HealthLawProf Blog

Worth Reading This Week

Diana Winters, Not Sick Yet: Food-Safety-Impact Litigation and Barriers to Justiciability, SSRN/Brooklyn L.Rev.

Mark Rothstein, Access to Sensitive Information in Segmented Electronic Health Records, SSRN/JLME 

David A. Asch et al, Automated Hovering in Health Care — Watching Over the 5000 Hours, NEJM

Michael Frakes, Does Medical Malpractice Deter? The Impact of Tort Reforms and Malpractice Standard Reforms on Healthcare Quality, SSRN

[NPT]

 

A Walk on the Scary Side

    I said last week that I would use these posts to think out-loud about how I would teach ACA this coming year.  I'm pretty sure the students will be very interested.  The Kaiser Family Foundation reports that 6 out of 10 Americans[and I'll bet 10 out of 10 law students] are aware of the Supreme Court’s decision  upholding the constitutionality of the Affordable Care Act (ACA) and that “Overall, eight in ten Democrats approve of the court’s decision to uphold the primary provisions of the health care law, while eight in ten Republicans disapprove.”    That’s a big difference and I’m curious to learn more about what is driving this continued division.  

   I live in far West Texas where ACA is viewed with apprehension and concern. Like all of us on Health Law Professor Blog, I  spent a lot of time last week talking to the media, and one of the most fun experiences was when I found myself on our local Fox news channel both on TV and on drive-time Radio.  The Fox station here is excellent and thoughtful, so I thought I’d go to Fox News’ national home page and see what kind of information Republicans were getting. According to the Pew Research Center bi-annual media consumption poll, “Four-in-ten Republicans (40%) now say they regularly watch Fox News”

Here’s the headline from Fox: “Five major ObamaCare taxes that will hit your wallet in 2013”  by John Klatch.  So which of their reporters is John Kartch?  Well, he’s not exactly a reporter.  He’s executive director of Americans for Tax Reform, Grover Norquist’s organization.    You remember from the primaries—they are the ones that ask all candidates to sign “The Pledge” that they will vote against all new taxes.    I had, apparently, stumbled onto the “opinion” section.  Ok, what are these five taxes—how is ACA going to increase the amount I pay for health-care?   Apparently a lot!

You can follow the link to see all five, but here’s his take on the new $2,500 annual cap on Flexible Spending Accounts (which are a way of putting aside pre-tax money to pay for medical expenses).    Pointing out that $2500 is far less than major expenses like braces for a child’s teeth he writes:

 “This cruel tax provision will limit the options available to such families, all so that the federal government can squeeze an additional $13 billion out of taxpayer pockets over the next ten years. The targeting of FSAs by President Obama and congressional Democrats is no accident. The progressive left has never been fond of the consumer-driven accounts, which serve as a small roadblock in their long-term drive for a one-size-fits-all government health care bureaucracy.”

After explaining this and four others, including the increase in capital gains tax which I hadn’t realized would be a consequence of ACA,  he sums up “as you can understand, there is a reason why the authors of ObamaCare wrote the law in such a way that the most brutal tax increases take effect conveniently after the 2012 election.  It’s the same reason President Obama, congressional Democrats, and the mainstream media conveniently neglect to mention these taxes and prefer that you simply “move on” after the Supreme Court ruling.” Scary. 

Conclusions?  Let’s not forget in our professional excitement about ACA’s passage that many Americans are hearing a lot of scary information and are braced for worst yet to come.  It behooves us as professors teaching students from many different backgrounds who come to us with world views perhaps different from our own to be aware of what kind of information very widely read and respected media sources are presenting to their audience.

JSB

 

The ACA’s Human Impact

As scholars work through the details of the Health Care Cases, I hope we don’t miss the monumental importance of the survival of the ACA to ordinary people. For example, during this discussion, a pediatric occupational therapist named Frances called in. She spends her life providing care to kids, but without the ACA, she could not afford to have her retinal melanoma monitored. She says, “the private sector won’t touch me with a ten foot pole,” “every day I fear this thing will start growing,” and then breaks down crying as she says, “I see this ruling as hope, that, every day I can see the kids” (that she treats).

The host then turned to a scholar in health care policy at the American Enterprise Institute, who said, among other things, “we should get away from a specific individual” situation when discussing the law. I imagine the same, repeated response, to any story about crises averted by the 30 million or so people who will gain insurance coverage under the ACA. The next caller, Tom, talked about paying $1400 a month for insurance, pre-Obamacare, getting dropped by his insurer, being a “walking dead man,” and then getting a $297 a month plan under provisions of the ACA. His verdict: “The program saved my life, those five justices saved my life.” The host mercifully spared the AEI scholar from having to respond.

When historians look back at the media circus around this case, perhaps the most shocking thing to them will be how a country could be dragooned into endless discussions of broccoli purchase mandates, crowding out the stories of people like Frances and Tom. No doubt many of the celebrities who orchestrated the discussion have never been without insurance, and can barely imagine what it would be like to lack it. Kudos to WBUR’s On Point for featuring the voices of people who know all too well.

The suffering and the desperation are real, but far too many people don’t speak up.  Thank goodness for the mother of Deamonte Diver, who did: 

In 2007, Maryland’s Medicaid dental-care program came under fire after a Prince George’s County boy died from an untreated tooth infection that spread lethal bacteria to his brain. Five years later, the same system that failed 12-year-old Deamonte Driver is now touted as one of the best in the nation, officials said Wednesday at a children’s dental care panel on Capitol Hill.

Health-care representatives from across the country addressed the state of children’s dental care at the event hosted by Pew’s Children’s Dental Care campaign. Maryland’s efforts at reform, spurred in large part by Deamonte’s death, received top marks in a 2011 Pew Charitable Trusts report released in May.

