Friday, March 9, 2012
David Orentlicher, Rights to Health Care in the US: Inherently Unstable, SSRN/AJLM
Janet Dolgin & Katherine Rouse Dieterich, The 'Other' Within: Health Care Reform, Class, and the Politics of Reproduction, SSRN/Seattle L.Rev.
Gail Wilensky, Directions for Bipartisan Medicare Reform, NEJM
Nathan Cortez, A Medical Malpractice Model for Developing Countries? SSRN/Drexel L.Rev.
Elizabeth Weeks Leonard, an Associate Professor of Law at the University of Georgia Law School, participated in the 15th Annual Journal of Constitutional Law Symposium at Penn Law, FDR and Obama: Are there Constitutional Law Lessons from the New Deal for the Obama Administration? You can download her excellent essay entitled New Deal Lessons for the Affordable Care Act: The General Welfare Clause with this link. View as PDF
Thursday, March 8, 2012
In a previous post, I argued that our current system of regulating innovative medical activities—under which the requirement of prior ethical oversight depends on whether what is being done falls within the regulatory definition of “research” with “human subjects”—can result in insufficient attention to ethical issues raised by activities that, although technically not “research,” rely on risky and unproven interventions.
Another consequence of the assumption that “research” necessarily requires greater oversight than other innovative activities is that it can lead to excessive attention to activities that do meet the definition of research but that do not raise the kind of ethical concerns that warrant IRB review.
An example is survey and interview research. Existing regulations recognize that most survey or interview studies do not warrant case-by-case case IRB oversight, and explicitly declare such research “exempt” from the requirement of IRB review if certain conditions are met. The problem, though, is that some institutions insist that only the IRB—not an individual researcher or academic department—has the right to determine when a survey or interview qualifies for the exemption. Thus, as long as an activity falls within the broad regulatory definition of “human subject research” the researcher is required to apply to the IRB for an official “exemption” determination, and cannot begin the research until someone from the IRB office confirms that the exemption criteria do in fact apply.
While the process of applying for an exemption is less onerous than having to seek IRB review and approval of a protocol, it can nonetheless impose burdens and delays. Moreover, if the premise behind the exemption is that certain types of low-risk research should be allowed to proceed without any IRB oversight, it seems contradictory to require researchers to apply to the IRB and wait until their “exemption applications” are approved.
Last summer’s Advance Notice of Proposed Rulemaking for Revisions to the Common Rule took a welcome step towards remedying this problem by proposing the replacement of existing “exemption” categories with a new category of “excused” research, which was defined to include all surveys and interviews with competent adults (a broader category than what is recognized under the existing exemption regulations, which generally apply only to studies in which identifiable information about participants will not be recorded). Under the ANPRM, researchers would be able to begin “excused” studies after filing a simple registration form, without the need to wait for an official sign-off from an IRB representative. As a condition of registration, researchers would have to affirm their compliance with minimum standards for data security and information protection.
I was therefore discouraged to learn last week, at a meeting of the Secretary’s Advisory Committee for Human Research Protections, that a “strong majority” of comments received on the ANPRM were resistant to the idea of letting researchers begin survey or interview projects based on their own assessment of whether their studies fell under the “excused review” criteria. Citing researchers’ lack of “objectivity” and “expertise,” these commentators suggested that, before beginning their studies, researchers should be required to submit an explanation of why they believe the excused designation is warranted, and then wait for an official go-ahead from an IRB official before the research begins. Such an approach would undermine one of the ANPRM’s main benefits, which is to make it possible for researchers to initiate survey and interview studies without having to ask the IRB first.
Federal regulators are now considering whether to incorporate the ANPRM’s proposed framework into future regulatory revisions.
Hamline University School of Law’s Health Law Institute invites applications for J-Term 2013 and Summer 2013 for visiting faculty members in Saint Paul, Minnesota.
Courses taught during these terms are compact and may be taught during evenings and weekends. We are particularly interested in candidates who can teach Fraud & Abuse, Mergers & Acquisitions, and Complementary & Alternative Medicine. But we will happily consider proposals for other courses. Past summer and J-Term courses have included HIPAA Privacy, Elder Law, Health Reform, and the Compliance Institute. Students may include law students, graduate students, lawyers and healthcare professionals.
Candidates should have distinguished records of academic and professional achievement. Interested applicants should, by June 15, 2012, send a resume and letter of interest to Associate Professor Thaddeus Pope, Director of the Health Law Institute ([email protected]). Information about the Health Law Institute can be found at law.hamline.edu/healthlaw.
