May 6, 2011
Worth Reading This Week
David Orentlicher, The Commercial Speech Doctrine in Health Regulation: The Clash between the Public Interest in a Robust First Amendment and the Public Interest in Effective Protection from Harm, SSRN/AJLM
Lawrence M. Sung , Medical Alert: Alarming Challenges Facing Medical Technology Innovation, SSRN/Journal of Business & Technology Law
Jessica Wilkerson, Conspicuously Absent: Birth Choice as the Next Feminist Fight, SSRN
Paula Braveman, Susan Egerter and David R. Williams, The Social Determinants of Health: Coming of Age, SSRN/Annual Review of Public Health
Mixed Messages on Malpractice
In January H.R.5 (Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011), here was introduced in the House. Just hours later this year's State of the Union address, available here, included a somewhat intriguing statement: "I'm willing to look at other ideas to bring down costs, including one that Republicans suggested last year -- medical malpractice reform to rein in frivolous lawsuits." Why would the President make such a statement? Was this a Clintonesque attempt to capture the opposition's agenda? Another move to the center? Or a signal that there was a malpractice reform deal to be done this year (after its rejection last year) to save healthcare reform?
The Republican legislation (H.H.5) isn't even that interesting, retooling reforms that have been passed in most states over the last 30 years (combined with a long shot attempt at protecting drug companies) although avoiding even more draconian measures that are still being dreamt up by well-lobbied state legislatures, such as here. Frankly, it's hard to resist cynicism as yet another cycle of posturing and misinformation about malpractice, error and litigation costs gathers momentum. Then, to make things more interesting, the President included $250m in his budget to fund liability demonstration projects in the states; monies not available for caps but available for Health courts, discussed here (and not incidentally opening up a can of worms involving state constitutions that protect trial by jury!).
The malpractice tragedy is that the only reforms that can find traction are these same politically motivated attacks on a legal process that is clearly inefficient and probably inaccurate, but sometimes seems to be all we've got. A couple of recent reports emphasize the aspects of the medical error disaster that we have failed to address.
The first casts further doubt on the medical profession's ability to police itself. The common law implications of institutions failing to disclose adverse results associated with individual physicians were recently discussed here. But what are the downstream results when institutions do take action against physicians with clinical privileges? The answer, provided in the Public Citizen report, State Medical Boards Fail to Discipline Doctors With Hospital Actions Against Them, available here, is all too frequently, not very much! The report analyses 10 years of data in the National Practitioner Data Bank, here. It found that 5,887, or 55%, of physicians who had their clinical privileges revoked or restricted had experienced no state licensing actions. Over 2000 of this cohort had one or more of the most serious violations, such as incompetence or "immediate threat to safety." It is hard to fault Public Citizen's conclusion:
Hospital disciplinary reports are peer review actions that are one of the most important sources of information for medical board oversight. Subsequent state medical board action against a physician’s license provides a greater assurance than a hospital disciplinary action alone that the practitioners medical practice would be monitored or limited and that other state medical boards and future employers will have a more complete account of a practitioner’s practice history…. Our analysis of physicians with clinical privilege reports but no state licensure action raises serious questions about whether state medical boards are responding adequately to hospital disciplinary reports and whether, as required by federal law, state medical boards are receiving such reports.
The second report serves to remind us of the scale of the medical error problem. Jill Van Den Bos and colleagues in an April Health Affairs article, available here (subscription), sought to quantify preventable adverse events. The researchers concluded,
The estimated total cost of measurable medical errors in the United States was $17.1 billion in 2008, which was 0.72 percent of the $2.391 trillion spent on health care that year in the United States.
Another important conclusion was that "ten errors [headed by postoperative infections and pressure ulcers] are accountable for 69 percent of the total medical cost for measurable medical errors."