Change is possible, when those who are treated worst by the current system speak up. [FP]

Bad Medicaid facts make bad spending precedent

Cross-posted at Concurring Opinions:

The Healthcare Cases contain a major factual fallacy that Medicaid is somehow now two programs, old Medicaid and new Medicaid.  Dismayingly, Chief Justice Roberts persuaded Justices Breyer and Kagan to sign on to this ridiculous description of Medicaid.  And the dissent bought it too.  As I’ve said before, healthcare is an imperfect vehicle for constitutional change.  Here’s why that description is both wrong and potentially dangerous.

The Roberts plurality on Medicaid and the joint dissent both describe Medicaid as if it had been structured to cover certain categories of the poor as a way to protect states.  History tells us this characterization is quite far from the truth.  As I have described elsewhere, in 1965, Medicaid was limited to covering the unfortunately named “deserving poor” because the states had only provided benefits to the deserving poor.  That “choice” was not really a choice at all, but rather the result of path dependence on the part of both the states and the federal government.  Prior to the New Deal, states were responsible for welfare-type programs, and welfare programs only extended help to certain poor who were deemed blameless in their poverty.  This notion of blamelessness was a direct descendent of the Elizabethan Poor Laws, which found certain poor liable for their poverty and allowed assistance for only certain “deserving poor” – and those poor happened to be widows, orphans, disabled, and elderly.  Sound familiar?  It should, as these are essentially the same categories that were covered in 1965, when Kerr-Mills became Medicaid, a more centralized and clearly federal program. 

Since 1965, the federal government has slowly added to Medicaid eligibility, thereby also slowly eroding some of the old notions regarding the deserving poor.  And, the states have always had the option of extending Medicaid to poor beyond the old categories, an option that every state has exercised to some degree.  For example, all states provide some coverage to parents of needy children, not just pregnant women, and some states have covered childless, non-disabled adults under age 65.  Thus, extending eligibility and eliminating the categorical characterizations of eligibility is not unprecedented.  And again, that distinction lies in biases about who should receive governmental assistance that date to the colonial period, not a deliberate choice to protect states.  [more after the jump] 

So, the Medicaid expansion is not “new” Medicaid or “Medicaid 2.0″.  It is a modernization of the Medicaid program that should have occurred years ago, with or without the expansion of health insurance to all Americans.  (By the way, the essential health benefits package is also not new, it was introduced as an element of flexibility for states in the Deficit Reduction Act of 2005.  Ironic that the states now point to it as coercion, when it was originally written to benefit them and provide them more flexibility.)

This characterization of “new Medicaid” is dangerous because it essentially tells the federal government that it cannot set the parameters of its conditional funding programs.  The federal government has always created the baselines of Medicaid, one of which is eligibility, allowing states flexibility to increase coverage but never decrease it.  The Roberts plurality seems to miss that eligibility for a federal program is a key element of “preserv[ing] control over the use of federal funds.” [slip at 49]  If eligibility for federal funding is beyond the federal government’s control, then this case truly does open the floodgates for coercion litigation.  This will be another National League of Cities v. Usery, or New York v. U.S., or Lopez… pick your judicially-enforced federalism precedent. 

 The danger is not only that such a flood may affect wide-ranging cooperative federalism programs such as education, welfare, environmental protection, and highway infrastructure, but also that we still don’t know what coercion is.  The Roberts plurality refused to define it, and the joint dissent did too, providing nomenclature - the “anti-coercion rule” – but not articulating any kind of test.  [slip at 37]  The dissent’s formula was simply: “if States really have no choice other than to accept the package, the offer is coercive, and the conditions cannot be sustained under the spending power.”  [slip at 35]  We hear echoes of Justice Stewart’s famous “I know it when I see it” line (and we know how clearly the Court has resolved obscenity cases).  Perhaps the dissent acknowledged the ambiguity in its invitation for coercion litigation by stating (at least twice) that determining the difference between influence and coercion is “difficult.” 

So, the bad facts leave us with a deeply undertheorized expansion of the coercion concept.  Despite the lack of a rule, let alone a viable theory, coercion litigation is sure to follow this decision.

[NH]

 

ACA Slide Deck

If you are starting to think about your ACA slides for the Fall semester Renée Landers has a nice graphic illustrating the SCOTUS votes, available here (not all subsriptions may include media). [NPT]

Call For Papers: Journal of Law and Health’s Annual Symposium: The Legal and Ethical Implications of Posthumous Reproduction

Dear Colleagues:

You are invited to submit an Article for possible inclusion in Journal of Law and Health’s Annual Symposium: The Legal and Ethical Implications of Posthumous Reproduction. The Journal of Law and Health is a student-run publication dedicated to publishing innovative articles that offer diverse perspectives on the intersection between law, health and medicine.

The selection of the Symposium topic was a result of the recent Supreme Court decision in Astrue v. Capato, 132 S. Ct. 995 (2012). In that case, the Supreme Court held that children conceived through in vitro fertilization after the death of a parent were not automatically entitled to survivor benefits under the Social Security law. The Court stated that the children’s eligibility to receive the benefits depended upon their ability to inheritance under the state’s intestacy system. The facts of the Astrue case indicate just one of the legal consequences of posthumous reproduction.  The Symposium aims to give judges, legislators, and academics the opportunity to present research that highlights the legal and ethical issues that may occur because of the availability of posthumous reproduction.

If you are interested in presenting at the Symposium, please submit a 600-word abstract describing your topic and a copy of your curriculum vitae by October 1, 2012 to Journal of Law and Health at health.journal@law.csuohio.edu. Please include “Submission: Annual Symposium” in the subject line. Persons selected to participate in the Symposium will be notified by Friday November 16, 2012. The First Annual Journal of Law and Health Symposium will be held in March 2013. Please see the enclosed sheet for important dates and other information. 

Thank you greatly for your time, effort, and interest. If you have any additional questions, please feel free to contact Sasha Swoveland at sasha.swoveland@law.csuohio.edu. Please feel free to pass along this information to colleagues that you think would be interested.

