HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

A Member of the Law Professor Blogs Network

Wednesday, February 29, 2012

Health Care Fraud Trends and Data Mining Background

Fraud and abuse detection and deterrence is one of the most rapidly evolving areas of health care law. I found this backgrounder from Perkins Coie on recent developments very helpful.  A few years back, Kathy Giannangelo wrote a good introduction to the use of data mining technology in the field.  A few excerpts: 

On the national level, the Centers for Medicare and Medicaid Services (CMS) created the Medicare-Medicaid Data Match Program, or Medi-Medi project, in 2001. . . . Federal regulations require that each state Medicaid agency maintain a claims processing and information retrieval system (the Medicaid Management Information System). The Surveillance and Utilization Review Subsystem, a mandatory component of the Medicaid Management Information System, exists to safeguard against inappropriate payments for Medicaid services. Patterns of fraudulent, abusive, unnecessary, or inappropriate utilization can be detected by analyzing and evaluating provider service utilization.

According to section 6034 of the Deficit Reduction Act, the Medi-Medi programs are to use computer algorithms to search for payment anomalies. The abnormalities being sought include billing or billing patterns identified with respect to service, time, or patient that appear to be suspect or otherwise implausible. This data-oriented approach to mining combined Medicare and Medicaid claims to detect improper billings and utilization patterns has created the ability to find vulnerabilities in both programs.

While the field of surveillance studies often critiques dataveillance, these strike me as model initiatives for the types of corporate audit trails that should be adopted far more widely in an economy as complex as ours.

[FP]

February 29, 2012 | Permalink | Comments (0) | TrackBack (0)

Sunday, February 26, 2012

Position Announcement: Boston University School of Law - Visiting Assistant Professor Program in Health Law

The Boston University School of Law announces openings in its Visiting Assistant Professor Program in Health Law.

PURPOSE: The BU Health Law program is an interdisciplinary research and teaching effort at Boston University, including the School of Law and the Department of Health Law, Bioethics & Human Rights at the School of Public Health. The Health Law program is dedicated to scholarly research at the intersection of law and health policy, broadly conceived. Topical areas include, but are not limited to: health care financing and organization; insurance; global health; public health; emergency preparedness; bioethics; health & human rights; cost, quality and access; health care markets; food & drug law; biomedical research; innovation; and health disparities. The Visiting Assistant Professor in Health Law is a post-JD experience designed to prepare candidates for tenure-track faculty positions in law schools.

PROGRAM: Recipients will hold a full-time, two-year appointment in the School of Law as a Visiting Assistant Professor. Recipients teach one seminar per semester (six credits per year) and devote the balance of their time to research and writing. Recipients also participate in faculty workshops at BU and can observe health policy and research in practice at Boston Medical Center. Professor Wendy Mariner and Associate Professors Kevin Outterson and Abigail Moncrieff lead the program. Other faculty members include Professor George Annas, Professor Leonard Glantz, and Professor Emeritus Fran Miller.

The program builds on the unique strengths of BU programs in Law and Public Health, giving the candidate multi-disciplinary exposure to the richness of health law, with support from BU faculty mentors. Recipients will also want to take advantage of the wealth of educational and cultural opportunities available in the city of Boston.

STIPEND AND BENEFITS: The recipient will be provided with an office, library privileges, health benefits, and a stipend of approximately $50,000. You are invited to attend all faculty scholarship workshops. Depending on a candidate’s interests and BU’s resources, a recipient may be able to spend time in other supporting BU Schools.

ELIGIBILITY: Applicants must hold a JD or other similar degree in law. Outstanding academic credentials and an excellent research proposal will be required. Preference will be given to candidates who have a strong draft article in health law that has potential for development and publication. Boston University is an equal opportunity employer.