As Uwe Reinhardt reminded us last year the total cost of the malpractice system (including defensive medicine) is at most $55 billion, or 2.4 percent of healthcare spending, available here. And, malpractice reform would only reduce a fraction of those costs, maybe 0.5 percent of healthcare spending. Until we recognize that the larger medical error number is the one we should concentrate on, progress will be unlikely.
Reducing healthcare costs by reducing malpractice costs is not only unlikely but also arguably back-to-front. Mark Rothstein, in "Health Care Reform and Medical Malpractice Claims" available here, convincingly makes that reverse case,
one of the leading reasons why individuals bring medical malpractice claims is to ensure the availability of funds for future medical care. Because health care coverage at affordable rates will be accessible in the public or private sector without regard to preexisting conditions, and annual and lifetime caps will be prohibited, significant numbers of injured patients are likely to forego medical malpractice claims. Consequently, even with more patient visits, the total number of medical malpractice claims is unlikely to rise and might even decline.
Calling out our state medical boards, renewing our commitment to patient safety, and striving to reduce malpractice claims through healthcare reform continue to be more positive avenues for reform than encouraging another cycle of malpractice reform.
May 5, 2011
Guest Blogger Leslie Francis: An Update on the National Committee on Vital and Health Statistics (NCVHS)
In my last “guest” blog, I’m going to put in an unabashed push for a federal advisory committee on which I serve as co-chair of the Subcommittee on Privacy, Confidentiality and Security. The National Committee on Vital and Health Statistics (NCVHS) is one of the oldest federal advisory committees. It is the statutory advisory committee with responsibility for providing recommendations on health information policy and standards to the Secretary of the Department of Health and Human Services (HHS). The NCVHS website contains a wealth of information about data stewardship, data uses, and data protection. Over the years, NCVHS has steadfastly advocated for the responsible collection and protection of data needed for the improvement of public health and health care. Balancing the protection of individual privacy and confidentiality with the immense possibilities of health information is not easy, and NCVHS has made many important recommendations in this regard. In this post, I want to highlight two particularly important NCVHS initiatives.
First, NCVHS has led the way in understanding how to protect confidentiality in the development of health information exchanges. In 2006, NCVHS made a broad set of recommendations for safeguarding privacy in the context of a Nationwide Health Information Network. These recommendations included an opt-in for individual participation in health information exchange. They also included assessment of the feasibility of allowing special confidentiality filters for particularly sensitive types of health information, and the importance of developing contextual access controls to electronic health records and health information exchanges. In 2008, NCVHS recommended that interoperable electronic health records should be designed to allow separate management of sensitive categories of health information. In 2010, NCVHS recommended definitions for certain sensitive categories of information as outlined in federal and state law. These categories include reproductive history, sexually transmitted disease information, genetic information, substance abuse treatment information, and mental health information. In considering these recommendations, it is important to remember that NCVHS is not suggesting that this information should not be available at all. Rather, NCVHS is observing that the law requires separate handling of certain types of health information and, as well, that patients may wish certain types of information to be given special handling. Without design capabilities for separate handling of mental health information, reproductive information, or sexually transmitted disease information, for example, capabilities for adolescents and their parents to each have access to health records through patient portals may go unrealized.