Respectfully,

Trent Stechschulte
Editor-in-Chief, Journal of Law and Health

Journal of Law and Health
Cleveland-Marshall College of Law
2121 Euclid Avenue LB 138
Cleveland, Ohio 44115-2214
health.journal@law.csuohio.edu

 Important Dates

Abstract and CV deadline:  October 1, 2012
 * Abstracts should be no longer than 600 words.

Offer Date deadline:   November 16, 2012
* The Journal of Law and Health will contact by this date, if it is interested in publishing your paper.

Symposium Presentation:   March 2013
* As part of the publication, every author is required to present at the Annual Journal of Law and Health Symposium. The Journal will be able to reimburse/ pay for travel expenses of speakers. Please contact Sasha Swoveland, if you have any further questions regarding the symposium.

Final Version deadline:   August 1, 2013
* Your final draft of the paper is due on this date. Once papers are collected, the Journal will begin its editing process.

Important Contact Information

Editor-in-Chief:  Trent Stechschulte   419.236.5310
Senior Editor:  Sasha Swoveland   330.232.4946  
Submissions:   http://law.bepress.com/expresso/

 

Health Law Program Updates: The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics

Health Law Prof Blog is starting a new feature to keep readers updated on some of the many changes in health law degree and certificate programs across the country over the past year or so. If you have health law degree or certificate program updates, please send them to me, Katharine Van Tassel at vantassel@comcast.net or, after July 30, at vantassel@uakron.edu and I will post them for you.

Here is the next Program Update in our series: 

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, co-directed by Professors I. Glenn Cohen and Benjamin Roin, is entering its 8th year this fall. The Center was founded in 2005 as an interdisciplinary program intended to respond to the need for leading legal scholarship in these fields. Today, we advance this mission through our faculty and fellows’ academic publications and commentary; course offerings intended to train the next generation of practitioners and scholars; and conferences, panel discussions, and lectures on current issues at the intersection of law and medicine. 

The Center has four main areas of activity. First, we  run a two-year academic fellowship program, which is mostly geared toward preparing aspiring law professors for the market, as well as a student fellowship for Harvard graduate students interested in pursuing their own independent scholarship.  Our Academic Fellows have enjoyed great success, placing in tenure-track positions at top schools including Harvard, UC Berkeley, BU, UCLA, Cornell, and the University of Arizona.  

Second, we host extensive programming each year, ranging from lunchtime panels to a major annual conference. This past year's events had a heavy focus on health care reform, but also brought together academics, policymakers, practitioners, students, and the public to discuss reproductive ethics, family law, and the first major attempt to revise the regulations governing human subjects research in over two decades.  

Third, our faculty affiliates and fellows offer courses in a range of areas broadly falling under the health law heading, including a yearly workshop in health law and policy.  This public workshop has become a premier venue for leading scholars in health law, biotechnology, and bioethics to launch, discuss, and improve their newest ideas with comments from students, faculty, and other  ttendees.   

Fourth, and finally, we support the scholarship of our prolific affiliated faculty. 

This summer, we welcomed a new Executive Director, Holly Fernandez Lynch, who will help the Center expand into its next phase of development, which will likely introduce new opportunities for students, a revamped and resource-heavy website for those interested in our fields, experimentation with different fellowship models and Center projects, and more programming.  On that front, we're planning a number of events for the upcoming academic year, including a major symposium on Institutional Financial Conflicts of Interest in Research Universities to be held November 2, 2012.  The world-class speaker list includes Francis Collins, Ezekiel Emanuel, Derek Bok, and many more.   

To keep up with what's happening at the Petrie-Flom Center, you can sign up for updates though our email list serve.  You can also find out more about what we've been up to in our newsletter, The Petrie Dish.  If you'll be in Cambridge, please let us know - we'd love to see you at one of our workshops or other events.  And we're always eager to pursue collaborations with other centers and institutions that have related missions to our own.  Be in touch!

[KVT] 

Call for Nominations ~ Foundations of Health Law

The American Society of Law, Medicine & Ethics
 &
 The Section of Law, Medicine & Health Care, AALS
 &
 The American Health Lawyers Association

Seek nominations of foundational works of scholarship in health law, very broadly defined, published in English before December 31, 2010.  

We intend to publish an edited volume in an academic press.

Nominations must be accompanied by a brief description, not to exceed 300 words, of the importance of the scholarly work, addressed to:

Ted Hutchinson, Executive Director
American Society of Law, Medicine & Ethics
765 Commonwealth Avenue
Boston, MA  02445
thutchinson@aslme.org

The first round of nominations will close on December 31, 2012.

On behalf of the sponsors:

Kevin Outterson, Boston University School of Law, mko@bu.edu        

I. Glenn Cohen, Harvard Law School, igcohen@law.harvard.edu  

Introducing the Fourth of the Four New Members of the HealthLawProf Regular Blogging Team - Porfessor Leslie P. Francis

The HealthLawProf Blog is very pleased to introduce the third of the four new members of our regular blogging team here at the HealthLawProf Blog, Professor Leslie P. Francis. Here is her bio and read more here:

Leslie P. Francis is Distinguished Professor of Law and Philosophy and Alfred C. Emery Professor of Law at the University of Utah.  At  Utah, she also holds adjunct appointments in the Division of Medical Ethics in the Department of Internal Medicine, in the Public Health program in the Department of Family Medicine, and in the Political Science Department.  Francis received her Ph.D. in Philosophy from the University of Michigan in 1974 and her J.D from the University of Utah in 1981.  She was a law clerk to Judge Abner Mikva of the United States Court of Appeals for the District of Columbia Circuit in 1981-82.

