June 10, 2011
Worth Reading This Week
Ben Trachtenberg, Health Inflation, Wealth Inflation, and the Discounting of Human Life, SSRN/Oregon Law Review,
Allison K. Hoffman,Three Models of Health Insurance: The Conceptual Pluralism of the Patient Protection and Affordable Care Act, SSRN/U Pa L.Rev.
Clark C. Havighurst & Barak D. Richman, Who Pays? Who Benefits? Unfairness in American Health Care, SSRN/Notre Dame Journal of Law, Ethics and Public Policy
Nina A. Kohn, The Lawyer's Role in Fostering an Elder Rights Movement, SSRN/William Mitchell
June 9, 2011
Personal Health Records: Is Unraveling Inevitable?
I look forward to reconnecting with everyone who is attending the health law professors conference in Chicago. My presentation will be applying some of the ideas of Scott Peppet (on self-quantification and unraveling) to personal health records. I found these ideas from Peppet's post on biometric identification particularly interesting:
The biometric technologies firm Hoyos (previously Global Rainmakers Inc.) recently announced plans to test massive deployment of iris scanners in Leon, Mexico, a city of over a million people. . . . [T]he company’s roll-out strategy is explicitly premised on the unraveling of privacy created by the negative inferences & stigma that will attach to those who choose not to participate. Criminals will automatically be scanned and entered into the database upon conviction. Jeff Carter, Chief Development Officer at Hoyos, expects law abiding citizens to participate as well, however. Some will do so for convenience, he says, and then he expects everyone to follow: “When you get masses of people opting-in, opting out does not help. Opting out actually puts more of a flag on you than just being part of the system. We believe everyone will opt-in.” (For the full interview, see Fast Company’s post on the project.)
I've previously looked at the limits of individualist accounts of autonomy in work on pharmaceuticals (here and here), and scholars like Robert Ahdieh are questioning individualism in law & economics generally. As Nic Terry has argued, many of the critiques of CDHC apply to PHRs, and vice versa.
As of a few years ago, "it wasn't illegal to hire and fire people based on their smoking habits" in 21 states. I think there will be many difficult questions raised in coming years by the growth of medical records of all types, and how many secondary uses of them are permitted. For example, some dating sites will now verify the income and assets of their users. How soon before they (and other certification and evaluation intermediaries) start vouching for health profiles? Does law have a role in these situations? I'll try to explore these questions, and I'll post more details about the presentation after getting some feedback.
June 8, 2011
Reproductive Rights Are Taking a Hit across the Board in Indiana
This has been a very difficult year for the preservation of reproductive rights. As Emily Bazelon reported in the New York Times last week, state legislatures have adopted a broad range of restrictions on abortion. Newly-adopted provisions would ban abortions after 20 weeks, require women to receive counseling at pregnancy crisis centers before their abortions, and cut off state and federal funding for contraception, screening for cancer or sexually transmitted diseases, and other non-abortion services at Planned Parenthood clinics.
Along with South Dakota, Indiana has led the way. In November, Republicans gained control of the House and joined with the already-Republican Senate and Gov. Mitch Daniels to push through their anti-choice agenda.
And it’s not just the General Assembly and governor, nor just Republican office-holders in Indiana. When Planned Parenthood requested a temporary restraining order against its loss of federal funds, a Democratic district court judge in Indianapolis declined to intervene. After last week’s letter from HHS informing Indiana that its cut-off of funding violates Medicaid law, there is good reason to think the judge will reconsider her decision when she decides whether to issue a preliminary injunction later this month. And in a case I discussed previously on this blog, a Democratic prosecutor in Indianapolis filed murder charges against a woman who tried to commit suicide while pregnant. When the woman survived her attempt, doctors delivered her fetus by cesarean section, but the infant died a few days later. Even though Indiana does not make attempted suicide a crime, the prosecutor is trying to make it a crime for pregnant women.
June 7, 2011
Federal Regulatory Reform and Valuing Public Health
The Administration has taken initial steps to implement Executive Order 13563, “Improving Regulation and Regulatory Review,” released in January. Intended to streamline the federal regulatory process and address complaints from business about the burdens of regulations, there is strong interest in its practical applications. In a nutshell, it requires that regulations be simplified, harmonized, tailored to impose the least burden on society, and performance-based rather than dictating behavior. It also requires that they be based upon a determination that benefits justify costs, and receive increased public participation during promulgation.
President Obama, in the Wall Street Journal editorial wrote, "My hope is that the whole process might inaugurate a broader, less polarized, more fact-based conversation about how we might promote economic growth and job creation while also protecting the health, safety and welfare of the American people."
