HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Saturday, February 12, 2011

Paul Fronstin: "Employer and Employee Reactions to Health Reform: Findings From the 2010 EBRI/MGA Consumer Engagement in Health Care Survey and the 2010 SHRM Organizations’ Response to Health Care Reform Poll"

Paul Fronstin, Director of the Health Research & Education Program at the Employee Benefit Research Institute has posted "Employer and Employee Reactions to Health Reform: Findings From the 2010 EBRI/MGA Consumer Engagement in Health Care Survey and the 2010 SHRM Organizations’ Response to Health Care Reform Poll" on SSRN:

Paul Fronstin This paper presents data from the 2010 EBRI/MGA Consumer Engagement in Health Care Survey and the Society for Human Resource Management’s 2010 SHRM Organizations’ Response to Health Care Reform Poll to examine how employers might respond to health reform and employees’ expectations of changes to health coverage. Employers are uncertain regarding changing benefits in response to health reform, but they are likely to pass along any cost increases to workers. Workers are mostly expecting such cost increases. Employers are evenly split as to whether they will change health coverage as a result of health reform while workers are split between thinking their benefits will remain the same or erode. While few workers expect employers to drop coverage after 2014, and very few employers plan to drop coverage, employers are evenly split between having decided to continue to offer coverage and being undecided about the future of employment-based health coverage.

 

 

February 12, 2011 | Permalink | Comments (0) | TrackBack (0)

Thursday, February 10, 2011

Three Perspectives on Retained Objects

Adverse events involving retained objects continue to attract discrete judicial treatment and major investment in amelioratory processes. Three recent cases or reports are illustrative. 

First, the problem seems to be a stubborn one. Minnesota's adverse events reporting statute continues to lead the nation in transparency. According to the latest report, "Adverse Health Events in Minnesota" (7th Annual Report, Jan. 2011), available here, the state's number (305 for the year) and profile of adverse events remained essentially unchanged over the year with retained objects, falls and pressure ulcers dominating. Specifically, regarding retained objects a statewide initiative to eliminate retained sponges in labor and delivery continued to be a success. Elsewhere, however, problems remain. According to the Minnesota report, "in many cases, the root causes reveal that there remains wide variation within and across teams in how items are accounted for, whether non-radiopaque items are allowed in the sterile field, whether physicians are aware of and follow current policies and practices around documenting placement of or counting items, and whether team members are empowered to question the placement or removal of items" (at 13).

Second, for the courts the retained object question continues to rotate around the level of exceptionalism that should be recognized; specifically, the extent to which the plaintiff's evidentiary burden should be modified compared to mainstream malpractice allegations. Kentucky seems to be having a particularly difficult time with this question. Two years ago in Nazar v. Branham, 291 SW 3d 599 (Ky 2009), the Supreme Court of Kentucky moved from a negligence per se rule to one based on res ipsa loquitur. More recently in Baxter v. AHS Samaritan Hosp., LLC, 2010 WL 133796, Ky.App., Jan. 15, 2010, review denied (Jan 14, 2011), a Kentucky appellate court characterized res ipsa as evidentiary in nature and so not a matter than the jury should be instructed on. Perhaps understandably, the dissent wondered how a jury could figure out whether they should infer negligence if they were not instructed on the issue. More generally, are retained objects cases really the ones where we need to increase the plaintiff's litigation costs?

Finally, process reform when coupled with HIT may hold the greatest promise for reducing the scale of the retained object problem. A new medical journal report (Victoria M. Steelman, "Sensitivity of detection of radiofrequency surgical sponges: a prospective, cross-over study," American Journal of Surgery, February 2011, Vol. 201, Issue 2, Pages 233-237, subscription required) both provides a positive answer to the question whether RFID is an effective technology here and usefully compares the prevailing models for avoiding retained object adverse events. According to the researcher RFID tracking provided accuracy (at 100%) far surpassing existing sponge detection processes such as the surgical count or radiography.

