The keynote speaker will be Dr. Jeffrey Brenner, founder of the Camden Coalition of Healthcare Providers, and 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. One such distinguished presenter is Jessica Mantel, Co-Director of the Health Law & Policy Institute, University of Houston, Law Center and Assistant Professor of Law. Professor Mantel will take part in the panel concerned with “ACOs in Theory: Issues Raised by Integrated Delivery,” and will be presenting ACOs: Can we have our cake and eat it too?
Professor Jessica Mantel joined the University of Houston Health Law & Policy Institute as co-director after eight years of service with two government agencies in Washington, D.C. She worked most recently as a senior attorney in the Office of the General Counsel for the Department of Health and Human Services. In that position she advised Centers for Medicare and Medicaid Services on legal issues dealing with Medicare matters, including implementation of the prescription drug benefit, hospital payments, incentive payments for the adoption of electronic health records, and health care reform. She previously worked as a health policy analyst in the Government Accountability Office evaluating Medicare payment issues. Prior to her service with government agencies, she practiced as an associate in the Health Care Department of the firm of Ropes & Gray in Boston and clerked for the Honorable Karen Nelson Moore of the U.S. Court of Appeals for the Sixth Circuit in Cleveland. Her research interests include the impact of various legislative and regulatory schemes on emerging trends in the health care delivery system and the allocation of limited health care resources. In 1997, Mantel received both her J.D. from the University of Michigan Law School and an M.P.P. from the University of Michigan School of Public Policy. She also holds a B.A. in psychology from the University of Pennsylvania.
Two promising health law students were recently awarded scholarships to attend Seton Hall Law’s Healthcare Compliance Certification Program this June. The program immerses attendees in the laws, regulations, industry codes and compliance standards applicable to the life sciences industry. This year, the scholarships, which are given annually, were awarded to Jenna Smith, a 2L at Loyola University Chicago School of Law, and Abraham Gitterman, a 2L at the University of Maryland School of Law.
For more information on the scholarships and on how students may apply for next year, click here (and scroll down past “Government Scholarships”).
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.
Findings suggest detainees were unnecessarily dosed with a medication known to induce hallucinations, paranoia and psychosis
Seton Hall University School of Law’s Center for Policy and Research has issued a report, Drug Abuse: An Exploration of the Government Use of Mefloquine at Guantánamo, documenting the medically inappropriate use of a dangerous pharmacological treatment on Guantánamo Bay detainees.
According to the report, the U.S. military routinely administered mefloquine, a controversial malaria treatment, at five times the standard prophylactic dose. Mefloquine, even at the standard dose, is known to cause adverse side effects such as paranoia, hallucinations, aggression, psychotic behavior, memory impairment, convulsions, suicidal ideation and possibly suicide.
The prophylactic dose of mefloquine is 250 mg. On arrival at Guantánamo, as a matter of standard operating procedure, detainees received 1250 mg of mefloquine. The larger dose of mefloquine was administered without taking a patient history of any kind.
Dr. G. Richard Olds, tropical disease specialist and founding Dean of the Medical School of the University of California at Riverside, commented on the long-lasting effects of the drug: “Mefloquine is fat soluble, and as a result, it does build up in the body and has a very long half-life. This is important since a massive dose of this drug is not easily corrected and the ’side effects’ of the medication could last for weeks or months.”
The Centers for Disease Control and Prevention reports, and the U.S. military concedes, that malaria is not a threat in Guantánamo. For that reason, U.S. military personnel and contractors are not prescribed any prophylactic anti-malarial medication.
“Mefloquine was administered to detainees contrary to medical protocol or purpose,” commented Professor Mark P. Denbeaux, Director of the Seton Hall Law Center for Policy and Research. “The record reveals no medical justification for mefloquine in this manner or at these doses. On this record there appears to be only three possible reasons for drugging these men: gross malpractice, human experimentation or ‘enhanced interrogation.’ At best it represents monumental incompetence. At worst, it’s torture.”
