Friday, November 11, 2011
Stuart Benjamin, Bootstrapping, SSRN/L & Contemp. Prob.
Sara Rosenbaum, Equal Access for Medicaid Beneficiaries — The Supreme Court and the Douglas Cases, NEJM
Jordan Paradise, Claiming Nanotechnology: Improving USPTO Efforts at Classification of Emerging Nano-Enabled Pharmaceutical Technologies, SSRN/Nw J Tech&IP
Glenn Cohen, Regulating Reproduction: The Problem with Best Interests, SSRN/Minn. L.Rev.
Thursday, November 10, 2011
HRSA has restored access to the NPDB public file, here. There are, however, strings attached that are designed to stop the kind of re-identification that led to a physician complaint and the database's temporary closure. That timeline is detailed at Pro Publica, here. Now, prior to gaining access to the public file, HRSA requires users to agree to its "Data Use Agreement," here, that prohibits using "the dataset alone or in combination with other data to identify any individual or entity or otherwise link information from this file with information in another dataset in a manner that includes the identity of an individual or entity."
Senator Grassley, here, is unimpressed by this new precondition and the Association of Health Care Journalists has written to Secretary Sibelius, here, noting "We believe these rules are ill-advised, unenforceable and probably unconstitutional. Restricting how reporters use public data is an attempt at prior restraint."
This one is unlikely to die down anytime soon! [NPT]
Those of you who saw Glenn Cohen's NYT opinion piece on the recent, failed Mississippi personhood proposal may be interested in this paper, titled "Regulating Reproduction: The Problem with Best Interests." From the abstract:
Should the state permit anonymous sperm donation? Should brother-sister incest between adults be made criminal? Should individuals over the age of fifty be allowed access to re-productive technologies? Should the state fund abstinence education?
One common form of justification that is offered to answer these and a myriad of other reproductive policy questions is concern for the best interests of the children that will result, absent state intervention, from these forms of reproduction. This focus on the Best Interests of the Resulting Child (BIRC) is, on the surface, quite understandable and stems from a transposition of a central organizing principle of family law justifying state intervention - the protection of the best interests of existing children - visible in areas such as adoption, child custody, and child removal. The Article demonstrates that while parallel reasoning is frequently offered (by legislatures, by courts, by commentators, by physicians) to justify state interventions that seek to influence whether, when, and with whom individuals reproduce, such justifications are problematic and misleading.
A very interesting philosophical take on the many thorny issues raised by new reproductive technologies.
Tuesday, November 8, 2011
The Center for Biological Diversity (CBD) is one of the few environmental organizations to launch an outreach campaign focusing on the environmental harm caused by the need to sustain increasing numbers of people on Earth. Traditionally, environmental groups have shied away from identifying population as a problem, instead focusing on human behavior. The underlying message has been that as long as activities are done safely and resources are used sustainably, there is no need to control populations. Environmental groups seem terrified to take on the value-laden, religiously charged issue of birth control, which is the obvious solution and only way to address overpopulation.
This was not true in the early years of the movement. Barry Commoner's 1972 book, The Closing Circle, Paul Ehrlich's The Population Bomb in 1968 and other writings exposed problems caused by overpopulation, and described the Earth's limited ability to provide raw materials for growing numbers of humans. But as environmental organizations sprang up, few took on the question of how to address that issue.
Last week, the world human population reportedly reached 7 billion. Articles about the milestone said the numbers exacerbated climate change and other environmental problems, as in pieces appearing in the Huffington Post and USA Today. An LA Times article included an excellent list of questions facing human society: "whether a growing population or growing consumption remains the biggest environmental challenge, how best to help lift a billion people out of poverty and misery, [and] whether governments should provide contraception for those who cannot afford it." Although some writers claim the "population bomb" has been diffused due to the "green revolution" and changing demographics (as in the article found here) the population continues to increase, and the issues remain. The question for environmental groups is whether they will take on the birth control issue, a direction the CBD may be leading them, or continue to let family planning groups and organizations addressing poverty fight those battles without them.
The court's opinion is here.
