August 6, 2011
Hazel Glenn Beh: "Non-Compete Clauses in Physician Employment Contracts are Bad for Our Health"
Restrictive covenants in employment contracts describe a class of ancillary agreements between employers and employees whereby the employee agrees not to compete with the employer after termination of the contract. Typically the non-compete clause contains a limit on the duration, scope of activity, and geographic area to which it extends. Nationally, there is widespread criticism of the use of restrictive covenants in physician employment contracts because of the potential harm to the public. Here, we offer medical workforce shortages as yet another reason to discourage non-compete agreements in this context. We describe the national and local shortage. We will briefly outline the origin and purpose of restrictive covenants and discuss the state of the law in Hawai‘i, and propose a legislative solution.
Stacey B. Lee: "Generic Manufacturers' Labeling Catch-22"
In Wyeth v. Levine, the Supreme Court eliminated brand-name manufacturers’ ability to use the preemption defense against state law failure to warn claims involving allegedly misbranded pharmaceutical drugs. Since that time, a heated debate has ensued among federal courts and legal scholars regarding that holding’s effect on generic manufacturers. Lost amid these judicial opinions and scholarly articles, however, is a more fundamental inquiry. Regardless of whether preemption is a viable defense, what type of legal and regulatory framework is needed to ensure generic manufacturers possess the necessary tools to fulfill their responsibility of providing consumers and the medical community with current and accurate labeling instructions for their products? This Article proposes such a framework.
Orly Lobel & On Amir: "Healthy Choices: Regulatory Design and Processing Modes of Health Decisions"
Orly Lobel, Herzog Endowed Scholar and Professor of Law at the University of San Diego School of Law, and On Amir, Associate Professor of Marketing at UC San Diego School of Management, posted, "Healthy Choices: Regulatory Design and Processing Modes of Health Decisions" on SSRN:
This article demonstrates experimentally that individuals making decisions about their health management are affected by the decision making environment and that law and policy can serve important roles in improving the decision environment. With the support of a generous grant from the Robert Wood Johnson Foundation, we conducted two series of experiments. First a lab experiment with approximately 700 respondents and next a web-based experiment with over 3000 respondents, including 300 medical doctors. In each of the experiments, in addition to manipulating the decision making environment and choice sets, we manipulated the state of the decision maker. In the first series of experiments we used the psychological mechanism of cognitive depletion and in the second series we tested the effects of cognitive overload. Most broadly, unlike past measures of risk aversion, our studies demonstrate that preferences for risk are not fixed in an individual but rather are highly sensitive to the role, context, and state of the decision maker in patterned ways. The project provides new evidence that cognitive processes affect decision making and judgment of risk, often leading to medically suboptimal choices. The lab studies suggest that often people process risk sub-optimally, e.g. favoring potentially harmful omissions over less harmful acts and being influenced by the order of warnings or choices, rather than their substantive value.
August 5, 2011
Worth Reading This Week
Kevin Outterson, Higher First Amendment Hurdles for Public Health Regulation, NEJM
David Fidler & Larry Gostin, WHO’s Pandemic Influenza Preparedness Framework: A Milestone in Global Governance for Health, SSRN/JAMA
Sean P. Keehan et al, National Health Spending Projections Through 2020: Economic Recovery And Reform Drive Faster Spending Growth, Health Affairs
Michelle Mello & Noah Messing, Restrictions on the Use of Prescribing Data for Drug Promotion, NEJM
Students Urged to Sell Kidneys to Repay Student Loans
Hat tip to Paul Caron over at Tax Prof Blog who posted this story:
The Scotsman, Debt-Hit Students Urged to Sell Their Kidneys:
Students should be able to sell their kidneys for tens of thousands of pounds to pay off university debts, according to a Scots academic. Sue Rabbitt Roff believes making it legal to sell the body part would boost the number of organs available to save lives and help students struggling with money. She argues that donors should be paid the average UK annual income of around £28,000. ...