Dean Olds concluded, “In my professional opinion there is no medical justification for giving a massive dose of mefloquine to an asymptomatic individual. I also do not see the medical benefit of treating a person in Cuba with a prophylactic dose of mefloquine.”
Professor Stephen Soldz, Director of the Center for Research, Evaluation, and Program Development, Boston Graduate School of Psychoanalysis and President of Psychologists for Social Responsibility, added, “For years there has been an almost complete lack of transparency regarding medical practices and procedures at Guantánamo. The military has failed to provide credible explanations for its procedures. Detainees and their attorneys have been denied access to their own medical records, an egregious ethical violation. All health providers should join the call for Guantánamo to respect fundamental rules regulating medical ethics everywhere.”
The report, Drug Abuse: An Exploration of the Government Use of Mefloquine at Guantánamo, may be found here.
TruthOut.org published an article independent of the Seton Hall Law report. Read it 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 Center for Policy and Research enables students to gain practical experience while engaging in research and analysis that promotes respect for the rights of individuals worldwide. The students examine primary sources pertaining to national security law and practices of the U.S. government, as well as the reliability of forensic evidence for criminal investigations and prosecution. Seton Hall Law is located in Newark, NJ and offers both day and evening degree programs. For more information, visit http://law.shu.edu.
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.
On August 19, 2010, on behalf of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Seton Hall Law Professors Kathleen Boozang and Carl Coleman, along with Research Fellow Kate Greenwood, submitted comments on the National Institutes of Health’s proposed revisions to its regulations governing conflicts of interest in federally-funded research. While the Center’s November 2009 White Paper Conflicts of Interest in Clinical Trial Recruitment & Enrollment: A Call for Increased Oversight endorsed limits on conflicts of interest beyond those that the NIH has proposed, the revised regulations are a step in the right direction and in its comments the Center commends the NIH for its decisive action on this issue.
Briefly, the Center:
Supports the NIH’s proposal that that researchers disclose to their institutions any significant financial interest that “reasonably appears to be related to the Investigator’s institutional responsibilities,” with “institutional responsibilities” defined to include “activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.” This comports with the Center’s recommendation in the White Paper that investigators not be charged with determining for themselves whether one or more of their financial interests could be affected by a specific research project.
Supports the NIH’s decision to significantly lower the monetary threshold at which a researcher’s financial interest becomes “significant” to $5,000, but argues that a lower threshold would be better. Collection of data about all of a researcher’s relationships with industry, even those that fall below the proposed $5,000 threshold, would facilitate better conflict of interest assessment and management and make possible research into the effects of conflicts on research integrity and human subject welfare.
Supports the NIH’s decision not to exclude income from non-profit entities for lectures and similar engagements from the definition of significant financial interest and its conclusion that any equity interest in a non-publicly traded entity is significant, as are any and all intellectual property rights, but encourages the agency to revisit its decision to shield from disclosure (1) equity interests held by investigators in commercial or for-profit institutions and (2) royalties and other remuneration other than salary paid to an investigator by an institution that appoints or employs him or her.
Notes that the draft revised regulations do not address the White Paper’s criticisms that the conflict of interest regulations place no “substantive limits on the kinds of conflicts that may exist” and fail to put forth “a required minimum response for conflicts that pose the greatest risks to participants and the integrity of the research” and encourages the NIH to consider again the benefits of setting forth required minimum responses to those conflicts that are the most problematic.
Supports the NIH’s decision to require that grantees provide “sufficient information to enable the [agency] to understand the nature and extent of the financial conflict, and to assess the appropriateness of the Institution’s management plan.”
Supports the requirement in the draft revised regulations that any significant financial interest that (1) is still held by a principal investigator or senior/key person, (2) is related to PHS-funded research, and (3) is a financial conflict of interest must be disclosed to the public via the world wide web.