No Supreme Court case has ever held or implied that Congress’s Commerce Clause authority is limited to individuals who are presently engaging in an activity involving, or substantially affecting, interstate commerce…
To be sure, a number of the Supreme Court’s Commerce Clause cases have used the word “activity” to describe behavior that was either regarded as within or without Congress’s authority. But those cases did not purport to limit Congress to reach only existing activities. They were merely identifying the relevant conduct in a descriptive way, because the facts of those cases did not raise the question–presented here–of whether “inactivity” can also be regulated…
Appellants [assert] that even if one could be obliged to buy insurance when one sought medical care, one cannot be obliged to keep it. Although that argument, as we have noted, avoids the facial challenge objection, it strikes us as rather unpersuasive on the merits. Congress, which would, in our minds, clearly have the power to impose insurance purchase conditions on persons who appeared at a hospital for medical services–as rather useless as that would be–is merely imposing the mandate in reasonable anticipation of virtually inevitable future transactions in interstate commerce…..
That a direct requirement for most Americans to purchase any product or service seems an intrusive exercise of legislative power surely explains why Congress has not used this authority before–but that seems to us a political judgment rather than a recognition of constitutional limitations. It certainly is an encroachment on individual liberty, but it is no more so than a command that restaurants or hotels are obliged to serve all customers regardless of race, that gravely ill individuals cannot use a substance their doctors described as the only effective palliative for excruciating pain, or that a farmer cannot grow enough wheat to support his own family. The right to be free from federal regulation is not absolute, and yields to the imperative that Congress be free to forge national solutions to national problems, no matter how local–or seemingly passive–their individual origins.
Little, politics aside, seems to have come out of the $25m spent by AHRQ and HHS since 2009 on malpractice liability demonstration projects, here. For Politico Brett Norman, here, reports that federal legislation is now "on ice" and that "unless the supercommittee acts, it looks like tort reform will be left for now to the states — many of which have already taken some kind of action." [NPT]
Monday, November 7, 2011
Bloomberg reports, here, that DC Disctrict Court Judge Leon has ruled initially for the tobacco companies in their fight against the new, graphic cigarette warnings and mandatory consumer information, with the judge noting:
While the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company’s advertising space for government advocacy can be frustratingly blurry, here -- where these emotion-provoking images are coupled with text extolling consumers to call the phone number ‘1-800-QUIT’ -- the line seems quite clear.
Recall Kevin Outterson's NEJM warnings regarding the fall-out from Sorrell v. IMS Health, here. Micah Berman, Kathleen Dachille & Julie Ralston Aoki chimed in here. A pre-verdict Adweek interview with tobacco counsel Floyd Abrams is here [NPT]
Sunday, November 6, 2011
Now that we survived the end of the world predicted for last month, we can focus on the implications of the upcoming “11:11:11 11/11/11,” a repeating single digit time-and-date sequence that will not be repeated for another century that some see as another doomsday date, while others view it as an auspicious occasion for getting married or having a child.
Which got me thinking about possible once-in-a-lifetime health-related events of interest to law professors (which should not be confused with “never events,” a focus of health care reform for a number of years now). The generally accepted and what might seem to be relatively straightforward related truism is that we all experience one death (but see the end of the world prediction above) and one birth.
Except voters in Mississippi will decide on Tuesday whether to adopt Initiative 26 and change when life begins to “the moment of fertilization, cloning or the functional equivalent thereof." It has been noted that:
[This] amendment [to the Mississippi Constitution], if passed, will make it impossible [in Mississippi] to get an abortion and hamper the ability to get some forms of birth control. . . . Because the amendment would define a fertilized egg as a person, it could have an impact on a woman's ability to get the morning-after pill or birth control pills that destroy fertilized eggs, and it could make in vitro fertilization treatments more difficult because it could become illegal to dispose of unused fertilized eggs. This could [also] lead to a nationwide debate about women's rights and abortion while setting up a possible challenge to the landmark Roe v. Wade case, which makes abortion legal.
It also raises the intriguing question of whether everyone in Mississippi will now have two birthdays to celebrate, an eventuality my children would probably gladly embrace if it doubles the number of presents they receive every year. So much for my effort to identify once-in-a-lifetime health-law-related events. Of course there is always the possibility that the U.S. Supreme Court will decide to review The Patient Protection and Affordable Care Act, although even that is not a certainty, see here.
