomes (including stroke and CVD mortality) and all-cause mortality.”
We have similar research in law- a lot of it coming from the Empirical Legal Studies movement, including work done at the Center for Empirical Legal Research at Washington University Berkeley Emperical Legal Research , the Centre for Emprical Legal Studies at UCL (formerly known as University College London) among many others, but it is not as well funded or coming from as well established sources as the studies which attempt to find an evidence basis for medical practices. The salt reduction report was commissioned by the Institute of Medicine In contrast, the ACLU supports its empirical argument that the death penalty does not deter crime on an opinion survey of police chiefs. Translating information from research scientists to practicing physicians is still a slow process,—but no one questions the underlying principle that medical practice should be based on scientific evidence.
Part of the issue is funding. Medicine as a whole is in a constant quest to contain costs and stopping ineffective practices is an important component of that effort. But beyond a small number of progressive funders like the Robert Wood Johnson Foundation, there isn’t a lot of demonstrable interest, the kind supported by funding studies, in law making bodies in finding out what legal practices work and what do not.
This isn’t a new observation. Bryant Garth outlined the problem in 1997 when he explained the importance of more social science research into the foundational principles of practices civil procedure. But the steady flow of studies questioning conventional wisdom coming from the medical field has, as yet, no real counterpart in the world of law making.
Of course there will always be the problem of knowing the unknowable. But it would be interesting for law makers to consider taking a lesson from public health in challenging assumptions about the human body and mind or even more generally the physical world that underlie both common law and statutes.
May 17, 2013 in Bioethics, Comparative Effectiveness, Cost, Effectiveness, Health Care Costs, Health Law, Innovation, Policy, Public Health, Quality Improvement, Reform, Research | Permalink | Comments (0) | TrackBack (0)
Thursday, May 16, 2013
Guest Bloggers Professors Alice A. Noble and Mary Ann Chirba - The ACA’s Tobacco Use Rating: Implementation, Inconsistencies and Ironies
As the Affordable Care Act continues toward full implementation, the law’s complexity is on full display. As we have noted in earlier writings, the ACA continues the federal tradition of using a fragmented approach to allocating oversight responsibilities among federal and state regulators, while maintaining the role of private actors in health care insurance and delivery systems. The result is a dizzying array of plan types (self-insured, fully insured, small market, individual market, large market, grandfathered) subject to an equally dizzying blend of ACA, ERISA, and individual state requirements.
Time will tell if this uniquely American system will achieve the goals of reform, i.e., expanding access to care while improving its quality and controlling costs. Unexpected and unintended consequences, some fortunate and others not, will certainly flow from such a system. This post will consider the insurance market reforms, specifically, PHSA § 2701, “Fair Health Insurance Premiums,” added by ACA § 1201 and some unexpected and seemingly unintended consequences related to the tobacco use rating provision.
Section 2701, which takes effect beginning in 2014, prohibits discriminatory premium rates by limiting the variables that insurers in the small group and individual market may use in setting premium rates. Prior to the ACA, insurers had greater latitude in setting premiums based on personal factors such as gender or health status. This often resulted in unaffordable insurance premiums for those most in need of health coverage: individuals with serious or chronic health conditions or small groups that included uch individuals. The ACA prohibits this type of underwriting in the small group and individual markets by permitting insurers to consider only four factors when setting premiums in these markets: 1) whether the coverage is for self-only or family enrollment; 2) the geographic area; 3) the age of the insured premiums may vary by a ratio of no more than 3:1 for adults); and 4) tobacco use (premiums may vary by a ratio of no more than 1.5:1).
Individuals who use tobacco may be required to pay up to 50% more for their health insurance premiums. For the sake of this provision, tobacco use is defined as using tobacco products on average of four or more times per week within no longer than the past six months, excluding religious or ceremonial uses of tobacco. Permitting a tobacco-use premium is consistent with the ACA’s larger focus on individual responsibility: because tobacco use is voluntary and offers no health benefit, tobacco users should bear a significant portion of the higher health care costs associated with that activity. It is conceivable that over time, other voluntary activities, such as weight control, may be added to the list of permissible factors used to set premiums.