Professor Francis specializes in Ethics, Bioethics, Philosophy of Law, Health Law, and Disability Law.  At present, she is leading the College of Law’s efforts to develop the Biolaw Project. Francis’s most recent books are The Patient as Victim and Vector: Ethics and Infectious Disease (with Margaret Battin, Jay Jacobson, and Charles Smith; Oxford University Press 2009); and the Blackwell Guide to Medical Ethics (edited with Rosamond Rhodes and Anita Silvers; Blackwell’s 2006). She also has edited (with Anita Silvers), Americans With Disabilities: Implications of the Law for Individuals and Institutions (Routledge, 2000).  Articles published within the past year deal with topics such as syndromic surveillance, patient trust and electronic medical records, race and genetic discrimination, disability discrimination and access to health care, the intersection between disability discrimination and discrimination based on aged-ness, and federalism and the recognition of new legal rights. She is currently a member of the American Law Institute (elected 1986), the ethics committee of the American Society for Reproductive Medicine, and the National Committee on Health and Vital Statistics where she serves as cochair of the committee on Security, Privacy, and Confidentiality. In the spring of 2000, she was awarded the University of Utah’s Rosenblatt Prize for overall excellence in research, teaching, and academic service.

[KVT]

Reflections on the 4th of July

According to the American Pyrotechnics Association, the use of fireworks in the US has increased ten-fold over the past 25 years, reaching over 250 million pounds. At the same time, injury rates per pound have fallen approximately ten-fold as well.  Nonetheless, because of the immense increase in consumption, overall costs of fireworks injuries have continued to rise, to well over $100 million. And that doesn't count property damage, wildfire risks, or just plain air pollution.  The most typical victim is a male, age 10-14.

So, in posting on this 4th of July, I am tempted to reflect whether a ban on the sale of fireworks for private use would be an intolerable infringement on liberty.  It wouldn't be a tax, and it wouldn't be like forbidding sin or making you eat your broccoli.  But it would restrict a liberty that might well be regarded as one of the most traditional, a liberty even celebrated in our national anthem.  One can imagine howls of protest about a ban being unAmerican, another example of government trying to tell ordinary people how to live their lives.

Interestingly, this is not the reported public reaction to the many local bans being imposed in my state of Utah.  People are said to understand the need for bans and even cancellations of public fireworks displays, not to protect them or their children from themselves, but because of the serious fire dangers they pose. At the state level, Utah's governor is even entertaining the possibility of a ban on target practice, because of the risks of sparks causing fire dangers. This in a state with remarkably permissive concealed carry laws—the only statutory restrictions are airports and federal buildings—which even allow people to carry loaded weapons into schools and hospitals.

All this suggests to me that the rhetoric supporting universal health care in the United States may be seriously misconceived.  Suppose that instead all the focus on the need of individuals for insurance or the importance of encouraging healthy behaviors, we started instead with public dangers: infectious disease, toxic exposures, unhealthy air.  In other words, suppose we started health reform as the "old" public health, in a really serious way, with sufficient funding and ready availability.  We might just get used to seeing what governments can do for us all--something at least in my judgment we are very much in need of today.

Happy Fourth of July everyone!

- Leslie P. Francis

Are States Really Prepared for the Consequences of Refusing the Medicaid Expansion Money?

The ink is barely dry on the Supreme Court's Affordable Care Act decision, but at least 8 states have already raised questions about whether they will implement the now-optional expansion of Medicaid to childless adults under 133% of the federal poverty level, according to the American Health Lawyers Health Law Health and Life Sciences Law Daily. The governors of Missouri, Mississippi, Nebraska, Alaska, Georgia, Michigan, Florida, Louisiana, and Texas have all either said categorically that they will not implement the expansion, or that they are seriously studying whether or not to do so. All of them cite the costs of the expansion on their hard-pressed state treasuries as the reason for not implementing it, even though the states will pay only a small fraction of the overall costs of the expansion. Apparently, they view the Medicaid expansion as a sort of fiscal Trojan horse; it looks good on the outside, but once it gets in the gates, it will destroy the state treasury. Will these states really have the political will to refuse to take a large amount of federal money to help some of their poorest citizens? The poor are undoubtedly going to get sick and need care regardless of whether the states take the money or not. Who is bearing these costs now, if not the state-run or subsidized safety-net hospitals, or the other citizens of these states, through increased insurance premiums and state taxes? Or perhaps it is the employers of the working poor, who pay the price in lost productivity and absenteeism due to untreated employee illnesses? And how will people in non-expansion states feel about their federal tax money being redistributed to pay for health care for the citizens of the states that do expand their Medicaid programs? I hope that the political leaders of the "no-expansion" states review these costs and the real consequences of refusing the expansion carefully before making this decision, rather than just reacting in a knee-jerk fashion to the politics of the day.

Medical Device Manufacturers and Taxes

With regard to the costs of the ACA, National Public Radio ran an interesting story yesterday about the differing views of the effect that the new 2.3% excise tax on the sale of medical devices will have on the industry. A medical device manufacturer in the Boston area claimed that 70% of medical device manufacturers are not yet profitable, and that this will hurt innovation in the industry. An economist from a left-leaning think tank countered that the costs of the tax will merely be passed on to purchasers, such as hospitals and group purchasing organizations. Either way, consumers will lose, because those costs will be passed on in some fashion to the end-user, either through increased premiums or out-of-pocket costs. This is one of the major flaws in the ACA, it doesn't do enough to hold down the costs of care, and this could ultimately turn out to be its downfall.

Big Pharma and the Largest Health Care Fraud Settlement in U.S. History

The ACA also imposes hefty fees on the pharmaceutical manufacturing sector, of between $2.8 and $4.1 billion per year. However, big pharma has not been nearly as vociferous about the effect of these fees on its business as the medical device industry has been. And a news flash from yesterday may illustrate why--according to BNA's Health Care Fraud Report, GlaxoSmithKline just agreed to pay a $3 billion fine for misbranding, paying kickbacks, and improper marketing for a number of its most popular drugs, including Paxil, Avandia, and Wellbutrin. This is the largest health-care fraud settlement in U.S. history. Makes complaints about $2.8 in fees for the whole industry seem trite, don't you think?

