SPEAKER BIOGRAPHIES
|
Mark Barnes |
Mark Barnes, a partner at Ropes & Gray LLP, has
practiced and taught law and has administered governmental programs
in the health care field for the past 20 years. Educated at Yale Law School
and Columbia University School of Law, Mark taught full time at Columbia for
four years, and more recently has served as an Adjunct Professor of Law at a
number of law schools, including Brooklyn Law School and New York University
School of Law. He has taught courses in public health law, health care law
and finance, managed care law, and occupational health and safety.
Mr. Barnes served as the Director of Policy for the
New York State Department of Health AIDS Institute
in the early 1990s. In 1993, he was a consultant to
the White House National Health Care Reform Task
Force, and he served from 1992 to 1994 as Associate
Commissioner for Medical and Legal Policy for the
New York City Department of Health. In the mid
1990s, Mr. Barnes was the
Executive Director of the AIDS Action Council, where he lobbied and
advocated on AIDS funding and policy before Congress, federal agencies, and
the Office of the President.
Mr. Barnes represents hospitals, health care associations, physicians, social
services agencies, and related organizations in regulatory, reimbursement,
research, HIPAA compliance, and litigation matters.
He serves as a
member of the Advisory Committee for Human Research Protections of the
Secretary of the United States Department of Health and Human Services.
His recent articles on HIPAA compliance and conflicts of interest in human
research have appeared in the Journal of the American Medical Association
and in the BNA Health Law Reporter.
Mr. Barnes is recognized as one of the top lawyers in the field of research
compliance and HIPAA regulations. |
|
Michael D. Bell |
Michael Bell is Of
Counsel in Mintz Levin’s Washington, D.C. office,
where he practices in the firm’s Health Care
Section, specializing in legal and regulatory
matters arising under the Medicare, Medicaid and
other third party payment programs. He assists
health care organizations on a wide variety of legal
and strategic issues, but he concentrates his
practice on the areas of third party reimbursement,
fraud and abuse, compliance, and privacy and
electronic security issues. He also has significant
expertise in the regulation and operation of managed
care organizations, including Medicare Advantage
plans (formerly Medicare+Choice Organizations).
Mr. Bell was recently named General Counsel of Air
Products Healthcare, a premier regional home
healthcare provider in the New England, Northeast,
Mid-Atlantic, Chicago, Southeast and Tennessee
areas, and Senior Compliance Officer at Solaris
Health Systems, which operates a wide array of
organizations, services and facilities in central
New Jersey including acute care hospitals, inpatient
and outpatient rehabilitation centers, nursing and
convalescent facilities and specialized treatment
programs.
At Mintz Levin,
Mr. Bell serves as privacy counsel to over 40 health
care organizations, ranging from Fortune 50
companies to independent pharmacy organizations. He
assists covered entities, business associates, data
base architects and software designers on a variety
of complex disclosure issues, resolution of
incidents, policy and procedure formulation, and
strategic developments, including the design and
implementation of electronic medical record and
prescribing systems and FDA Part 11 complaint
databases. He is the manager of the firm’s HIPAA
partnership with the National Association of Chain
Drug Stores for which he oversees the continual
update of a 50-state privacy survey and preemption
analysis.
Michael is frequent speaker on the issues of privacy and security and is
the primary author of a widely-distributed HIPAA
Privacy Manual, a HIPAA Security Manual, which is
published by URAC, a book chapter in The HIPAA
Patient Privacy Compliance Guide (AIS Publishing),
and three online HIPAA training courses. He is a
legal reviewer for the NIST/URAC/WEDI Security
Workgroup where he has assisted in development and
review of HIPAA Security Standards crosswalks to
existing ISO, NIST, and CMS security standards.
He assists medical device manufacturers with a
variety of reimbursement-related issues, including
the establishment and revision of device and
procedure codes, coverage policies, and Medicare new
technology add-on payments. He also provides fraud
and abuse counseling, performs regulatory due
diligence and reimbursement analyses of device
manufacturers for corporations and investment banks,
and conducts legal training for sales
representatives.