Like so many other aspects of the ACA, implementing the tobacco-use premium provision is anything but straightforward especially in light of highly fragmented health insurance markets. In addition to the type of plan or policy, grandfather status under the ACA, an insurer’s ability to employ tobacco-use rating also depends on state law and the application of federal wellness programs regulations.
Several of the thornier aspects of this crazy quilt are especially deserving of attention, as follows:
1. Type of Insurance Coverage
The ACA’s tobacco use rating provision does not apply to the following kinds of insurance plans:
- Self-insured employer-sponsored plans, whether large or small
- Grandfathered plans in all markets
- Insured plans in the large group market through 2016
- Insured plans in the large group market after 2016, but only if the state does not permit insurers to offer large group policies on the state’s health insurance exchange
These exceptions mean that, starting in 2014, and at least until 2017, the tobacco use premium applies only to individual and small group plans that are both insured and non-grandfathered, whether offered in or off state exchanges. As noted below, in 2017, upon the election of the state, large insurance issuers may also be subject to the provision.
HIPAA and the Medical Records of Deceased Nursing Home Patients
Warning: some of this post is HIPAA-wonky. But read on: the punch line is that HIPAA does not protect the living or the dead from blanket release of medical records to their personal representatives—unless state law provides otherwise or patients have thought to specify in advance that they do not want anyone to see the record or parts of it and state law gives them this opportunity. This means that the default position is that personal representatives may see highly sensitive health information, including mental health records or sexual or reproductive histories: veritable skeletons in family medical closets.
In an important recent decision, the 11th Circuit has held that the federal Health Insurance Portability and Accountability Act (HIPAA) preempts a Florida statute that gave spouses and other enumerated parties the right to request the medical records of deceased nursing home residents. Opis Management Resources v. Secretary, Florida Agency for Health Care Administration, 2013 U.S. App. LEXIS 7194 (April 9, 2013). The nursing homes had refused to respond to requests for records made by spouses and attorneys-in-fact, arguing that these requesters were not “personal representatives” under Florida law. The requesters filed complaints with HHS’s Office for Civil Rights, which determined that the refusals were consistent with HIPAA. The Florida Agency for Health Care Administration issued citations against the homes for violating Florida law, and the homes went to court seeking a declaratory judgment that the Florida statute was preempted by HIPAA.
The statute in question, Fla. Stat. § 400.145(1) (2013), requires nursing homes to release records to the spouse, guardian, surrogate, or attorney-in-fact of a resident or a deceased resident, unless the release has been expressly prohibited by the resident. Disclosures must include both medical and psychiatric records, with the exception of psychiatric progress notes and consultation reports. The Agency interpreted this statute to authorize release to personal representatives as permitted by the HIPAA Privacy Rule, 45 C.F.R. § 164.502(g)(4)(2013). This section of the Privacy Rule specifies that personal representatives have the same authority to access health information that individuals do, and that executors or others authorized to act on behalf of a decedent must be treated as personal representatives with respect to protected health information. The Privacy Rule also permits covered entities to disclose to persons involved in the deceased individual’s care or payment for care information relevant to that involvement, unless the disclosure is contrary to the known expressed preferences of the decedent, 45 C.F.R. § 164.510(b)(5)(2013).
HIPAA preempts contradictory state law and state law inconsistent with its purposes, 42 U.S.C. § 1320d-7 (2013). It does not preempt more stringent state privacy protections, 45 C.F.R. § 160.203(b)(2013). The 11th Circuit determined that the Florida statute provided less protection than HIPAA, because it allowed individuals to act as thought they were personal representatives without a proper HIPAA authorization in seeking records. HIPAA only allows a personal representative under state law to request records pursuant to a proper HIPAA authorization. The exception for individuals involved in care, or in paying for care, is a very narrow one, again not permitting the broad grant of authority found in the Florida statute. The court refused to read the Florida statute as in effect amending Florida law with respect to identifying personal representatives, leaving that task to the legislature.
In general, HIPAA defers to state law concerning the legal power of individuals acting for the person to access medical records. In many states, statutes simply give designated surrogates or proxies the authority to seek whatever records patients themselves would be able to request in accord with HIPAA. For decedents, the HIPAA requirement is simply that requests for records must come from the state-designated personal representative via a HIPAA authorization. (Custodians of health care records may, to be sure, refuse to release records under special circumstances such as danger to the person or others.)