Second, NCVHS has recently been exploring how to protect confidentiality as interoperable health information is increasingly proving useful for public health purposes. In February, 2011, NCVHS held a working session on community uses of health information. At that session, the Committee heard remarkable examples of uses of local data to improve community health. Many of these uses involve de-identified data or types of data (such as air quality measurements) that do not involve individuals at all, but others involve information that is individually identifiable or that applies to very small geographic areas (such as block or census tract). The benefits of this data are potentially enormous, but at the same time it is critical to ensure that individual confidentiality is protected and that community trust in not jeopardized. On May 12, NCVHS will be holding a second working session, on models for protecting confidentiality and legitimizing trust. This is very much a “scoping out” enterprise: given all the power of interoperable data for public health, what are best practices for protecting confidentiality? To listen in, or follow up, go to this link. If any readers of this blog are interested in following up with me on these or other issues about the security, privacy, and confidentiality of health information, I’d love to hear from you. I can best be reached at email@example.com
Best, Leslie Francis
Missing Care, Missing Drugs: Canaries in the Medical Coal Mine
While Washington has been focusing on repealing or rolling back parts of the Affordable Care Act, persistent embarrassments of the American health system show how untenable the status quo is. Both lower and middle class families are facing serious problems as they contend with providers' and insurers' cost constraints. I'll first address the familiar issue of health disparities. According to a recent news report, Lauren E. Wisk of the School of Medicine and Public Health at University of Wisconsin, Madison "examined data from the 2001-2006 Medical Expenditure Panel Surveys on 6,273 families with at least one child." Wisk's study shows that excessive financial burdens from cost-sharing are keeping many children from getting the care they need:
Families aren't choosing to spend their money on going to the doctor when someone is sick because of how much it cost them to see the doctor last time. They're sacrificing their health because it costs too much to be healthy. . . . We expect that if people aren't getting the care they need, they'll be sicker as a result. When you put this all together and look at the big picture, the cost of health care in the U.S. could actually be causing Americans to be sicker.
We might wonder: how can this be? Isn't the economy in recovery? But we've seen this picture before, in the developing world. Growth does not help everyone. India, for example, has had astonishing economic growth, but it "is home to about a third of the world's underweight and stunted children under the age of 5," and "the impressive economic growth of the past decade has made only a modest dent into the obstinately high incidence of severe underweight and stunting of children in the country." As Amartya Sen has shown, not only China, but also Bangladesh, are ahead of India in reducing the number of underweight children, despite the fact that "GNP per capita of $1,170" in India, "compared with $590 in Bangladesh." The critical number really is median GNP, and beyond that, real allocation to the sectors and concerns that matter. As the US surpasses Ivory Coast and Pakistan in inequality, don't count on gains from growth to go to the people who need it.
It's not just poor patients who need to worry about misplaced priorities in the health care system. We are increasingly seeing shortages of important drugs in the US. (Apparently this issue first caught mass media attention when prisons had a difficult time finding a key barbiturate used in executions.) Given that Congress is busy planning to cut funding for the statistical abstracts of the US and energy research (adding to prior DOJ cuts to studies of industrial concentration in the US), we shouldn't be surprised to learn that "no one is systematically tracking the toll of the shortages." Not many journalists are left to report on the government's failure to report, either. But the head of FDA’s Drug Shortages Program is worried: “This is affecting oncology drugs, critical-care drugs, emergency medicine drugs."
It turns out that much-ballyhooed globalization has some downsides, too:
“We’ve certainly reached a very global supply chain for drug products, with the active ingredients typically made outside of the United States,” said [a] vice president for regulatory sciences at the Generic Pharmaceutical Association. “It could be Europe, India — some cases China. If there’s a problem at a facility in Italy or India, it leads to disruption of the drug supply in the United States.”
And a whole new triage system has developed to address an entirely avoidable crisis:
“We have heard some horror stories where patients are really begging to get the drugs from other sources and where practices or institutions are forced to kind of triage patients and save the drugs for those — quote — most curable, where they have the best prognosis and using substitutes where there isn’t a cure possibility,” [said the] president-elect of the American Society of Clinical Oncology.
A moving piece by Hagop M. Kantarjian describes the dilemmas facing some leukemia doctors:
Recently I sent out a plea on this national crisis to 8,000 oncologists who subscribe to a monthly e-mail newsletter published by the leukemia department at the MD Anderson Cancer Center. Within 12 hours, my in-box was jammed with replies from doctors in more than 25 states, each with his or her own horror story. . . . Take, for example, the 43-year-old Kentucky father who got a substandard dose of cytarabine because his doctor used all the doses he could find but still didn’t have enough. “I don’t know what I’ll do next,” the doctor told me.