APPLICATION: Applications will be accepted on a rolling basis starting February 15, 2012 for the academic years 2012-14 (2 years). Applications are due by March 31, 2012. Include the following materials as pdf files:

• Curriculum Vitae;
• University transcripts;
• Research proposal in health law of not more than 2000 words;
• Writing sample, in draft form; and
• Three letters of recommendation, emailed directly from the recommender.

All application materials should be e-mailed to: Leanne Chaves leannekc@bu.edu.
Questions may be directed to Professor Mariner wmariner@bu.edu, Associate Professor Moncrieff arm11@bu.edu, or Associate Professor Outterson mko@bu.edu.

[KVT]

February 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Call For Papers And Presenters: Hamline Health Law Conference

Hamline University School of Law is hosting a conference in November entitled Honoring Patients Treatment Choices at the End of Life: New Tools, New Challenges, New Limits. Anyone interested in speaking at the Symposium and/or publishing in the Hamline Law Review's Symposium issue should submit both a CV and a 500-word abstract to healthlawsym2012@hamline.edu by March 30th, 2012. More details are here.

[KVT]

February 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Position Announcement: O’Neill Institute Law Fellows

The O’Neill Institute for National and Global Health Law is seeking exceptionally qualified candidates to serve as O’Neill Institute Fellows. Housed at Georgetown University Law Center in Washington, DC., the O’Neill Institute is a leading research institute for health law.  For more details about the Institute and its ongoing work please visit www.oneillinstitute.org.

Fellows are based at the Law Center and report to the O’Neill Institute Director and to the Faculty Director. Law fellows work on academic legal research and scholarship projects.  Duties include working closely with faculty to produce scholarly works for publication, in some cases leading to joint publication. Allocation of time is mainly determined by O’Neill Institute Faculty needs and taking into account fellow preferences; additionally, some time may be allocated to O’Neill projects.  Fellowships are for one year with possible extension for two years, and will begin in July 2012.  Fellows will receive an annual salary of $66,747 with great benefits.

Candidates should have a J.D. degree (or the equivalent), exceptional academic credentials, including publications, and health law-related research interests in areas like public health law, global health law, domestic health care law, empirical studies, regulatory impacts of health, health and human rights, etc. Successful candidates will have knowledge and/or experience in aspects of national and or global health law and ethics. A post-graduate degree (MPH, LL.M.), health degree, or significant work experience may be preferred.

Applications should be submitted electronically at the following website http://www.law.georgetown.edu/oneillinstitute/about/application-fellowship.html and must include: CV, cover letter, writing sample, professional references, official law school transcript, and other graduate school transcripts (if applicable).

The application deadline is Friday, February 29, 2012. Any questions about the position should be directed to oneillinstitute@law.georgetown.edu.

 [KVT] 

February 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Rule Requiring Pharmacy to Deliver Prescribed Medications Regardless of Religious or Conscientious Objection Held Unconstitutional

A decision that was handed down by the U.S. District Court in the Western District of Washington this week in Stormans v. Selecky held that the Washington State Department of Health’s Pharmacy Board’s rule that requires pharmacies to deliver lawfully prescribed drugs or devices to patients, with no exception for conscientious or religious objection, was unconstitutional as applied to a licensed pharmacy and two licensed pharmacists who challenged the rule. The opinion may be found at http://www.wawd.uscourts.gov/documents/HomePageAnnouncements/C07-5374%20Opinion.pdf. Hat tip to Vickie Williams, Associate Dean for Academic Affairs, Gonzaga University School of Law.