The decision in Opis Management does not change the scope of this HIPAA deference; it simply insists that Florida comply with HIPAA authorization requirements. But there is a genuine problem here for states to consider regarding access to medical records, for both the living and the dead. Currently, the default position is access to the entire medical record, with limited exceptions. This means that unless patients have thought to specify otherwise under state laws that give them this opportunity, personal representatives may have access to veritable skeletons in the family medical closet: mental health records, sexual histories, reproductive histories, determinations of parentage, and much more that patients might have believed would be kept confidential. In the days of silo-ed paper medical records, records would have been difficult to find or obtain. But in today’s emergent world of interoperable medical records, the results for confidentiality may be serious indeed.
Tuesday, May 14, 2013
Hospital Billing Varies Wildly, Government Data Shows
Coming right on the heels of the story by Steven Brill, Why Medical Bills are Killing Us, Time (March 4, 2013), the federal Centers for Medicare and Medicaid Services released the data for 3,300 hospitals that covers bills submitted from virtually every hospital in the country in 2011 for the 100 most common treatments and procedures performed in hospitals, like hip replacements, heart operations and gallbladder removal.
Barry Meier, Jo Craven McGinty and Julie Creswell reported on this data release in their New York Times story Hospital Billing Varies Wildly, Government Data Shows (May 8, 2013):
[H]ospitals charge Medicare wildly differing amounts — sometimes 10 to 20 times what Medicare typically reimburses — for the same procedure, raising questions about how hospitals determine prices and why they differ so widely.
A hospital in Livingston, N.J., charged $70,712 on average to implant a pacemaker, while a hospital in nearby Rahway, N.J., charged $101,945.
In Saint Augustine, Fla., one hospital typically billed nearly $40,000 to remove a gallbladder using minimally invasive surgery, while one in Orange Park, Fla., charged $91,000.
In one hospital in Dallas, the average bill for treating simple pneumonia was $14,610, while another there charged over $38,000.
[B]illing records showed that Keck Hospital of the University of Southern California charged, on average, $123,885, for a major artificial joint replacement, six times the average amount that Medicare reimbursed for the procedure and a rate significantly higher than the average for other Los Angeles area hospitals. ... Centinela Hospital Medical Center, also in Los Angeles and owned by Prime Healthcare Services, charged $220,881 for the same procedure.
One of the many disturbing aspects of this billing morass is that those who are least likely to afford these high costs are the most likely to have to pay the highest amounts for bills that may bear little relationship to the actual cost of treatment.
Medicare does not actually pay the amount a hospital charges but instead uses a system of standardized payments to reimburse hospitals for treating specific conditions. Private insurers do not pay the full charge either, but negotiate payments with hospitals for specific treatments.
Since many patients are covered by Medicare or have private insurance, they are not directly affected by what hospitals charge. Experts say it is likely that the people who can afford it least — those with little or no insurance — are getting hit with extremely high hospitals bills that may bear little connection to the cost of treatment.
“If you’re uninsured, they’re going to ask you to pay,” said Gerard Anderson, the director of the Johns Hopkins Center for Hospital Finance and Management.
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
Continue reading "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 "
Thursday, May 9, 2013
ACA Medicaid Expansion and Private Insurance
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.
More to come on § 1983 and Medicaid's remedy problem
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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Petrie-Flom Conference on the FDA--and Transparency of Clinical Trial Data
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
Introducing Guest Bloggers Mary Ann Chirba and Alice Noble
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).
Wednesday, May 1, 2013
SSRN Top Ten Health Law Downloads Between March 2 and May 1, 2013
The following are the top ten SSRN downloads for Health Law for the period between March 2 and May 1, 2010:
Friday, April 26, 2013
Sheltered Workshop Litigation in Oregon
I have just returned from the Jacobus tenBroek Disability Law Symposium sponsored by the National Federation of the Blind: Push Forward and Push Back--Continuing the Struggle for the Right to Live in the World. The Symposium is an annual event, bringing together disability advocates and scholars to share their work and their progress.