- Vickie Williams

Invitation to Sixth Annual IP Scholars Forum on the Impact of IP on Public Health

INVITATION TO SIXTH ANNUAL IP SCHOLARS FORUM
June 13, 2012

Dear Professor:

You are cordially invited to the Sixth Annual IP Scholars Forum, sponsored by the University of Akron School of Law’s Center for Intellectual Property & Technology, which will be held at the law school on Friday, October 26, 2012, from 9:00 AM – 2:00 PM.

The Forum’s purpose is to bring together a small group of prominent scholars for intensive, high-level discussions on cutting-edge issues of common interest. This year’s Forum will discuss “The Impact of IP on Public Health.”

This topic will celebrate the arrival of a new member of our faculty, Katharine Van Tassel, who comes to us from Western New England College of Law and St. Thomas University School of Law in Florida.  She has extensive experience in health law issues and serves as the editor of the Health Law Prof Blog. Professor Jay Dratler, Jr., although retired, will moderate the Forum with her help.

Because our topic this year is interdisciplinary, we have invited a number of noted health law scholars individually.  So far, the following professors have accepted our invitation:

• Frank Pasquale (Seton Hall University School of Law), Schering-Plough Professor in Health Care Regulation and Enforcement and an executive member of the AALS section on Law, Medicine, and Health Care.  Professor Pasquale has written many articles on health law and IP and is a frequent blogger on  Concurring Opinions, Madisonian.net, and HealthLawProf Blog.  His “short admission paper” (see below) will be entitled “The Emerging Intellectual Property Law of Health Data.”  It will focus on the barriers to health-data transparency that IP creates, and how regulation and incentives can break them down.

• Andrew Torrance (University of Kansas School of Law), former chair of the AALS Biolaw Section, founder of the Lexvivo blog, and co-founder of the Biolaw blog.  Professor Torrance has spoken and written often on biotechnology and intellectual property.  His short paper will be entitled “Nothing under the Sun that is Made of Man.”  It will focus on the  Supreme Court’s recent Prometheus decision and the patentability of genetic sequences, body fluids, body parts, and research and diagnostic methods that use them.

• Jim Chen (University of Louisville – Louis D. Brandeis School of Law), former dean of the Louis D. Brandeis School of Law, founder of the Jurisdynamics Network, and frequent blogger at the Biolaw blog.  Professor Chen is an expert on law, economics, and regulatory policy.  His short paper will address the intersection of IP with biodiversity and traditional knowledge.

As these examples show, the scope of discussion at this Forum can be quite broad.  Other possible topics include: the relationship between biodiversity and pharmaceutical research, compulsory licensing of pharmaceuticals, incentivizing R&D for “orphan drugs” and neglected diseases, open science, international exhaustion for pharmaceuticals, the national-emergency and other exceptions to patent enforcement, reverse payment settlements in pharmaceutical litigation, the newly passed gag laws in Pennsylvania, Colorado and Texas restricting doctors’ use of data on gas “fracking” chemicals, and the recently-introduced S. 1138, which would replace patents on HIV/AIDS treatments with prizes.

As usual, the only admission price is a short paper (10-15 pages, with minimal footnotes) on some aspect of the Forum topic.  If you attend, you should distribute your paper by e-mail about a month prior to the Forum.  Papers will not be formally presented at the Forum.  Instead, we will engage in free-flowing discussion based on the Forum topic and the papers submitted.  For those who would like to do so, we will arrange for papers to be published in symposium format in our Akron IP Journal.
If you wish, you may write on one of the topics addressed by our distinguished individual invitees.  Overlapping papers on the same subject may help provoke active discussion.  But if you wish to do so, we encourage you make personal contact and avoid complete overlap.

One other thing is new this year.  We are planning to publish a summary of our discussion, both online and in print, as a “White Paper.”  Our own Professor Ryan Vacca has volunteered to serve as the first reporter and to prepare a draft for circulation and review.  We expect this online summary to appear no later than sixty days after the Forum and to be printed in the spring issue of the Akron IP Journal.
As usual, we are unable to pay travel expenses.  However, we will provide a reception and dinner on the evening before the Forum and a light breakfast and lunch on the day of the Forum.

Following the Forum, at 3:00 PM, Professors Pasquale, Torrance, and Chen will offer a panel discussion to a much larger audience.  Invitees will include faculty from regional academic institutions, public-health community leaders, and lawyers and business people interested in health care and related innovation. Your attendance at this panel discussion will, of course, be most welcomed, and we hope you will contribute to this more public discussion.

If you choose to join us, we can arrange housing at a unique on-campus hotel made from old oat silos, which the University has acquired.  If you wish, we can also arrange recreational activities in the area, with such attractions as the Cuyahoga Valley National Park, the Cleveland Orchestra, or the Football or Rock & Roll Hall of Fame.  Although Northeast Ohio never provides a guarantee, we often have crisp, clear and bracing fall weather at that time of year.

As noted above, the Forum and the subsequent panel discussion will both be held on Friday, October 26, 2012, and an informal collegial dinner will be held the previous evening.  Attendance will be limited to permit intimate discussion, so please respond soon.  You may r.s.v.p. to Shannon Aupperle, at sfauppe@uakron.edu.

