February 5, 2011
Walsh on Lack of Subject Matter Jurisdiction over Health Care Reform Challenges
Professor Kevin Walsh (Richmond) has posted on SSRN his essay, The Ghost that Slayed the Mandate. Here’s the abstract:
Virginia v. Sebelius is a federal lawsuit in which Virginia seeks the invalidation of President Obama’s signature legislative initiative of healthcare reform. Virginia seeks declaratory and injunctive relief to vindicate a state statute declaring that no Virginia resident shall be required to buy health insurance. To defend this state law from the preemptive effect of federal law, Virginia contends that the federal legislation’s individual mandate to buy health insurance is unconstitutional. Virginia’s lawsuit is one of the most closely followed and politically salient federal cases in recent times. Yet neither the federal government nor any other legal commentator has previously identified the way in which the very features of the case that contribute to its political salience also require that it be dismissed for lack of statutory subject-matter jurisdiction. The Supreme Court has placed limits on statutory subject-matter jurisdiction over declaratory judgment actions in which a state seeks a declaration that a state statute is not preempted by federal law - precisely the relief sought in Virginia v. Sebelius. These limits insulate federal courts from the strong political forces surrounding lawsuits that seek federal court validation of state nullification statutes. This Essay identifies these heretofore neglected limits, shows why they demand dismissal of Virginia v. Sebelius, and explains why it is appropriate for federal courts to be closed to this type of suit.
February 4, 2011
Push to Repeal ObamaCare's 1099 Requirement Ignores Tax-Gap Problem
Hat Tip to Paul Caron over at TaxProf Blog for highlighting an article posted on Bloomberg entitled Push to ‘Correct’ IRS Small Business Rule Ignores Tax-Gap Data, by Ryan J. Donmoyer:
A year ago, Congress had instructed the Internal Revenue Service to improve small businesses’ compliance with tax laws and created rules to make it more difficult for entrepreneurs to hide their income.
Now, rules requiring businesses to report to the IRS transactions with vendors may become collateral damage in a political fight over the health-care law. President Barack Obama in his State of the Union address on Jan. 25, backed an effort to “correct” the “unnecessary bookkeeping burden” before the rules take effect in 2012, forgoing an estimated $1.9 billion annually to pay for the overhaul of the health-care system.
The about-face is designed to appease congressional Republicans and business groups such as the U.S. Chamber of Commerce that have criticized the rules along with the broader health-care law. It also shows how difficult it is to take steps to close the tax gap among small businesses, which data show have lower tax payment rates than corporations and salaried workers. ...
The IRS estimates that about $345 billion in taxes owed are unpaid every year. Auditors recover about $55 billion of that, leaving $290 billion that goes uncollected, a figure known as the tax gap. The agency attributes $109 billion of the gap to underreported business income earned by individuals. The IRS estimates that this group also fails to pay about $39 billion in self-employment taxes. The figures are drawn from a study of 2001 tax returns and are likely higher today, according to the Congressional Research Service.
The IRS says small businesses are able to underreport their taxes because many business-to-business transactions aren’t reported independently to the government as wages and investment income are. By contrast, about 98% of salaried workers pay what they owe because their employers report their wages to the IRS. The Bush administration, in response to demands from Senate Finance Committee Chairman Max Baucus, a Montana Democrat, in 2008 proposed requiring businesses to report to the IRS when they pay vendors more than $600 for goods. Similar requirements exist for purchases of services.
So Much for P4P, Jury out on Safer Patients Initiative
Post-election healthcare angst is not limited to the US. The proposed reforms in the UK are complex but involve market-based reforms and drastic cuts in bureaucracy, as described here. But, while the wonks debate the impact of the reforms we have some hard data about two quality improvement/error reduction reforms strategies much discussed on this side of the Atlantic. First, a study published in the BMJ last month cases serious doubts on the efficacy of Pay for Performance (P4P) models. Second, potentially more worrying, yet as yet far less definitive are this month's published studies suggesting that broad system-wide safety-related initiatives based on the Health Foundation’s Safer Patients Initiative (SPI), based on IHI models, have only modest impacts on safety improvements. The full report is available here.