Nic Terry

February 10, 2011 | Permalink | Comments (0) | TrackBack (0)

Worth Reading This Week

Mark Hall, Clearing Out the Underbrush in Constitutional Challenges to Health Insurance Reform, NEJM, February 2, 2011 (subscription)

Margaret Gilhooley, Drug User Fees, Health Priorities, Politics, the Deficit and Reform Directions, (SSRN) 

Benjamin D. Sommers and Sara Rosenbaum, Issues In Health Reform: How Changes In Eligibility May Move Millions Back And Forth Between Medicaid And Insurance Exchanges, Health Affairs, February 2011 30:228-236 (subscription)

Alberto Alemanno and Enrico Bonadio, Do You Mind My Smoking? Plain Packaging of Cigarettes Under the WTO TRIPS Agreement, John Marshall Review of Intellectual Property Law, Vol. 10, No. 3, 2011 (SSRN)

Nic Terry

 

February 10, 2011 | Permalink | Comments (0) | TrackBack (0)

Exploitations of Immortality

Rebecca Skloot's remarkable book The Immortal Life of Henrietta Lacks has quite a following among health lawyers. As an excerpt from the book explains,
Henrietta Lacks was a poor Southern tobacco farmer who worked the same land as her slave ancestors, yet her cells -- taken without her knowledge -- became one of the most important tools in medicine. The first "immortal" human cells grown in culture, her cells -- known as "HeLa cells" -- are still alive today, though she has been dead for more than 60 years.
If you could pile all HeLa cells ever grown onto a scale, they'd weigh more than 50 million metric tons -- as much as a hundred Empire State Buildings. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer, viruses, and the effects of the atom bomb; helped lead to important advances like in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks remains virtually unknown, buried in an unmarked grave.
Skloot tells the story of the Lacks family, which never shared in the prosperity based on the HeLa cells. This is old news for any property student familiar with Moore v. Regents, but it's particularly poignant in this context. Now Skloot has worked to share the book's proceeds with the Lacks family. As a recent news article explains,
Since the book’s debut a year ago, it has earned rave reviews, prizes, a movie deal with HBO and a steady spot on best-seller lists. And Ms. Skloot is making good on her pledge to share the financial windfall with the Lackses. Soon after the book came out, she created the Henrietta Lacks Foundation to help Mrs. Lacks’s descendants, some of whom suffered from the whirlwind of publicity, misinformation and scam artists surrounding HeLa cells, not to mention a lack of insurance to pay for any of the medical advances Mrs. Lacks’s cells made possible. . . .
The foundation — which is still in the process of applying for nonprofit status — is paying for a high-tech hearing aid for Mrs. Lacks’s youngest son, Zakariyya; truck repairs for her middle son, Sonny; new teeth for her granddaughter Kimberly; braces for her great-granddaughter Aiyana Rodgers; and, yes, tuition, books and fees for five of her grandchildren and great-grandchildren.
Whatever one thinks of the proper compensation for research subjects, it is disheartening to consider the economic difficulties of the Lacks family. (How can a society that spends, on average, $1425 per year on care and maintenance of its pets, not provide dental care for all?) I think part of the answer lies in our constant striving for "innovation," and the comparative devaluation of dissemination of innovation. My colleague Gaia Bernstein has written about these trends in several contexts. I have also worried about the lack of a US industrial policy for distributing the gains of innovation. I first came to these conclusions in the context of a paper I wrote on immortal stem cell lines, almost a decade ago. As the abstract argued:
[I]nnovations that now look benign might lead to an era of untrammeled biotechnological manipulation of our lives. For example, the same technology used to eliminate disease-causing genes or to clone embryos may eventually be deployed to produce genetically engineered children. That could, in turn, entrench class differences, since only the wealthy could afford the most desirable genetic enhancements. . . . Public debate on regenerative medicine must acknowledge this inequality. Societies and individuals can invest in it in good conscience only if they are seriously committed to extending extant medicine to all.
Without more attention to those at the bottom of the economic heap, the biotech project might recall these haunting lines from John Bunyan's "The Pilgrim's Progress:" "Now he had not run far from his own door, but his wife and children perceiving it, began crying after him to return, but the man put his fingers in his ears, and ran on, crying, Life! Life! eternal life." Gary Shteyngart's recent novel imagines a world where a company that sells modern-day "immortalization services" only takes on clients who promise to prioritize payments for the company's "dechronificaiton" over any claims by relatives for help. They don't even consider the possibility that those seeking endless self-preservation might be tempted to give to charity instead. Michel Houllebecq's much worse novel, The Possibility of an Island, carries the trope further, imagining a future where the wealthy simply clone themselves into the future rather than worrying about reproducing. In my article on immortality, I reach conclusions similar to those of Andre Gorz in The Immaterial. Whenever we come across a project that
will enable 'us' to free 'ourselves' from the contingency of our factuality. . . . to recreate and transcend 'ourselves' or even abolish the human condition[,] [t]his re-creation might be said the be the supreme stage of self-production. But it is a grammatical mirage. . .. [There is a] difference between the natural body and the body reprogrammed by science. . . .
In my own words, from my 2002 article:
Artificial-intelligence [based immortality] projects are unconvincing because their products lack bodies, and therefore cannot experience the sense-perceptions that are fundamental to human consciousness. Given the inevitable decay and profound importance of the brain, perpetual rounds of organ replacement seem only to offer their beneficiaries a series of lives, and not really a chance to maintain a coherent one. Neither the inorganic nor the organic forms of immortality offered by these two families of technologies offers indefinite life that is recognizably human or continuous with that of the person who employs them.
Nevertheless, I expect the "immortality project" will continue to attract followers. John Gray's book "The Immortalization Commission" follows the Soviet elite who wished for a this-worldly resurrection. He sees similar aspirations today:
The hopes that led to Lenin's corpse being sealed in a Cubist mausoleum have not been surrendered. Cheating ageing by a low-calorie diet, uploading one's mind into a super-computer, migrating into outer space [are all present day aspirations]. . . Longing for everlasting life, humans show that they remain the death-defined animal.
Today it is not a communist elite that is likely to continue the immortality project, but rather those billionaires who believe their lifespans should be as much longer than the average Joe's as their fortunes eclipse his bank account. There is a slight chance the innovations they fund can "trickle down" to all, but in a world of limited resources, new variations on cryonics may not be the best place for funds to be allocated. --Frank Pasquale, X-Posted to Health Reform Watch.