[KVT]

February 26, 2012 | Permalink | Comments (0) | TrackBack (0)

Saturday, February 25, 2012

ACA and Disparities

I was recently speaking at the Conference on Race, Class, Gender and Ethnicity (CRCGE) at UNC-Chapel Hill.  I heard a terrific talk by Ronny A. Bell on health disparities, which mentioned many initiatives in the ACA that aim to narrow the health disparities gap.  Here is a bit on Bell's background:

Dr. Bell is Professor in the Division of Public Health Sciences, Department of Epidemiology and Prevention, Wake Forest University School of Medicine, with training in nutrition and epidemiology.  Dr. Bell’s primary interests are chronic disease prevalence and risk factors, with particular emphasis on ethnic minority populations. He is Director of the Maya Angelou Research Center on Minority Health. Dr. Bell served as the Principal Investigator of the HEARTQUEST project, an NHLBI-funded contract serving as one of six vanguard Enhanced Dissemination and Utilization Centers (EDUCs) nationwide. The project targeted African Americans, Native Americans and whites in Robeson and Columbus counties, North Carolina, to address the tremendous cardiovascular disease burden in these communities.

While on my way to the conference, I read John McDonough's post on the need for critics of the ACA to propose their own methods of improving health care in the US.  I am particularly interested in whether critics of the Act have proposals to address disparities, or prefer to redefine or deny the problem.

[FP]

February 25, 2012 | Permalink | Comments (0) | TrackBack (0)

Imagining The Next Quarter Century of Health Care Law

IHLROn the occasion of the twenty-fifth anniversary of the Hall Center for Law and Health, we are pleased to announce this year's Indiana Health Law Review Symposium. A stellar group of health law scholars will celebrate this important milestone by looking ahead to the next quarter century of health care law and policy, casting their critical predictive analyses on the major themes of the field. Topics range from finance and access through quality and ethics to emerging scientific and technological challenges.

Making the event even more special will be this year's McDonald-Merrill-Ketcham Lectureship and Award for Excellence in Law and Medicine, jointly sponsored by the Indiana University School of Medicine and the Indiana University Robert H. McKinney School of Law. We are proud to announce that the 2012 awardee is Wendy Mariner, the Edward R. Utley Professor of Health Law, Bioethics & Human Rights at Boston University.

We hope you can join us for this celebration on April 12-13. The brochure is here and online registration is here.

[NPT/DO]

 

February 25, 2012 | Permalink | Comments (0) | TrackBack (0)

Friday, February 24, 2012

Worth Reading This Week

Susan Appleton, Reproduction and Regret, SSRN/Yale Journal of Law & Feminism

Alan Rubel, Justifying Public Health Surveillance: Basic Interests, Unreasonable Exercise, and Privacy, SSRN/Kennedy Institute of Ethics Journal 

Robert G. Hauser, Here We Go Again — Another Failure of Postmarketing Device Surveillance, NEJM

Steven J. Willis & Nakku Chung, No Health Care Penalty? No Problem: No Due Process, SSRN/AJLM

Marsha Gold, Medicare Advantage — Lessons for Medicare's Future, NEJM

[NPT]

 

February 24, 2012 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 21, 2012

Guest Blogger James T. O'Reilly: Changing The Culture of Those Who Market Probotic Cultures

Oreilly06

Fecal transplants, anyone? Yes, if you have a clostridium difficile infection, the best medicine may be to have a gastroenterologist implant a piece of non-infected fecal matter into your rectum and allow it to dissolve. No, please, no rush of donors to volunteer.  Before health law profs choke, gag, or put this into an exam question, the science of the lower bowels is becoming a major area for study. You’ll have a gut feeling that there will be a lot coming out on this topic, most of it banned from polite tableside conversation….

The National Institutes of Health study of probiotics regulatory options has wrapped up its third and final two-day session on Feb. 17 at the University of Maryland, with a report to follow this spring. Probiotics, including pills, yogurts, and liquids, are a potential billion-dollar market opportunity for bowel problems. If you’re just a regular guy like me, you can leave the marketing to Jamie Lee Curtis and other Activia activists. But for many, the bloating and gas and sometimes serious infections pose an opportunity for the preventive consumption of millions of special bacilli which re-populate the intestinal flora and are hoped to reduce the problems in the humane microbiome.