Is there a Middle Ground between Concierge Care and the Doc in the Box?
Concierge (or retainer-based) care is relatively well-known. For a four or five figure retainer plus 'cash only' at the time of visit the patient gets 24x7 care, patient-focused technologies, and access to a practice with fewer patients (as described here and in the definitive journal article by co-blogger Frank Pasquale). Equally, we have seen the steady proliferation of the doc-in-a-box, or less pejoratively, walk-in clinics (low cost mall or retail-store based clinics typically staffed by nurse practitioners) as detailed here and criticized by pediatricians here.
Katie Hafner's recent article in the New York Times, Concierge Medical Care With a Smaller Price Tag, suggests further stratification of the primary care market with the growth of low(er) cost concierge-like models that do accept insurance. Her article primarily discusses One Medical Group, that markets itself as "not your typical doctor's office." Their price may be three-figured but many concierge benefits are included, such as email contact with doctors, electronic appointment scheduling, and online prescription refill requests. The practice even has a blog and social networking feeds.
Another recent story in the Los Angeles Times suggests that while the "Walmart-ing" or Toyota-ing of US healthcare has barely begun, at least some healthcare providers have taken notice of the Apple stores' genius bars and their online reservation (appointment) systems!
These different models seem to have some teaching value; some of the issues that can be discussed include risk-pooling and adverse selection, the individual and group meanings of patient-centered care, the shift to and likely shortages associated with primary care, the values associated with preventative care and continuity of care, and the convergence of physician and patient attitudes towards technology.
February 3, 2011
Rodwin: Conflicts of Interest and the Future of Medicine : The United States, France and Japan
Marc Rodwin (Suffolk University Law School) has published a new book, Conflicts of Interest and the Future of Medicine: The United States, France and Japan with Oxford University Press.
Here is an over view:
Conflicts of interest result from physicians practicing medicine as entrepreneurs, from physicians’ties to pharma, and from investor-owned firms and insurers’ influence over physicians’ medical choices. These conflicts compromise physicians’ loyalty to their patients and their professional independence. The consequences are often devastating for patients—and society. Yet widespread conflicts of interest are not unique to the U.S. They exist in different forms in all advanced nations.
In Conflicts of Interest and the Future of Medicine, Marc A. Rodwin examines the development of these conflicts in the United States, France, and Japan. He shows that national differences in the organization of medical practice and the interplay of organized medicine, the market, and the state give rise to variations in the type and prevalence of such conflicts and how each nation addresses them. Most proposals to address physicians’ conflicts of interest are not effective. But drawing on the experiences of these three nations, Rodwin demonstrates that we can mitigate these problems with carefully planned reform and regulation.
Dr. Blumenthal to step down from leading ONC
Dr. David Blumenthal is stepping down from his post as the National Coordinator of HIT (ModernHealthcare). This seems to be a surprise decision although Blumenthal himself reportedly said that his decision to return to Harvard University this Spring had been planned when he accepted the position back in March 2009. Blumenthal was the third Coordinator and President Obama's first. He was also the first HIT czar to have a serious budget and major funds to dispense courtesy of the stimulus-funded HITECH Act. His resignation comes at a crucial time as HHS is working on Stages 2 and 3 of the Meaningful Use standards, standards expected to be considerably more rigorous than the Stage 1 standards (described here).
Reading the Tea Leaves in Vinson's RulingNYT reporter Kevin Sack notes that Judge Vinson tips his hand in his health care ruling by referencing, out of the blue, colonial tea policy. This isn't dog-whistle opinion writing, but red meat for those with a certain vision of red America. At Health Affairs, Tim Jost patiently dismantles the opinion. He concludes:
This is a radical decision. Judge Vinson has a clear vision of the limited federal government the founders intended that is very much in line with that espoused by the Tea Party Movement. He mourns the fact that the Supreme Court has allowed Congress to assume control over much of the American economy, and grasps any toehold he can find in precedent to push back against that authority. Despite repeated cautions in governing precedent that the courts should defer to congressional judgments in economic matters where rational, Judge Vinson is confident in the wisdom of his own judgments and readily substitutes them for those of Congress. . . .