This year's symposium contained several sessions of particular interest to readers of HealthLawProf. One was a discussion of significant litigation raising Olmstead issues about placements in the community (rather than only residential placements). For people with physical or intellectual disabilities, sheltered workshop employment opportunities may be a critical step in achieving work independence especially at the point of transition from school. However, these workshops all-too-often have exploited those they are meant to serve, trapping them in sub-minimum-wage jobs where they fail to receive the support needed to transition into non-segregated workplace settings. Disability Rights Oregon (Oregon's Protection and Advocacy agency) has brought a class action suit against the state's system of sheltered workshops. So far, Lane v. Kitzhaber has achieved a ruling that Olmstead's integration mandate applies to employment services. The Department of Justice initially filed a statement of interest in the case and filed a motion to intervene in March 2013. Kathy Wilde, Litigation Director at Disability Rights Oregon, spoke about the case and its potential to transform the reach of Olmstead from institutions to the community.
The symposium also featured a session on the likely impacts of ACA on people with disabilities--to be discussed in my next post.
Tuesday, April 9, 2013
Health Care Turf Wars Playing Out On The Legal Stage
Much of the increased need for primary health care services anticipated to follow full implementation of the ACA, especially in rural areas, will likely be filled by nurse practitioners and physician assistants. Yet, restrictive state licensing regulations in many states will hamper the ability of these mid-level practitioners to fill the void. Modern Healthcare's 11th annual workforce report (subscription required) focuses on the scope of license issues facing these professionals just as their roles in providing health care could expand dramatically. The report suggest that turf wars between physicians and mid-level practitioners is at the root of some of the scope of license restrictions at issue.
This is an area where modern communication technology could really shine to provide both access to care and to ensure quality of care. As we move towards a more team-oriented approach to providing health care, either by choice or by sheer necessity, we need to be creative about remote supervision of mid-level practitioners by physicians where appropriate, and also be honest about when a physician's expertise is really needed, and when a mid-level practitioner is perfectly able to do the job. The physicians shouldn't really be worried, they will continue to be the team quarterbacks. But if the law is being used to protect the team's home turf through outdated restrictions on scope of practice, a comprehensive review of the field is needed.
Friday, April 5, 2013
Useful Article on Privacy and Secondary Uses of Information
A quite useful article on privacy and secondary uses of information just came across on ssrn: Clark D. Asay, Consumer Information Privacy and the Problem(s) of Third-Party Disclosures, forthcoming in the Northwestern Journal of Technology and Intellectual Property. Asay nicely crystallizes language for two aspects of secondary uses of personally identifiable information. "Incognito" harm is that people may have absolutely no idea of the identities of the myriad entities that may possess information about them. "Downstream" harm is that people may have absolutely no idea or control about subsequent transfers of information. Asay's proposed solution is legislation to introduce a more robust notice and choice regime for personally identifiable information. While his discussion concerns commercial information generally, it is certainly relevant to health information, as such information roams widely in the non-HIPAA world (which includes the wealth of information once HIPAA-protected but then transferred to non-HIPAA covered entities).
Thursday, April 4, 2013
Medical-Legal Partnerships—Collaborating to Transform Health Care for Vulnerable Patients
The 15th annual Southern Illinois Healthcare/Southern Illinois University Health Policy Institute, Medical-Legal Partnerships—Collaborating to Transform Health Care for Vulnerable Patients will be held at SIU in Carbondale on May 17, 2013.
Featured Speakers--Morning Session
Ellen Lawton, JD, Lead Research Scientist at George Washington University and responsible for the University's National Center for Medical-Legal Partnership in the Department of Health Policy.
Megan Sandel, MD MPH, Associate Professor of Pediatrics at the Boston University Schools of Medicine and Public Health, the Medical Director of National Center for Medical-Legal Partnership, and a Co-Principal Investigator with Children's Health Watch.
Robert Pettignano, MD, MBA, Associate Professor of Pediatrics at Emory University. He is the Medical Director of Campus Operations and Tri-President of the 1998 Society at Children’s Healthcare of Atlanta at Hughes Spalding.
Emily Benfer, JD, LLM, Clinical Professor of Law and Director of the Health Justice Project, Loyola University Chicago.