As a member of the study dialogue, I recommended that the probiotics marketers who now have an “anything goes” approach should be constrained to tell the whole relevant truth. If they label their product with probiotic claims, there must (at the end of the marked shelf life) be enough active biologic entity in the consumer’s dose of that product, such that the probiotic will actually deliver the promised benefit. A yogurt whose Cosmo ad promised faster “transit time” in the gut (and we’re not talking speedier subway cars) must actually deliver. To get to the enforcement of this ideal state the FDA and FTC must have clear guidance, hence the NIH’s efforts.

I recommended to NIH and FDA the use of the OTC Monographs (21 CFR Parts 330 et seq.) as the readily available, Supreme Court-blessed, no statute needed, mechanism for the characterization of biologic contents, effectiveness studies, supporting documentation and actually defensible marketing claims. To say that industry threw a lot of anal output my way is to say it mildly. The probiotic toothbrush makers, the probiotic lipstick makers and the goddess of yogurt-borne regularity will  not embrace FDA review and FTC norms. They prefer to be vendors of pricier versions of old, normal, little-regulated foods or cosmetics or within that magical, regulation-eluding mélange cloaked as “dietary supplements”.  We’ll watch for the final report and will cover it in this blog, but for now, probiotic fans must caveat their emptor, each time they empty their wallets. Wishing you all faster transit time and fewer consumer frauds…..

- Jim O’Reilly

February 21, 2012 | Permalink | Comments (0) | TrackBack (0)

Guest Blogger Carl H. Coleman: What to Look for at This May's World Health Assembly: An International Convention on R&D for the Developing World?

ColemanI spent most of last week participating in the second annual Executive Course on Intellectual Property, Diplomacy, and Global Public Health, co-sponsored by Seton Hall Law School and the Graduate Institute of International and Development Studies in Geneva.  One of the key issues discussed in the course was a World Health Organization (WHO) working group’s recent recommendation for the adoption of a binding international convention to promote research and development related to diseases predominantly affecting developing countries.  The proposal is expected to be on the agenda for the May 2012 meeting of the World Health Assembly (WHO’s governing body), where it is likely to generate significant discussion.

The recommendation is grounded in a recognition that our existing intellectual property system—under which companies recoup their R&D costs by patenting their products and selling them to end users at high monopoly prices—provides no incentive to develop products that will be used primarily by individuals who have no money to spend.

Creating an alternative financing system for medical products predominantly used in developing countries raises several challenging issues.  First, funding for R&D has to come from somewhere; companies cannot be expected to invest the resources necessary to invent medical products for developing countries if they have no reasonable expectation of recovering their costs.  While voluntary donations can help in the short term, a stable and sustainable system will depend on binding financial commitments by WHO members.  In a time of global financial insecurity, convincing governments to make these commitments may be a hard sell.

Even if governments can be convinced to make the necessary financial commitments, a second challenge remains: determining where the funds are best directed.  Ideally, funding should go to developing products that actually result in significant health improvements for the world’s population, but it is impossible to know in advance whether a particular line of research will end up producing public health gains.  One possible solution to this problem is awarding prizes to researchers who achieve pre-defined objectives.  Unlike traditional research grants, which are awarded prospectively based on judgments about a project’s potential, a prize system does not pay anything unless the research actually succeeds.

The trick with a prize system is determining the circumstances under which prizes should be granted.  At one extreme, prizes could be offered for fully achieving public health outcomes that are undeniably important—for example, a prize for creating a safe, effective, and inexpensive vaccine for HIV, tuberculosis, or malaria.   The problem is that, from the perspective of a particular research team, the likelihood of achieving such a broad objective in a reasonable period of time is likely to be too low to warrant a significant investment of resources up front.  An alternative approach is to award “milestone” prizes for achieving smaller steps along the product development pathway.  This approach provides more realistic incentives, but achieving a milestone is no guarantee that a successful product will result.  As such, a milestone system is likely to result in some prize money going to research that ultimately produces no public health benefits at all.