But the ramifications of this case go far beyond the minimum coverage requirement. We will see what the courts of appeal and ultimately the Supreme Court do with this opinion. If it is upheld, it will mean a dramatic contraction of the authority of Congress. . . .What I find most disheartening is that someone with the health care knowledge of Jost has to get bogged down in a fight like this. He's written a series of excellent posts on topics including medical loss ratios, preventive services, a patient bill of rights, grandfathered plans, tax exempt hospitals, the small employer tax credit, the Web portal, reinsurance for early retirees, and young adult coverage. If we had a rational health care debate, we'd be focusing on practical issues like these--rather than, as Jack puts it, a faux "defense of liberty" that is little more than a "defense of selfishness." --Frank Pasquale
February 2, 2011
Todres: Moving Upstream: The Merits of a Public Health Law Approach to Human Trafficking
Jonathan Todres (Georgia State University College of Law) has posted "Moving Upstream: The Merits of a Public Health Law Approach to Human Trafficking" in the North Carolina Law Review.
Here is the abstract:
Human trafficking, a gross violation of human rights and human dignity, has been identified by numerous government leaders as one of the priority issues of our time. Legislative efforts over the past decade have produced a patchwork of criminal laws and some assistance programs for victims. There is no evidence, however, that these efforts have reduced the incidence of trafficking. This lack of meaningful progress prompts questions as to what the best framework is for addressing human trafficking. This Article begins with a discussion of the limitations inherent in the current law-enforcement-centric approach to the problem. It then explores the merits of a public health approach to human trafficking. As evidenced with governmental and community responses to issues such as road safety and smoking, public health strategies have proven successful in reducing harm by focusing on prevention and addressing underlying causes. Ultimately, this Article concludes that, although a public health approach alone is not sufficient, public health methodologies can advance anti-trafficking efforts in ways currently underutilized or not contemplated by a criminal law model, and reveal deep-seated structural challenges impeding the success of current legislative and policy initiatives designed to combat human trafficking.
Worth Reading This Week
Does Sorry Work? The Impact of Apology Laws on Medical Malpractice, Benjamin Ho, Cornell University - Johnson School of Management & Elaine Liu, University of Houston
Can Health Law Truly Become Patient-Centered? Joan H. Krause, University of North Carolina (UNC) at Chapel Hill - School of Law
Designing Oversight for Nanomedicine Research in Human Subjects: Systematic Analysis of Exceptional Oversight for Emerging Technologies, Susan M. Wolf & Cortney M. Jones, University of Minnesota Law School
Throwing the Individual Mandate Under the Bus?
Kaiser Health News has posted useful summaries of the editorial and news pages' reaction to Judge Vinson's ruling. As is so often the case Ezra Klein's comments stand out. Most of his piece discusses the economic 'activity'/'inactivity' arguments. But, his final paragraph asks the difficult question about the individual mandate, concluding "The legislation will work much better with an individual mandate. But many people will be covered, and many goals achieved, in the absence of the mandate." Is it too soon to have this conversation?
Introducing Our Fourth and Final New Co-Editor, Frank Pasquale
Our new blogging team is now up and running with the welcome addition of our fourth and final new Co-Editor, Frank Pasquale. Here is his bio:
Frank Pasquale is Schering-Plough Professor in Health Care Regulation and Enforcement at Seton Hall Law School and a visiting fellow at the Princeton University’s Center for Information Technology Policy. He has a JD from Yale, was a Marshall Scholar at Oxford, and graduated from Harvard summa cum laude. He has been a visiting professor at Yale and Cardozo Law Schools. He has published widely on information law and policy. In 2010, he was twice invited by the National Academy of Sciences’s Committee on Law, Science, and Technology and its Government-University-Industry Roundtable to present on the privacy and security implications of data sensor networks. He also was invited by the Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology to present at a roundtable organized to inform ONC’s Congressionally mandated report on privacy and security requirements for entities not covered by HIPAA (relating to Section 13424 of the HITECH Act). He is the Chair of the Privacy & Defamation section of the American Association of Law Schools for 2010, and presently serves on the executive board of AALS's Section on Law & Medicine.
