Happy Birthday HRW

Today marked two years for Health Reform Watch on this site, and  I just wanted to say thank you to all our readers and contributors and to The Center for Health & Pharmaceutical Law & Policy here at Seton Hall Law for making it possible. We strive to give the reader not a comprehensive view, but a series of views sprung from some of the finer legal minds this country has to offer. It seems to be working.

The health law and reform community is not an especially large population, but the ramifications of health reform (or the lack thereof) have shown themselves over the course of these last two years to be staggeringly large.  I’m pleased to say that this blog just surpassed 360,000 visits, over 275,000 since the start of 2010. But that doesn’t count the views of our numerous posts syndicated to The Health Care Blog, nor the excerpts published in the New York Times or Washington Post, etc. And as we as a country attempt to come to terms with the direction in which health care is heading, I’m pleased to say that our Guide to Accountable Care Organizations, published last March, has been linked almost everywhere and, for most days last year, and until recently (Damn, NPR), enjoyed being the  number one google search in America for  “Accountable Care Organizations.”  I’d like to think we’ve helped lead towards clarity.

The list of news organizations, blogs, think tanks, politicians and medical/legal journals which have cited HRW in these two short years is something we are very proud of (and something, upper right hand corner, which I need to update) : it means that we, from the environs of legal academia, have helped put that academic view into the popular debate in a time when to do so may be most constructive. And because a spoon full of sugar makes the medicine go down, we hope being informative has been at least somewhat entertaining.

In the year to come, we hope to continue to bring to the table the  insights of  thought leaders across the spectrum of health & pharmaceutical law & policy– and spur informed debate. Because quite simply, when it comes to health care reform

Since it costs such a lot to win, and even more to lose,
You and me bound to spend some time wonderin’ what to choose.
–J. Garcia

The Individual Mandate, a Brief History — Part I, Conservative Origins

In recent years, politicians of every stripe have eaten their words about the wisdom of requiring all Americans to possess health coverage. This hasn’t been real news since the 2007 Democratic primary debates, when candidate Obama claimed his reasons for opposing the mandate were similar to those expressed by Hillary some 15 years ago.

A few years later it was President Obama’s turn. And by 2010, the entire Republican party performed a synchronized heel-face turn, virulently opposing the solution they advocated decades earlier. All of this culminated with the recent passage of the “Repealing the Job-Killing Health Care Law Act” in the House, by which point the mandate had become a 21st century Intolerable Act.

The media have dutifully reported each foible as if such strategic backpedaling were something new under the sun. But the 22-year path to ACA § 1501(b) is a story in its own right, a sort of philosophical history of American health reform policy.

The think-tank solutions (1989 - 1992)

Back in the late 1980s, the individual mandate wasn’t controversial at all–just another idea being kicked around in conservative think tanks. Although economist Mark V. Pauly, an adviser to the first Bush administration, is often cited as the mandate’s creator, conservative thinkers Stuart M. Butler and Edmund F. Haislmaier were dreaming up similar proposals at the Heritage Foundation as early as 1989.

While Democrats debated the choice between employer mandates and single-payer, Pauly and other conservatives looked for market-based remedies to what all agreed was a national “health care crisis.”  The problem with the health insurance market was that it operated more or less like normal accident insurance. As Butler once framed it:

If a young man wrecks his Porsche and has not had the foresight to obtain insurance . . . society feels no obligation to repair his car. But health care is different. If a man is struck down by a heart attack in the street, Americans will care for him whether or not he has insurance. If we find that he has spent his money on other things rather than insurance, we may be angry but we will not deny him services . . . .

A mandate on individuals recognizes this implicit contract. . . . [E]ach household has the obligation, to the extent it is able, to avoid placing demands on society by protecting itself.^[1]

Like the ACA, Butler’s proposed mandate operated through the tax code, using tax credits to make individual insurance more affordable for those who needed the help. Butler’s idea was to replace the tax exclusion for “company-based” plans with above-the-line tax credits: Butler’s plan gave a 20% tax credit to anyone with a health plan meeting basic coverage requirements, along with a “steeply rising” credit for out-of-pocket expenses in relation to household income.^[2]

Later versions of the Heritage plan went further and actively discouraged employer-run plans by turning them into normal health plans, subject to the same proposed federal requirements–including the requirement to accept any applicant, employee or not.^[3] Butler disliked the income exclusion because it was, first of all, unfair to those who had to purchase their own plans; the exclusion also perpetuated what he felt was an arbitrary emphasis on health insurance as an employment benefit. So long as insurers could deny applicants with preexisting conditions, the employer-centric status quo also discouraged workers from switching jobs–a concern eventually answered by HIPAA in 1996.