Or the 45-year-old retired Air Force lieutenant colonel from Colorado, father of an incoming Air Force Academy cadet, whose leukemia came back after six months. His doctor looked all over the state for cytarabine with no luck and so was forced to give his patient second-line therapy. Or the 15-year-old boy from Florida who is in remission but can’t get the therapy that will cure him.
I see two takeaways from this sad situation. First, the next time someone says that generic "health care costs" are too high, consider whether they really mean we need to reallocate funds from less productive sectors to this, life-threatening crisis. Second, we need to reconsider the wisdom and necessity of far-flung, fragile supply chains for critical products. Barry Lynn has been making this point for some time. His book Cornered argues that "the drive to reduce costs has led to several competing manufacturers relying on a single overseas supplier for certain components and that this makes the whole system vulnerable to an event like an earthquake, a strike, or a war that might put the single supplier temporarily out of business." Even for those skeptical of Lynn's thesis in, say, the automotive or computer sector, his warnings should be salient for the food and health care industries. Too many lives have been put at risk by supply chains that are not robust enough to handle predictable challenges.
X-Posted: Health Reform Watch.
Guest Blogger Vickie J. Williams: Extreme Concierge Care and Incentivizing Physicians
First, a big thank you to Katharine Van Tassel and the Health Law Prof Blog for allowing me the opportunity to be a guest blogger this month. With so much going on in the world of health care delivery and financing in the United States, it is an exciting time to be both a student and a teacher of health care law. Like all good teachers, I consider myself to be both of these things simultaneously. And besides, everybody around my law school is tired of listening to my rants about health care law and health care delivery reform, so I need a fresh audience.
The New York Times had an interesting article by Paul Sullivan on April 29 about what I call “extreme” concierge medical practices. These physicians treat the very rich, sort of like what we see on the USA Network television show “Royal Pains.” The article noted that the number of doctors practicing concierge medicine has risen fivefold in the last five years, but most of these doctors are practicing the more pedestrian model of concierge medicine, where subscriptions cost in the $1,500 - $2,000 range. The typical concierge practice caters to the upper-middle-class who want same-day appointments, extra time with the doctor, etc. In contrast, “extreme” concierge practices cater to the fantastically wealthy, who, for example, want to have their yachts outfitted with “ready rooms” where a doctor can practice telemedicine remotely on a patient. These physicians charge as much as $75,000 per year to ensure that clients can access their “extensive Rolodex” of medical specialists without having to endure long waiting lists.
These practices raise both legal and ethical questions, even more so than the typical concierge practice. Defenders of these practices, such as the American Medical Association, claim that their existence enhances the number of options for health care delivery and financing for all, although it also recognizes the ethical concerns raised by their existence. And some proponents of these practices appear to embrace a “trickle down” theory of access, claiming that the solutions to access provided by concierge practices will “migrate” to even the poorest people in the world. Others who practice concierge medicine don’t believe that it will have any real effect on the larger policy issues we face in financing and delivery of health care.
I’m not sure where I come out on this. I don’t believe in “trickle down” economics, but then I think of the high-powered fashion editor Miranda Priestly (played by Meryl Streep) explaining to her assistant Andy (played by Anne Hathaway) in the movie “The Devil Wears Prada,” that Andy’s cerulean blue ready-to-wear sweater is the product of “trickle-down” from the prior year’s high fashion trend. The reason that “trickle-down” works in the fashion context is that there are financial incentives for ready-to-wear manufacturers to duplicate what has worked for high-end designers. Therefore, if we want to see the general population benefit from the “extreme concierge” model, we need to provide incentives like the ones that exist in such practices to doctors in regular practice. Why do doctors want to go into concierge practices? They want more control over their schedules, to spend more time with fewer patients, and to be financially rewarded for good outcomes, rather than sheer volume. They don’t want to spend their days handling insurance paperwork. How can we provide these incentives to doctors who treat the rest of us?