Pasquale has been quoted in the New York Times, San Francisco Chronicle, Los Angeles Times, Boston Globe, Financial Times, and many other publications. He has appeared on CNN, CNBC, WNYC's Brian Lehrer Show, the Canadian Broadcasting Corporation's documentary "Engineering Search," and on National Public Radio's Talk of the Nation. His publications include "Beyond Innovation and Competition," "Ending the Specialty Hospital Wars," "Cognition-Enhancing Drugs: Can We Say No?," "The Three Faces of Retainer Care," "Two Concepts of Immortality," "Restoring Transparency to Automated Authority," and "Data and Power."
February 1, 2011
FAO Report Identifies Health Threats that Effective Fisheries Regulation Might Address
Yesterday, the United Nations Food and Agriculture Organization released a report, the State of the World's Fisheries and Aquaculture. It emphasizes the increasing importance of fish to global diets and highlights how global fish stocks continue to decline, as 32% of the world's fish stocks are considered over-exploited, depleted or recovering. Increasingly, countries are relying on aquaculture to fill the gaps.
The report raised several red flags about fisheries and health, a big one being the concern with the presence of contaminants like methyl mercury and dioxin in some fish and fish products. In many areas public health authorities advise against consumption, but in many poor areas the resulting lower intake of fish, often the primary protein source, can lead to a dangerous reduction of the intake of essential nutrients. The report, however, is not very useful about policy solutions, since it acknowledges that the relative dangers need to be balanced, but there is no consensus among scientists about how to do it.
The other red flag is related to the declining stocks, which is not encouraging for an increasing world population, many of whom rely on eating fish to survive. But fish are often migratory and in those cases effective laws and regulations to stem overfishing need to be uniform to succeed. A huge barrier to a solution is the lack of effective national, regional and international coordination and collaboration to regulate fishing. To address this, the International Plan of Action to Prevent, Deter and Eliminate Illegal, Unreported and Unregulated Fishing (IPOA-IUU) was adopted by the FAO in 2001.The problem with this, as with many international agreements, is its lack of teeth. But it provides a great framework, and out of it many national action plans have been generated. Legally binding agreements are also being negotiated. But as yesterday’s report makes clear, more cooperation is needed, especially in regions that lack resources and infrastructure.
January 31, 2011
Introducing Our Third New Co-Editor, Mary Munson
You may have already noticed several posts from the third new member of Health Law Prof's new blogging team, Mary Munson. Ms. Munson is the Executive Director of the Graduate Program in Environmental Sustainability at the St. Thomas University School of Law. She has a B.S. from the Massachusetts Institute of Technology, an M.P. and M.A. from the University of Virginia, a J.D. from the Marshall-Wythe School of Law, College of William and Mary and an LL.M. from Queen Mary College, University of London.
We are very proud to be adding Ms. Munson as one of our new Co-Editors and here is her bio:
Ms. Munson earned advanced degrees in law, international law, environmental science and natural resource planning, and has been awarded a Sea Grant Congressional Fellowship, Drapers Guild Scholarship and Virginia Environmental Endowment Law Fellowship. She has two decades of experience as an environmental lawyer, lobbyist and program director at various environmental nongovernmental organizations. She has represented these organizations in major federal litigation involving natural resources, concerning issues as diverse as land use capacities, endangered species, energy transmission and greenhouse gas emission control. She has also testified before House and Senate committees on proposed legislation and worked as a legislative assistant for a United States Senator covering marine conservation issues. Internationally she led a legal team to investigate environmental policies in the Czech Republic and was instrumental in achieving a law limiting the use of massive, destructive fishing nets in the European Community. She served three terms as chair of the Everglades Coalition, an umbrella group of more than 50 organizations dedicated to restoring the Florida Everglades. She has served on various boards, including three years on the Florida Water Resources Advisory Board, the U.S. Trade Representatives Industry Sector Advisory Committee on Timber Products, and advisory committees for Biscayne National Park and Miami Dade County’s Crandon Park. Most recently, as legal director of the Center for Earth Jurisprudence, Ms. Munson directed the creation of the new LL.M. program in Environmental Sustainability at St. Thomas University, in addition to teaching environmental law.