An intriguing approach that has received a great deal of attention in the academic literature is the Health Impact Fund, championed by philosophy Professor Thomas Pogge of Yale University.  Under that approach, funds would be awarded based on the demonstrated health impact of new medical products, as measured by the extent to which using the product causes individuals to experience additional quality-adjusted life years.  Because Health Impact Fund payments would depend on a product’s demonstrated impact on the health status of the intended beneficiaries, companies would have an incentive not only to create the product and put it on the market, but also to engage in activities that promote the product’s accessibility and correct use.   Unfortunately, the latest report from the WHO working group suggests that the members were not enthusiastic about adopting the Health Impact Fund model, perhaps based on concerns about the complexity of administering it. 

However the details of the system are ultimately worked out, the fact that serious attention is being given to incentivizing the development of medical products for developing countries is an encouraging development.   Let’s hope that this May the process of creating a binding international agreement will finally begin in earnest.

- Carl H. Coleman

 

February 21, 2012 | Permalink | Comments (0) | TrackBack (0)

Friday, February 17, 2012

Worth Reading This Week

Sara Rosenbaum & Tim Jost, All Heat, No Light — The States' Medicaid Claims before the Supreme Court, NEJM

Bradford DeLong & Ann Marie Marciarille, Bending the Health Cost Curve: The Promise and the Peril of the IPAB, SSRN

Mark A. Hall, Regulating Stop-Loss Coverage May Be Needed To Deter Self- Insuring Small Employers From Undermining Market Reforms, Health Affairs

 Frank Pasquale, The Hippocratic Math, SSRN/Journal of Legal Medicine (reviewing Greg Bloche's The Hippocratic Myth)

[NPT]

 

February 17, 2012 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 15, 2012

O'Neil and Black on Fraud

We'll focus on the darker corners of medicine this week.  First, Cathy O'Neil's post on Vioxx

Let’s face it, nobody comes out looking good in this story. The peer review system failed, the FDA failed, Merck scientists failed, and the CEO of Merck misled Congress and the people who had lost their husbands and wives to this damaging drug. The truth is, we’ve come to expect this kind of behavior from traders and bankers, but here we’re talking about issues of death and quality of life on a massive scale, and we have people playing games with statistics, with academic journals, and with the regulators.

Just as the financial system has to be changed to serve the needs of the people before the needs of the bankers, the drug trial system has to be changed to lower the incentives for cheating (and massive death tolls) just for a quick buck. As I mentioned before, it’s still not clear that they would have made less money, even including the penalties, if they had come clean in 2000. They made a bet that the fines they’d need to eventually pay would be smaller than the profits they’d make in the meantime.

Second, William K. Black on the French entrepreneur extraordinaire behind the breast implants controversy

Control frauds occur when the persons controlling a seemingly legitimate entity use it as a “weapon” to defraud. Such frauds occur in the private, NGO, and public sector. I write primarily about accounting control frauds because accounting is the “weapon of choice” for financial control frauds. . . . 

Shareholders and creditors are the primary intended victims of accounting control fraud, which creates record, but fake profits. Other forms of control fraud create real profits. Anti-purchaser control frauds target the customer and involve deception as to the quality and/or quantity of the product. Anti-public control frauds target the public. Illegal logging, the illegal seizure and exploitation of mines, and purchasing goods one knows are likely to be stolen are examples of frauds designed to harm primarily the public. . . .

Poly Implant Prothese (PIP) was a French manufacturer of saline and silicone breast implants. The FDA found severe problems with PIP’s production of saline implants a decade ago and alerted PIP and its French regulatory counterpart to the problems in 2000. The FDA described the saline implants as “adulterated” due to eleven flaws in its manufacturing processes.. . . 