I am posting the following announcement for Professor Kathy Cerminara from the Shepard Broad Law Center at Nova Southeastern University in Ft. Lauderdale, Florida:
The Therapeutic Jurisprudence Community has arranged for a therapeutic jurisprudence (TJ) track, featuring both English-speaking and Spanish-speaking presentations, at the 33rd Congress of the International Academy of Law and Mental Health, to be held in Amsterdam July 14-19, 2013. Preparations for that Congress are already under way. Here is some important information about submitting either an English-language or a Spanish-language proposal. (If you have not participated in one of these Congresses, they are informative, interdisciplinary, and energizing. See here for information about this and previous Congresses. For more on TJ, see here.
TJ-related proposals for either individual presentations or panel discussions are welcome. Individual presentation proposals will be grouped into panels once all proposals are submitted. If you would like to organize and propose an entire panel, that would be wonderful, and would be welcome on any TJ topic. In particular, panels on the role of TJ in law school teaching and legal scholarship, TJ perspectives on health law, and TJ and the social sciences (both recent and needed research) are welcome and encouraged. To the extent possible, we urge panel organizers to try to draw together speakers from various disciplines or from various professional backgrounds (e.g., academics, judges, and attorneys; medical professionals, judges, and attorneys; or social scientists, clinical professors, and judges).
To reduce administrative issues, persons who wish to submit abstracts for the TJ track should submit those abstracts directly to the TJ track organizers rather than through the Congress website. Abstracts are due to TJ track organizers by May 22, 2012, to permit the TJ track organizers to organize and submit all the TJ track proposals as a group before the May 31 Congress submission deadline. TJ track organizers are Kathy Cerminara at [email protected] (English) or Francisca Farina at [email protected] (Spanish).
NPR's "Morning Edition" today featured a fascinating book, Fragile Beginnings, about medical care for very premature infants. Written by a physician, the book traces the history of treatment, the remarkable progress that has been made in recent decades, and the ethical dilemmas that parents and physicians face. The book should do much to raise awareness about some of the most difficult moral questions in health care.
Yet as I listened to the author describe his experience with his own daughter, I wondered whether book-writing parents are too quick to divulge the private matters of their children. In this case, the child apparently is doing very well despite a rocky start. But should the whole world know about her medical history?
It may be that on balance the benefits of telling her story outweigh any harms, but shouldn't that be a decision for her to make when she is mature enough to decide? Divulging a child's medical information may be particularly worrisome, but similar concerns are present when parents discuss other details about a child's life. I'm not sure where lines should be drawn on this issue, but I do think it's an issue that needs more consideration.
[DO; cross-posted at Faculty Lounge]
[U]nlike in other countries, sellers of health-care services in America have considerable power to set prices, and so they set them quite high. Two of the five most profitable industries in the United States — the pharmaceuticals industry and the medical device industry — sell health care. With margins of almost 20 percent, they beat out even the financial sector for sheer profitability. The players sitting across the table from them — the health insurers — are not so profitable. In 2009, their profit margins were a mere 2.2 percent. That’s a signal that the sellers have the upper hand over the buyers.
I don’t agree that insurers are being bullied as buyers. If we’re going to bring up the financial sector, a better analogy would compare pay differentials between revenue-generating traders (providers) and the back office clerical and IT workers (insurers), rather than assume some common baseline of industrial profitability. The health care providers actually (try to) improve health; the insurers (are supposed to) support that primary effort. But overall, the story Klein tells here is broadly consistent with many other explanations of high prices in US health care.
What will solve that problem? Probably not health care reform, though regulators will struggle mightily to impose some discipline via IPAB and other entities. Followers of Clayton Christensen think pure technological innovation may wildly succeed where an oft-captured regulatory system is failing. Farhad Manjoo provides some empirical support for their hopes:
Wednesday, March 7, 2012
There always have been good reasons to doubt the cost-containing impact of Obamacare. While the Affordable Care Act will do much to ensure access to health care coverage for the uninsured, it will do far less to address the high costs of health care in the United States. Just as with Medicare and Romneycare, Obamacare largely left cost containment for another day. A recent studysuggests that even the limited cost savings expected from the new law may not materialize. Many experts have touted electronic medical records as a way to reduce spending, and proponents frequently cited an estimate of $80 billion in annual savings. However, researchers found that electronic medical records can encourage physicians to order more tests for their patients, resulting in greater spending. As the authors recognized, the jury is still out on the effect of electronic records. Still, the results are consistent with the view that the greatest threat to the health care law lies not in the constitutional challenges but in the law’s design defects.
[DO; cross-posted at Faculty Lounge]