Thomas L. Hafemeister, J.D., Ph.D.; Associate Professor of Law, University of Virginia School of Law; Associate Professor of Medical Education, University of Virginia School of Medicine. I have been affiliated with the law school for the past ten years, where I teach what one student described as “value-added” courses in Bioethics and the Law, Medical Malpractice and Health Care Quality, Mental Health Law, and Psychiatry and Criminal Law. I received my JD/PhD from the University of Nebraska where I was part of the first class in the first formal joint degree law-psychology program in the country. In addition to various publications related to the courses that I teach, a colleague and I recently completed a three-year study funded by the National Institute of Justice exploring the differences between financial abuse of the elderly and other forms of elder abuse. I am also in the process of publishing a series of articles addressing society’s response to violence across the lifespan (child abuse, intimate partner violence, elder abuse) and looking for a book contract for a series of articles on PTSD, war veterans, and the criminal justice system. In addition, I recently agreed to serve as co-author of the Sixth Edition of Law and the Mental Health System: Civil and Criminal Aspects, which is part of the American Casebook Series published by West.
Guest Blogger Kathy Cerminara - Relative Value of Health Care Options at the End of Life: The Elephant in the Room
Exactly a month ago, the IOM released its much-anticipated report, Essential Health Benefits: Balancing Coverage and Cost, recommending that HHS consider, among other matters, the relative value of health care options when defining the essential benefits package that health insurance exchanges and individual and small-group health insurance policies must offer beginning in 2014.
Brushing aside temporarily the difficulties presented by determining what care is “medically necessary,” it is well-nigh impossible to dispute the IOM’s starting point of relative value as encompassing both cost-effectiveness and medical necessity. As Ezekiel Emanuel recently pointed out, and as health policy scholars have long argued, the United States’ health care system delivers a little for a lot. Rather than providing cost-effective, medically necessary care to the majority of patients, the United States spends a great deal on relatively few people and relatively nothing on millions of uninsured persons – relatively nothing, that is, until emergences land those uninsured persons in facilities with complex conditions that could have been headed off with basic preventive care.
Near the end of life, the relative value of medical care is especially out of whack; according to the Dartmouth Atlas, “[p]atients with chronic illness in their last two years of life account for about 32% of total Medicare spending, much of it going toward physician and hospital fees associated with repeated hospitalizations.” HHS should encourage discussion of that fact when crafting its essential health benefits package proposal. Relative value in end-of-life care merits frank discussion between patient and physicians, among physicians, between patients and their families, and in all spheres of policymaking.
Rather than calling for consideration of those purely imaginary death panels, this suggestion marries the realities of health care economics with good, patient-centered, medical ethics. As Mary Ann Baily argues here , it is ethically necessary to consider costs near the end of life. Greer Donley and Marion Danis argue here that patients deserve to consider costs with relation to many choices near the end of life, so that they may consider which treatment plan options might be most compatible with their values and life goals. Certainly, Zhang et al. have demonstrated that patients who discuss with their physicians end-of-life options ranging from highly intensive care to foregoing of treatment often choose less-intensive (and thus less costly) paths through their final days. For many of those patients, the real motivation in taking the least costly path is obtaining relief from highly technical, impersonal, sterile treatments and instead peacefully spending time with their families and friends in their last days. The reduction of costs is a happy by-product of increased patient empowerment and peace at the end of life.
The danger HHS faces in addressing the issue of relative value in end-of-life care is clear from the “death panels” furor. Yet the reality is that lower-cost interventions constitute better care for many dying patients. Ignoring the issues posed by medical costs near the end of life, as a polite guest might ignore the presence of an elephant in her host’s drawing room, only leads to stilted, less-than-honest conversation. The process of crafting the essential health benefits package should include discussions about the elephant.
Health Law Prof Blog is pleased to introduce our newest guest blogger, Professor Kathy Cerminara. The following is her short bio.
Professor Kathy Cerminara bridges the medical and legal professions with her work on patients’ rights in the end-of-life decision-making arena. She co-authors the nationally known treatise, The Right to Die: The Law of End-of-Life Decisionmaking, is a reviewer for several medical and medical-legal journals and book publishers, and is on the legal panel of the editorial board of the forthcoming Cambridge Dictionary of Bioethics. Her scholarship most recently has focused on the intersection between end-of-life care and health care coverage policy, specifically the coverage rules applicable to hospice care. During the 2011-2012 academic year, she is visiting at the St. Louis University School of Law. At the Nova Southeastern University Shepard Broad Law Center, where she is a full professor, she teaches Torts, Civil Procedure, medical-legal seminars, and other health-law-related courses. She also created and was the initial director of that law school’s online Master of Science in Health Law program for non-lawyers. She received her J.D. magna cum laude from the University of Pittsburgh and her LL.M. and J.S.D. from Columbia University. She is an affiliate member of the Health Law and Elder Law sections of The Florida Bar and a member of the American Health Lawyers Association and the American Society of Law, Medicine & Ethics.