PIP did not inform its poorer customers that it was illegally selling them inserts made with cheaper, unapproved industrial-grade silicon.  PIP also did not inform its customers that “the casing around the filling was also faulty and prone to rupture or leakage'” 

No sooner had [PIP's CEO] (for the second time) been found to have endangered his customers, than he was planning to go back into the business of producing and selling breast implants. [His business plan described the CEO] as a "creative genius". . . It takes a special kind of depravity to describe oneself as a “creative genius” after a life of defrauding one’s customers through means that put their health at undue risk.

Both are very troubling cases. [FP]

February 15, 2012 | Permalink | Comments (0) | TrackBack (0)

Stanford Law Review Articles Debate Virginia v. Sebelius

The Stanford Law Review has just published an interesting back-and-forth on Virginia v. Sebelius in their first print issue of the year, available at here. First, Kevin Walsh, Assistant Professor at the University of Richmond School of Law, writes about "The Ghost That Slayed the Mandate." Then, the Attorney General, Solicitor General, and Deputy Attorney General of the State of Virginia respond in "State Sovereign Standing: Often Overlooked, but Not Forgotten." 

If you are interested in submitting a response for publication in SLR Online, here is the link.

[KVT]  

February 15, 2012 | Permalink | Comments (0) | TrackBack (0)

O’Neill Institute Law Fellowships

The O’Neill Institute for National and Global Health Law is seeking exceptionally qualified candidates to serve as O’Neill Institute Fellows. Housed at Georgetown University Law Center in Washington, DC., the O’Neill Institute is a leading research institute for health law.  For more details about the Institute and its ongoing work please visit www.oneillinstitute.org

Fellows are based at the Law Center and report to the O’Neill Institute Director and to the Faculty Director. Law fellows work on academic legal research and scholarship projects.  Duties include working closely with faculty to produce scholarly works for publication, in some cases leading to joint publication. Allocation of time is mainly determined by O’Neill Institute Faculty needs and taking into account fellow preferences; additionally, some time may be allocated to O’Neill projects.  Fellowships are for one year with possible extension for two years, and will begin in July 2012.  Fellows will receive an annual salary of $66,747 with great benefits. 

Candidates should have a J.D. degree (or the equivalent), exceptional academic credentials, including publications, and health law-related research interests in areas like public health law, global health law, domestic health care law, empirical studies, regulatory impacts of health, health and human rights, etc. Successful candidates will have knowledge and/or experience in aspects of national and or global health law and ethics. A post-graduate degree (MPH, LL.M.), health degree, or significant work experience may be preferred. 

Applications should be submitted electronically at the following website http://www.law.georgetown.edu/oneillinstitute/about/application-fellowship.html and must include: CV, cover letter, writing sample, professional references, official law school transcript, and other graduate school transcripts (if applicable). 

The application deadline is Friday, February 29, 2012. Any questions about the position should be directed to oneillinstitute@law.georgetown.edu.

[KVT]

February 15, 2012 | Permalink | Comments (0) | TrackBack (0)

Tuesday, February 14, 2012

Physician-Assisted Suicide and the Slippery Slope

Last week's ruling by the Georgia Supreme Court provides further evidence that the slippery slope is not a real problem with a right to physician-assisted suicide. Since 1994, Georgia's assisted suicide ban prohibited the public promotion and provision of assisted suicide services, but did not reach the private decision of patient and physician to choose physician-assisted suicide. The court struck the law down on first amendment grounds--since it targeted those who publicly advertised or offered services but not others--but even while the law has been in force, there have not been any reports that physicians have misused their freedom to provide physician-assisted suicide privately.

Kevorkian

According to a 1994 article in the Georgia State University Law Review, the legislature had rejected a broad ban, in part because it was worried about chilling palliative or other legitimate end-of-life care, but also because it did not want to interfere with private decisions of patient and physician for physician-assisted suicide.

The statute was passed at a time when Jack Kevorkian was actively assisting suicides in Michigan, and the legislature was concerned about him, or someone like him, promoting the practice in Georgia.

