March 9, 2012
Worth Reading This Week
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.
New Deal Lessons for the Affordable Care Act: The General Welfare Clause
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
March 8, 2012
Guest Blogger Carl Coleman: The Role of IRBs in Survey and Interview Research
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 Health Law Institute Seeks Summer and J-Term Law Visiting Faculty
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 (firstname.lastname@example.org). Information about the Health Law Institute can be found at law.hamline.edu/healthlaw.
Call for Proposals: 33rd Congress of the International Academy of Law and Mental Health
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@example.com (English) or Francisca Farina at firstname.lastname@example.org (Spanish).
Parents and the Privacy of Children
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]
Of Princes, Paupers, and Physicians
[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:
As computers get better, we’ll need fewer humans across a range of specialties. Look at mammography: One of the main ways radiologists can improve their breast diagnoses is by “double reading.” When two radiologists independently examine a collection of mammograms, the number of cancers detected increases substantially. A study published in 2008, however, found that a radiologist who uses ImageChecker can skip the second reading: A computer and a human are just as good as two humans.
[T]he doctors who are the juiciest targets for automation might not be the ones you’d expect. They’re specialists . . ., the most highly trained, highly paid people in medicine. It’s precisely these factors that make them vulnerable to machines. By definition, specialists focus on narrow slices of medicine. They spend their days worrying over a single region of the body, and the most specialized doctors will dedicate themselves to just one or two types of procedures. Robots, too, are great specialists. They excel at doing one thing repeatedly, and when they focus, they can achieve near perfection. At some point—and probably faster than we expect—they won’t need any human supervision at all.
Robots and automation are already taking on prominent roles in wars, factories, and political campaigns. The type of pattern recognition common to some medial specialties may be natural to them, particularly as electronic medical records and digitization take hold. Of course, an all purpose “physician robot” would be a much harder endeavor. In the context of a discussion of rationing, one health law textbook suggests that a mapping of possible interventions “would require rigorous scientific information on each of the almost 10,000 diagnostic entries in the International Classification of Diseases (9th ed.) (known as ‘‘ICD-9’’) and for each of the 10,000 medical interventions listed in the AMA’s Common Procedural Terminology (known as ‘‘CPT’’ codes).” ICD-10 has about 7 times more codes than ICD-9. But just as chess was once considered a field impenetrable to artificial intelligence, and now has been mastered by some computers, so too might medicine itself become subject to the exponential growth in information processing characteristic of mature digitized industries. It’s becoming clear that “the variety of jobs that computers can do is multiplying as programmers teach them to deal with tone and linguistic ambiguity.”
So will technology save us from ever-increasing health care costs? I’m not optimistic, because politics and economics are a constraint on all these developments. The same patterns of patronage and tribute that make comparative effectiveness research such a hard sell in the USmay well restrain technology adoption. Just as specialists dominate the RUC, they can probably find ways to slow the adoption of technological substitutes for their hard-won expertise. AsUmair Haque has observed, “In a neofeudal polity, patronage replaces meritocracy. ‘Success’ for an organization, coalition, or person is to become a client of a powerful patron, pledging your services (soft and hard, informal and formal), in perpetual alignment with the patron’s interests.” We’ll see many physicians in coming years invest time and effort in technological innovation, and others devoted to deterring its spread in order to protect current income streams.
At this point, you’re probably expecting me to side decisively with the technologists as heroes. But I can’t do so. I don’t buy an economic model premised on incentivizing innovation by setting off a race among radiologists (or, more realistically, financiers) to be the first to patent the machine that can replace all the other radiologists. Rather, I think the real foundation for radically productive innovation in this and other fields is a baseline of social support and commitment to retraining for professionals who could be displaced by the technology. I’m not saying, “pay radiologists what they make now, forever.” Rather, I’m trying to articulate a variant of a “guaranteed basic income” argument for those who invest heavily in learning about science, technology, and medicine. This baseline of educated users, improvers, and evangelizers of technology is the foundation of any venturesome economy. As Amar Bhide has explained,
[T]he different forms of innovation interact in complicated ways, and it is these interconnected, multilevel advances that create economic value. . . . To state the proposition in the terminology of cyberspace, innovations that sustain modern prosperity have a variety of forms and are developed and used through a massively multiplayer, multilevel, and multiperiod game.
We may well find that in decades to come, machines can do the jobs of radiologists and pathologists much better than people can. But if that transition occurs, it’s important to recognize how much current specialists invested to attain their skills, how hard they presently work to maintain a high level of medical skill in this country, and how future innovations may well dry up if people feel that those on STEM career paths are utterly vulnerable to being “kicked to the curb” once a machine does their job slightly better. Not only is “sole inventorship” a myth; we often fail to appreciate the complex educational and service apparatus necessary for innovation to take place. As Alperovitz and Daly have shown, any system that grants 93% of its gains to 1% of the people is an ongoing instruction in the economic futility of the efforts of the vast majority of its citizens. [FP; X-Posted at Health Reform Watch.]
March 7, 2012
Bending the Cost Curve: In which Direction?
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]