And the Winners Are…
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”).
Center Examines PPACA’s Impact on NJ Health Insurance Law in Study Funded by the Robert Wood Johnson Foundation
In early 2011, the Center for Health & Pharmaceutical Law & Policy began efforts on a seven-month research study, “New Jersey Law Reform in Response to Patient Protection & Affordable Care Act,” in collaboration with the Rutgers Center for State Health Policy. Seton Hall Law’s research will address the interplay between the Patient Protection and Affordable Care Act (ACA) and State health insurance law, regulation, and practice.
Professor John V. Jacobi, Research Fellow & Lecturer in Law Kate Greenwood, and several law students are currently reviewing the legislative and regulatory changes that the ACA requires and permits New Jersey to make. They will develop a “cross-walk” between current law and law that is fully compliant with the ACA. They will also relate the provisions of the ACA to current New Jersey practice, and describe options available to the State of New Jersey as it undertakes the task of implementing the new Act. Seton Hall and Rutgers researchers will produce interim research briefs and a final paper incorporating legal, economic, and public policy analyses. The study is being administered by the Rutgers Center for State Health Policy and is funded by a grant from the Robert Wood Johnson Foundation.
And the Winners Are…
Filed under: Health Law, Health Policy Community
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”).
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.
60 Minutes, Glaxo’s Bad Day & Why Compliance is So Terribly Important
Filed under: Compliance, Pharma, Quality Improvement
In case you missed it: 60 Minutes segment with whistleblower Cheryl Eckerd, a former manager of global quality assurance for GlaxoSmithKline. She describes her experience inspecting Glaxo subsidiary, Cidra, in Puerto Rico. It views like an in-house counsel’s nightmare and a PR professional’s worst day. CBS states:
“But in November, we found out just how much could go wrong at one of the world’s largest drug makers. A subsidiary of GlaxoSmithKline pleaded guilty to [a felony] distributing adulterated drugs.
“There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough.”
Ms. Eckerd brought suit under the Federal Whistleblower Act, with the government ultimately recovering $750 million; Ms Eckerd who was “downsized” by Glaxo, received $96 million as her share of the recovery. In addition, when Ms. Eckerd made the information she had gathered about the plant in Puerto Rico available to the FDA, federal agents executed a search warrant and seized drugs worth “hundreds of millions of dollars.”
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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Risks to Directors and Trustees of Health Care & Life Sciences Companies: Corporate Compliance in a Distressed Economy
Filed under: Compliance, Health Policy Community
“Risks to Directors and Trustees of Health Care & Life Sciences Companies: Corporate Compliance in a Distressed Economy,” was sponsored by Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, Epstein Becker & Green P.C., and Navigant Consulting, Inc. The program urged profit and nonprofit health care organizations to prioritize effective corporate compliance programs, particularly in today’s economy.
Moderated by Professor Kathleen Boozang, the program featured keynote speaker Mark Anderson, the New Jersey Medicaid Inspector General, as well as presentations by Lynn Shapiro Snyder and Hervé Gouraige of Epstein Becker & Green P.C. and Sandra Piersol and Geoffrey Kaiser of Navigant Consulting, Inc.
The participants focused on the financial challenges and potential exposure for board members of health care and life sciences entities in maintaining an effective compliance program in order to minimize noncompliant behavior and corporate liability risks. Current trends in HHS Corporate Integrity Agreements (CIA’s) have shown a movement toward imposing personal liability on boards of directors for failure to ensure that a company has an effective corporate compliance program.
Inspector Anderson first addressed the 2007 statute governing the New Jersey Office of Medicaid Inspector General, focusing in particular on the statute’s broad definitions of “fraud” and “abuse,” which allows his office broad discretion. Asking the key question, “is your compliance compliant?”, he emphasized that effective compliance programs go beyond simple written policies and procedures, but are specific to the entity’s need to prevent fraud and abuse, and are supported at every level of management — with the tone set “at the top.” He concentrated on one specific element of compliance programs — self-disclosure of problems within one’s own organization — and stressed that self-disclosure is essential to compliance and is in the company’s best interest, as his office provides incentives to health care entities to self-disclose. These incentives include forgiveness or reduction of interest payments, waiver of penalties and/or sanctions, timely resolution of overpayment, and a decrease in likelihood of imposition of an OMIG Corporate Integrity Program.