The Dundee University academic makes the controversial comments in an article in the British Medical Journal today. Mrs Roff, senior research fellow at the university's Department of Medical Sociology, told The Scotsman: "We are allowing young people to undertake £20,000 to £30,000 of university fee payments. "We allow them to burden themselves with these debts. Why can't we allow them to do a very kind and generous thing but also meet their own needs?"
U.S. Physicians Spend Nearly Four Times More On Health Insurance Costs Than Canadian Counterparts
U.S. physicians spend nearly $61,000 more than their Canadian counterparts each year on administrative expenses related to health insurance according to a study funded by the Robert Wood Johnson Foundation. Per-physician costs in the U.S. averaged $82,975 annually, while Ontario-based physicians averaged $22,205 -- primarily because Canada's single-payer health care system is simpler. The Study in the August issue of Health Affairs is here. As ScienceDaily explains:
Canadian physicians follow a single set of rules, but U.S. doctors grapple with different sets of regulations, procedures and forms mandated by each health insurance plan or payer. The bureaucratic burden falls heavily on U.S. nurses and medical practice staff, who spend 20.6 hours per physician per week on administrative duties; their Canadian counterparts spend only 2.5 hours.
The bottom line is that the U.S. spends an additional $27 billion every year when compared to the costs incurred by physicians in Canada. [KVT]
August 4, 2011
Recommended Reading on Health Information Regulation
There is an impressive new issue of the American Journal of Law & Medicine out, with top names in the field participating in a symposium entitled "Marketing Health: The Growing Role of Commercial Speech Doctrine in FDA Regulation." I also wanted to recommend a piece from Simon Stern and Trudo Lemmens on pharma ghostwriting, which is getting a lot of play in Canada. Titled "Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles," the piece could lead to some interesting litigation opportunities. Here is the abstract:
Ghostwriting and guest authorship of medical journal articles raise serious ethical and legal concerns, bearing on the integrity of medical research and evidence used in legal disputes. Ghostwriting involves undisclosed authorship, usually by medical communications agencies or a pharmaceutical sponsor of the published research; guest authorship involves taking authorial credit for the published work without making a substantial contribution to it. Commentators have objected to these practices because of concerns involving bias in ghostwritten clinical trial reports and review articles. We also note the effects of ghostwritten articles on questions involving the legal admissibility of scientific evidence. Efforts to curb ghostwriting practices, undertaken by medical journals, academic institutions, and professional disciplinary bodies, have thus far had little success and show little promise.These organizations have had difficulty adopting and enforcing effective sanctions, for specific reasons relating to the interests and competencies of each kind of organization.
Because of those shortcomings, a useful deterrent in curbing the practice may be achieved through the imposition of legal liability on the ‘guest authors’ who lend their names to ghostwritten articles. We explore the doctrinal grounds on which such articles might be characterized as fraudulent. A guest author’s claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO). The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This doctrine has been used by the U.S. Supreme Court to impose sanctions on the authors and corporate sponsors of a ghostwritten article. We discuss the potential penalties associated with each of these varieties of fraud.
This promises to inspire some difficult legal challenges to industry practices that have long been considered undesirable as a policy matter.
Guest Blogger Eleanor D. Kinney: Greetings from Puerto Vallarta!! El 27 de Julio
El 27 de Julio
This is my third blog on Mexico. Last week I talked about the expansion of coverage for the poor that the Mexican federal government launched in conjunction with Mexico’s states. It is a significant and one might even argue an audacious expansion given the relative poverty of Mexico and its stage of development. These programs are detailed on the website of the Comisión Nacional de Protección Social en Salud and the commission’s annual reports. (See Comisión Nacional de Protección Social en Salud, Informe de Resultado del Segundo Semestre de 2009 (2009).