Georgia's experience with physician-assisted suicide adds to reassuring evidence about the slippery slope from other states and other end-of-life practices. Oregon has permitted assisted suicide by statute for nearly 15 years, and the state's annual reports tell us that patients rarely use physician-assisted suicide (about 1/5 of one percent of deaths in Oregon), and that it has not placed vulnerable patients at risk. Users of assisted suicide are just as likely to have health insurance or receive hospice care as other terminally ill patients, and they tend to be better educated. Washington and Montana have permitted assisted suicide by statute or court decision for only a few years, but in neither state is there evidence of a slippery slope.

Continue reading

February 14, 2012 | Permalink | Comments (0) | TrackBack (0)

Friday, February 10, 2012

Guest Blogger Carl Coleman: Ethical Questions Over Vaccination Campaign in Haitii

ColemanOne of the peculiarities of our current approach to regulating innovative medical activities is the importance placed on determining whether a novel approach to a problem constitutes “research with human subjects.” If an activity is characterized as research, it is typically subject to an extensive system of prospective ethical oversight, designed to ensure that the rights and well-being of the participants will be adequately protected. By contrast, innovative medical activities that do not meet the definition of research can often be conducted without any prior review or approval, regardless of the risks or uncertainties involved.

Recent proposals to roll out a cholera vaccination campaign in Haiti, a country that has been devastated by a deadly cholera epidemic for the past 15 months, have led me to wonder about the sharp line we draw between research and non-research in determining the necessity of prior ethical oversight.

Given that the primary intent of such a campaign would be to benefit the Haitian people currently at risk of developing cholera, rather than to develop “generalizable knowledge” for the benefit of future populations, it is unlikely that such a campaign would be considered “research” as that term is typically defined. Yet, even if it does not technically constitute research, a campaign to distribute cholera vaccines in Haiti clearly raises significant ethical issues for which prospective oversight seems warranted.

For example, while a vaccine campaign would undoubtedly provide real health benefits to some individuals, it also involves risks, including the potential diversion of resources from interventions that offer greater long-term health benefits (particularly the improvement of water and sanitation systems) and the possibility of creating a false sense of security that reduces individuals’ willingness to engage in behavioral change. In addition to risks, vaccine campaigns can have significant implications for social justice and equity, particularly when there are insufficient vaccines for the entire population and decisions must be made about how scarce resources will be prioritized.

As NPR reports, the Swiss arm of Doctors without Borders has cited some of these concerns in its decision not to participate in the Haitian vaccination campaign, calling the campaign a “distraction” from more pressing issues of water and sanitation control.

Considerations related to risk-benefit assessment, social justice, and other ethical matters are precisely the kind of issues that must be formally assessed by interdisciplinary committees before a proposal to conduct research with human participants is allowed to proceed. Yet, for activities that do not meet the definition of research, there is no agreed-upon mechanism for prior ethical oversight, even when the ethical issues are substantial and the evidence basis is scant.

In a 2009 report that I helped draft, the World Health Organization called on policy-makers to ensure that “most, if not all, emergency public health activities are subject to some form of ethical oversight, whether or not those activities are formally characterized as research.” Those responsible for the decision to launch a cholera vaccine in Haiti would be well advised to take these recommendations to heart.

- Carl H. Coleman

February 10, 2012 | Permalink | Comments (0) | TrackBack (0)

Introducing Guest Blogger Professor Carl H. Coleman

ColemanA big welcome to our guest blogger for the month of February, Carl H. Coleman, who is a Professor of Law at Seton Hall Law School where he serves as Director of Global Initiates for Seton Hall’s Center for Health Pharmaceutical Law & Policy and Gibbons Institute for Law, Science & Technology. He is the lead author of The Ethics and Regulation of Research with Human Subjects (Lexis, 2005, with Menikoff, Goldner, and Dubler), as well as numerous articles on health law and policy in leading legal and heath policy journals. During the 2006-07 academic year, he served as Bioethics and Law Advisor at the World Health Organization (WHO), and he continues to work closely with WHO on various projects related to ethics and public health. In addition, he is a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP), which is charged with providing expert advice to the Office for Human Research Protections of the U.S. Department of Health and Human Services.