February 10, 2011 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 9, 2011

Virginia Seeks Direct High Court Review of PPACA Challenge

BNA reports

Virginia Attorney General Kenneth T. Cuccinelli II (R) announced Feb. 9 that the state has filed a petition for direct review by the U.S. Supreme Court of a key decision on the validity of the Patient Protection and Affordable Care Act.

The petition, filed late Feb. 8, argues that the constitutionality of the individual mandate provision, and the validity of PPACA as a whole, are questions of imperative public importance that justify the court's taking the unusual step of considering the case before the U.S. Court of Appeals for the Fourth Circuit rules on the appeal.

The individual mandate, which is scheduled to take effect in 2014, would require virtually all U.S. citizens to obtain health insurance or pay a monetary penalty.

In the decision for which Virginia is seeking review, the U.S. District Court for the Eastern District of Virginia ruled in December that the individual mandate is unconstitutional, but severed it from the remainder of the law, thus allowing other sections of PPACA to take effect as planned. Both parties appealed the decision to the Fourth Circuit, which granted expedited review Jan. 26.

The Virginia case was the first in which a court declared that Congress did not have authority to enact the individual mandate. In late January, a federal district court in Florida subsequently ruled the entire statute invalid based on its inability to sever the unconstitutional provision.

Two other district court rulings upholding the individual mandate are pending on appeal.

- KVT

February 9, 2011 | Permalink | Comments (0) | TrackBack (0)

Tanning Tax: Vanity Tax or Public Health Measure? An Exercise in Human Rights Protection

Frank Pasquale, one of the recent additions to our new blogging team here at the Health Law Prof Blog, raises an interesting question in an entry he posted over at Concurring Opinions:

I have previously blogged in favor of a vanity tax, so I was happy to see the health reform legislation included a 10% tax on tanning salons. But not everyone is so pleased to see it:

When an article about the fallout from the tax — which took effect [recently] — appeared on the Washington Post’s Web site …, dozens of commenters questioned the tax’s legality. The case can seem deceptively simple: Since patrons of tanning salons are almost exclusively white, the tax will be almost entirely paid by white people and, therefore, violates their constitutional right to equal protection under the law.

