Livestream Podcast, Seton Hall Law Review ACO Symposium
Filed under: Accountable Care Organization, Seton Hall Law
In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s SETON HALL LAW REVIEW Symposium explored recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs).
Legal scholars and practitioners from around the country presented in panel discussions on structural development, public health implications and lessons learned from state ACO programs. The luncheon keynote speaker was Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers.
Streaming Audio Podcasts of Each Panel are Below, Beside the Radio in Blue–Just Click and Listen
Panels & Panelists
Introduction to Accountable Care Organizations
Introduction to ACOs Panel, Seton Hall Law Review_Symposium_1.asx
Jorge Lopez (Partner, Akin Gump Strauss Hauer & Feld LLP): Promise and Pitfalls: Health Reform’s Medicare ACO Shared Savings Program
Hal Teitelbaum (CEO and Managing Partner, Crystal Run Healthcare): The Prospect of Being Hanged: Focusing the Physician Mind on ACOs
Michael Kalison (Chairman of Applied Medical Software, Inc.; Of Counsel, McElroy, Deutsch, Mulvaney, & Carpenter): The Lessons of Gainsharing
ACOs in Theory: Issues Raised by Integrated Delivery
ACO Theory: Issues, Seton Hall Law_Review_Symposium_2.asx,,
Jessica Mantel (Co-Director, Health Law & Policy Institute, University of Houston, Law Center): ACOs: Can we have our cake and eat it too?
Priscilla Keith (Adjunct Professor and Director of Research and Projects, Hall Center for Law and Health, Indiana University School of Law - Indianapolis): The Impact of Accountable Care Organizations on Public Health
Tara Ragone (Research Fellow, Seton Hall Law School): The Role of Competition in Integrated Delivery: ACOs, Federal and State Antitrust Law, and the State Action Doctrine
Dr. Brenner, Seton Hall Law_Review_Symposium _Keynote.asx
Jeffrey Brenner, M.D., Founder & Executive Director, Camden Coalition of Healthcare Providers
Jeffrey Brenner is a family physician and has practiced in Camden for eleven years as a front-line primary care provider for patients of all ages. Having owned a private practice in Camden, he has experience in implementing electronic health records and running a paperless office, open-access scheduling, as well as first-hand knowledge of the various challenges facing primary care in the current health system.
He currently serves full-time as the Coalition’s Executive Director, where he spends much of his time meeting with stakeholders and policymakers, advocating for the models of care the Coalition has developed and demonstrated through data centric results. Jeff is a faculty member of the Robert Wood Johnson Medical School in Camden and is also a former resident of Camden, having lived in the city for over 8 years. He is a graduate of Vassar College and the Robert Wood Johnson Medical School.
ACOs in Practice: Research on Current Implementation of ACOs
ACOs in Practice, Current Implementation Research, Seton Hall Law_Review_Symposium_3.asx
Louise Trubek (Adjunct Professor of Law, Seton Hall Law, Clinical Professor Emerita, University of Wisconsin Law School), Barbara Zabawa (Whyte Hirschboeck Dudek, S.C); Felice Borisy-Rudin (University of Wisconsin Law School): Accountable care organizations in two states: A preliminary analysis
Sallie Sanford (Assistant Professor of Law, University of Washington - School of Law & School of Public Health): State-based ACO and Medical Home Pilots: Early Lessons from the Other Washington
John Jacobi (Faculty Director & Dorothea Dix Professor of Health Law & Policy, Seton Hall University School of Law), Lessons from ACO Implementation in New Jersey.
Thomas Greaney (Chester A. Myers Professor of Law and Director, Center for Health Law Studies, Saint Louis University School of Law), Accountable Care Organizations: A New New Thing with Some Old Problems.
A Symposium Law Review with papers from the event is forthcoming. For more information regarding the Symposium, please contact Gianna Cricco-Lizza, Symposium Editor, at gianna.criccolizza@student.shu.edu
Symposium: Implementing the Affordable Care Act: What Role for Accountable Care Organizations?
Filed under: Accountable Care Organization, Health Law, Seton Hall Law
In conjunction with the Center for Health & Pharmaceutical Law & Policy, this year’s SETON HALL LAW REVIEW Symposium will explore recent changes in the structure of health care delivery, in particular the rising popularity of Accountable Care Organizations (ACOs).
