HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Monday, February 14, 2011

Where your health (and other) dollars go...

This week's candidate for the must-show graphic for your health law class. Available here is an excellent New York Times chart breaking down the proposed federal budget. The enormity of the health budget is dramatic, but you can also zoom in on the specifics of proposed health spending (and the proposed cuts).

Nic Terry

February 14, 2011 | Permalink | Comments (0) | TrackBack (0)

P.S.R. Murthy: "Health Care System in Tribal Areas – An Insight (With Reference to Andhra Pradesh State, India)"

P.S.R. Murthy has posted "Health Care System in Tribal Areas – An Insight (With Reference to Andhra Pradesh State, India)" on SSRN:

Indian Tribals are traditional, conservative and under-privileged people. They are socially and economically weaker and also under abject poverty and live in a subsistence economy and general backwardness. This is because of their ill-health which is a cause and consequence of poverty. The major impediments to good health are inequity in health system and radical poverty of the masses. Illness lowers learning ability, reduces productivity, income and savings and it leads to poor quality of life and thus perpetuating poverty. India has the largest tribal population in the world. There are about 427 recognized scheduled Tribal groups in India. As per 2001 Census' the tribal population of India is 84.3 million, larger than that of any other country in the world. Myanmar, with the tribal population of 44 million is the second largest. Tribes of Andhra Pradesh have added grandeur to the region with their rich heritage of culture, innocent lifestyle and age-old ethnicity. In other words, their customs, rituals, fairs, festivals have drawn the attraction of all the anthropologists of the country who have conducted surveys on them with enthusiasm and vigor. Presently there are 32 lakh tribals 50 lakh nomads and other backward people in Andhra Pradesh. The state of Andhra Pradesh has been chosen as Study area in view the congregation of larger number of tribal’s live in below poverty line without any basic medical facilities. There is an urgent need to concentrate on them for their survival. Failing which the race will be wiped out due to perpetual contaminated and dangerous diseases prevailing in the entire tribal areas due to non availability timely Medical assistance and Government sponsored Health Care Projects in spite of the budgetary allocation of scores of Public money for their welfare and well being. The basic training focused on hygiene, malaria prognosis and first aid. Community health workers were selected from among married women in their twenties and thirties, preferably with a modicum of education. Other major achievements included the provision of drugs, equipment and vehicles for 32 primary health centers and of vehicles for mobile medical units; matching grants for the construction of 181 subcentres; the establishment of a referral fund for medical emergencies; and the provision of training kits. 

February 14, 2011 | Permalink | Comments (0) | TrackBack (0)

As Montana Goes, So Goes the Country?

The Montana state legislature has taken up two important patient liberty questions this session.  May physicians provide aid in dying (also described as physician assisted suicide) to terminally ill persons?  May marijuana be used for medical purposes?

 In December 2009, the Montana Supreme Court held that under Montana law, "a terminally ill patient's consent to physician aid in dying constitutes a statutory defense to a charge of homicide against the aiding physician."  Baxter v State, 224 P.3d 1211 (Mont. 2009).  If Senate Bill 116  were to pass, Montana law would override the court’s ruling and make physician aid in dying illegal.

Last week, the Montana House of Representatives voted to repeal the state’s six-year old medical marijuana law (House Bill 161).  According to a report in the New York Times, the move to repeal reflects both a change in the partisan make-up of the legislature and a marijuana industry whose size has far exceeded expectations.

- David Orentlicher

February 14, 2011 | Permalink | Comments (0) | TrackBack (0)

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.


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.


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 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

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

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

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

To subscribe to the Health Law Prof Blog and have e-mails with new posts automatically sent to you, please go to and enter your e-mail address.  To add the Health Law Prof Blog to your RSS Feed, open the following link: . - KVT

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

Saturday, February 5, 2011

Walsh on Lack of Subject Matter Jurisdiction over Health Care Reform Challenges

Professor Kevin Walsh (Richmond) has posted on SSRN his essay, The Ghost that Slayed the Mandate. Here’s the abstract:

Walsh Virginia v. Sebelius is a federal lawsuit in which Virginia seeks the invalidation of President Obama’s signature legislative initiative of healthcare reform. Virginia seeks declaratory and injunctive relief to vindicate a state statute declaring that no Virginia resident shall be required to buy health insurance. To defend this state law from the preemptive effect of federal law, Virginia contends that the federal legislation’s individual mandate to buy health insurance is unconstitutional. Virginia’s lawsuit is one of the most closely followed and politically salient federal cases in recent times. Yet neither the federal government nor any other legal commentator has previously identified the way in which the very features of the case that contribute to its political salience also require that it be dismissed for lack of statutory subject-matter jurisdiction. The Supreme Court has placed limits on statutory subject-matter jurisdiction over declaratory judgment actions in which a state seeks a declaration that a state statute is not preempted by federal law - precisely the relief sought in Virginia v. Sebelius. These limits insulate federal courts from the strong political forces surrounding lawsuits that seek federal court validation of state nullification statutes. This Essay identifies these heretofore neglected limits, shows why they demand dismissal of Virginia v. Sebelius, and explains why it is appropriate for federal courts to be closed to this type of suit.

(Hat Tip: PrawfsBlawg and Civil Procedure & Federal Courts Blog)

-- KVT

February 5, 2011 | Permalink | Comments (0) | TrackBack (0)

Friday, February 4, 2011

Push to Repeal ObamaCare's 1099 Requirement Ignores Tax-Gap Problem

Hat Tip to Paul Caron over at TaxProf Blog for highlighting an article posted on Bloomberg entitled Push to ‘Correct’ IRS Small Business Rule Ignores Tax-Gap Data, by Ryan J. Donmoyer:

A year ago, Congress had instructed the Internal Revenue Service to improve small businesses’ compliance with tax laws and created rules to make it more difficult for entrepreneurs to hide their income.