Before coming to Seton Hall, he was Executive Director of the New York State Task Force on Life and the Law, where he worked on projects on assisted reproductive technologies, genetic testing and screening, physician-assisted suicide, and surrogate healthcare decision-making. He received his J.D., magna cum laude, from Harvard Law School, where he was Supervising Editor of the Harvard Law Review. Following law school, he served as law clerk to the Hon. James L. Oakes, Chief Judge of the U.S. Court of Appeals for the Second Circuit.

February 10, 2012 | Permalink | Comments (0) | TrackBack (0)

Thursday, February 9, 2012

Prosecutors and Pregnancy Update

Shuai

Earlier this year, I reported on the murder prosecution of Bei Bei Shuai, a woman who swallowed rat poison in a suicide attempt while pregnant. While Ms. Shuai survived and doctors delivered her fetus by C-section, the baby died a few days later.

Yesterday, the Indiana Court of Appeals paved the way for Ms. Shuai to be released on bail nearly 11 months after she was jailed. However, the court declined to dismiss the murder charge against her. 

[DO]

February 9, 2012 | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 8, 2012

Potentially Exclusionary Bundled Discounts for Pediatric Vaccines

For those who have been following disputes over drug shortages: late last year there was an interesting intervention from the American Antitrust Institute (AAI).  As the AAI notes, "shortages ... illustrate the relationship between competition and public policy in healthcare."  The AAI worries that certain business practices may be exacerbating drug shortages: 

We set forth the basis for the concern that certain bundled discounting practices in the market for important pediatric and teenage (henceforth “pediatric”) vaccines may be  anticompetitive.  A number of recent cases (e.g., LePage’s Inc., v. 3M and FTC v. Intel) have given antitrust authorities the opportunity to reflect on the correct  analytical frameworks for evaluating the competitive effects of bundled discounts and market-share or volume discounts. Because vaccination has positive spillover effects on those that are not immunized, the harms resulting from exclusionary bundled discounts also extend to the general population. This highlights the integral role that  competition  policy  plays in  achieving  broader public policy goals in healthcare. As the lead antitrust agency in this area, the FTC is ideally positioned to probe bundled discounts involving vaccines to determine if further action is necessary.

Given extant antitrust concerns about GPO's, this is an area that bears further attention. 

[FP]

February 8, 2012 | Permalink | Comments (0) | TrackBack (0)

Health Law Headlines of the Week (Week of Jan. 29, 2012)

Compiled by Thomas L. Hafemeister, J.D., Ph.D., Assoc. Prof., Univ. of Virginia School of Law

Emily P. Walker, Memo Reveals Obama Thinking on Malpractice, MedPage Today, Feb. 3, 2012.

A memo from two White House aides to President Obama reveals the administration's thinking on medical malpractice reform and its role in passage of the Affordable Care Act.

The memo—and Obama's response to it—made clear that, in July of 2009, the president was most interested in an approach that included early disclosure of an error, an apology, and mediation, in hopes that it would secure buy-in on healthcare reform from the American Medical Association (AMA), which supported that approach.

Ultimately he didn't want to do anything on malpractice reform that would upset the chances that healthcare reform would pass.

The memo and the President’s hand-written response can be found in a Jan. 27 posting by The New Yorker. They are part of a lengthier article containing various memos from the President that explores “the making” of his Presidency published in The New Yorker. The Southern Methodist University Law Review has also published an article that similarly explores the approach taken to medical malpractice reform in the Affordable Care Act, what influenced the approach taken, and the likely consequences of that approach.

Mark Oppenheimer, A Counselor’s Convictions Put Her Profession on Trial, N.Y. Times, Feb. 3, 2012.

Continue reading

February 8, 2012 | Permalink | Comments (0) | TrackBack (0)