Legal scholars and practitioners from around the country will present panel discussions on structural development, public health implications and lessons learned from state ACO programs. Luncheon keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers.
Scheduled Panels & Panelists include
Introduction to Accountable Care Organizations
Jorge Lopez (Partner, Akin Gump Strauss Hauer & Feld LLP): Promise and Pitfalls: Health Reform’s Medicare ACO Shared Savings Program
Hal Teitelbaum (CEO and Managing Partner, Crystal Run Healthcare): The Prospect of Being Hanged: Focusing the Physician Mind on ACOs
Michael Kalison (Chairman of Applied Medical Software, Inc.; Of Counsel, McElroy, Deutsch, Mulvaney, & Carpenter): The Lessons of Gainsharing
ACOs in Theory: Issues Raised by Integrated Delivery
Jessica Mantel (Co-Director, Health Law & Policy Institute, University of Houston, Law Center): ACOs: Can we have our cake and eat it too?
Priscilla Keith (Adjunct Professor and Director of Research and Projects, Hall Center for Law and Health, Indiana University School of Law - Indianapolis): The Impact of Accountable Care Organizations on Public Health
Tara Ragone (Research Fellow, Seton Hall Law School): The Role of Competition in Integrated Delivery: ACOs, Federal and State Antitrust Law, and the State Action Doctrine
Keynote
Jeffrey Brenner, M.D., Founder & Executive Director, Camden Coalition of Healthcare Providers
Jeffrey Brenner is a family physician and has practiced in Camden for eleven years as a front-line primary care provider for patients of all ages. Having owned a private practice in Camden, he has experience in implementing electronic health records and running a paperless office, open-access scheduling, as well as first-hand knowledge of the various challenges facing primary care in the current health system.
He currently serves full-time as the Coalition’s Executive Director, where he spends much of his time meeting with stakeholders and policymakers, advocating for the models of care the Coalition has developed and demonstrated through data centric results. Jeff is a faculty member of the Robert Wood Johnson Medical School in Camden and is also a former resident of Camden, having lived in the city for over 8 years. He is a graduate of Vassar College and the Robert Wood Johnson Medical School.
ACOs in Practice: Research on Current Implementation of ACOs
Louise Trubek (Clinical Professor, University of Wisconsin Law School), Barbara Zabawa (Whyte Hirschboeck Dudek, S.C); Felice Borisy-Rudin (University of Wisconsin Law School): Accountable care organizations in two states: A preliminary analysis
Sallie Sanford (Assistant Professor of Law, University of Washington - School of Law & School of Public Health): State-based ACO and Medical Home Pilots: Early Lessons from the Other Washington
John Jacobi (Faculty Director & Dorothea Dix Professor of Health Law & Policy, Seton Hall University School of Law), Lessons from ACO Implementation in New Jersey.
Thomas Greaney (Chester A. Myers Professor of Law and Director, Center for Health Law Studies, Saint Louis University School of Law), Accountable Care Organizations: A New New Thing with Some Old Problems.
The event will take place at Seton Hall Law School with luncheon served at The Newark Club, One Newark Center, 22nd floor. There is no charge for Seton Hall Law alumni; cost for all others, $25. Four NJ/NY CLE credits will be available. Visit http://law.shu.edu/lawreviewsymposium to register. For more information regarding the Symposium, please contact Gianna Cricco-Lizza, Symposium Editor, at gianna.criccolizza@student.shu.edu.
Distinguished Guest Practitioner Mark Swearingen Lectures on Trends in Healthcare Law Enforcement
On Wednesday, September 21, 2011, Distinguished Guest Practitioner Mark Swearingen spoke at Seton Hall Law School on a number of healthcare law enforcement topics that were of keen interest to the audience of health lawyers and health lawyers-in-training. Mr. Swearingen, who graduated from Seton Hall Law in 1998, is a shareholder at Hall, Render, Killian, Heath & Lyman, P.C., a large healthcare law boutique based in Indianapolis, Indiana.
Among other things, Mr. Swearingen discussed two recent Stark Law cases: United States v. Tuomey Healthcare System, in which a jury award of $49.4 million is currently on review in the Fourth Circuit Court of Appeals, and United States v. Bradford, a summary judgment decision from the Western District of Pennsylvania that also largely favors the government.