Now, rules requiring businesses to report to the IRS transactions with vendors may become collateral damage in a political fight over the health-care law. President Barack Obama in his State of the Union address on Jan. 25, backed an effort to “correct” the “unnecessary bookkeeping burden” before the rules take effect in 2012, forgoing an estimated $1.9 billion annually to pay for the overhaul of the health-care system.

The about-face is designed to appease congressional Republicans and business groups such as the U.S. Chamber of Commerce that have criticized the rules along with the broader health-care law. It also shows how difficult it is to take steps to close the tax gap among small businesses, which data show have lower tax payment rates than corporations and salaried workers. ...

The IRS estimates that about $345 billion in taxes owed are unpaid every year. Auditors recover about $55 billion of that, leaving $290 billion that goes uncollected, a figure known as the tax gap. The agency attributes $109 billion of the gap to underreported business income earned by individuals. The IRS estimates that this group also fails to pay about $39 billion in self-employment taxes. The figures are drawn from a study of 2001 tax returns and are likely higher today, according to the Congressional Research Service.

The IRS says small businesses are able to underreport their taxes because many business-to-business transactions aren’t reported independently to the government as wages and investment income are. By contrast, about 98% of salaried workers pay what they owe because their employers report their wages to the IRS. The Bush administration, in response to demands from Senate Finance Committee Chairman Max Baucus, a Montana Democrat, in 2008 proposed requiring businesses to report to the IRS when they pay vendors more than $600 for goods. Similar requirements exist for purchases of services.


February 4, 2011 | Permalink | Comments (0) | TrackBack (0)

So Much for P4P, Jury out on Safer Patients Initiative

Post-election healthcare angst is not limited to the US. The proposed reforms in the UK are complex but involve market-based reforms and drastic cuts in bureaucracy, as described here.  But, while the wonks debate the impact of the reforms we have some hard data about two quality improvement/error reduction reforms strategies much discussed on this side of the Atlantic. First, a study published in the BMJ last month cases serious doubts on the efficacy of Pay for Performance (P4P) models. Second, potentially more worrying, yet as yet far less definitive are this month's published studies suggesting that broad system-wide safety-related initiatives based on the Health Foundation’s Safer Patients Initiative (SPI), based on IHI models, have only modest impacts on safety improvements. The full report is available here.

Nic Terry


February 4, 2011 | Permalink | Comments (0) | TrackBack (0)

Is there a Middle Ground between Concierge Care and the Doc in the Box?

Concierge (or retainer-based) care is relatively well-known. For a four or five figure retainer plus 'cash only' at the time of visit the patient gets 24x7 care, patient-focused technologies, and access to a practice with fewer patients (as described here and in the definitive journal article by co-blogger Frank Pasquale). Equally, we have seen the steady proliferation of the doc-in-a-box, or less pejoratively, walk-in clinics (low cost mall or retail-store based clinics typically staffed by nurse practitioners) as detailed here and criticized by pediatricians here.

Katie Hafner's recent article in the New York Times, Concierge Medical Care With a Smaller Price Tag, suggests further stratification of the primary care market with the growth of low(er) cost concierge-like models that do accept insurance. Her article primarily discusses One Medical Group, that markets itself as "not your typical doctor's office." Their price may be three-figured but many concierge benefits are included, such as email contact with doctors, electronic appointment scheduling, and online prescription refill requests. The practice even has a blog and social networking feeds.

Another recent story in the Los Angeles Times suggests that while the "Walmart-ing" or Toyota-ing of US healthcare has barely begun, at least some healthcare providers have taken notice of the Apple stores' genius bars and their online reservation (appointment) systems!

These different models seem to have some teaching value; some of the issues that can be discussed include risk-pooling and adverse selection, the individual and group meanings of patient-centered care, the shift to and likely shortages associated with primary care, the values associated with preventative care and continuity of care, and the convergence of physician and patient attitudes towards technology.

Nic Terry


February 4, 2011 | Permalink | Comments (0) | TrackBack (0)

Thursday, February 3, 2011

Rodwin: Conflicts of Interest and the Future of Medicine : The United States, France and Japan

Mrodwin Marc Rodwin (Suffolk University Law School) has published a new book, Conflicts of Interest and the Future of Medicine: The United States, France and Japan with Oxford University Press.



Here is an over view:

Book Cover CI andFuture of Medicine Conflicts of interest result from physicians practicing medicine as entrepreneurs, from physicians’ties to pharma, and from investor-owned firms and insurers’ influence over physicians’ medical choices. These conflicts compromise physicians’ loyalty to their patients and their professional independence. The consequences are often devastating for patients—and society. Yet widespread conflicts of interest are not unique to the U.S. They exist in different forms in all advanced nations.

In Conflicts of Interest and the Future of Medicine, Marc A. Rodwin examines the development of these conflicts in the United States, France, and Japan.  He shows that national differences in the organization of medical practice and the interplay of organized medicine, the market, and the state give rise to variations in the type and prevalence of such conflicts and how each nation addresses them. Most proposals to address physicians’ conflicts of interest are not effective.  But drawing on the experiences of these three nations, Rodwin demonstrates that we can mitigate these problems with carefully planned reform and regulation.   


February 3, 2011 | Permalink | Comments (0) | TrackBack (0)