Butler predicted that people would gradually leave their employer plans for small groups, such as union-administered plans, Farm Bureau plans, and local HMOs. The small groups, bolstered by the formerly uninsured now required by law to join, would gain bargaining power with size. The higher premiums of those with preexisting conditions were answered with larger tax credits and state-operated subsidized high-risk pools, while low risk individuals enjoyed the benefits of fierce competition between plans intended for their lucrative demographic.^[4]

Mark Pauly’s individual mandate operated much like the Heritage plan’s, but served a slightly different reform scheme. Pauly, too, would cease exempting the value of employer-provided health benefits from taxable income, although self-insured employers could otherwise continue to operate much as they do now. There were other differences, such as the Pauly plan’s less generous tax credit system; but the individual mandate played essentially the same market-stuffing role in both proposals.^[5]

The primary difference between these conservative think tank mandates and the ACA is how they are enforced. Under the Pauly and Heritage proposals, you simply would possess whatever minimum coverage the federal government required. The 1992 version tasked state programs with randomly assigning the voluntarily uninsured to existing plans.^[6] This is considerably more invasive than the ACA:  following the lapse of the three-month grace period, failure to comply with the mandate results in a “personal responsibility payment,” but no actual health coverage.

In 2011, the Pauly and Heritage plans seem surprisingly bold. Such an abrupt shift from the employer-provided model would likely have been more difficult and costly than either Heritage or Pauly let on. For example, the CBO predicted doing so would slow future wage growth for many workers.^[7] But, at least in theory, the shift would benefit many low-income households, which would receive the same insurance tax credit everyone else did. And for the young invincibles, the proposed out-of-pocket deductions would make the lower-premium, higher out-of-pocket plans less risky.

These proposals met with few questions about government power, federalism, or individual liberties. Years later, Heritage scholar Robert E. Moffitt hammered libertarian critics for ignoring the disastrous economic effects of “free riders” on responsible citizens by focusing on “metaphysical abstractions.”

“An individual mandate for insurance, then, is not simply to assure other people protection from the ravages of a serious illness, however socially desirable that may be; it is also to protect ourselves. Such self protection is justified within the context of individual freedom; the precedent for this view can be traced to none other than John Stuart Mill. It does not necessarily follow, however, that we would have a right to prescribe anything beyond our own self-protection.”^[8]

Still, any legislation adopting the think tank mandates would need to smooth out their harsher aspects-e.g., they’d need exclusions for religious objectors and extreme hardships. But these proposals were realistic, enforceable, and rooted in a genuinely conservative emphasis on personal responsibility.

---

^[1] Start M. Butler, Assuring Affordable Health Care for All Americans, Heritage Lectures 218, p. 8(1989).

^[2] Butler, supra, at 4, 6.

^[3] A Qualitative Analysis of the Heritage Foundation and Pauly Group Proposals to Restructure the Health Insurance System (”CBO Analysis”), CBO Memorandum, p. 4 (April 1994) (available online at http://www.cbo.gov/ftpdocs/48xx/doc4896/doc23.pdf).

^[4] Butler, supra, at 5-7.

^[5] CBO Analysis, supra, at 17-23.

^[6] Stuart M. Butler, A Policy Maker’s Guide to the Health Care Crisis Part II: The Heritage Consumer Plan (”Guide Part II”), Heritage Talking Points, p. 12 (1992) (available online at http://s3.amazonaws.com/thf_media/1992/pdf/APolicyMakers%20GuidetoTheHealthCareCrisisPart2-S%20Butler.pdf).

^[7] CBO Analysis, supra, at 22.

^[8] Robert E. Moffit, Perspectives: Personal Freedom, Respnsibility, and Mandates, 13 Health Affairs 101, 103-4 (1994) (available online at http://content.healthaffairs.org/content/13/2/101.full.pdf+html).

Center Works on Pilot to Improve Access to Critical Community Services in Newark, NJ

.The Greater Newark Healthcare Coalition is a new nonprofit comprising Newark’s hospitals, Federally Qualified Health Centers, primary physicians, and many community groups, as well as city and state government representatives, gathered to improve access to care for the region’s most vulnerable populations. Professor John Jacobi, Faculty Director of the Center for Health & Pharmaceutical Law & Policy and Dorothea Dix Professor of Health Law & Policy, serves as the Coalition’s board chair.  The Coalition has already spun off a Health Information Exchange, and is engaged in a number of exciting pilot projects.