As the court in Bradford explains, the case involved two physicians, Kamran Saleh and Peter Vaccaro, who leased a nuclear camera so that they would no longer have to refer their patients to the local hospital, Bradford Regional Medical Center, for nuclear imaging. Faced with the prospect of losing over a third of its $2,274,094 in annual gross nuclear medicine revenues, the hospital responded by threatening to revoke the doctors’ admitting privileges. Lengthy negotiations ensued, at the end of which the hospital agreed to sublease the camera from the two physicians; the camera remained at the physicians’ offices but other physicians with privileges at the hospital could use it.
Four local physicians who “provide[d] the same or similar services to patients as Drs. Saleh and Vaccaro” brought a qui tam action alleging that the sublease violated the Anti-Kickback and Stark Acts and that the defendants falsely certified compliance with those laws in connection with claims submitted to Medicare in violation of the False Claims Act. The court agreed that the defendants violated the Stark Act, because the amounts the hospital paid under the sublease were inflated to account for the referrals the hospital lost as a result of Drs. Saleh and Vaccaro’s decision to lease their own camera. The court deferred on the Anti-Kickback and False Claims Act charges, because it was unable to conclude at the summary judgment stage that the defendants acted knowingly.
As Mr. Swearingen commented, even if the sublease arrangement in Bradford was, on paper, above approach, the facts leading up to it were not good for BRMC and Drs. Saleh and Vaccaro. That the hospital responded to losing business to the two physicians by first threatening to revoke their privileges and then entering into a financial arrangement that brought them back into the fold suggests that the sublease was about more than the use of a camera. The facts in Tuomey were in several key respects similar to those in Bradford. Tuomey, too, involved a hospital faced with the prospect of a group of physicians performing outpatient procedures elsewhere, which would have meant a loss to the hospital of $6-9 million in annual revenues. To keep the physicians in the fold, the hospital entered into part-time employment contracts with them. The government alleged– and the jury presumably found–that the contracts would have been money-losers for the hospital but for the associated facility and other fees that the hospital was able to bill in connection with the physicians’ services.
Mr. Swearingen also highlighted the fact that the hospital in Bradford lost the case despite having obtained an expert opinion that the amount it paid for the camera under the sublease was fair market value. The defendant hospital in Tuomey similarly lost despite having obtained not one but two valuation analyses and multiple legal opinions. The hospital in Tuomey relied on an advice of counsel defense and, notably, attorney-client privileged communications were entered into evidence at trial. Going forward, Mr. Swearingen emphasized, fair market value and legal opinions “will be scrutinized” and “may not be dispositive.”
Online Graduate Certificate Program in Pharmaceutical & Medical Device Law to Begin in May 2011
After the successful launch of its online program in Health & Hospital Law, Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is set to start again its newest online program, the Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance, on May 1, 2011. Applications are due April 15, 2011.
The Graduate Certificate in Pharmaceutical & Medical Device Law & Compliance is a non-degree program designed for individuals who seek in-depth knowledge about legal, regulatory, and ethical issues related to the pharmaceutical and medical device industries. Taught exclusively online, it offers students nationwide a targeted immersion in key substantive issues along with the practical skills necessary to research and communicate effectively about the law.
The intensive program is geared to busy professionals who want to cover a significant amount of material in a relatively short period of time. The program is open to students who have earned a baccalaureate degree from an accredited college or university. It is specifically designed to meet the needs of mid- to senior-level professionals in the health care industry, but highly motivated students from other backgrounds are also welcome to apply. It is not necessary to have prior academic or work experience in health care in order to do well in the program.
The first class begins May 1, 2011 and applications are being accepted now. Additional information is available here.
New Jersey’s Commissioner of Health and Senior Services Discusses Medical Marijuana and Two Other Regulatory “Case Studies” at Seton Hall Law
Filed under: Health Policy Community, State Initiatives
John V. Jacobi, Dorothea Dix Professor of Health Law and Policy and Faculty Director of the Center for Health and Pharmaceutical Law and Policy at Seton Hall Law School; Dr. Poonam Alaigh, New Jersey Commissioner of Health and Senior Services
On Tuesday, March 1, 2011, New Jersey’s Commissioner of Health and Senior Services Dr. Poonam Alaigh gave a lively and illuminating talk to an audience from within and outside the Seton Hall Law School community. Reflecting her medical training, Dr. Alaigh organized her talk around three “case studies”: (1) the implementation of the New Jersey Compassionate Use Medical Marijuana Act; (2) the rulemaking procedure to amend the hospital licensing standards relating to nurse anesthetists; and (3) the decision by the Department of Health and Senior Services to defer implementation of New Jersey’s menu-labeling law. Two central themes of Dr. Alaigh’s presentation were the remarkable complexity of the legislative and rulemaking processes and the importance of a patient-centered approach to healthcare regulation.