Supports the draft revised regulations’ requirement that investigators complete training on “the Institution’s policy on financial conflicts of interest, the Investigator’s responsibilities regarding disclosure of significant financial interests, and of these regulations” before the commencement of research and then at least once every two years. As recommended in the Center’s White Paper, it would be beneficial for the training to include as well a discussion of the nature of conflicts of interest and their potential for harm.
Recommends that the agency adopt its own suggestion that institutions be required to “maintain up-to-date, written, enforced policies” on institutional conflicts of interest, as they are for investigator conflicts, and that these policies be made publicly available via the world wide web. The nudge this requirement would provide is necessary because institutions have been slow to develop and adopt policies on institutional conflicts.
Recommends that the section of the regulations devoted to remedies be revised to include a non-exclusive list of potential enforcement actions such as temporary withholding of cash payments pending correction of the deficiency, suspension or termination of the contract or grant in whole or in part, monetary assessments and penalties, and suspension or debarment from eligibility for future contracts or grants.
The Center’s comments in their entirety are available here.
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 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:
OECD Convention & Other Anti-corruption StandardS
UK Bribery Act: Current Perspective & History
To Europe and Beyond: the Impact of the U.S. Foreign Corrupt Practices Act
EU Competition Law in Healthcare
Approval Processes for New Drugs & Devices
Harmonization Efforts by the European Medicines Agency & U.S. Food & Drug AdministratioN
A Sampling of Healthcare Reimbursement & Delivery Programs Around the World
Current Transnational Landscape for Enforcement by Authorities
Lessons Learned from U.S. Healthcare Fraud & Abuse Enforcement and Compliance Programs
Scientific & Educational Activities • Managing Risk: Third Party Relationships
Global Anti-Corruption Issues and Efforts: A View from Trace International
Organizational & Operational Keys to Effective Compliance Program Organization
Beyond Sales & Marketing: Interactions with Government Officials Throughout the Product Life-cycle
Advertising and Promotion of Drugs, Devices and OTC products
Public Procurement Processes for Healthcare Products & Services
Role of Drug & Device Industry Codes
Privacy & Data Protection Laws as Related to Anti-corruption Compliance
Assessing and Demonstrating Compliance Program Effectiveness
[Ed. note: We are pleased to welcome to the blog Michael Poreda, a 3rd year student here at Seton Hall Law and the Executive Director of its Urban Education Law and Policy Initiative (UELPI)--a student organization formed to promote awareness of, dialogue about, and activism benefiting urban education. On April 5, 2010, UELPI will be convening a panel to discuss the challenges of administering special services to students with autism in urban communities.]
I recently sat down with Leslie Long and Michele Adubato of Newark’s North Ward Center to discuss the issue of autism services in Newark. Founded in 1970, the North Ward Center is a non-profit community development organization that delivers social services to low-income families in Newark and Essex County through five institutions. In 2011, the Autism Center will become the sixth institution. The Autism Center will be headed by Michele Adubato, a former special education teacher and school administrator who has worked with children with autism for many years. Leslie Long comes from a background of public policy. She has directed programs for people with developmental disabilities throughout New Jersey.
I went to speak with Adubato and Long after finding that New Jersey has the highest autism rates in the country, yet the reported rates of autism in Essex County are lower than in surrounding communities and lower than the state average.[1] I wanted to know if students with autism in Newark were getting the same services as students elsewhere in the New Jersey, and if not, whether law or policy played a role in the disparity.
Adubato is disturbed by the Newark school system’s proclivity not to diagnose children with autism because of a policy against stigmatization. Adubato says the key with autism is early intervention. The stigma-avoiding “wait-and-see” approach that the Newark school system often takes with children exhibiting autism-like behaviors avoids early intervention.