Randall Kennedy dismisses that claim out of hand. But I hope the angry tanners join me in endorsing a plan to address the grave injustice here: legal scrutiny of face-whitening creams. Tax tanning, tax lightening, and we may well move closer to a society that can transcend the fickle “beauty bias."

Frank's post on vanity taxes is an excellent read. But it raises the question of whether the tanning tax is appropriately described as a vanity tax or as a public health measure akin to the cigarette tax or the soda tax designed to decrease a particular, unhealthy self-regarding behavior? (By self-regarding, I mean behavior that impacts only the individual).

The tanning tax appears to be directed at tanning that can lead to skin cancer so I see this as a public health measure. Is this a distinction without a difference? Does the label change the analysis?

According to Mapping the Issues: Public Health, Law and Ethics, by Lawrence O. Gostin recently posted on SSRN it does. This short but powerful essay, published in Public Health Law and Ethics: A Reader (expanded and updated 2nd ed., 2010), explains that when public health officials pass paternalistic legislation that reaches out to regulate self-regarding behavior, such as mandating motorcycle helmets or banning trans-fats, the analysis that should be applied is one that recognizes the individual liberty, autonomy, privacy and property interests of the targeted individuals. The degree of invasion of these interests should then be balanced against the communal interest to be achieved by the public health measure. In addition, a consideration of whether the proposed public health measure is the least restrictive means should become part of the calculus. Viewed this way, often education is the optimal public health tool. Does this analysis change the way that the tanning tax should be viewed?

Maybe it does. First, it removes from the calculus the consideration of the benefits that will be gained from the use of the tax revenues. This moves the focus from a political one to a scientific one and changes the social justice inquiry from the impact on a particular group to the impact on the individual. The questions then become: What are the benefits in reduction of skin cancer as a population health matter that will be gained from passage of the measure and do these benefits substantially outweigh the incursion into the sphere of personal liberty? And, finally, is education a lesser restrictive means?

How we discuss the tanning tax takes on bigger dimensions when taken in the context of the myriad of other programs that are being developed to deal with the rising cost of health care. Currently, the United States sits at a cross roads with the choice to either proceed to promote the health and well-being of the population while promoting and protecting human rights or to enhance public health at the expense of these rights. Two separate programs being proposed to deal with the "obesity crisis" by impacting lifestyle choices in order to encourage healthy food consumption exemplify these divergent paths.

The first is the West Virginia Pilot Project (the “West Virginia Project”) and the second is the USDA’s Economic Research Service's Program. In early 2007, the federal government approved the West Virginia Project which provides health care for low-income, Medicaid beneficiaries in West Virginia. The West Virginia Project punishes those who do not join, and religiously adhere to, weight-loss or anti-smoking programs, or who otherwise fail to comply with government mandates, by denying important medical services. (Click here for a study revealing the negative impact of the West Virginia Project on access to health care as of 2009). This type of program reaches out to broadly regulate the behavior of low-income individuals that is self-regarding; in other words, conduct that impacts only the individual. Unlike the situation with nicotine and its addictive properties where health advocates argue that the choice to smoke is not voluntary, health advocates’ position with regard to high fat and sugar foods is that consumers lack the capacity to make wise and rational decisions because consumers are not well enough informed. Does this rationale support the intervention of the government to take the choice to consume high fat and sugar foods away from competent adults? If it is true and there is a capacity problem based on ignorance, isn’t the solution education?

In contrast, USDA’s Economic Research Service's proposed program targets this capacity problem by incorporating findings from decision-analysis, behavioral economics, food marketing and food psychology to provide a series of strategies for informing and influencing individual choice through education to favor a healthier diet. This type of program seeks to both promote public health while protecting human rights.

With dozens of measures in the legislative works being designed to protect the government fisc by promoting personal accountability for healthy choices, identifying those measures that are directed at public health and labeling them as such may make a great deal of difference to the way we analyze them. These labeling choices may mean the difference between enhancing public health while protecting human rights rather than enhancing public health at the expense of these rights.