The bulk of Dr. Alaigh’s presentation addressed the unusually extensive back-and-forth between the Department and the Legislature that has characterized the implementation of New Jersey’s medical marijuana law. After the New Jersey Senate invalidated the Department’s initial set of draft regulations, on the grounds that they “would not comply with the intent of the law and would make it much too difficult for eligible patients to access relief through marijuana,” the Department promulgated a revised set of draft regulations reflecting the terms of a bi-partisan compromise. Dr. Alaigh described the massive effort she and her staff — at times, she said, her entire staff — have made to educate themselves about both the science supporting the use of marijuana for medical purposes and the experience of other states with medical marijuana laws. Dr. Alaigh believes the result of the Department’s hard work is a regulatory regime that serves patients in need while avoiding the fraud and criminal diversion problems experienced in California and Colorado. She described New Jersey’s medical marijuana program as the “gold standard” and said that the Department has fielded calls from officials in other states interested in adopting something similar. Among the unique elements of New Jersey’s program is a registry of de-identified patient treatment and outcomes data that will allow researchers to learn more about marijuana’s safety and efficacy.
Dr. Alaigh also spoke about the Department’s rulemaking amending the hospital licensing standards relating to nurse anesthetists. On the one hand, Dr. Alaigh explained, nurse anesthetists are advanced practice nurses who by statute do not require the supervision of a doctor. On the other hand, Dr. Alaigh knows from practice how quickly a patient’s condition can turn critical while under anesthesia. The final regulation provides that nurse anesthetists can administer anesthesia in a hospital setting in accordance with a joint protocol that ensures that an anesthesiologist (1) is available at all times for consultation and (2) is physically present “during induction, emergence and critical change in status.” Dr. Alaigh noted that this result was not likely to have made either anesthesiologists or nurse anesthetists happy. A sign of success for a regulator, perhaps?
The third and final case study that Dr. Alaigh discussed was the Department’s decision not to promulgate draft regulations implementing New Jersey’s menu-labeling law and instead to wait for the federal Food & Drug Administration to implement the menu-labeling provisions of the Patient Protection and Affordable Care Act. As Dr. Alaigh explained in a post on her blog, “[p]ausing to see what the FDA proposes in nine weeks is reasonable. It avoids unnecessary duplication and costs for restaurant owners who would have to invest in new menus and then redo them when the federal rules supersede the state law.” That’s right, Dr. Alaigh has a blog, NJ Health Beat. You can keep up with her here.
The Limits of Disclosure as a Response to Finanacial Conflicts of Interest in Clinical Research
Filed under: Conflicts of Interest, Research
Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has issued a White Paper, “The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research,” in which the Center agrees that public policy should encourage researchers and institutions to make information about their financial relationships with industry available to the public, but-contrary to many other commentators’ recommendations- concludes that disclosure of financial information should not routinely be required as part of the informed consent process.
While reiterating the Center’s prior recommendations for direct measures to eliminate, reduce, and manage problematic financial relationships in clinical research, the Center notes that, despite “the importance of transparency as an ethical value, incorporating financial issues into the informed consent process would provide few, if any benefits to research subjects and could in fact cause significant harms.”
The Center notes the problem of “information overload,” as clinical research informed consent documents have already become “long and complex, thereby confusing and overwhelming potential research participants,” and evidence indicates that “participants are often unable to sift through the morass of information to tease out the content they find salient or material.” In addition, qualitative studies have shown that “brief concise statements about financial interest within informed consent documents were rarely understood, and sometimes only served to confuse potential participants.
The Center concludes that, if a conflict of interest is so serious that its disclosure would lead a reasonable person to refuse to participate in a study, the proper remedy is to eliminate the conflict. It is therefore essential to ensure that information about financial interests is made available to institutional review boards (IRBs) and conflicts of interest committees, so that they can ensure that any problematic conflicts are eliminated before a study begins.