Diane Goffinet, JD, Senior Attorney, Land of Lincoln Assistance Foundation and member, Network Advisory Council , National Center for Medical-Legal Partnerships.
Featured Speakers-- Afternoon Session
Joel Teitelbaum, JD,LLM , Associate Professor and Vice Chair for Academic Affairs in the Department of Health Policy at the George Washington University. He also serves as Director of the School's Hirsh Health Law and Policy Program.
Ed Paul, MD, Director, Medical Education, Yuma Regional Medical Center and Clinical Associate Professor, Family & Community Medicine, The University of Arizona College of Medicine.
For more information go to: http://www.law.siu.edu/healthlaw/15hpi.php
Thursday, March 28, 2013
More on the Cola Wars
Two weeks ago, I wrote about the court decision striking down New York City's ban on certain sugary drinks sold in large containers. It seems that Mississippi has taken quite a different course than that recommended by Mayor Bloomberg of New York.
On March 21st, Mississippi Gov. Phil Bryant signed a law preventing counties, districts, and towns from enacting rules that limit portion sizes. This bill has been dubbed by the state as the “Anti-Bloomberg” bill. The Governor opined that the bill was intended to limit the role of government, and that it “is not the role of the government to microregulate citizens’ dietary decisions.” The Governor added that “[t]he responsibility for one’s personal health depends on individual choices about a proper diet and appropriate exercise.”
Interestingly enough, according to the Centers for Disease Control and Prevention, in 2011 approximately 34.9% of Mississippi’s adult population was obese, which was the highest rate of obesity in the nation. Gov. Bryant countered with studies that show Mississippi’s obesity rate among children has dropped by 13.3% from 2005 to 2011. What the Governor failed to mention was that despite this drop, Mississippi still ranks among the top six states in the nation for obesity among high-school students, with approximately 16% being obese.
Mike Cashon, executive director of the Mississippi Hospitality and Restaurant Association, which lobbied for the Mississippi bill, reportedly opined that “It doesn’t prevent local government from promoting health foods. What it does do is prevent them from creating policy mandates for the sake of consistency and uniformity.” Arguably, this bill also keeps one of the largest profit sources in play for the restaurant and hospitality industry. Non-alcoholic beverages cost restaurants between $0.05 and $0.20 per serving, while reaping charges of $2.00 or more. In fact, the paper cup used to serve a soft drink costs more than the soda itself.
I am grateful to Jeffrey Enquist, U of Utah 3L and Biolaw Center fellow, for providing me with this post.
Tuesday, March 26, 2013
Just When I Thought I Had Seen Everything, Dialing for Coverage
Just when I thought I had seen everything when it comes to deciding who gets health insurance and who does not, comes a report in Sunday's New York Times about how Tennessee administers its Medicaid program for "medically needy" residents. These are people who have very high medical bills, but would normally not qualify for Medicaid because their income is too high. If their medical debt is high enough that their income falls below a certain threshold after the medical debt is taken into account, they may be eligible for Medicaid. Qualifying for Medicaid may mean the difference between having access to needed health care and being unable to get treatment for a high-cost illness. Keep in mind that to qualify for the program, in addition to having high medical bills such that they are impoverished after the bills are paid, people must be elderly, blind, disabled, or be the caretaker of a child who qualifies for Medicaid. These traditional Medicaid populations are considered by society to be "the neediest among us," according to Justice Roberts' opinion on the Affordable Care Act's Medicaid expansion.
Apparently, Tennessee limits enrollment in this program to the first 2,500 eligible callers who get through on the phone to the Tennessee Department of Human Services starting at 6:00 p.m. on a particular day once every six months. So if you are one of "the neediest among us," and happen to be able to continually hit "re-dial" on your phone at that time, or can use multiple phone lines to call, you might get lucky enough to get health insurance. According to the executive director of the Tennessee Justice Center, this system leaves "huge numbers of desperately ill people . . . out in the cold." As lawmakers in many states (including Tennessee) debate about whether to expand Medicaid under the Affordable Care Act, they should consider whether or not the richest country in the world should require some of its most vulnerable residents to play the equivalent of a game of roulette in order to get access to health care.