Per Capita Health Expenditures
United States, Canada and Mexico, 2007
% of GDP
Organization for Economic Cooperation and Development, 2007
Mexican health care is much less expensive when compared to the United States and even Canada. According to figure 1, the per capita health expenditures in Mexico are about one-eighth those of the United States and one-fourth those of Canada. “Well, that’s it,” one might postulate, “How can such inexpensive care be of high quality?” However, we know from comparative studies of health care quality that cost of services is not a proxy for quality. And Mexico is no exception.
In the last decade Mexican health authorities have paid considerable attention to improving the quality of health care in Mexico. In 2000, the administration of Vincente Fox launched a major quality initiative (called a “crusade”) to improve health care quality in Mexico. E. Ruelas, Health Care Quality Improvement in Mexico: Challenges, Opportunities, and Progress From the Undersecretary of Health, Mexico City, Mexico, Proc (Bayl Univ Med Cent). 2002 July; 15(3): 319–322.
These efforts have proven effective with marked improvements in quality measures. The 2006 Encuesta Nacional de Salud y Nutrición (National Health and Nutrition Survey) showed that respondents favored private providers over social security institutions and other public providers. A. Puig et al. Assessing Quality across Healthcare Subsystems in Mexico, J Ambul Care Manage. 2009 Apr-Jun;32(2):123-31.
Nevertheless there are important improvements in the public sector health care system in Mexico. My husband, Dr. Charles Clark, is working with colleagues in the state of Hidalgo Mexico on diabetes care in that state. Charlie is a retired professor of medicine at Indiana University. While we have been here, my husband and daughter went to Real de Monte in Hidalgo to visit a diabetes public health and medical care initiative. As many of you may know, the prevalence of diabetes in Mexico is one of the highest worldwide.
The Real de Monte program for diabetes control and prevention is described in a document called Diabetes and Cardiovascular Epidemiology and Prevention Program, Real del Monte Hidalgo, 2011-2020, (it isn't available on the web, but those who are interested in reading it can cantact me). There are some striking features of this program which caught my eye. First is the evidence of its high quality. The program exhibits best practices in terms of modern diabetes treatment and prevention. The program investigators are clearly in touch with the leading experts in diabetes throughout the world and are familiar with the latest research. Finally, there is an evaluation component in place to measure the initiative’s effectiveness. Of note, these diabetes initiatives in Hidalgo go back many years and have been reported on in the US medical literature. In 2003, Hidalgo investigators reported:
In Hidalgo we have embraced the new paradigms of care: patient centered medical care, multidisciplinary diabetes teams, and the incorporation of health professionals with a working knowledge of day-to-day clinical practice. The challenges created by the increasing burden of diabetes in a country with limited resources are being met by the diabetes program in Hidalgo.
See J. Rodríguez-Saldaña et al., Staged Diabetes Management in Mexico: optimizing care with limited resources, Diabetes Voice (Dec. 2003); 48(4).
Diabetes is not the only disease getting attention in the state of Hidalgo. This state has a very detailed and sophisticated health plan. See Secretaría de Salud y Servicios de Salud de Hidalgo, Actualización del Programa Estatal de Salud 2005-2011. This plan is modern, evidence-based and thorough.
Another quite different indication of health care quality in the Mexican health care system is the growing number of people in the United States who are willing to travel to Mexico to obtain medical and surgical care for very serious conditions. There is a strong positive trend in the number of Americans traveling abroad to places like Mexico for health care. According to Modern Healthcare, there were 750,000 Americans who traveled abroad for healthcare in 2007 and this number is predicted to increase 700% to 6 million by 2010. See C. Sipe, Best Hospitals in Mexico: Internationally Accredited Facilities in Mexico (Mexico Real Estate Investment, Aug. 22, 2008).
Forces are at work to increase the confidence of Americans in Mexican health care. Medical tourism companies are available to facilitate treatment in Mexican health care facilities. Also, the Joint Commission International (JCI) provides accreditation and certification for hospitals and other health care facilities abroad. Ostensibly, such accreditation and certification gives foreign health care facilities an imprimatur of quality that is attractive to US citizens. See Joint Commission International, Joint Commission International Accreditation and Certification. There are at least two JCI accredited hospitals in Mexico and more on coming on line. The JCI website displays particularly successful health care institutions outside the United States and includes OCA Hospital in Monterey, Mexico. Joint Commission International, JCI Success Stories, OCA Hospital.