The “conversation” is being led by Cass Sunstein, Administrator of the White House Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget. Before taking up his post he was a Professor at Harvard Law School, after earning a reputation for his insights and writing on economics and cost benefit analysis on the faculty of the University of Chicago School of Law from 1981 to 2008.
Sunstein was a witness at a House Energy and Commerce Committee Subcommittee on Oversight and Investigations hearing on Friday. In his statement, Sunstein described how 30 departments and agencies have reviewed their regulations to determine how they can be streamlined, reduced, improved, or eliminated.
The President's regulatory reform critics point to examples of rules from agencies like the Occupational Safety and Health Administration’s new rule that would allegedly “double-count complaints and capture aches and pains caused from outside the workplace,” according to one article (It is difficult to assess who is telling the truth when Sunstein’s testimony described the final OSHA rule as “removing over 1.9 million annual hours of recordkeeping burdens on employers and save more than $40 million in annual costs”).
A few of the hearing witnesses referred to the proposed “Regulations from the Executive In Need of Scrutiny Act of 2011” (H.R. 10), which would block any major safeguard from moving forward unless Congress approved it within 60 legislative days. This misguided effort would bring in Congress to review regulations that may impose costs on the private sector, and could undermine important public health and safety regulations.
The Natural Resources Defense Council’s David Goldston, in his testimony, pointed out that this is at odds with the accepted and “hard learned” administrative process where detailed technical matters required by Congress are delegated to specialized experts. However, a statement by William L. Kovacs of the U.S. Chamber of Commerce recommended H.B. 10 as a means to achieve regulatory reform.
A main issue in regulatory reform will be how cost benefit analysis (CBA) is carried out. CBA is not new, since it has always been used by agencies to evaluate proposed rules. In fact, President Reagan issued an Executive Order on regulations in 1981 requiring that agencies do CBA by determining that the “ potential benefits to society for the regulation outweigh the potential costs to society” and the selected rules must “maximize the net benefits to society.” Today’s CBA discussions, however, can now be informed by over thirty years of CBE discourse, including Sunstein’s work, on the challenges of quantifying benefits to the public, as with pollution rules that benefit human health, so they can be compared to costs on private companies that would have some cost public’s interest in a strong economy. The political leanings of House leadership are now firmly on the side of maximizing the values used for economic interests. How CBA will be used by agencies in new regulations needs to be closely scrutinized, since it will reveal how tradeoffs are truly being made.
The subcommittee has scheduled a hearing on health issues related to reg reform on Monday, June 13, 2011, at 2:00 p.m. in 2322 Rayburn House Office Building. The hearing is entitled “The Views of the Department of Health and Human Services on Regulatory Reform: An Update,” and promises to reveal the extent to which the Administration and Republican House leaders are at odds on this issue.
Government works, maybe
So, individual mandate aside, the good citizens of Massachusetts seem to like their new health reform law, according to a new Harvard SPH survey, available here. Of course, the cost curve there hasn't been bent, although most respondents didn't blame the legislation for increased costs.
Reducing costs was Ezra Klein's topic today in the Washington Post, available here, comparing Republican partial privatization of Medicare with ACA's IPAD.
… a choice we’ve been left with: a plan that has never worked or a plan that’s never been tried. As for the approach that’s helped every other industrialized country achieve universal coverage at about half our costs? Well, we’re still not ready to talk about that.
June 6, 2011
Guest Blogger Lindsay F. Wiley: World Health Assembly Adopts a New Influenza Preparedness Agreement on Virus Sample Sharing and Access to Vaccines
I want to thank Katharine Van Tassel and everyone else at Health Law Prof Blog for allowing me to join them this month as a guest blogger. I’m new to the academy – having just taken a position as Assistant Professor of Law at American University less than a year ago – and so I truly appreciate the opportunity to join the ongoing discussion here about recent developments in health law news and scholarship.
My current projects include a book chapter on international and comparative legal frameworks for addressing natural disasters and the global health impacts of environmental degradation; a law review article tentatively titled Uncovering a Collective Right to Health in Public Nuisance Jurisprudence; and early research on what legal theory might contribute to an emerging ethical debate over the use of stigma as a public health tool. So it’s a summer of disaster, nuisance and stigma for me. I’ll be starting my guest blogging stint with some recent developments in global health law. I’d also like to post about the process of developing a health law survey course, something that’s very much on my mind as I wrap up my first year of full-time teaching.
At the end of last month, the Sixty-fourth World Health Assembly concluded an historic session in Geneva that included discussion of several hot-button issues. Though it has received little attention from the press, arguably the most significant new development from the perspective of international health law was the WHA’s adoption of a new Pandemic Influenza Preparedness Framework agreement (the PIP Framework). The lack of fanfare is perhaps understandable given that pandemic influenza is so 2009. Indeed, WHO’s own press release gave the new agreement lower billing than the declaration by an independent Review Committee that “the pandemic (H1N1) 2009 was indeed a real pandemic” and that it “found no evidence WHO was influenced by industry in its decision making” as the events of 2009 unfolded.