The problems facing children with autism in Newark are many. At basic level, many parents are simply unaware of the symptoms of autism, the services available, the prognoses, or their rights. Even when a parent is concerned about a child’s development, the parent may find the public schools resist diagnosis and the entitlement to special services that comes with the diagnosis. Furthermore, in Adubato’s experience, the schools in Newark are not delivering the same caliber of services that are delivered in some suburban schools. Even if a parent does get a diagnosis and some services, parents are unaware of their legal rights concerning the schools system’s proposed special education plan for the disabled student. It is common for schools to select achievement goals for students with autism that do not actually address the most pressing issues of self-expression. Parents are often unaware that they have a right to refuse the school’s proposed Individualized Education Plan (IEP) and to demand what they deem an appropriate IEP.
The transition into adulthood poses another major legal problem for students with autism. Special services are only available through the school system up to age twenty-one. Afterwards, the state administers services to people with autism through the Department of Developmental Disabilities (DDD). Getting an approval for services can be downright treacherous. Ms. Adubato related one frustrating story of a grandmother who was told that her autistic grandson needed to write his own application for special services. DDD then used the grandson’s ability to write an application for special services as evidence that he wasn’t entitled to special services.
When it is inaugurated, the Autism Center will become a “one stop shop” for people with autism. It will be a charter school for children with autism and provide parents with legal guidance for navigating the confusing bureaucratic world of special services.
On April 5, 2010 at 4pm, UELPI will host “Serving Urban Students With Autism: Newark, New Jersey,” a panel discussion at Seton Hall University School of Law. We plan to bring together an educator, a parent, a lawmaker, a lawyer, and a member of an urban board of education to discuss the challenges of delivering services to students with autism in urban communities. Kim Williams will share the challenges she faced as the parent of a student (now an adult) with autism who passed through the Newark public schools. Michele Adubato will discuss why she left Newark schools after years of service there to found a special autism charter school. Assemblywoman Grace Spencer will comment on the state’s recent efforts to help people with autism, and Attorney Paul Prior will share his perspective on the legal issues facing students with autism. Suzanne Mack, a long-time member of the Jersey City Board of Education and the parent of an autistic child, will discuss her perspectives on building a large urban autism program. The panel is tailored to meet the interests of a diverse audience: students, educators, parents, and lawyers all stand to gain important insights from this dialogue.
Be heard. All are welcome to attend, free of charge; reception to follow. Seton Hall Law University School of Law, One Newark Center, Newark, NJ 07102. RSVP at Urbaneducationandpolicy@gmail.com
[1] In 2007-2008, New Jersey’s average rate of enrollment of students with autism of 2.29 per 1000. Essex County’s rate was 2.0 per 1000. See Nancy Scotto Rosato & Sandra Howard, Reporting of Autism in the New Jersey Special Child Health Registry Prior to the Implementation of the 2007 Mandatory Reporting Law, available at http://www.state.nj.us/health/fhs/eis/documents/report_on_autism.pdf.
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.
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
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) Banningpayments 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.
“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.
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.”
The thought of it might have kept Michelle Obama awake at night, but it’s a real issue that happens more often than is recognized. Insurance companies can deny coverage to men and women who have been victims of domestic violence. They often do. Through detailing the story of a 52-year-old attorney who was denied health insurance due to a past incidence of domestic violence, a recent article by Kaiser Health News helps to illustrate the prevalence of such practices among insurance providers.
Last Tuesday, House Speaker Nancy Pelosi addressed the treatment of domestic violence as a pre-existing condition before Congress. She said that Democrats were no longer going to accept this practice and promised that such would be banned in forthcoming health care reform legislation. Another Democrat engaged in the fight is Senator Patty Murray of Washington, who is a member of the Health, Education, Labor and Pensions (HELP) Committee. In 2006, Murray attempted the same type of reform by introducing an amendment to ban domestic violence as a pre-existing condition; the amendment did not pass. One of the “no” votes came from Senator Michael Enzi of Wyoming. He’s still on the HELP Committee and sits there now as its highest ranking Republican.