The Center notes that its conclusion that financial conflicts of interest should not be routinely disclosed as part of the informed consent process is not inconsistent with the California Supreme Court’s decision in Moore v. Regents of the University of California.
While Moore creates the possibility that, in the right set of circumstances, a physician’s failure to disclose research-related financial interests could give rise to liability, it does not mean that any and all financial relationships with industry must necessarily be disclosed. Rather, as in any informed consent claim, liability would depend on the plaintiff’s ability to establish the element of causation–i.e., that, if the omitted information had been disclosed, a reasonable person in the plaintiff’s position would not have consented to the procedure. As explained above, under the Center’s proposed framework, any conflict serious enough to affect a reasonable person’s decision about enrollment would already have been eliminated before the research began.
“The Limits of Disclosure as a Response to Financial Conflicts of Interest in Clinical Research” may be found at http://law.shu.edu/HealthLawPublications.
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices.
Fourth Annual Student Health Law Conference To Be Held at Seton Hall Law on October 22nd
Filed under: Health Care Employment, Health Law, Seton Hall Law
The American Society of Law, Medicine & Ethics (ASLME) and Seton Hall University School of Law will co-sponsor the Fourth Annual Student Health Law Conference: Taking the Health Law Career Path on Friday, October 22, 2010, in Newark, New Jersey.
This conference, which is attended by law students from law schools throughout the country, seeks to expose law students to the myriad career paths for attorneys in health and life sciences. The conference provides an introductory session on health law, panels on a variety of employment opportunities in health law, and a networking reception with the conference speakers. Career paths that will be represented include academia, compliance, private firms, government agencies, nonprofit organizations, drug and device companies, health insurers, and hospitals. Speakers for this year’s conference have been chosen for their health law expertise and background.
The format of the conference is a series of panels focused around a particular kind of health law career. Each panel is approximately one hour long and comprised of two to four panelists. Students will have the opportunity to explore nontraditional employment opportunities across the health law spectrum, receive support and guidance from professionals familiar with the experience needed for various careers as well as recruitment and hiring processes, and network with health law attorneys.
Interested in learning more about career paths for attorneys in health and life sciences? Click here for information on attending the conference.
Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Filed under: Compliance, Health Law, Seton Hall Law
Press Release: Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris
Co-presented by:
Seton Hall School of Law and Sciences Po
June 21 - 25, 2010- Sciences Po, Paris, France
- www.sciences-po.fr/spf/healthcare
PRESS RELEASE
Phone: 973.642-8863
E-mail: simone.handler-hutchinson@shu.edu
Website: law.shu.edu/Paris OR www.sciences-po.fr/spf/healthcare
The Healthcare Compliance Certification Programme, co-organized by Sciences Po Executive Education (Paris, France) and Seton Hall University School of Law (Newark, N.J) to be held from June 21-25, 2010 on the Paris campus of Sciences Po today announced its 2010 topics and faculty.
FEATURED FACULTY:
CURRENT & FORMER REGULATORY & ENFORCEMENT OFFICIALS:
Paul McNulty, Partner, Baker & McKenzie, LLP (DC) Former U.S. Deputy Attorney General
Kirk Ogrosky, Partner, Arnold & Porter LLP (DC), Former Deputy Chief, Health Care Fraud, Criminal Division, U.S. Dept. of Justice
INTERNATIONAL ORGANIZATIONS
Alex Conte, Senior Legal Analyst, Anti-Corruption Division, OECD
Dr. Guitelle Baghdadi-Sabeti, Team Leader, Good Governance for Medicines, World Health Organization
Marie-Claire Pickaert, Deputy Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA)
COMPANY COMPLIANCE PROFESSIONALS:
Dirk Brinckman, Assistant General Counsel, Johnson & Johnson (Brussels)
Roeland Van Aelst, Vice President, EMEA & Canada, Office of Health Care Compliance & Privacy, Johnson & Johnson
KEYNOTE & ACADEMIC SPEAKERS:
Paul Benkimoun, Healthcare Journalist, Le Monde
Claude Le Pen, Professor, Université Paris-Dauphine