One project will address the community care needs of very high utilizers of hospital emergency department services.  The Coalition plans to indentify an initial cohort of frequent users and provide them with intensive case management with the goal of matching them with appropriate, community-based services. This approach has been shown in other states to both improve the lives of frequent users and reduce unnecessary hospital visits.

Professor Jacobi and Research Fellow Kate Greenwood will analyze the role of existing laws and policies in either facilitating or frustrating the Coalition’s efforts. They hypothesize that while funding flows (relatively) freely to hospital emergency departments because of the legal entitlement to care in that setting, these funds will not readily follow frequent users as they seek community health and social services better suited to their needs.  They hope to assist state and regional policymakers and service providers in their efforts to reform the funding and delivery mechanisms to better meet the needs of this very vulnerable population.

Sunlight is a Weak Disinfectant

One of the most robust “memes” in contemporary law is the power of disclosure. In health law, disclosure comes up again and again: patients need to give “informed” consent, insurers are supposed to explain their policies clearly, and conflicts of interest, when not proscribed, should at the very least be exposed. But there are growing challenges to the disclosure meme, both within health law and without.

George Lowenstein and Peter Ubel note some problems with disclosure approaches in this article on the weaknesses of behavioral economics generally:

It seems that every week a new book or major newspaper article appears showing that irrational decision-making helped cause the housing bubble or the rise in health care costs. Such insights draw on behavioral economics, an increasingly popular field that incorporates elements from psychology to explain why people make seemingly irrational decisions, at least according to traditional economic theory and its emphasis on rational choice. . . . But the field has its limits. As policymakers use it to devise programs, it’s becoming clear that behavioral economics is being asked to solve problems it wasn’t meant to address.

[T]ake conflicts of interest in medicine. Despite volumes of research showing that pharmaceutical industry gifts distort decisions by doctors, the medical establishment has not mustered the will to bar such thinly disguised bribes, and the health care reform act fails to outlaw them. Instead, much like food labeling, the act includes “sunshine” provisions that will simply make information about these gifts available to the public. We have shifted the burden from industry, which has the power to change the way it does business, to the relatively uninformed and powerless consumer.

The same pattern can be seen in health care reform itself. The act promises to achieve the admirable goal of insuring most Americans, yet it fails to address the more fundamental problem of health care costs. . . . [T]he act tries to lower costs by promoting incentive programs that reward healthy behaviors. . . . [But s]tudies show that preventive medicine, even when it works, rarely saves money.

At its worst, disclosure can become merely pro forma; as Kafka (via Trudo Lemmens) puts it, “Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this is repeated over and over again; finally it can be calculated in advance, and it becomes part of the ceremony.” Omri Ben-Shahar has argued that disclosure is one of many aspects of consumer protection law with little real impact on individual welfare. As Amelia Flood reports,

Ben-Shahar, who spent last summer studying all the mandated disclosure statutes in Illinois, Michigan and California, argues that consumer protection advocates have gotten it wrong when it comes to mandating information access for consumers. He says consumers get lost in a sea of technical language, unread disclaimers and long-shot lawsuits. . . . According to Ben-Shahar, disclosures are of more use to consumer ratings groups like Zagat and Consumer’s Digest than they are to most consumers.

So perhaps there is some hope here: third-party aggregators and raters might use disclosures as part of an overall effort to rate various hospitals or doctors. The question then becomes–who shall pay (and rate) the raters? One irony here is that doctor rating sites have themselves been accused of being insufficiently transparent about the ways in which they evaluate physicians. New York Attorney General Cuomo even pursued the matter. His office eventually settled with insurers who ran rating sites. They pledged to “fully disclose to consumers and physicians all aspects of their ranking system.”

What’s the lesson here? First, that consumers are, by and large, too busy to process piecemeal disclosures by professionals like physicians and other health care providers. Second, third party raters can fill some of this information gap by aggregating information. Third, this process of aggregation and rating itself will likely need to be closely supervised by a good-faith regulator, lest it fail to take into account the full range of interests (and quality of information) proper for the task.

Alliance for Health Issues Major Resource, “Covering Health Issues”

Amazing resource for health care and health care reform info over at Alliance for Health, “Covering Health Issues, 5th Edition, 2010 Update.” Made possible by the Robert Wood Johnson Foundation, it has 12 chapters and covers such issues as Health Reform, Cost of Health Care, Quality of Care, Mental Health & Substance Abuse, Long-Term Care, and Disparities. The collection is a veritable treasure trove of information presented in a readily accessible manner. Though the phrase is lacking because access is free, the Fast Facts alone are worth the price of admission. A few to think about (footnotes omitted):

• Two-thirds of people age 65 today will need some long-term care in their lifetimes.