Some states have already taken the matter into their own hands, but 8 states and the District of Columbia still do not disallow insurance companies to reject coverage to men and women who have been victimized by domestic violence. Read more
The American Society of Law, Medicine & Ethics (ASLME) and Seton Hall University School of Law will co-sponsor the Third Annual Student Health Law Conference on Friday, October 16, 2009 in Newark, New Jersey, from 8:30AM to 5:00PM.
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.
Today at Health Reform Watch we are truly pleased to introduce and welcome Neelu Pal, MD. She is both a board certified surgeon and a first year law student (”One L”) here at Seton Hall Law. Dr. Pal will be writing a regular column for us as she traverses the rigors of her first year in law school. The first year is hard– and transformative in a way that is actually rather hard to express: one simply does not think the same after the experience. Many have ably chronicled the process– Scott Turow’s One L is a classic; Paper Chase (yes I am that old) a personal favorite.
Turow:
In baseball it’s the rookie year. In the navy it is boot camp. In many walks of life there is a similar time in trial and initiation, a period when newcomers are forced to be the victims of their own ineptness and when they must somehow master the basic skills of the profession in order to survive. For someone who wants to be a lawyer, that proving time is the first year of law school.
Professor James R. Elkins,College of Law, West Virginia University on Turow’s One L and the first year of law school:
If legal education is an authentic rite of passage it may reflect an underlying archetypal transformation.
But perhaps most interesting– and not so well chronicled– is that Neelu Pal comes to this experience as a full fledged surgeon– schooled entirely in another method of thought. It is this meeting of the minds; this melding of law & medicine that we find fascinating– and truly look forward to publishing over the course of this next year. We here at Health Reform Watch and Seton Hall Law invite you to visit– Where Law & Medicine Meet.
About Dr. Pal
Neelu Pal is a board certified general surgeon who completed residency training in 2005 at University of Medicine and Dentistry in Newark. She went on to complete fellowship training in Bariatric surgery at University Medical Center at Princeton in 2007. She is currently self employed and in the process of starting a private practice in Jersey City. She believes that the law and medicine are based on similar profound ethical principles and is interested in this confluence and the impact that it has on health care delivery. She is especially interested in the areas of patient safety, fraud and abuse and drug and device law. Read
Curriculum Vitae
Self Employed as aConsultant for FairCode Associates, MD and Advanced Medical Reviews, CA
Fellowship in Bariatric Surgery – University Medical Center at Princeton, Princeton NJ
General Surgery Residency - University of Medicine and Dentistry (UMDNJ), Newark, NJ
Internship - University of Kansas Medical Center, Kansas City, Kansas
Postgraduate Training - Department of Surgery Armed Forces Medical College Pune, India
Medical Education - Bangalore Medical College, Bangalore, India
Board Certification by the American Board of Surgery
Medical Licenses
New York State License - Unrestricted, Current Certificate
New Jersey State License - Unrestricted, Current Certificate
Pennsylvania State License - Unrestricted, Current Certificate
Memberships
American Medical Association (AMA)
American College of Surgeons (ACS)
Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)
American Women Surgeons (AWS)
Selected Research Experience
Research in the cellular effects of ischemia-reperfusion, University of Chicago, Department of Vascular surgery, 1999
Clinical study to compare the outcome of below-knee amputation in ischemic limbs performed by the Burgess (long posterior flap) and skew flap techniques, Armed Forces Medical College, 1997
Clinical study to determine the outcome of intra-arterial urokinase therapy for the management of limb ischemia due to thrombophlebittis obliterans, Armed Forces Medical College, 1996
Clinical study on the use of omental flap for revascularization of ischemic lower limbs, Armed Forces Medical College, 1995
Selected Publications and Presentations
“Sigmoid and Cecal Volvulus” Book Chapter, eMedicine, Feb 2008.