Kathleen Boozang, Professor of Law, Seton Hall Law School (Newark, NJ)
LEADING LEGAL AND COMPLIANCE COUNSEL AND ADVISORS:
Peter W.L. Bogaert, Managing Partner, Covington & Burling (Brussels)
John Rupp, Partner, Covington & Burling LLP (London)
Karolos Seeger, Partner, Debevoise & Plimpton LLP (London)
Susie Smith, Bevan Brittan LLP (UK)
Ted Acosta, Leader, Life Sciences & Corporate Compliance Fraud Investigation & Dispute Services, Ernst & Young LLP
Jill Deal, Partner, Venable LLP (DC)
Kristof Van Quathem, Data Protection Advisor, Covington & Burling LLP (Brussels)
Carolyn Lindsey, Director of Member Services, TRACE International
Owen Bevan, Director, Legal & Compliance Practice, Corporate Executive Board
PROGRAMME CURRICULUM:
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Seton Hall Law Announces Frank Pasquale as the Schering-Plough Professor in Health Care Regulation and Enforcement
Seton Hall University School of Law has announced the appointment of Frank Pasquale as the Schering-Plough Professor in health care regulation and enforcement. Professor Pasquale has been a member of the Seton Hall Law Faculty since 2004 and is the Associate Director of the Center for Health & Pharmaceutical Law & Policy. He has distinguished himself as an internationally recognized scholar in health, intellectual property, and information law. He has made numerous academic presentations at universities across North America and at the National Academy of Sciences. A prolific writer, Professor Pasquale’s work has been featured in top law reviews, books, peer-reviewed journals, and online blogs, including Health Reform Watch, of which he is Editor-in-Chief. A frequent media presence, he has appeared in the New York Times, San Francisco Chronicle, Los Angeles Times, Boston Globe, Financial Times, and on CNN, WNYC’s Brian Lehrer Show, and National Public Radio’s Talk of the Nation.
Professor Pasquale has testified before Congress and before the New York City Broadband Advisory Commission. He has presented before the Task Force on Competition Policy and Antitrust Laws of the House Committee on the Judiciary, appearing with the General Counsels of Google, Microsoft, and Yahoo.
At Seton Hall Law, Professor Pasquale has taught courses in health care finance and regulation, intellectual property law, and administrative law. He received his J.D. from Yale Law School, his M.Phil. from Oxford University, and his B.A. summa cum laude from Harvard University.
As the Schering-Plough Professor in Health Care Regulation and Enforcement, Professor Pasquale will contribute scholarship which will include public policy analysis of issues related to administrative law, the regulatory and enforcement concerns of providers and patients, FDA law, and drug and device innovation.
This Professorship was made possible by a $2.5 million endowment from the former Schering-Plough Corporation and the Schering-Plough Foundation. The Schering-Plough Foundation supported the advancement of health, education, public policy, and community initiatives.
Former UN Special Rapporteur Paul Hunt on International Law & Health as a Human Right & the Human Rights Responsibilities of Pharmaceutical Companies
Professor Paul Hunt. Photo by Sean Sime Photography
During his week-long visit to Seton Hall Law School, Paul Hunt, Professor of Law, University of Essex School of Law, provided several lectures to students and faculty on international human rights law and health law. These guest lectures included “Health as a Human Right” in Professor Elizabeth Defeis’ International Law class; “On Human Rights Guidelines for Pharmaceutical Companies” in Professor Kathleen Boozang’s Pharmaceutical and Medical Device Marketing and Compliance Class; a faculty colloquium on “GlaxoSmithKline and the Human Right to Healthcare;” and participation in classroom discussion of human rights issues raised by hospitals’ repatriation of indigent aliens in Professor Lori Nessel’s Immigration & Human Rights Clinic.
In his public presentation, “The Human Rights Responsibilities of Pharmaceutical Companies,” Professor Hunt argued that pharmaceutical companies have certain social/human rights responsibilities, including the duty to take reasonable steps to enhance equitable access to medicines. You can find an audio recording of this presentation below as well as copies of Professor Hunt’s Reports to the UN General Assembly regarding “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” and “the responsibilities of pharmaceutical companies, including innovator, generic and biotechnology companies, with regard to the right to health in relation to access to medicines.”