• An estimated 22.3 million people were classified as substance dependent or substance abusers in 2007. Substances abused range from alcohol, pain relievers and tranquilizers to hallucinogens, cocaine and heroin.

• Each year, about one in four adults (26.2 percent) suffers from a diagnosable mental illness, according to National Institute of Mental Health.

• In a ranking of 19 industrialized countries, the U.S. had the highest number of unnecessary deaths.

• Among 37 nations, the U.S ranks 29th in terms of infant mortality with nearly twice as many infant deaths per capita than France.

• The United States spent $2.3 trillion on health care in 2008, or $7,681 per person. This amounted to 16.2 percent of the nation’s gross domestic product (GDP).

• Health care costs more than tripled from 1990 to 2008,² and are projected to rise to 19.3 percent of GDP in 2019.

• Nearly 82 percent of the uninsured in 2009 lived in families headed by workers.

• In 2008, 17.2 percent of full-time employees and 25.5 percent of part-time employees age 19-64 were uninsured all year.

Seton Hall Announces Summer Study Abroad International Health Law Program

Seton Hall University School of Law’s Leuven-Geneva Program in Health, Intellectual Property and International Law combines a broad-based introduction to the laws, policies and institutions of the European Union (EU) with a unique, interdisciplinary examination of cutting-edge issues in intellectual property, pharmaceutical development and global public health.

The Program will consist of two courses. European Union Law, a two-credit course, will be taught mainly at the Leuven Institute in  Leuven, Belgium and will include a special trip to Luxembourg to visit the European Court of Justice. Students will also visit some of the main EU institutions in Brussels, such as the European Parliament and Commission.

The goal of this part of the Program is to introduce students to the essential principles and institutions of the EU and to explore firsthand the challenges facing this unique confederation of different languages and cultures. For the Geneva component of the Program, students will study Health and Intellectual Property Law in a Global Environment, a four-credit course, co-taught by one intellectual property law professor and one health law professor.  The course will be conducted in collaboration with Geneva-based international organizations involved in health and intellectual property law issues, including the World Health Organization, UNAIDS, the World Trade Organization and the World Intellectual Property Organization.

Students will work on a series of case studies related to the work of these organizations, both in the classroom and in on-site meetings with organizational representatives. In addition to students from the Seton Hall Program, the Geneva component of the Program will also be open to students from the University of Zurich Ph.D. program in Biomedical Ethics and Law.

More information about the program is available here: http://law.shu.edu/Students/academics/studyabroad/Geneva/index.cfm

Risks to Directors and Trustees of Health Care & Life Sciences Companies: Corporate Compliance in a Distressed Economy

“Risks to Directors and Trustees of Health Care & Life Sciences Companies: Corporate Compliance in a Distressed Economy,” was sponsored by Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Epstein Becker & Green P.C., and Navigant Consulting, Inc. The program urged profit and nonprofit health care organizations to prioritize effective corporate compliance programs, particularly in today’s economy.

Moderated by Professor Kathleen Boozang, the program featured keynote speaker Mark Anderson, the New Jersey Medicaid Inspector General, as well as presentations by Lynn Shapiro Snyder and Hervé Gouraige of Epstein Becker & Green P.C. and Sandra Piersol and Geoffrey Kaiser of Navigant Consulting, Inc.

The participants focused on the financial challenges and potential exposure for board members of health care and life sciences entities in maintaining an effective compliance program in order to minimize noncompliant behavior and corporate liability risks.  Current trends in HHS Corporate Integrity Agreements (CIA’s) have shown a movement toward imposing personal liability on boards of directors for failure to ensure that a company has an effective corporate compliance program.

Inspector Anderson first addressed the 2007 statute governing the New Jersey Office of Medicaid Inspector General, focusing in particular on the statute’s broad definitions of “fraud” and “abuse,” which allows his office broad discretion.  Asking the key question, “is your compliance compliant?”, he emphasized that effective compliance programs go beyond simple written policies and procedures, but are specific to the entity’s need to prevent fraud and abuse, and are supported at every level of management — with the tone set “at the top.”  He concentrated on one specific element of compliance programs — self-disclosure of problems within one’s own organization — and stressed that self-disclosure is essential to compliance and is in the company’s best interest, as his office provides incentives to health care entities to self-disclose.  These incentives include forgiveness or reduction of interest payments, waiver of penalties and/or sanctions, timely resolution of overpayment, and a decrease in likelihood of imposition of an OMIG Corporate Integrity Program.