“Intestinal fistulas: surgical perspective” Book Chapter, eMedicine, Feb 2008.
“Radiation Enteritis and Proctitis” Book Chapter, eMedicine, Feb 2008.
“Effect of limb length in Roux-en-Y Gastric Bypass in patients with BMI 45-50 kg/m2″ Poster, ASBS Annual Meeting, San Diego, CA, June 2007.
“Bilopancreatic limb obstruction after Roux-en-Y Gastric Bypass” Poster, ASBS Annual Meeting, San Diego, CA, June 2007.
“The Malpractice Insurance Crisis in Medicine” Grand Rounds, Department of Surgery, UMDNJ, Newark, NJ, April 2005.
“Appendicitis and Pregnancy” Grand Rounds, Departments of Surgery and Obstetrics and Gynecology. University of Kansas Medical Center, Kansas City, KS, May 2001.
“Below knee amputation - study with special reference to skew flap and long-posterior flap techniques,” M.S. Dissertation,Armed Forces Medical College, Pune (India), March 1998.
“A case of carcinoid tumor of the kidney,“Presentation at the Armed Forces Medical College Symposium, Armed Forces Medical College, Pune (India), October 1997.
“A case of traumatic diaphragmatic hernia - unusual mode of injury,” Presentation at Command Hospital, Pune Surgical Society meeting, Pune (India), March 1997.
Posts from Health Reform Watch have been cited by media sources throughout the country, including The New York Times, Washington Post, L.A. Times, Kaiser Health News, The Health Care Blog, NPR's Planet Money Blog, Duke Univ. Med. Center News, American Health Line Alerts, BusinessWeek.com, Concurring Opinions, Balkinization, The New England Journal of Medicine, Harvard's Nieman Foundation for Journalism, Las Vegas Sun, Maggie Mahar, Ezra Klein, Tom Geoghegan, and the official homepage of the Office of the Democratic Majority Leader of the House of Representatives, Steny Hoyer.
Click on the blue links to play, click again to pause: Hatch-Waxman "Pay for Delay Audio:
Panelists included Michael Kades, Attorney Advisor, Federal Trade Commission; Charles A. Gallia, Counsel, Gibbons P.C.; Anastasia Winslow, Assistant General Counsel, Bristol-Myers Squibb; and David Opderbeck, Associate Professor of Law and Director, Gibbons Institute of Law, Science & Technology.
Hunt Lecture:
From the original post:
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
...Read More Maizel Lecture:
From the original post:
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 ...Read More PPACA Discussion:
From the original post:
On Friday, April 9th, Seton Hall was treated to an expert round table discussion on the new health reform measures. Visiting professor Tim Greaney ...Read More
A set of Commonwealth Fund–supported Health Affairs articles examines the potential of the Affordable Care Act's Small Business Health Care Options Program to provide affordable options for small employers who now face high premiums and administrative costs when they insure their employees.
Many small employers—which make up the vast majority of American businesses—struggle to afford and manage health insurance for their employees. Timothy Jost discusses how the SHOP exchanges will make it easier for small employers to offer affordable plans.
In this Commonwealth Fund–supported article, Jon Kingsdale argues that the reason many small firms do not currently offer health insurance to employees is not lack of availability—as there is a thriving commercial market for small-group coverage—but because of cost.
Only a few employers will take advantage of rules allowing some small businesses to avoid pending health reform measures, rendering the rules relatively obsolete and minimizing their impact on health insurance costs, according to new analysis and simulations conducted by health policy researchers.
The White House plans to announce a compromise designed to allay the concerns of religious organizations on a Health and Human Services rule that would require religious employers to cover birth control, a senior administration official confirmed to POLITICO.
Sometimes lost in the discussion of medical marijuana is the extent to which it has become a small but growing source of new tax revenue to cities and states.
The decision to soften a requirement that religious-affiliated organizations pay for insurance plans offering free birth control was meant to appease Catholics on the left — not bishops.