Professor Hunt practiced as a litigation solicitor in London before specializing in international and domestic human rights law. He has undertaken human rights work in Europe, the Middle East, Africa and the South Pacific. From 2002-2008, he served as a UN Special Rapporteur on the right to the highest attainable standard of health, and in 2008, was awarded Honorary Doctorate by the Nordic School of Public Health. He is a member of the Human Rights Centre at Essex University and Adjunct Professor at Waikato University, New Zealand.
Professor Hunt’s lecture can be streamed to your browser by clicking on the link below. Clicking on this link will also provide you with a link to download the mp3. Click here to listen to Paul Hunt’s Lecture
The two UN reports mentioned by Mr. Hunt can be accessed by clicking on the thumbnails or captions below:
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| UN Report on Right to Health | UN Report on GlaxoSmithKline |
Recording of Sam Maizel’s Discussion of Distressed Hospitals
A noted expert in the restructuring of health care business debts, both in and out of court, Sam Maizel treated Seton Hall to a one hour crash course on the fiscal crisis encountered by many of America’s hospitals. The significant financial hurdles that the hospital industry is facing has made the bankruptcy process that many hospitals encounter one of the fastest growing fields in health law.
Mr. Maizel has represented the federal government as a trial attorney in the U.S. Department of Justice’s Commercial Litigation Branch. He also served in the JAG Corps in Operation Desert Shield and Desert Storm after serving in the 101st Airborne Division and the 3rd US Infantry Regiment. Mr. Maizel now practices in Los Angeles for Pachulski Stang Ziehl & Jones LLP.
You can download Mr. Maizel’s talk here, or alternatively, you can stream it to your browser by clicking “Play” below:
Recording of Professors Tim Greaney, John Jacobi, Frank Pasquale, and Sidney Watson Discussing Health Reform
On Friday, April 9th, Seton Hall was treated to an expert round table discussion on the new health reform measures.
Visiting professor Tim Greaney, as well as Seton Hall’s John Jacobi and Frank Pasquale, joined Professor Sidney Watson from Saint Louis University School of Law, to discuss the historic health care legislation to a packed crowd. Dean Kathleen Boozang served as the moderator of the panel discussion.
Topics discussed included a general overview of the Patient Protection and Affordable Care Act (PPACA), a discussion of the statute’s affect on Medicaid and Medicare, and the constitutionality of the individual mandate.
The panelists also discussed the strategies that they believe are required to properly implement PPACA’s immediate reforms, as well as the statute’s long term goals.
For background on PPACA, the Kaiser Family Foundation has posted a summary of the statute discussed by the panelists.
A recording of the round table discussion can be downloaded in MP3 format here. Alternatively, the recording can be streamed to your browser by clicking on the Play button below.
Seton Hall Announces Summer Study Abroad International Health Law Program
Filed under: Health Law, Health Policy Community
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
Online Graduate Certificate Program in Health & Hospital Law to Launch in April 2010
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy is set to launch a new online program in Health & Hospital Law. The new Graduate Certificate in Health & Hospital Law is a non-degree program designed for individuals who seek in-depth knowledge about legal, regulatory, and ethical issues related to health care delivery. Taught exclusively online, it offers students nationwide a targeted immersion in key substantive issues along with the practical skills necessary to research and communicate effectively about the law.
The intensive program is geared to busy professionals who want to cover a significant amount of material in a relatively short period of time. The program is open to students who have earned a baccalaureate degree from an accredited college or university. It is specifically designed to meet the needs of mid- to senior-level professionals in the health care industry, but highly motivated students from other backgrounds are also welcome to apply. It is not necessary to have prior academic or work experience in health care in order to do well in the program.
The first class begins April 18, 2010 and applications are being accepted now. Additional information is available at: law.shu.edu/onlinecertificate
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy Issues White Paper Calling for Major Reforms in the Financing and Oversight of Clinical Research
Filed under: Conflicts of Interest, Research, Transparency
Seton Hall University School of Law’s Center for Health & Pharmaceutical Law & Policy has called for major substantive reforms in the financing and oversight of clinical research. In a White Paper entitled “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” the Center proposes legal and policy changes to address conflicts of interest in the relationships between industry and doctors that can create unwarranted risks to trial participants and to the scientific integrity of research.
Kathleen Boozang, a dean who oversees the Law School’s Center, explains that “Some of the ways that drug and device trial sponsors pay the physicians who lead clinical trials can tempt them to recruit individuals for clinical trials who would be better off receiving conventional therapy. This is of particular concern if physicians encourage their own patients to enroll in trials that these same physicians are overseeing.”