- KVT

February 9, 2011 | Permalink | Comments (0) | TrackBack (0)

Call For Abstracts - 139th American Public Health Association Annual Meeting

Call for Abstracts - 139th APHA Annual Meeting (October 29 - November 2, 2011). The theme is "Healthy Communities Promote Healthy Minds & Bodies." The submission deadline is Friday, February 11, 2011.

Health Law Special Primary Interest Group (SPIG) sessions provide an opportunity to present to APHA members your research and analysis of topics relating to Health Law and Policy. The Health Law SPIG encourages submission of abstracts related to this year's Annual Meeting theme:Healthy Communities Promote Healthy Minds and Bodies; however, abstracts on other timely topics related to health law and policy also are welcome.

The topics listed below are intended as suggested categories for submission of abstracts, but should not be seen as exclusive, as the final focus (and titles) of the panel sessions for the conference will depend on the abstracts that are received. With that in mind, please submit your abstract under the topic that is most relevant. In addition, if you are proposing a session or panel, please note that on each abstract submitted as a part of the panel. Please also note whether or not you would still be interested in presenting the abstract if the panel is not accepted as a whole.

   *   Advancing human rights and social justice through law

   *   Alcohol, tobacco, firearms, and food

   *   Environmental health law

   *   Global justice through international law

   *   Health disparities, social determinants of health and the law

   *   Housing, the built environment, population health, and the law

   *   Mental health

   *   Preemption and public health

   *   Public health law research methods and legal theory

   *   The Patient Protection and Affordable Care Act

Abstracts that focus on interdisciplinary, translational and systems sciences are particularly encouraged as well as abstracts tied to NIH and Healthy People 2020 priorities. Papers on research methods are also strongly encouraged.

Contact Annette Ferebee at annette.ferebee@apha.org if you have any questions concerning continuing education credit. Contact the program planner for all other questions.The Program Chair is Heather A. McCabe, JD, MSW, Assistant Assistant Professor, Indiana University School of Social Work hamccabe@iupui.edu

February 9, 2011 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 8, 2011

Professor Tribe on SCOTUS and Health Reform

Essential reading here.

February 8, 2011 | Permalink | Comments (0) | TrackBack (0)

Records Transparency and the Continuing DoD/VA Disconnect

Between them the Department of Defense and the Department of Veterans Affairs annually provide almost $100 billion of healthcare. They stand apart from most US healthcare entities because of their size, vertical integration, and enthusiastic adoption of HIT (in particular electronic medical records). Unfortunately, the two organizations have a less than stellar history when it comes to their records systems working together. The latest in a long line of GAO reports on the disconnect is now available. The suitably blunt recommendations? Joint strategy, joint planning and joint investment.

Nic Terry

 

February 8, 2011 | Permalink | Comments (0) | TrackBack (0)

U.S. Senate Holds Long Overdue Hearing on Reform of Toxics Act

Last Thursday, the U.S. Senate Environment and Public Work Committee’s Superfund, Toxics and Environmental Health Subcommittee held a hearing on "Assessing the Effectiveness of U.S. Chemical Safety Laws." The purpose was to hear about suggestions  to amend and improve the 1976 Toxic Substances Control Act (TSCA),  a law designed to reduce public exposure to health-endangering chemicals through information gathering and control when there is unreasonable risk to public health or the environment. Toxic chemicals covered by TSCA can be found in everyday objects, including children's products, cleaning and personal care products, electronics, food and beverage containers and other common items. Toxics have been found to pose risks of cancer, learning disabilities, infertility, birth defects, among others. The text of all of the testimony described below can be accessed here.

According to testimony by Steve Owens, the Environmental Protection Agency (EPA)’s Assistant Administrator, Office of Chemical Safety and Pollution Prevention, there are flaws that need to be addressed. He pointed out that when TSCA was enacted, it grandfathered in, without any evaluation, all chemicals that existed in 1976. Further compounding this problem, the statute never provided adequate authority for EPA to reevaluate existing chemicals as new concerns arose or science was updated, and failed to grant EPA adequate authority to compel companies to provide toxicity data. As a result, EPA has only been able to require testing on only 200 of the 84,000 chemicals listed on the TSCA Inventory, and has regulated or banned five of these chemicals under Section 6 of TSCA. He recommended the following changes:

  • Chemicals should be reviewed against safety standards that are based on sound science and reflect risk-based criteria protective of human health and the environment;
  • Responsibility for providing adequate health and safety information should rest on industry;
  • EPA should have clear authority to take risk management actions when chemicals do not meet the safety standard;
  • EPA should have clear authority to set priorities for conducting safety reviews on existing chemicals;
  • The law should encourage innovation in green chemistry, and support research, education, recognition, and other strategies that lead to safer and more sustainable chemicals and processes;
  • Congress should provide adequate funding.

