March 24, 2012
The Individual Mandate, Broccoli and Slippery Slopes
For two years, critics of the individual mandate have made significant headway in the battle for public opinion--and with some courts--by invoking an appealing slippery slope argument. If Congress can require people to buy a good or service solely becaue they are living in the United States, we will become vulnerable to an unlimited federal authority. Today, we must buy health care coverage, tomorrow we might have to buy vegetables or GM cars.
Not only is this a specious argument, but the slippery slope runs the other way. If the Supreme Court were to prohibit the federal government from making us buy things, then the commerce clause power would be seriously eroded.
First, the speciousness of the constitutional challenge. If the goal is to protect the public against an expansive federal power, striking down Obamacare will not in fact serve that purpose. If the Supreme Court invalidates the individual mandate, the justices will protect the public only against mandates to purchase health care insurance and a few other kinds of insurance that must be procured in advance of a voluntary economic transaction.
To be sure, a ruling against the mandate would mean that Congress could not force us to go out and buy vegetables or GM cars. But the government has other ways to make us buy those goods. Congress still would have the power to require grocery stores and restaurants to include vegetables with every sale, and it still would have the power to require service stations to sell gasoline only to owners of GM vehicles.
Now the slippery slope implications of the constitutional challenge.To protect us from unwanted purchase mandates, the Court would need to curtail the ability of Congress to regulate the terms of economic transactions. The justices would have to prohibit Congress from mandating the purchase of product A as a condition of purchasing product B. But then the Court would have to invalidate all kinds of laws that impose important conditions on economic transactions. Currently, you cannot buy a new automobile without seat belts, a new baby’s crib without safety latches, or a new television set without a V-chip. There is no way for the Court to draw a principled line between requiring sales of seat belts with every sale of a car and requiring sales of vegetables with every sale of food (say with an exception if you could prove you had already bought vegetables that day or week).
In fact, we do not need the courts to protect us from being overwhelmed by purchase mandates. History tells us that Congress has exercised considerable self-restraint when it comes to telling us what we must buy. For example, as the 11th Circuit pointed out, Congress never has required homeowners to purchase flood insurance as a condition of building a house in a flood plain, even though the Constitution clearly would allow for that and even though taxpayers end up footing the bill for flood relief. When all is said and done, Obamacare critics simply have not explained why the Court must strike the individual mandate down.
[DO; with a similar post at Faculty Lounge]
March 23, 2012
Worth Reading This Week
Michael Steinman, et al, Industry Support of CME — Are We at the Tipping Point? N Engl J Med
Tim Jost, Implementing Health Reform: The Reinsurnace, Risk Adjustment, And Risk Corridor Final Rule, Health Affairs
Robert Kocher & Bryan Roberts, Meaningful Use Of Health IT Stage 2: The Broader Meaning, Health Affairs
James Reschovsky, et al, Paying More for Primary Care: Can It Help Bend the Medicare Cost Curve? Commonwealth Fund
March 22, 2012
Symposium: “Is a For-Profit Structure a Viable Alternative for Catholic Health Care Ministry?
Next week, Seton Hall will be hosting a symposium on Catholic health care. As noted by Health Reform Watch:
On March 26-27, Seton Hall Law will be home to a two day Symposium entitled “Is a For-Profit Structure a Viable Alternative for Catholic Health Care Ministry?” Funded through the generosity of a number ofcontributors, the Symposium is being hosted by Seton Hall Law’s Center for Religiously Affiliated Nonprofit Corporations and its Center for Health & Pharmaceutical Law & Policy, in collaboration with the University of St. Thomas, John A. Ryan Institute for Catholic Social Thought, the Terrence J. Murphy Institute for Catholic Thought, Law and Public Policy and the Veritas Institute.
In an April 2010 article, a reporter for The Boston Globe pondered whether “… for-profit Catholic health care is an oxymoron, or whether profitability and religious mission can be integrated.” This Symposium will examine whether a for-profit structure is a viable alternative for Catholic health care ministry.
More details here.
March 19, 2012
Guest Blogger Carl H. Coleman: New French Legislation on Human Subject Research
While U.S. regulators are still considering whether to follow through with last summer’s initial foray into reforming the Common Rule, changes to the human subject protection laws are already well underway in France. Earlier this year, the French legislature enacted a new Law on Research on the Person, commonly referred to as the Loi Jardé. The law significantly alters the regulatory landscape for French biomedical researchers, simplifying requirements in some cases while adding complexity in others.
The new law, which will take effect upon publication of official decrees, divides biomedical research with human beings into three categories:
- Interventional studies, defined to include studies involving interventions “not justified by the person’s usual care”
- Interventional studies not involving medications and involving no more than minimal risks (according to a list to be developed by the Ministry of Health)
- Non-interventional research, defined as studies of standard treatment that do not involve any extra or unusual diagnostic, treatment, or surveillance procedures
Research in all three categories will require the approval of a comité de protection des personnes (CPP), state-run ethics committees that are entrusted with similar responsibilities as American institutional review boards (IRB).
For research that falls under the law’s third category—including post-marketing studies in which cohorts of patients are followed to monitor a treatment’s effectiveness and side effects—the requirement of CPP approval is new. The requirement was added to ensure that patients who are enrolled in studies are aware that research is being carried out and are not subject to additional burdens. According to the law’s sponsors, requiring CPP approval of non-interventional research is necessary to ensure that French researchers are able to publish the results of their work in international scientific journals.
Some studies falling into the second category of the new law may benefit from additional regulatory flexibility, including the possibility of dispensing with the use of written consent forms.
The law will also create a national system of CPP oversight, which will take effect in the summer of 2014. Under the new system, CPPs will be assigned on a national basis, without regard to the study’s location.
Visiting Position in Health Law at Duquesne School of Law
Duquesne University School of Law in Pittsburgh will likely have an opening for a visiting professor to teach Health Law and related courses. This opening will be for one, or possibly both semesters, during the 2012-2013 academic year. We especially encourage applications from racial minorities, women, and others who would enrich the diversity of our academic community. Interested applicants should send a résumé, along with a letter of interest, to Faculty Recruitment Committee at firstname.lastname@example.org. Electronic submissions are preferred. Candidates are strongly discouraged from submitting an application by mail. Past teaching and scholarly experience in the field of Health Law is preferred.
Beyond Best Interests: Alternative Justifications for Regulating Reproduction
I just read two companion papers that are likely to be of interest to our readers written by Assistant Professor I. Glenn Cohen of the Harvard Law School, who is also the Co-Director of the Petrie-Flom Center for Health Law Policy. In Beyond Best Interests, 96 Minn. L. Rev. _ (forthcoming, 2012) http://ssrn.com/abstract=2014069, and Regulating Reproduction: The Problem with Best Interests, 96 Minn. L. Rev. 432 (2011) http://ssrn.com/abstract=1955292, Professor Cohen starts by pointing out that those who argue for regulating reproduction often justify it based on concern for the interests of the children who will result from the types of reproduction they would like to regulate/prevent. Professor Cohen then argues that this justification for regulating reproduction is problematic and misleading: unless the state’s failure to intervene would foist upon the child a “life not worth living,” any attempt to alter whether, when, or with whom an individual reproduces cannot be justified on the basis that harm will come to the resulting child, since but for that intervention the child would not exist. Next, he surveys a series of possible substitute justifications: non-person-affecting principles, reproductive externalities, wronging while overall benefitting, legal moralism, and virtue ethics, and shows that they too run into serious problems. At the very least, he argues, adopting one of these substitute justifications should lead us to regulate reproduction much much less than we currently do.