Let’s say your job is to take off at a sprint, get moving about 20 mph and slam yourself full speed into a brick wall — 60 times in a single afternoon. We’d give you a helmet and lots of padding to protect yourself. Because of the toll this would take on your body, we’d make you do it only once a week. And we’d reward you handsomely. Read full art […]
This is it. This is the year you finally get in shape, shed those pounds or meet that fitness pledge you made at 11:59 p.m. on Dec. 31. But do you have to build the new you in a hot, stuffy gym, cheek by jiggly jowl with a dozen other sweaty resolutionaries awaiting their turn on the elliptical machine? Read full article >>
I’m not saying my co-workers are fat. In fact, a fair number of them are toothpick skinny — including, unfairly, the guy who brings in his latest cupcake creation every other day. Many of them are also super-active, always running, biking and yoga-ing in their free time. Read full article >>
Listen up, ladies, because it’s confession time, and as you may know, this is not my gender’s forte. So let’s get this over with: Although we are bigger, stronger and faster than you are, we must acknowledge that when it comes to flexibility, most of us are pretty much outclassed. We aren’t built like you, and we don’ t bend like you do. Read full […]
When people ask me to list my favorite healthy foods, quinoa always tops the list. And not just because the National Restaurant Association named it the hottest trend in side dishes in 2010. My boys think I like quinoa because when it was first discovered it was named “the mother grain.” Yes, I am proud to be a mother myself, but check out all the real […]
A federal advisory panel voted down Eisai's attempt to gain an approval for Dacogen as a treatment for acute myeloid leukemia. The pharma company has been trying to gain an OK to use the drug for elderly patients for whom chemo has failed. The advisers voted 10 to 3 against, making any formal approval unlikely. Story
Investigators have turned in intriguing animal data suggesting that an orphan drug used to treat lymphoma may be effective in countering Alzheimer's disease. And with the news grabbing headlines around the world, researchers say they need to race to a more conclusive understanding of how the drug works in humans as physicians field demands for the treat […]
NeurogesX ($NGSX) finds itself on the ropes this morning, with its badly battered shares taking yet another beating after an FDA panel unanimously shot down an attempt to get an approval to use its pain patch for HIV-related neuropathy. Earlier in the week, regulators issued an internal assessment that NeurogesX never laid out a clear set of data supporting […]
The debate over the true cost of developing new drugs has created a virtual cottage industry of analysis in recent years. Critics maintain that the pharma industry has wildly overblown costs to justify the often extraordinary price it can place on a new product. Industry officials countered by citing Tufts' figure of more than a billion dollars per new […]
The FDA has finally issued its eagerly anticipated draft of rules governing the development of biosimilars, laying out a roadmap for a multibillion-dollar industry that's been rapidly taking shape under the wing of big biopharma companies and a slate of multinational players. Analysts quickly concluded that the rules largely fit a broad framework that F […]
Every new drug ever approved involved years of workby dedicated teams of investigators. In the case of the newcystic fibrosisdrug Kalydeco from Vertex ($VRTX), the story also includes Boston businessman Joe O'Donnell, who helped raise much of the money the Cystic Fibrosis Foundation used to back the development of the treatment. The Boston Globe toda […]
Drug developer Altheos has expanded its Series A round by an additional $12.5 million, just in time for the launch of a Phase IIa dosing trial for its glaucoma treatment. The South San Francisco startup can now herald the fact that its "A" round raised a not-insignificant $32.5 million. Existing investors Bay City Capital, Novo A/S, Canaan Partners […]
Japan's Takeda is adding a new drug development center in Shanghai intended to complement the international clinical work now under way in Singapore and Cambridge, MA. Both of the existing operations, including the cancer drug developer Millennium in Cambridge, work with contract research organizations to advance new treatments through the clinic. Now t […]
Just 10 months after abandoning its second effort to go public, Aldagen is selling out to a small regenerative medicine company for just $16 million in shares and the chance to earn another chunk of stock based on the clinical success of its stem cell therapies. The news isn't likely to spur much joy among its investors. Durham, NC-based Aldagen reporte […]
Since its launch back in 2009, Boston-based Acetylon Pharmaceuticals has fueled its work on a next-gen HDAC inhibitor with $40 million drawn from wealthy individual backers as well as the Leukemia and Lymphoma Foundation. But with its lead program in a classic Phase Ia dose-escalation safety study, Celgene has stepped in with a $15 million strategic investme […]
By Carolyn Y. Johnson, Globe Staff Robert Langer, a biomedical engineer at MIT best known for his contributions in the fields of tissue engineering and drug delivery, has been named the winner of the 2012 Priestley Medal, a prestigious prize...