The National Resources Defense Council’s testimony raised the concern that chemical manufacturers have provided little or no information to the EPA regarding their potential health or environmental impacts of their new chemicals. NRDC advocates new legislation to strengthen TSCA by shifting the burden of proof from EPA to the chemical industry; requiring all new or existing chemicals to be tested for safety, and establishing safety standards for chemicals to protect children and other vulnerable groups. (A brief background on NRDC’s position can also be found here). 

The three witnesses from the chemical industry came from a slightly different angle. They emphasized jobs provided by the industry, and the need to meet growing demands for products as the world population increases, particularly in the developing world. According to the President of the American Chemistry Council, many of the scares about chemical risks are unfounded, based upon “disinformation,” and that companies test their chemicals well. However, he supports “modernization,” and that EPA needs to be better funded. He emphasized cost effectiveness, systematic prioritization, encouraging innovation, and making risks to children an important factor in “safe use” determinations. He also addressed the need to address existing overlapping and confusing regulations at different levels of government.

Finally, the Dean of the George Washington University School of Public Health and Health Services provided technical and scientific evidence to support reforms. She predicted that unless Congress acts, the European Union and other countries will move into the lead in this area of efficient and effective chemicals management , putting the U.S. at a competitive disadvantage.

The hearing exposed somewhat of a consensus that TSCA is in need of reform, and that EPA requires more authority and funding. I think the challenge is finding an option that is streamlined and efficient. TSCA is the only major environmental statute that has never been reauthorized, so clearly these hearings are long overdue.

- Mary Munson

February 8, 2011 | Permalink | Comments (0) | TrackBack (0)

School Lunches and Childhood Obesity

The New York Tiimes reports on a recent study that provides additional support for the new school lunch guidelines that are required by The Healthy, Hunger-Free Kids Act of 2010.  Researchers in Michigan found that children who eat the school lunch are 29 percent more likely to be obese than students who bring their lunch from home. - David Orentlicher

February 8, 2011 | Permalink | Comments (0) | TrackBack (0)

Sunday, February 6, 2011

Announcing a Partnership Between the Law, Medicine and Healthcare Section of the American Association of Law Schools and the Health Law Prof Blog

Joan Krause (University of North Carolina School of Law), the Chair of the Law, Medicine and Healthcare Section of the American Association of Law Schools sent out this announcement to the members of the Section recently:  

 In an effort to keep members of the Section better informed of current Section news, I am very pleased to announce a new partnership between the AALS Section on Law, Medicine, and Health Care and the Health Law Prof Blog, located at http://lawprofessors.typepad.com/healthlawprof_blog/

The Blog will post Section announcements, as well as newsworthy items from Section members such as conference announcements and paper abstracts (with links to SSRN and a picture of the author, if desired).  If you have a newsworthy item to post, please contact Professor Katharine Van Tassel at kvantassel@stu.edu

In addition, the Blog will be starting a guest blogging series and members of the Section are invited to participate.  A guest blogger will blog for one month by preparing four posts (one per week).  These entries will be short, one- to two-page commentaries. If you are interested in ... participating on the Health Law Prof Blog as a guest blogger, please contact Professor Katharine Van Tassel at kvantassel@stu.edu.

To subscribe to the Health Law Prof Blog and have e-mails with new posts automatically sent to you, please go to http://www.feedblitz.com/f/f.fbz?AddNewUserDirect and enter your e-mail address.  To add the Health Law Prof Blog to your RSS Feed, open the following link:  http://feeds.feedburner.com/typepad/syuC . - KVT

February 6, 2011 | Permalink | Comments (0) | TrackBack (0)