Lynn Shapiro Snyder, Co-Chair of the Health Care Fraud Practice Group at Epstein Becker & Green, spoke about the looming threat of enforcement activities aimed at board members of health care and life sciences entities, and noted that, until recently, the risk has been reputational rather than legal.  She highlighted the blurred line between governance and management obligations, and questioned whether boards need their own consultants to determine whether to sign off on a company’s compliance program.  Later, suggesting a simple, cost-effective way to examine the effectiveness of a compliance program, she recommended that compliance officers file (and follow) a “dummy report” within their own organization, thereby bringing to light gaps and issues in the company’s program.

Sandra Piersol, a Director with the Healthcare Disputes and Investigators practice at Navigant Consulting, addressed how directors and trustees can determine whether they have an effective corporate compliance program.  Discussing the seven elements of an effective compliance program, she emphasized ensuring that the compliance officer has direct access to the board of directors, setting the “tone at the top,” and the need for ongoing training and communication.  She provided a list of structural and operational questions to be considered when examining whether an entity’s corporate compliance program is effective, and concluded with the recommendation that boards should request the performance of an objective and comprehensive review of the program activities performed by persons independent of the compliance program.

Hervé Gouraige, Co-Group Leader of the National Litigation Practice at Epstein Becker & Green, spoke about the risk to board members of personal liability for an ineffective compliance program.  After an overview of the law as it relates to board oversight of compliance, Gouraige discussed the requirement that companies have a process established to address compliance risks within the organization.  Second, he underscored that the process must be executed by the chief compliance officer and monitored by the board.  Finally, he explained that the board must be involved in the selection of a chief compliance officer who is capable of, and willing to, stand up to the board.  He stressed that the chief compliance officer should not also be the general counsel, due to the conflicting duties and obligations of those positions.  He also suggested that there be a separate board committee — which includes the CEO, general counsel, and chief compliance officer — to monitor the compliance program.  Annually, this committee should meet without the CEO and general counsel as well.  Finally, Gouraige suggested that in order to learn about — and address — problems before a prosecutor does, compliance officers periodically spot check internal emails between employees.

Geoffrey Kaiser, Managing Director in the Healthcare Dispute, Compliance and Investigations Practice at Navigant Consulting, focused on the benefits of having an effective compliance program.  He noted that, although it is difficult to quantify the harm avoided by any program, an effective program can reduce or mitigate the risk of violations, particularly through education, which is a cost-effective way to sensitize employees to risk.  Second, having an effective voluntary information and reporting system allows a board of directors to introduce corrective measures proactively.  Third, having an effective corporate compliance program in place can influence prosecutorial discretion.  In addition, having an effective compliance program can reduce the severity of penalties facing an organization at sentencing — not only affecting the amount of the fine, but also the range in which the fine will be imposed.

Overall, each speaker highlighted the cost-effectiveness and benefits of devoting resources to an effective compliance program.  Inspector Anderson, stating that the economic environment cannot dictate compliance policies, emphasized that cutting such programs is short-sighted and a future compliance violation could potentially decimate a company in the long run.  Gouraige explained that it would be a terrible mistake to cut compliance, due to the “wisdom of the long-term investment.”  The speakers, in a question and answer session moderated by Professor Boozang, addressed effective ways to increase board attention to corporate compliance, including focusing on corporate compliance as one of the many legal requirements required by boards and underscoring the investment — rather than the cost — of implementing an effective corporate compliance program.  As attendee Eve Costopoulos of Merck aptly stated, “if you don’t pay today, you’ll pay tomorrow.”

All Photos by Sean Sime

A Hat Tip to Pharmalittle

Health Reform Watch wishes to congratulate the folks over at Pharmalittle for being named one of the Top 100 Pharma Blogs. They deserve it–and if you’ve never checked out their site– I highly encourage you to do so. Upon the dissolution of Ed Silverman’s Pharmalot, which was hosted here in Newark by the Star Ledger, a group of contributors and commenters banded together to pick up the mantle. For those of you who have a keen interest in Pharma (and who doesn’t?), you’ll find truly insightful and often witty commentary over at Pharmalittle. As an example, this post of theirs announcing their Top 100 status is classic:

HAT TIP TO OURSELVES….

Pharmalittle to be Honored at White House

OK, so we lied. It’s all part of the same strategy. As the impressive badge on the left (suitable for framing) shows, this blog has been named one of the top 100 pharma blogs. Did anyone know there were that many pharma blogs?

Anyway, a lot of people out there will wonder how we accomplished this. It’s simple. We followed basic marketing principles:

1. We promoted the blog for off-label uses. For example, it makes a great eye chart and may help slow the growth of cataracts.