Jonathan Wiggs / Globe Staff Photo Steve Nash, brother of Charla Nash, who received a full face transplant at Brigham and Women's Hospital late last month, appeared at a press conference today with his wife, Kate. Charla Nash did not...
Editor’s note: See another Health Affairs post on this topic by Tim Jost. How do you shop for health insurance today? For many of us, our employer makes the decision for us. And if there is a choice of health plans, the employer also provides helpful summaries of the benefits, premium differences, and cost-sharing so [...]
Editor’s note: Another Health Affairs Blog post, by Mila Kofman and Sabrina Corlette, also discusses the February 9 final rule implementing Affordable Care Act (ACA) requirements that health plans provide consumers with short, easy to understand summaries of benefits and coverage. Tim Jost’s post below discusses this new rule; additionally, it ha […]
The Affordable Care Act’s state health insurance exchanges for small businesses present a host of opportunities for states now creating them, but they also present design and regulatory challenges that could make or break the success of the program, according to a cluster of articles in the February issue of Health Affairs, released yesterday. The [...]
Despite wide institutional acceptance of a medical professionalism charter that endorses openness and honesty in physicians’ interactions with patients, not all doctors comply, according to a survey whose results are published in the February 2012 issue of Health Affairs, released today. Although about two-thirds of doctors responding to the survey did agr […]
Briefs continue to be filed at a furious pace in the Affordable Care Act Supreme Court litigation. On January 6, the federal government led off with its brief challenging the decision of the Eleventh Circuit federal court of appeals that the ACA’s minimum coverage requirement (individual mandate) is unconstitutional. The states and the National Federat […]
Press Release: Seton Hall University School of Law Launches European Healthcare Compliance Certification Programme in Paris 
June 21 - 25, 2010
[Ed. note: We are pleased to welcome to the blog Michael Poreda, a 3rd year student here at Seton Hall Law and the Executive Director of its Urban Education Law and Policy Initiative (UELPI)--a student organization formed to promote awareness of, dialogue about, and activism benefiting urban education. On April 5, 2010, UELPI will be convening a panel to discuss the challenges of administering special services to students with autism in urban communities.]
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 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.
“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, 
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 
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 
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.”
The thought of it might have kept 
The American Society of Law, Medicine & Ethics (ASLME) and Seton Hall University School of Law will co-sponsor the Third Annual Student Health Law Conference on Friday, October 16, 2009 in Newark, New Jersey, from 8:30AM to 5:00PM.
Posts from Health Reform Watch have been cited by media sources throughout the country, including The New York Times, Washington Post, L.A. Times, Kaiser Health News, The Health Care Blog, NPR's Planet Money Blog, Duke Univ. Med. Center News, American Health Line Alerts, BusinessWeek.com, Concurring Opinions, Balkinization, The New England Journal of Medicine, Harvard's Nieman Foundation for Journalism, Las Vegas Sun, Maggie Mahar, Ezra Klein, Tom Geoghegan, and the official homepage of the Office of the Democratic Majority Leader of the House of Representatives, Steny Hoyer.