It Isn't Easy Being NICE
In late October, the UK announced its intention to rein in what many observers viewed as a model for the sensible rationing of health care. For nearly a decade, the National Institute of Health and Clinical Excellence (NICE) had employed rigorous expert assessments to decide whether new drugs or other medical treatments were sufficiently cost-effective that they should be covered by the National Health Service. But denying coverage for new therapies is bound to provoke controversy, and NICE received its share of criticism. Hence, the UK government plans to eliminate the power of NICE to make coverage decisions based on its analyses. Of course, Congress withheld that kind of power from the Patient Centered Outcomes Research Institute that will be created under the Patient Protection and Affordable Care Act. The change in policy at NICE reminds us of the discussion by Calabresi and Bobbitt in "Tragic Choices" that society deals with life-and-death decisions implicitly because of the social conflict that results from efforts at explicit resolution.
Introducing the Second of Our New Co-Editors, David Orentlicher
Health Law Prof extends a big welcome to the second of our new Co-Editors, Professor David Orentlicher. Here is Professor Orentlicher's bio:
David Orentlicher, MD, JD, is visiting professor at the University of Iowa College of Law. He holds permanent appointments as Samuel R. Rosen Professor and co-director of the Hall Center for Law and Health at Indiana University School of Law-Indianapolis and as adjunct professor of medicine at Indiana University School of Medicine.
A graduate of Harvard Law School and Harvard Medical School, he previously served as director of the Division of Medical Ethics at the American Medical Association. While there, Dr. Orentlicher led the drafting of the AMA’s first patients’ bill of rights. He also helped develop many other positions—on end-of-life decisions, organ transplantation, reproductive issues, and physicians’ conflicts of interest—that have been incorporated into federal and state law and cited by courts and government agencies in their decision-making. At the time, he was on the adjunct faculty of the University of Chicago Law School and Northwestern University Medical School.
Dr. Orentlicher has held a number of distinguished visiting professorships, serving as Visiting DeCamp Professor in Bioethics at Princeton University, Frederick Distinguished Visiting Professor of Ethics at DePauw University, and George E. Allen Professor of Law at T. C. Williams School of Law, University of Richmond.
He has published Matters of Life and Death with Princeton University Press, and is co-author of the law school textbook Health Care Law and Ethics, now in its 7th edition. Dr. Orentlicher also has written widely in leading legal and medical journals on critical issues in law and medicine, including health care reform, new reproductive technologies, and organ transplantation, as well as on questions in constitutional law.
Dr. Orentlicher served in the Indiana House of Representatives between 2002 and 2008. He was named “Best Politician” in 2007 by NUVO, Indianapolis’ alternative newspaper, for his work on property tax reform, reproductive rights, and equality for all persons. During his three terms, he also authored legislation to promote job creation, protect children from abuse and neglect, and make health care coverage more affordable.
Introducing the First of Our New Co-Editors, Nicolas P. Terry
This week Health Law Prof is very proud to begin the introductions of the four new members of our new blogging team. Today, you will notice several entries from Professor Nicolas P. Terry. Soon, you will see our masthead change to indicate that Professor Terry has been added as one of our new Co-Editors. Here is Professor Terry's bio:
Nicolas P. Terry is the Chester A. Myers Professor of Law at Saint Louis University School of Law where he teaches Torts, Products Liability, Health Information Technology, Law & Science, and Health Care Quality. Educated at Kingston University and the University of Cambridge, Professor Terry began his academic career as a member of the law faculty of the University of Exeter in England. He has served as a Senior Fellow at Melbourne Law School and holds the secondary appointment of Professor of Health Management & Policy at the Saint Louis University School of Public Health. He has held visiting faculty positions at the law schools of Santa Clara University, the University of Missouri-Columbia, Washington University, and the University of Iowa. From 2000-08 Professor Terry served as co-director of Saint Louis University’s Center for Health Law Studies — consistently ranked by U.S. News & World Report as the finest health law program in the nation. From 2008-10 Terry served as the School of Law’s Senior Associate Dean. Professor Terry’s research interests lie primarily at the intersection of medicine, law, and information technology. His recent law review publications dealing with health information privacy include “Physicians And Patients Who ‘Friend’ Or ‘Tweet’: Constructing A Legal Framework For Social Networking In A Highly Regulated Domain,” http://works.bepress.com/nicolas_terry/1 43 Ind. L. Rev.285-341 (2010); “Personal Health Records: Directing More Costs and Risks to Consumers?” 1 Drexel L. Rev. 216 (2009); “What’s Wrong with Health Privacy?” 5 J.Health & Bio. L. 1-32 (2009), and “Ensuring The Privacy and Confidentiality of Electronic Health Records” (with Leslie P. Francis) 2007 U. Ill. L. Rev. 681-735.