2. We gave kickbacks to everyone on the internet. Really.

3. We buried studies 34, 57, and 105.

4. We changed the endpoints in study 35 and left out the last six months of data.

5. We delayed the appearance of generic Pharmalittle (liloxazorx) through a bunch of nuisance suits.

6. We intimidated people who read other blogs.

7. We hired Key Opinion Leaders like Anonymous to talk us up.

8. We funded studies showing all the dangers of other pharma blogs.

9. We convinced people that failure to read Pharmalittle will result in the end of innovation in the industry and the complete dissolution of life-saving medications.

10. We avoided being bought by Pfizer.

11. There is no evidence reading Pharmalittle leads to weight gain, morbid obesity, and diabetes. And anyone who thinks differently will never find Study 57 anyway.

12. We don’t believe in morbid obesity. If you’re going to be obese, at least be up-beat about it.

And stuff like that.

Read more from Pharmalittle here.

Introducing Tracy E. Miller, Executive Director of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy

Today we are very pleased to welcome Tracy E. Miller, J.D., to Health Reform Watch. Ms. Miller is the Executive Director of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy. She received her J.D. from Harvard Law School, cum laude, and her undergraduate degree from Brown University, magna cum laude.  From 2001-2007, Ms. Miller served as General Counsel and Senior Vice President of the Catholic Health Care System (CHCS), a health care system comprised of hospitals and nursing homes in New York City and the Hudson Valley.  While at CHCS, Ms. Miller oversaw legal and compliance services for the Health System and its ten member facilities. Prior to joining CHCS, Ms. Miller was Vice President for Quality and Regulatory Affairs at the Greater New York Hospital Association.

From 1996-2000, Ms. Miller was Associate Professor in the Department of Health Policy at the Mount Sinai School of Medicine, where her scholarship and publications focused on a range of topics, including medicine online, financial disclosure, and trust in the patient-physician relationship, and managed care regulation.  During that time, Ms. Miller also served as Project Director of the National Quality Forum Planning Committee, a group of national leaders in health care delivery and quality convened by Vice President Gore. The committee was charged with building a new national organization to set standards for quality measurement and improvement across the health care industry. Prior to joining Mount Sinai, Ms. Miller was the founding Executive Director of the Governor’s Task Force on Life and the Law, a commission of experts and leaders drawn from healthcare, legal, civic, and religious organizations to craft policy for New York State.  In that capacity, she developed law and policy on issues raised by medical advances, including New York’s health care proxy law, the do-not-resuscitate law, and the law on the procurement and distribution of organs for transplantation.

Ms. Miller is the Past Chairperson of the 1100-member Health Law Section of the New York State Bar Association and a Member of the Health Law Section Executive Committee from 1995-2001.  She has written and spoken extensively to national and state organizations on healthcare policy, law and ethics.  She joined Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy as Executive Director in 2008.

Seton Hall Regent Donna M. O’Brien Honored with NIH Director’s Award

[Ed. note: Today's post was culled from Seton Hall University News and was written by Jill Mathews]

Seton Hall University Board of Regent member Donna M. O’Brien, President of Community Healthcare Strategies, LLC, has been selected to receive the National Institutes of Health (NIH) Director’s Award. This award is being presented in recognition of Ms. O’Brien’s work in developing The National Cancer Institute’s (NCI) Community Cancer Centers Program (NCCCP). She will receive her award during a presentation on July 29th in Bethesda, Maryland.

The National Cancer Institute (NCI), the largest institute of the National Institutes of Health, leads the nation’s research efforts to discover better ways to prevent, diagnose and treat cancer. In 2007, NCI launched NCCCP as a three-year pilot program to extend the reach of NCI’s cancer research into more U.S. states, cities and towns, including rural areas and inner cities. The NCCCP program has 16 community hospital cancer centers in 14 states representing a cross-section of this country’s population and its health care organizations — with a special focus on reaching minority and underserved patients. The NCCCP program sites serve 27,000 cancer patients each year. Plans are underway to expand the program.

The NCCCP program is creating a platform in the healthcare delivery system for personalized medicine and developing a national electronically-linked network which will collect high quality biospecimens and patient data to support molecular medicine and the work of the Cancer Genome Atlas. The overarching goal is to bring science, early-phase clinical research, and evidence-based therapies to people in their home communities.

Ms. O’Brien currently coordinates healthcare projects in several locations across the U.S. Her prior experience includes serving as Executive Vice President of Catholic Health Services of Long Island, Associate Director of the Alliance for Catholic Health and Human Services in New York City, and as Assistant Administrator for Hospital Administration at the University of Texas M.D. Anderson Cancer Center. She was a Member of the New York State Governor’s Commission to Restructure Healthcare Facilities for the Twenty-first Century and currently serves on the Board of Regents for Seton Hall University and on the Board of Directors of the Flushing Savings Bank.