Sincerely,

Jeffrey M. Samuels
David L. Brennan Professor of Law
and Director, Center of Intellectual
Property Law and Technology

Jay Dratler, Jr.
Goodyear Professor Intellectual Property, Emeritus
 
Katharine Van Tassel
Professor of Law
 
A. Samuel Oddi
Giles Sutherland Rich Professor
in Intellectual Property
 
Ryan Vacca
Assistant Professor of Law
 
Robert C. Kahrl
Distinguished Practitioner-in-Residence

 

 

Harmonizing the ACA with State Tort and Licensure Systems and Hospital Peer Review

The Supreme Court’s decision affirming the constitutionality of most of the Patient Protection and Affordable Care Act of 2010 (“ACA”) is likely to have a profound impact on health care quality, cost and access. This decision allows the country to move forward with ACA programs that encourage the movement from a customary-care model of medical practice to an evidence-based model. However, it appears that the three main state systems for health care quality improvement — the tort, licensure and hospital peer review systems — may stand in the way.

A large and rapidly growing group of empirical studies suggests that the current normative practice of custom-based medicine in the United States has a profoundly negative impact on the quality and cost of health care. The customary care, or eminence-based model of medical practice is based on physician preference and not on objective, scientific evidence.

These quality and cost problems with the customary-care model have triggered a new, national push to move the United States to a modern, evidence-based model of medical practice through major changes in government-provided health care, including the numerous, multi-billion dollar new programs created by the ACA, as well as changes in the VA Hospital System and Medicare.

The evidence-based model of medical practice is grounded in empirical data generated by clinical outcomes and effectiveness research which suggests the optimum treatment for a rapidly growing number of clinical conditions. This use of empirical data generated through scientific methodology to make medical decisions shows great promise for enhancing quality of care while decreasing the cost of care.

Importantly, in conjunction with the American Recovery and Reinvestment Act of 2009, the ACA will be providing hundreds of millions of dollars of funding for research to develop evidence-based clinical practice guidelines that will be used to define the “best  practices” that the Act promotes. For example, under § 10303 of the ACA, these best practice will be used to create more of the same types of patient outcome measures that are already being utilized in Medicare. The ACA creates a new oversight entity, the Patient-Centered Outcomes Research (PCOR) Institute, to direct the Comparative Effectiveness Program that will create data banks comparing the effectiveness of two or more treatments. These databanks will provide much needed decision-making tools for both health care providers and consumers in light of the multiple medications and treatments that are marketed to deal with the same health condition.

Adding another layer to this push for the nation-wide adoption of evidence-based medical practice is the creation by the ACA of the Center for Quality Improvement and Patient Safety (“CQIPS”). This Center will develop tools to facilitate the adoption of best practices by health care providers. CQIPS will award grants and provide technical assistance to help providers adopt best practices. With the addition of this Center, the ACA now has a system for the development of best practices (AHRQ), a system for publicizing these best practices (PCOR) and a system for integrating these best practices (CQIPS) into the everyday practices of hospitals and physicians.

Central to the ACA are the Health Benefit Exchanges and, in keeping with ACA’s theme of improving quality and cost of care, these exchanges also work instrumentally to move the ball forward in these areas. To qualify to sell insurance to consumers through these exchanges, insurers must evaluate providers by the same quality benchmarks that are being used by CMS. As with the CMS reimbursements under Medicare, the higher the rating, the greater the private insurance reimbursement will be for health care services. Continuing the parallel, just like Medicare, the insurance companies must also publish the quality of care and patient satisfaction data that they gather.

Together, the quality improvement provisions under the ACA and CMS create a powerful regulatory engine that should work to move the United States from a system that follows the customary care model of medical care to a modern, evidence-based system of medical care.

State Quality Improvement Systems

Reflecting an understanding of the benefits of evidence-based treatment choices, a significant number of state tort systems are moving away from using customary care as the exclusive proxy for quality of care in medical malpractice actions. These tort systems are allowing the introduction of risk-benefit analysis grounded in empirical science as evidence of what is reasonable care. A recent study by Professor Michael Frakes at the Cornell University School of Law suggests that these tort systems are operating instrumentally to encourage health care professionals to transition away from custom-based to evidence-based medical practice. By virtue of applying their own state law, the state licensure systems of these states are likely to follow suit.

However, there are a significant number of state tort and licensure systems that have not adopted evidence based standards of care. If there is a conflict between customary and evidence-based care choices, physicians are likely to follow custom-based standards to avoid medical malpractice liability, in spite of the incentives contained in the ACA to change. The ACA has some provisions that may start to address the need for these states to adopt the use of evidence-based standards of care, but more is needed. One avenue is to educate state legislators and judges regarding this problem.

Unfortunately, the ACA completely ignores the third major system for improving quality of healthcare, the hospital peer review system. Private hospital peer review is a self-policing system where physicians informally evaluate each other and sanction those physicians who are allegedly failing to provide quality patient care. The majority of standards relied upon in hospital peer review are customary-care standards. A finding that a physician has violated one of these standards can mean that the physician could lose hospital staff privileges and, more importantly, be reported to the National Practitioner Data Bank. This report could mean the end of a physician’s career. Thus, it appears that hospital peer review also encourages the perpetuation of custom-based practices undermining the national efforts to improve the quality and cost of healthcare through the practice of evidence-based treatment choices.

The ACA should be revised to modify hospital peer review so that it can work in tandem with the new federal laws, as well as with state tort and licensure law, to encourage physicians to adopt the evidence-based model of medical practice in order to improve health care quality, cost and access. [Cross posted on Health Affairs]

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Guest Blogger Professor Will Huhn: How the Supreme Court Upheld the Individual Mandate: It Is and Is Not a "Tax"

In Part II of his opinion upholding the Affordable Care Act, Chief Justice Roberts concluded that the individual mandate is not a "tax" within the meaning of the federal Anti-Injunction Act. However, in Part III-C of his opinion he found that the mandate is a "tax" for purposes of the General Welfare Clause. How could he reach both of those conclusions?

The Anti-Injunction Act prohibits the courts from entertaining challenges to any tax laws until those taxes are assessed. If the AIA had applied to this case, the courts would not have able to rule on the constitutionality of the Affordable Care Act until 2014, when the law goes into effect. By ruling that the individual mandate is not a tax within the meaning of the Anti-Injunction Law Justice Roberts made it possible for the courts to rule on this issue at this time.