The rather bland reporting of the new PIP Framework belies its status as the culmination of four years of negotiation among WHO’s 193 Member States that included some of the most contentious debates in the organization’s recent history. The controversy began in 2006 when Indonesian officials refused to share samples of avian influenza collected within their borders. At a time when fear over the pandemic potential of H5N1 avian flu was significant, Indonesia’s refusal to share samples elicited strong reaction from diplomats and commentators in the U.S. and elsewhere.
Essentially, Indonesian officials argued that they would not be willing to share further avian flu samples until they received assurances that they would also be able to share in the benefits of vaccine research made possible by the samples. WHO collects virus samples and ultimately makes them available to private companies for vaccine research and development. Indonesia argued that such a system was equivalent to biopiracy – the exploitation of resources found in developing countries for the benefit of companies (and ultimately populations) in wealthy countries.
As David Fidler outlined in a 2008 article in Emerging Infectious Diseases, both sides of the controversy framed their arguments using international law. The WHA passed a resolution in 2007 asserting that the International Health Regulations (as revised in 2005) included an obligation to share virus samples. Indonesia maintained that the IHR requirements applied only to information sharing, not the sharing of physical material like virus samples. Moreover, Indonesia argued that the Convention on Biological Diversity, adopted to combat biopiracy, applied to virus samples and mandated prior informed consent and provision for fair and equitable sharing of benefits.
Ensuing negotiations over virus sample and benefit sharing were described by William Aldis in a 2008 article in Health Policy and Planning as revealing a growing rift between developing countries’ and developed countries’ competing conceptions of “health security.” Policymakers in developing countries, Aldis argued, tend to view health security as something akin to human security – an idea rooted in health equity and human dignity. At the same time, those in wealthy countries conceive of health security as something akin to national security – an idea rooted in protection of populations from disease threats that know no borders.
Ultimately, the agreement endorsed last week by the WHA claims to settle the dispute by including a statement that WHO Member States “should” share samples of influenza viruses with pandemic potential. By doing so, they agree to the onward transfer of such materials to other entities as set forth in the Standard Material Transfer Agreements, included in an annex to the PIP Framework. The Framework also directs the WHO Director General to put into place a traceability mechanism to track and report the movement of virus samples within and out of the WHO’s system. The reporting obligation can be temporarily modified in an emergency. The Director General is also directed to further develop and maintain a stockpile of antivirals, vaccines, and related supplies to be used in the event of an influenza outbreak with pandemic potential. The agreement includes establishment of a PIP Benefit Sharing System that aims to “prioritize … antiviral medicines and vaccines against H5N1 and other influenza viruses with human pandemic potential … to developing countries, particularly affected countries, according to public health risk and needs and particularly where those countries do not have their own capacity to produce or access influenza vaccines, diagnostics and pharmaceuticals.”
Disease outbreaks with pandemic potential highlight the mutual interdependence between rich and poor when it comes to threats that “know no borders.” Historically, however, our response to these threats has fallen far short of fully respecting the goals of health equity and social justice that Larry Gostin, Jennifer Prah Ruger, and others have argued should underpin the emerging field of global health law. Whether this new agreement is a meaningful step in the right direction remains to be seen. At a time when global health resources are becoming dangerously scarce – to such an extent that the WHA’s main focus during the recent meeting was to undertake a massive reform effort in response to this year’s budget shortfall – it is hard to imagine that our commitment to global health equity will be substantially strengthened in coming years.
Introducing Guest Blogger Lindsay F. Wiley
Health Law Prof Blog is very pleased to welcome Lindsay F. Wiley as the guest blogger for June. Here is a her brief bio:
Lindsay F. Wiley is an Assistant Professor of Law at the American University Washington College of Law. Professor Wiley’s teaching interests include torts, health law and policy, public health law, global health law and health and human rights. Her current research focuses on access to health care and healthy conditions in the U.S. and globally. She has published on various law and policy issues at the intersection of public health, food systems, and environmental change. Prior to joining the faculty at American University in 2010, Professor Wiley was the Global Health Law Program Director at the O’Neill Institute for National and Global Health Law at Georgetown University. She had also previously worked at the Center for Law and the Public’s Health at the Johns Hopkins Bloomberg School of Public Health, the American Society for Law, Medicine and Ethics, and Gordon, Feinblatt, Rothman LLC in Baltimore, MD. She received her AB, magna cum laude, and JD, magna cum laude, from Harvard, where she served on the Harvard Law Review, and her MPH from Johns Hopkins.