The Patient Protection and Affordable Care Act (PPACA) takes baby steps towards providing those incentives, through encouraging and rewarding good outcomes rather than just numbers of procedures performed, but we need to do much more. We need to re-think how we train new doctors, and how we finance their training. Given the public’s reluctance to engage in anything more than baby steps when it comes to health care reform, it will be a long haul. But if we keep thinking about what makes doctors want to engage in “extreme” concierge practices, some good to the general public (other than a new television show) may come out of this model of practice.
May 4, 2011
Introducing Guest Blogger Vickie Williams
Associate Dean for Academic Affairs and Associate Professor of Law, Gonzaga University School of Law (Assistant Professor, 2003-2008). Adjunct lecturer, University of Washington School of Law (2000, 2003). Teaching areas: Health Care Law, Civil Procedure, Constitutional Law, Conflict of Laws, Federal Jurisdiction. Shareholder and associate, Bennett Bigelow & Leedom, P.S., Seattle, Washington (1995-2003). Associate, Perkins Coie, Seattle, Washington (1990-1995). Professor Williams was a board member, Secretary/Treasurer and then President of the Washington State Society of Healthcare Attorneys from 1997 through 2004. She is admitted to practice in the State of Washington, the Western District of Washington, the Eastern District of Washington, and the Ninth Circuit Court of Appeals. She is a member of the American Health Lawyers Association, the Health Law Section of Washington State Bar Association, the Washington State Society of Healthcare Attorneys. She publishes and speaks on topics related to Health Law, Civil Procedure, Constitutional Law, and the intersection of these areas.
United Nations Discussions on Sustainability and Informed Consent
The United Nations Commission on Sustainable Development (CSD) is holding its Nineteenth Session at the U.N headquarters in New York City this week. Although not well reported in the U.S. press, it is a major meeting, where the international community discusses action to achieve Integration of social, economic and environmental dimensions of development. This year, the delegates are focusing on transport, consumption and production patterns, mining, chemicals, and waste management. The latter three topics are fertile ground for discussions on protection of health in developing countries.
The CSD emerged from Agenda 21, the plan of action for sustainable development adopted in June 1992 by the United Nations Conference on Environment and Development (UNCED), also known as the “Rio Earth Summit.” Agenda 21 called for the creation of the CSD to ensure effective follow-up of UNCED, enhance international cooperation, and examine progress in the implementation of Agenda 21.
An interesting dynamic so far has been the position of some developed countries on the principle or “free, prior and informed consent,” or the right to be informed about potential dangers to public health and safety, and to be able to reject activities deemed too risky. This appears in the U.N. Declaration of the Rights of Indigenous Peoples, and discussions at the CSD often revolve around indigenous rights since their lands, health and safety are so often affected by development.
This dynamic emerged in working group discussions about policy options on chemicals and mining. In the negotiating text (preliminary versions of all of them available here) on chemicals, the European Union and Mexico introduced language to emphasize parties’ “right to know”, but it was opposed by Canada. Similarly, in the discussion of a negotiating text on mining, the United States, Canada, Australia and New Zealand asked for deletion of language to enable “free, prior and informed consent” regarding indigenous and local communities. In general, the United States calls for adherence to existing standards and conventions, but does not seem to be on the cutting edge of the fight for indigenous rights. But the negotiations are in their early stages.
For excellent day to day coverage of the negotiations, including the positions and “corridor discussions” of many of the parties, see the International Institute for Sustainable Development’s daily reports accessible at their excellent website.
May 3, 2011
Move over Massachusetts, Here Comes Vermont
If you don't think Massachusetts or federal healthcare reform have gone far enough then look to Vermont. The Governor's healthcare reform plan, H.202 has now been passed by both the House and Senate. Media coverage is here and here. Industry reaction here. The draft conference committee report is available here. What's unique is that the Vermont universal healthcare plan uses a single payer model (or at least close thereto). The bill starts with an ACA "Health Benefit Exchange for Vermont" with enrollment beginning in 2014. Then, with federal waivers, the exchange will transition to a single payer called Green Mountain Care. [NPT]