The General Welfare Clause of the Constitution confers upon Congress the power to tax and spend:

The Congress shall have Power to lay and collect Taxes, Duties, Imposts and Excises, to pay the Debts and provide for the common Defense and general Welfare of the United States .... (Art. I, Sec. 8, Cl. 1).  

In today's decision the Supreme Court held that the enforcement mechanism for the individual mandate is a tax within the meaning of this constitutional provision. How could the Court decide that the individual mandate is not a tax for purposes of the AIA but is a tax within the meaning of the Tax and Spending Clause of the Constitution?

This issue was raised at oral argument. As I described in an earlier post, (Solicitor General Verrilli's Argument on the Anti-Injunction Act, (March 27, 2012)), Justice Samuel Alito asked Solicitor General Robert Verrilli how the enforcement mechanism for the individual mandate could be both a tax and not a tax. General Verrilli responded that under the Constitution "the form of the words doesn't have dispositive effect on the analysis,"whereas in the interpretation of a statute "the precise choice of words does have a dispositive effect": 

JUSTICE ALITO: General Verrilli, today you are arguing that the penalty is not a tax. Tomorrow you are going to be back and you be arguing that the penalty is a tax. Has the Court ever held that something that is a tax for purposes of the taxing power under the Constitution is not a tax under the Anti-Injunction Act?

GENERAL VERRILLI: No, Justice Alito, but the Court has held in the license tax cases that something can be a constitutional exercise of the taxing power whether or not it is called a tax. And that's because the nature of the inquiry that we will conduct tomorrow is different from the nature of the inquiry that we will conduct today. Tomorrow the question is whether Congress has the authority under the taxing power to enact it and the form of words doesn't have a dispositive effect on that analysis. Today we are construing statutory text where the precise choice of words does
have a dispositive effect on the analysis. 

Taking his cue from the Solicitor General, Justice Roberts employed two altogether different modes of legal reasoning - two different sources of legal authority - in deciding these two issues. In interpreting the AIA the entire matter turned upon the intent of Congress, and Chief Justice Roberts took a very literal approach to the question of determining their intent. In the Affordable Care Act Congress called the individual mandate a "penalty" and not a "tax." The issue before the Court in Part II of his opinion was whether Congress intended to block any court challenges prior to 2014. Justice Roberts reasoned persuasively that the statutory text of the ACA revealed that Congress did not intend for the AIA to apply to the individual mandate portion of the ACA.

But when it came to determining whether or not the enforcement mechanism of the individual mandate was or was not a tax within the meaning of the Constitution, Chief Justice Roberts switched interpretive gears. Roberts stated:

It is of course true that the Act describes the payment as a “penalty,” not a “tax.” But while that label is fatal to the application of the Anti-Injunction Act, supra, at 12–13, it does not determine whether the payment may be viewed as an exercise of Congress’s taxing power. It is up to Congress whether to apply the Anti-Injunction Act to any particular statute, so it makes sense to be guided by Congress’s choice of label on that question. That choice does not, however, control whether an exaction is within Congress’s constitutional power to tax. (39) 

In his interpretation of the General Welfare Clause (or Tax and Spending Clause), the Chief Justice utilized a different interpretive approach - what he referred to as a "functional approach." (41). The Chief identified three factors that militated in favor of finding the enforcement mechanism functioned as a "tax" and not as a fine for wrongful behavior. First, the amount due for not purchasing health insurance is less than the cost of health insurance. Second, the government need not prove that the person failing to purchase health insurance had was guilty of wrongful intent, as is almost always the case with criminal laws. Third, the assessed fee was to be collected by the Internal Revenue Service, but the IRS was not permitted to impose criminal sanctions for failure to pay the fee. The Chief Justice cited precedent to support his reliance upon these three practical considerations in determining whether or not the individual mandate constitutes a tax. Justice Roberts also cited a number of examples of taxes that are intended to affect people's behavior but which are nevertheless clearly within Congress' power to enact under the General Welfare Clause: 

Some of our earliest federal taxes sought to deter the purchase of imported manufactured goods in order to foster the growth of domestic industry. See W. Brownlee, Federal Taxation in America 22 (2d ed. 2004); cf. 2 J. Story, Commentaries on the Constitution of the United States §962, p. 434 (1833) (“the taxing power is often, very often, applied for other purposes, than revenue”). Today, federal and state taxes can compose more than half the retail price of cigarettes, not just to raise more money, but to encourage people to quit smoking. And we have upheld such obviously regulatory measures as taxes on selling marijuana and sawed-off shotguns. See United States v. Sanchez, 340 U. S. 42, 44– 45 (1950); Sonzinsky v. United States, 300 U. S. 506, 513 (1937). Indeed, “[e]very tax is in some measure regulatory. (42-43)

Furthermore, the Chief Justice reasoned that the enforcement mechanism for the individual mandate does not function as a "penalty:"

In distinguishing penalties from taxes, this Court has explained that “if the concept of penalty means anything,it means punishment for an unlawful act or omission.” United States v. Reorganized CF&I Fabricators of Utah, Inc., 518 U. S. 213, 224 (1996); see also United States v. La Franca, 282 U. S. 568, 572 (1931) (“[A] penalty, as the word is here used, is an exaction imposed by statute aspunishment for an unlawful act”). While the individual mandate clearly aims to induce the purchase of health insurance, it need not be read to declare that failing to doso is unlawful. Neither the Act nor any other law attaches negative legal consequences to not buying health insurance, beyond requiring a payment to the IRS. The Government agrees with that reading, confirming that ifsomeone chooses to pay rather than obtain health insurance, they have fully complied with the law. Brief for United States 60–61; Tr. of Oral Arg. 49–50. (43) 

The Chief Justice addressed the contrary argument of the dissenters by providing an example:

The joint dissenters argue that we cannot uphold §5000A as a tax because Congress did not “frame” it as such. Post, at 17. In effect, they contend that even if the Constitution permits Congress to do exactly what we interpret this statute to do, the law must be struck down because Congress used the wrong labels. An example may help illustrate why labels should not control here. Suppose Congress enacted a statute providing that every taxpayer who owns a house without energy efficient windows must pay $50 to the IRS. The amount due is adjusted based on factors such as taxable income and joint filing status, and is paid along with the taxpayer’s income tax return. Those whose income is below the filing threshold need not pay. The required payment is not called a “tax,”a “penalty,” or anything else. No one would doubt that this law imposed a tax, and was within Congress’s power to tax. That conclusion should not change simply because Congress used the word “penalty” to describe the payment. Interpreting such a law to be a tax would hardly “[i]mpos[e] a tax through judicial legislation.” Post, at 25. Rather, it would give practical effect to the Legislature’s enactment. (39) 

In Part II of his opinion the Chief Justice was tasked with deducing the intent of Congress in the enactment of a specific statute; In Part III his job was to determine the meaning of the General Welfare Clause of the Constitution. In resolving the second question Justice Roberts found that a reasonable person could conclude that the enforcement mechanism for the individual mandate operates as a tax - a tax upon persons who do not have health insurance.

The Chief Justice stated that for constitutional purposes the label that Congress attached to the law does not matter as much as the actual effect of the law. If it looks like a tax and walks like a tax and quacks like a tax then it is a tax, and therefore Congress had the power to enact such a law under the General Welfare Clause.

Is it justified to utilize two such different analytical approaches in different portions of the same opinion? I think so. Questions of statutory interpretation are very different from questions of constitutional interpretation. In the interpretation of a statute the courts are to be guided by the intent of the legislature, and the legislature's precise words matter. Accordingly, when Congress called the enforcement mechanism for the individual mandate a "penalty" instead of a "tax" that use of language signaled their intent. The interpretation of the Constitution, by contrast, cannot be controlled by the specific terms used in a piece of legislation. The Constitution is concerned with the actual effect of a law on the lives of the citizens of this Nation. Neither Congress nor a state legislature can evade constitutional requirements through the clever use of semantics. If this were a situation where Congress called what was in effect an unlawful penalty a "tax," the Court would be justified in striking down the law. In this case, the law was declared constitutional despite the language that Congress used to describe the Act.The Chief Justice concluded this portion of his opinion with these words:

The Affordable Care Act’s requirement that certain individuals pay a financial penalty for not obtaining health insurance may reasonably be characterized as a tax. Because the Constitution permits such a tax, it is not our role to forbid it, or to pass upon its wisdom or fairness. (44)

- Will Huhn

 

Welcome to Guest Blogger Professor Wilson R. Huhn

It gives me great pleasure to introduce guest blogger Professor Wilson R. Huhn:

Wilson R. Huhn is a C. Blake McDowell, Jr., Professor and Associate Director of the Constitutional Law Center at The University of Akron School of Law. He currently teaches courses in Constitutional Law, Advanced Constitutional Law, Jurisprudence, and Commercial Paper. He received his B.A. at Yale University and J.D., cum laude, at Cornell University, where he was a member of the Cornell Law Review. Prior to joining the Akron Law faculty in 1984, Professor Huhn served as law clerk for the late Judge Leo A. Jackson in the 8th District Court of Appeals and as an associate at Squire, Sanders and Dempsey.

Professor Huhn's book "ObamaCare: Is It Necessary, What Will It Accomplish, Is It Constitutional" (Carolina Academic Press 2012) is available in electronic format for Kindle.  His book "The Five Types of Legal Argument" (Carolina Academic Press, 2002, 2008) is required reading at a number of law schools nationally.The graduating class selected Professor Huhn Outstanding Professor of the Year in 1987, 1997, 1999, 2003, 2005 and 2008, the Akron law alumni awarded him the Outstanding Publication prize in 2004 and 2006, and the law faculty named him the "Most Valuable Player" for his contributions to legal scholarship, 2001-03. Professor Huhn volunteers his time on community boards and is active organizing and coaching adaptive recreation programs for youths with special needs.

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Introducing the Third of the Four New Members of the HealthLawProf Regular Blogging Team - Professor Vickie J. Williams

The HealthLawProf Blog is very pleased to introduce the third of the four new members of our regular blogging team here at the HealthLawProf Blog, Professor Vickie J. Williams. Here is her bio and read more here:

Associate Dean for Academic Affairs and Associate Professor of Law, Gonzaga University School of Law (Assistant Professor, 2003-2008).  Adjunct lecturer, University of Washington School of Law (2000, 2003).  Teaching areas:  Health Care Law, Civil Procedure, Constitutional Law, Conflict of Laws, Federal Jurisdiction. Shareholder and associate, Bennett Bigelow & Leedom, P.S., Seattle, Washington (1995-2003). Associate, Perkins Coie, Seattle, Washington (1990-1995).  Professor Williams was a board member, Secretary/Treasurer and then President of the Washington State Society of Healthcare Attorneys from 1997 through 2004.  She is admitted to practice in the State of Washington, the Western District of Washington, the Eastern District of  Washington, and the Ninth Circuit Court of Appeals.  She is a member of the American Health Lawyers Association, the Health Law Section of Washington State Bar Association, the Washington State Society of Healthcare Attorneys.  She publishes and speaks on topics related to Health Law, Civil Procedure, Constitutional Law, and the intersection of these areas.

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ACA's Backstory

For those interested in the behind-the-scenes analysis of the Supreme Court's decision last week in NFIB v. Sibelius, some of it surprisingly revealing, see:

Jan Crawford on the switch by the Chief Justice to uphold the individual mandate, reported on Face the Nation.

Kevin Sack and Eric Lichtblau on the genesis of the attorneys general challenge to the Affordable Care Act, reported at the New York Times.

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