Over 60% of testing of experimental drugs and medical devices now occurs in physicians’ private offices; unlike years past, industry funds a much higher percent of clinical trials than government, frequently paying researchers significantly more than government does. For some physician practices, conducting clinical trials represents a significant portion of their income.
According to Carl Coleman, a Seton Hall Law professor who collaborated on the White Paper, “A different kind of problem arises if people are enrolled in trials who don’t meet the criteria for who should participate - these individuals’ health can be put at risk, and their participation can skew the results of the trial, which is bad for everyone.”
Federal regulations in this area have not kept up with the rapid changes in how research occurs, and even those regulations that exist are poorly enforced, according to recent government studies. Understanding that the collaboration among industry, government, and medicine in the pursuit of clinical research is critical to driving scientific progress, particularly as industry increasingly replaces the government as the primary source of research funding, the Center’s recommendations include:
1) Establishing a norm of financial neutrality between treatment and research. Ensuring that physicians receive comparable compensation for treatment and research will help ensure that their decisions to conduct research, as well as to recommend that a particular individual participate in a clinical trial, are grounded in reasons unrelated to their personal financial interests. This will be best accomplished, in the first instance through regulations that ban certain kinds of research compensation, and provide examples of acceptable payment methodologies that industry can follow. Reform by prosecution signals what practices government dislikes, but does not provide a clear vision of ideal approaches to managing conflicts of interest related to the conduct of research.
2) Establishing federal guidelines as to the principles or methodology by which to determine fair market value of physician time spent in clinical work. Federal regulations should be promulgated that establish a benchmark formula for determining fair market value of physicians’ time, effort and expenses for clinical research. Such regulations would promote the goal of financial neutrality between treatment and research. Physicians cannot be underpaid for research either - compensation for clinical trial work should therefore include reimbursement for any additional expenses that are unique to the research environment.
3) Banning payments with equity interests; disqualification of investigators who hold direct interests in the outcome of the research. Federal regulations should prohibit compensation for research in the form of an equity interest in the sponsor of a clinical trial. The law should preclude researchers who have investments that give them a direct interest in the outcome of the research from leading clinical trials. Where absolutely necessary, such individuals might appropriately serve as consultants.
4) Banning payments of finder’s fees and bonuses for recruitment and retention of trial subjects. Certain forms of compensation create conflicts of interest that can incentivize investigators to enroll individuals in a clinical trial who are too healthy or too sick to participate, or to deemphasize information that might discourage individuals from consenting to trial enrollment. Federal law should ban such compensation methods, including finder’s fees and bonuses for meeting recruitment and retention goals.
5) Reforming federal regulations to compel and better guide the evaluation of relationships between industry and would-be physician investigators prior to the commencement of research. The White Paper includes overlapping but sometimes distinctive recommendations for federal regulation to evaluate and oversee investigator or institutional conflicts of interest, both for research within and without academic medical centers. Specific to research outside of academic medical centers, federal regulations should spell out clearly the obligation of community-based physicians acting as investigators or institutions acting on their behalf to report information about compensation for research and other financial interests to Institutional Review Boards.
Summarizing the importance of this White Paper, Boozang states, “The pharmaceutical and medical device industries save millions of lives each year with their innovations. It is imperative that we maintain the integrity of research, and the public’s trust in the process.”
Seton Hall Law School’s Center for Health & Pharmaceutical Law & Policy. The Center is a think tank that fosters dialogue, scholarship, and policy solutions to critical issues in health and pharmaceutical law. As part of its mission, it convenes policymakers, consumer advocates, the medical profession, industry, and government in the search for concrete solutions to the ethical, legal, and social questions presented in the health and pharmaceutical arenas. The Center also runs a compliance training program covering the state and federal laws governing the development and marketing of drugs and medical devices. The White Paper, “Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight,” may be found here.
Seton Hall University School of Law, New Jersey’s only private law school and a leading law school in the New York metropolitan area, is dedicated to preparing students for the practice of law through excellence in scholarship and teaching, with a strong focus on clinical education. The Law School’s health law program has been ranked as one of the top programs in the country. Founded in 1951, Seton Hall Law School is located in Newark and offers both day and evening degree programs. For more information visit law.shu.edu.
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