Prescriber Data Aggregation Goes Mainstream
Thanks to a recent Los Angeles Times editorial, Your Rx or your privacy, the somewhat esoteric world of prescribing data aggregation shows signs of going mainstream. If you've been following the litigation you'll know that Maine, New Hampshire and Vermont adopted laws that in various ways regulate the use or alienability of prescribing information. Data aggregators purchase the information from pharmacists, de-identify, otherwise process and aggregate it, before selling it on to pharmaceutical manufacturers who use it to tune their detailers' interactions with physicians. The three statutes are not identical, varying in details such as whether physician consent to data collection uses an opt-in or opt-out model.
in 2008 in IMS Health Inc. v. Ayotte, 550 F.3d 42 (1st Cir. 2008), the First Circuit upheld the New Hampshire statute. The Supreme Court showed a lack of interest and denied cert. Two years later in August 2010 a different panel of the First Circuit upheld the Maine statute, IMS Health Inc. v. Mills, 616 F.3d 7 (1st Cir. 2010). Both opinions rotated around finding that the statutes prohibited certain conduct and so did not implicate protected speech. In November 2010 the Second Circuit in IMS Health Inc. v. Sorrell, 2010 WL 4723183 (2nd Cir. 2010) disagreed, applied a commercial speech analysis, and held that the Vermont statute failed to survive intermediate scrutiny, notwithstanding a Physicians Amicus Brief submitted in the Second Circuit case and written by Kevin Outterson, Christopher Robertson, and fellow blogger David Orentlicher (available on SSRN).
Given the industry interests involved and the new circuit split it was no great surprise when the Supreme Court granted cert. (Sorrell v. IMS Health Inc., U.S., January 7, 2011). But, Supreme Court interest notwithstanding, is this brouhaha anything more than a somewhat esoteric objection to drug detailing by a few New England doctors or a mainstream privacy issue? The Los Angeles Times thinks the latter. Two classic privacy arguments seem to inform that opinion. First, there is the question of proportionality limits on data collection; these records are collected to further law enforcement interests. The use of such data should be limited to that stated purpose. Second, the specter of re-identification hangs over this data. Patient information may be removed but how close to what would be protected health information (if held by a covered entity) does this data get after its processing by sophisticated data aggregators? Nic Terry.
And the score is 2-2…
I suspect that many of you view the district court opinions alternatively upholding or striking down the Affordable Care Act to be similar to the hockey season; of only passing interest until the playoffs begin in the Supreme Court in a couple of years. However, the regular season games continue to be played, albeit without too many surprises. Today, the cumulative score reached 2-2 with Judge Roger Vinson's ruling in Florida v. HHS, No. 10-91 (N.D. Fla., Jan. 31, 2011) (available here) striking down the individual mandate (and in the absence of a severability clause, everything else).
Arguably, the stakes were a little higher in this latest case, with the plaintiffs including the governors of twenty-six states. Certainly the volume of words has increased with the latest opinion clocking in at 78 pages. And, in between deference to Hamilton and Madison some of those words do give one pause; for example the Judge's statement "At a time when there is virtually unanimous agreement that health care reform is needed in this country, it is hard to invalidate and strike down a statute titled 'The Patient Protection and Affordable Care Act.'"
If you are of a mind to wait for the playoffs but want to expose your students to the issues I recommend a couple of pieces; our friends from BU have published the pithily titled "Can Congress Make You Buy Broccoli? And Why That’s a Hard Question" in the New England Journal and Mark Hall recently posted "Commerce Clause Challenges to Health Care Reform" on SSRN. Nic Terry.