Presented here have been two different perspectives on the quality of health care in Mexico. One is the examination of efforts in one Mexican state regarding the care of diabetes. As an anecdote, it is persuasive evidence of a very successful program in one state. It is exemplary of how high quality care can be available at a very reasonable cost. Hopefully, it is indicative of more widespread initiatives throughout the country.
The second perspective is the phenomenon of medical tourism from the United States to Mexico. Americans are voting with their feet in seeking significantly lower cost and affordable care. As the US health care sector moves toward implementation of reforms, it will be most interesting to watch the role that medical tourism plays in pushing down costs. Millions of baby boomers (myself included) are moving to Mexico for retirement. K.J. Dunham, Will U.S. Baby Boomers Cross the Border to Retire? Wall Street Journal (January 19, 2006). A major reason for this push is the availability of high quality health care at a much more affordable cost.
I look forward to comments and discussion.
Hasta la Vista!
August 3, 2011
Pulling the Plug: The HIT Model to Avoid
During its nine-year history the UK's massive health IT project frequently flirted with disaster. The National Programme for IT in the NHS, its official title, was an £11.4 billion (almost $19 billion) program launched in 2002 that has so far cost £6.4 billion, here. A bad sign was the persistent dearth of good news. Rather, we learned of controversies (such as doctors refusing to use EMRs because of privacy concerns), underperforming, here, and, of course, the ever-present cost overruns. The project's appellation of the world's largest civilian IT project that once seemed like a compliment soon became a weight dragging the project into a death spiral. And yesterday, according to The Independent, here, the UK government decided to terminate the program. According to The Guardian, here, "The IT project has floundered almost since the day it was conceived." The program's obituary was delivered by The House of Commons Public Accounts Committee which has published a scathing report, here, summed up by its Chair as follows:
The Department of Health is not going to achieve its original aim of a fully integrated care records system across the NHS. Trying to create a one-size-fits-all system in the NHS was a massive risk and has proven to be unworkable…
This intention was a worthwhile aim, but one that has proved beyond the capacity of the Department to deliver and the department is no longer delivering a universal system.
Implementation of alternative up-to-date IT systems has fallen significantly behind schedule and costs have escalated. The Department could have avoided some of the pitfalls and waste if they had consulted earlier with health professionals. The Department has failed to demonstrate the benefits achieved for the £2.7 billion spent to date on care records systems.
The Department has accepted it is unable to deliver its original vision of a uniform care records system with an electronic record for every NHS patient.
What will replace the national program? According to The Independent, a number of individual projects run by NHS Trusts (the local and regional organizational units of NHS services). The Australian federal HealthConnect project, here, suffered a similar fate, and was replaced with a more modest decentralized State model with some central technical assistance, here.
The question of course is whether there are lessons to be learned from these two failures as ONC leads us into Stage 2 of Meaningful Use, here, as it dispenses more of the $30 billion subsidy funds provided by the stimulus package? At first sight the programs look so different that one is tempted to conclude that the US dodged the bullet of building a top-down centralized system when, instead, it elected to subsidize individual physician and hospital purchases. On the other hand, a less comforting conclusion could be that the current political and economic climate is not going to tolerate any government health IT program that appears to be under-performing. [NPT]
August 1, 2011
An Historic Day for Women's Health
The HHS announcement is here. The underlying IoM report (Clinical Preventive Services for Women: Closing the Gaps, July 19, 2011) is here. ACA introduced deductible-free coverage for mammograms and cervical cancer screenings. The new Guidelines for Women’s Preventive Services add well-woman visits, support for breastfeeding equipment, contraception, and domestic violence screening. [NPT]