Lynn Shapiro Snyder, Co-Chair of the Health Care Fraud Practice Group at Epstein Becker & Green, spoke about the looming threat of enforcement activities aimed at board members of health care and life sciences entities, and noted that, until recently, the risk has been reputational rather than legal. She highlighted the blurred line between governance and management obligations, and questioned whether boards need their own consultants to determine whether to sign off on a company’s compliance program. Later, suggesting a simple, cost-effective way to examine the effectiveness of a compliance program, she recommended that compliance officers file (and follow) a “dummy report” within their own organization, thereby bringing to light gaps and issues in the company’s program.
Sandra Piersol, a Director with the Healthcare Disputes and Investigators practice at Navigant Consulting, addressed how directors and trustees can determine whether they have an effective corporate compliance program. Discussing the seven elements of an effective compliance program, she emphasized ensuring that the compliance officer has direct access to the board of directors, setting the “tone at the top,” and the need for ongoing training and communication. She provided a list of structural and operational questions to be considered when examining whether an entity’s corporate compliance program is effective, and concluded with the recommendation that boards should request the performance of an objective and comprehensive review of the program activities performed by persons independent of the compliance program.
Hervé Gouraige, Co-Group Leader of the National Litigation Practice at Epstein Becker & Green, spoke about the risk to board members of personal liability for an ineffective compliance program. After an overview of the law as it relates to board oversight of compliance, Gouraige discussed the requirement that companies have a process established to address compliance risks within the organization. Second, he underscored that the process must be executed by the chief compliance officer and monitored by the board. Finally, he explained that the board must be involved in the selection of a chief compliance officer who is capable of, and willing to, stand up to the board. He stressed that the chief compliance officer should not also be the general counsel, due to the conflicting duties and obligations of those positions. He also suggested that there be a separate board committee — which includes the CEO, general counsel, and chief compliance officer — to monitor the compliance program. Annually, this committee should meet without the CEO and general counsel as well. Finally, Gouraige suggested that in order to learn about — and address — problems before a prosecutor does, compliance officers periodically spot check internal emails between employees.
Geoffrey Kaiser, Managing Director in the Healthcare Dispute, Compliance and Investigations Practice at Navigant Consulting, focused on the benefits of having an effective compliance program. He noted that, although it is difficult to quantify the harm avoided by any program, an effective program can reduce or mitigate the risk of violations, particularly through education, which is a cost-effective way to sensitize employees to risk. Second, having an effective voluntary information and reporting system allows a board of directors to introduce corrective measures proactively. Third, having an effective corporate compliance program in place can influence prosecutorial discretion. In addition, having an effective compliance program can reduce the severity of penalties facing an organization at sentencing — not only affecting the amount of the fine, but also the range in which the fine will be imposed.
Overall, each speaker highlighted the cost-effectiveness and benefits of devoting resources to an effective compliance program. Inspector Anderson, stating that the economic environment cannot dictate compliance policies, emphasized that cutting such programs is short-sighted and a future compliance violation could potentially decimate a company in the long run. Gouraige explained that it would be a terrible mistake to cut compliance, due to the “wisdom of the long-term investment.” The speakers, in a question and answer session moderated by Professor Boozang, addressed effective ways to increase board attention to corporate compliance, including focusing on corporate compliance as one of the many legal requirements required by boards and underscoring the investment — rather than the cost — of implementing an effective corporate compliance program. As attendee Eve Costopoulos of Merck aptly stated, “if you don’t pay today, you’ll pay tomorrow.”
All Photos by Sean Sime
Turning Up the Heat on Fraud and Abuse–Part of the Solution to Health Reform?