Ms. O’Brien is a graduate of the College of the Holy Cross and she has her Masters of Health Administration from St Louis University. She is a Fellow in the American College of Healthcare Executives.

We Are Pleased to Introduce Professors Mark A. Hall & Carl E. Schneider

Mark A. Hall, Professor of Law and Public Health, Wake Forest University

Carl E. Schneider, Professor of Law and Internal Medicine, University of Michigan

We are very pleased to welcome Professors Mark Hall and Carl Schneider to the blog today.

Mark A. Hall, J.D., is the Fred D. & Elizabeth L. Turnage Professor of Law at Wake Forest University School of Law. He is one of the nation’s leading scholars in the areas of health care law and policy and medical and bioethics. The author or editor of fifteen books, including Making Medical Spending Decisions (Oxford University Press), and Health Care Law and Ethics (Aspen), he is currently engaged in research in the areas of consumer-driven health care, doctor/patient trust, insurance regulation, and genetics. He has published scholarship in the law reviews at Berkeley, Chicago, Duke, Michigan, Pennsylvania, and Stanford, and his articles have been reprinted in a dozen casebooks and anthologies.

Professor Hall also teaches in the MBA program at the Babcock School and is on the research faculty at Wake Forest’s Medical School. He regularly consults with government officials, foundations and think tanks about health care public policy issues, and was recently awarded the American Society of Law, Medicine and Ethics distinguished teaching award.

Carl E. Schneider, J.D. is the Chauncey Stillman Professor of Ethics, Morality, and the Practice of Law at the University of Michigan School of Law. He is also Professor of Internal Medicine at the University of Michigan. He was educated at Harvard College and the University of Michigan Law School, where he was editor-in-chief of the Michigan Law Review. He served as law clerk to Judge Carl McGowan of the United States Court of Appeals for the District of Columbia Circuit and to Justice Potter Stewart of the United States Supreme Court. He became a member of the University of Michigan Law School faculty in 1981 and of the Medical School faculty in 1998.

Professor Schneider has written extensively on bioethical issues, the law of bioethics, family law, constitutional law, professional training, and professional ethics. He is the author of The Practice of Autonomy: Patients, Doctors, and Medical Decisions (Oxford University Press, 1998), a study of the way the authority to make medical decisions is and should be allocated between doctors and patients, and is the co-author of The Law of Bioethics: Individual Autonomy and Social Regulation (West, 2003, 2006), a law school casebook. His family law casebook, An Invitation to Family Law (West), is entering its third edition. He is currently writing a book on the law regulating medical decisions of all kinds — especially contemporary and prospective decisions and decisions by competent patients and for incompetent patients. He is also engaged in research on consumer-directed health care, research supported by a Robert Wood Johnson Investigator’s Award.

Professor Schneider has lectured, taught, and published in several countries. He has been a visiting professor at Cambridge University, the University of Tokyo, and Kyoto University, has taught for many years in Germany, and was a visiting professor at the United States Air Force Academy in the winter of 2007. In addition, Professor Schneider has recently been reappointed for a second two year term on the President’s Council on Bioethics.

Introducing Kathleen M. Boozang, Associate Dean & Professor of Law

Today we are very pleased to welcome Kathleen M. Boozang to Health Reform Watch. Seton Hall University School of Law Associate Dean and Professor of Law,  Kathleen M. Boozang has dedicated much of her career to nonprofit governance issues, with a special focus on religiously-sponsored hospitals. In the last several years, however, she has expanded her research and teaching to explore the legal and policy issues related to the global pharmaceutical and medtech industries, many of which make New Jersey their headquarters. Dean Boozang oversees the Gibbons Institute of Law, Science and Technology, and the Center for Health & Pharmaceutical Law & Policy.

In addition to her duties at the Law School, Dean Boozang serves on the Board of Directors of the American Health Lawyers Association. This year she was named a Fellow to The Hastings Center, an independent nonprofit bioethics research institute. Also this year, Dean Boozang was elected as a Fellow to the American Bar Foundation , an honorary organization of legal practitioners. She serves on the Editorial Board of the Journal of Health and Life Sciences Law and is a past editor-in-chief of the Journal of Law, Medicine & Ethics. She is past president of the American Society of Law, Medicine & Ethics and also previously sat on the Advisory Board of the Journal of Health Law.