Giotto di Bondone, The Seven Vices: Envy (1266-1337)
[Ed. note: As noted in the post above, we are very pleased to welcome the Executive Director of the Center for Health & Pharmaceutical Law & Policy, Tracy E. Miller, J.D., to Health Reform Watch today.]
As the search for new sources to fund health care reform intensifies, it seems more certain that increased enforcement of fraud and abuse will be part of the equation. Both the House and Senate have incorporated increased enforcement as part of health care reform legislation. The health care reform bill released by House Democrats on July 14, 2009, included an additional $100 million to combat fraud and abuse as well as increased mandates for regulatory oversight and provider compliance programs. The reform bill adopted by the Senate Health, Education, Labor and Pensions Committee on July 15 also embraced new enforcement measures, creating senior level positions at HHS and DOJ to coordinate oversight activities. The bills follow on the heels of an announcement in May by the Obama Administration that it had created an interagency task force to coordinate fraud and abuse enforcement.
These new enforcement initiatives and proposals add to an already burgeoning increase in enforcement initiatives at the state and national levels, raising the question of whether additional programs can actually have a substantial impact beyond those already underway to combat fraud and abuse in the health care sector.
The Deficit Reduction Act (DRA) of 2005 provided states with an incentive to enact False Claims Act statutes similar to the Federal False Claims Act, allowing states to retain 10% of any funds collected under such acts. The impact of the laws adopted in the wake of the DRA is unfolding now in many states and will no doubt lead to a significant jump in qui tam actions. After a hiatus caused by litigation challenging the program, CMS has continued to roll out the Recovery Audit Contractors Program (RAC) which retains contractors paid on a contingency basis to identify fraud and abuse in the Medicare program. With funding and a mandate from Congress, CMS also established the Medicaid Integrity Program. The program authorizes CMS contractors to use data mining and analysis techniques that combine health care quality indicators, billing practices, and Medicaid reimbursement rules to predict aberrant billing practices in order to identify providers for audit.
At the state level, Attorneys General as well as state Medicaid fraud offices are also turning to data mining and analysis, enhancing their capacity to identify fraud and target their investigations.[1] State Attorneys General have increased their cooperation nationally, heightening the effectiveness of investigations and actions against corporations that conduct business in multiple states.
Whether increased enforcement funds and cooperation among federal agencies will actually produce significant dollars for health reform remains to be seen. But without question, the combined effect of mounting federal and state enforcement efforts has substantially increased the stakes for health care providers in undertaking a proactive approach to compliance. Indeed, growing use by federal and state enforcement agencies on data mining and analysis challenges providers to determine how they can use their own internal data to identify compliance problems and address them in advance of government action.[2]
[1] Using Data to Advance Compliance: Emerging Practices in Industry and Government
June 4, 2008
Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy program focused on best practices by industry to use data for compliance, and government use of data mining and analysis to enhance oversight. Lori Queisser, Senior Vice President, Global Compliance & Business Practices of Schering Plough and Eileen Erdos, Principal of Ernst and Young, provided insight about how industry can use data to inform internal compliance programs. James Sheehan, New York State Medicaid Inspector General and John Krayniak, Assistant Attorney General, New Jersey Medicaid Fraud Control Unit, spoke about government initiatives to use data to target and pursue enforcement. The program, by invitation only, afforded industry counsel the opportunity to have a dialogue with the region’s two leading state prosecutors. The point being, that the success of enforcement initiatives is not only measured in prosecutions, but also in industry tailoring its behavior to be in compliance.
[2] Using Data to Advance Compliance
On March 16, 2009, the Center for Health and Pharmaceutical Law & Policy co-sponsored a program with KPMG on Using Data to Advance Compliance. The program, held in New York City for an audience comprised primarily of hospital leaders in compliance, finance, and in-house legal services, featured a presentation by James Sheehan, Medicaid Inspector General for New York State, who discussed how the Office of Medicaid Inspector General is using data to target and pursue investigations. Experts from KPMG presented practical, concrete strategies for how facilities can use data to advance internal compliance efforts. Ed Kornreich, a partner at Proskauer Rose, examined the implications of data mining for Board fiduciary duties.
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