Throughout her legal career, Dean Boozang has been active in public service. She has served on numerous advisory boards and committees for healthcare providers and for the states of New Jersey and New York, including serving as an advisor to the Attorney General Task Force on Physician Compensation by Pharmaceutical Companies, which sought to determine if and how patient care in New Jersey is impacted by the practice of pharmaceutical companies giving gifts and other compensation to physicians. She is currently a member of the New York State Task Force on Life and the Law, an interdisciplinary commission with a mandate to develop public policy on bioethical issues.

Dean Boozang graduated from Washington University School of Law in St. Louis, Mo., where she was inducted into the Order of the Coif and served as the managing editor of Law Quarterly. She received her LL.M. from Yale Law School in 1990.

She was named the Seton Hall University Woman of the Year Award in 2006 and was named Washington University Law School’s Young Alum of the Year in 2004.

Introducing Kate Greenwood, J.D.

We are very pleased to welcome Kate Greenwood, J.D., to the blog today. Kate joined Seton Hall Law School in 2008 as a Faculty Researcher in the Center for Health & Pharmaceutical Law & Policy. She came to Seton Hall from Covington & Burling LLP after having graduated magna cum laude from Georgetown Law where she served as an Articles Editor of The Georgetown Law Journal.  She received her undergraduate degree in Economics from Swarthmore College. Prior to her work at Covington & Burling, Kate worked as an Equal Justice Works Fellow and Staff Attorney at the Association of the Bar of the City of New York, and served as a law clerk to the Honorable Mary A. McLaughlin of the Eastern District of Pennsylvania, and to the Honorable Maryanne Trump Barry of the Third Circuit Court of Appeals.

Her work on the legal and regulatory barriers to evaluating existing drugs to determine their safety and efficacy when used during pregnancy and developing new drugs to treat pregnancy complications was selected for presentation at the 2009 St. Louis University Health Law Scholars Workshop

Council of Economic Advisors’ Report Outlines the Benefits of Health Care Reform

The President’s Council of Economic Advisors released a new report today examining the economic necessity of health care reform.  In addition to need, The Economic Case for Health Care Reform (PDF) details the anticipated benefits of U.S. health care reform.

The report finds that “If health care costs continue to grow at historical rates, the share of GDP devoted to health care in the United States [will] reach 34 percent by 2040.”  

Citing the strain placed on federal, state, and local governments and the nearly 50 million uninsured Americans, the authors of the report suggest that health care reform is crucial to prevent disastrous increases in the Federal budget deficit.

Two key components of health care reform addressed in the report: (1) the containment of the growth rates of health care costs, and (2) the expansion of insurance coverage.

The Council estimates that slowing the growth of health care costs would have three key effects:

1. It would raise standards of living by improving efficiency. Slowing the growth rate of health care costs by increasing efficiency raises standards of living by freeing up resources that can be used to produce other desired goods and services.

2. It would prevent disastrous budgetary consequences and raise national saving. Because the Federal government pays for a large fraction of health care, lowering the growth rate of health care costs causes the budget deficit to be much lower than it otherwise would have been (assuming that the savings are dedicated to deficit reduction).

3. It would lower unemployment and raise employment in the short and medium runs. When health care costs are rising more slowly, the economy can operate at a lower level of unemployment without triggering inflation.

Likewise, the report outlines three important impacts of expanding health care coverage:

1. It would increase the economic well-being of the uninsured by substantially more than the costs of insuring them. A comparison of the total benefits of coverage to the uninsured, including such benefits as longer life expectancy and reduced financial risk, and the total costs of insuring them (including both the public and private costs), suggests net gains in economic well-being of about two-thirds of a percent of GDP per year.

2. It would likely increase labor supply. Increased insurance coverage and, hence, improved health care, is likely to increase labor supply by reducing disability and absenteeism in the work place.  This increase in labor supply would tend to increase GDP and reduce the budget deficit.

3. It would improve the functioning of the labor market. Coverage expansion that eliminates restrictions on pre-existing conditions improves the efficiency of labor markets by removing an important limitation on job-switching.  Creating a well-functioning insurance market also prevents an inefficient allocation of labor away from small firms by leveling the playing field among firms of all sizes in competing for talented workers in the labor market.

Read the full report here (PDF).

Ezra Klein to Leave American Prospect

Because, quite frankly, he is simply excellent at what he does, it’s well worth noting that he’ll be doing it somewhere else. Ezra Klein, formerly of American Prospect, has announced that he is moving to the Washington Post.

His parting blog, like almost everything else he writes, is a good read. Lets hope that WaPo affords him the freedom and support that American Prospect so wisely did.

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