Honors, Memberships and Publications
Mr. Bell was selected by Nightingale’s Healthcare News
as one of 14 Outstanding Young Healthcare Lawyers
for 2004. He is also a member of the Editorial Advisory
Boards for the Report on Medicare Compliance and The
Report on Patient Privacy, and he frequently writes
and presents at conferences and to trade
associations on the topics of privacy, security and
fraud and abuse compliance. In addition to the HIPAA
manuals described above, he is the author of
“Development of a Records Management System:
Evolution from Business Practice to Compliance
Practice” in the CCH Healthcare Compliance Guide.
Mr. Bell is admitted to practice in District of
Columbia and New Jersey, and is a member of the
American Health Lawyers Association and the American
Society for Pharmacy Law. He received his B.A. in
economics from Wake Forest University, and his J.D.
from Seton Hall University School of Law, with a
concentration in health law from the Health Law and
Policy Program. |
|
Kathleen Boozang |
Kathleen Boozang
is the Associate Dean for Academic Advancement and the
co-founder of the Health Law & Policy Program and
the Health Law Graduate Programs at Seton Hall
University School of Law in Newark, New Jersey. She
currently teaches Health Care Organizations, The Law
of Death & Dying, Alternative Medicine and
Non-Profit Organizations. Dean Boozang writes and speaks
extensively on alternative medicine, medical
futility, end-of-life care and sectarian providers.
Her current work focuses on the therapeutic
employment of placebos. Her most recent articles
address CAM usage with children, and managed care of
CAM.
Dean Boozang received her J.D. from Washington
University School of Law where she was Managing
Editor of the Law Review and was inducted into Order
of the Coif. In 1990, she received her LL.M. from
Yale Law School. Dean Boozang serves on several
hospital ethics committees and previously chaired
the Bioethics Committee for The Association of the
Bar of the City of New York. Professor Boozang is
also a member of the Board of the American Society
of Law, Medicine and Ethics and the New York State
Task Force on Life and the Law. She is Of- Counsel
to the firm of Greensfelder, Hemker and Gale PC in
St. Louis, Missouri. |
|
Thomas G. Goddard |
Thomas G. Goddard, JD, PhD,
CEO of Integral
Healthcare Solutions, has over 25 years of experience in law, health
and insurance policy research, and management consulting.
Dr. Goddard's consulting practice focuses on providing integral management
consulting and research services to public and private organizations, with
and emphasis on quality improvement in healthcare organizations. He also
provides integral life coaching services.
Before going into management consulting, Dr. Goddard was Chief Operating
Officer and General Counsel of URAC, a leading healthcare accreditation
organization. Dr. Goddard also has served as Vice President and General
Counsel of NYLCare Health Plans of the Mid-Atlantic; Counsel for
Government and Media Relations for the National Association of Insurance
Commissioners; President and CEO of the Goddard Public Affairs Corporation;
Director of the Alliance for Consumer Rights, State Legislative Counsel for
the Association of Trial Lawyers in America; Special Assistant to
then-Arizona Governor Bruce Babbitt; and a trial attorney in private
practice. Dr. Goddard is a founding member of the Integral Institute for
Medicine, and currently heads up Integral University's College of Integral
Healthcare Management.
Dr. Goddard received his B.A. in political science, his law degree from the
University of Arizona, and his M.A. and Ph.D. in industrial-organizational
psychology from George Mason University. Dr. Goddard has authored a
number of articles and book chapters and given hundreds of presentations
on a wide range of topics including integral theory, management analysis,
healthcare, and insurance.
|
|
John E. Hartwig |
Jack Hartwig is currently with Deloitte &
Touche (D&T) Dispute Consulting & Forensic Investigations
Practice in Philadelphia. Mr. Hartwig joined D&T in October 2001 after
a 30-year career in the Federal government. Since joining D&T,
he has worked on a number of health care dispute engagements,
including acting as an expert witness. He has also assisted external
legal counsel on Medicare voluntary disclosure matters.
Mr. Hartwig has
lectured extensively on a variety of health care issues, including
but not limited to, the Federal voluntary disclosure program and
research integrity. He has lectured on human research compliance issues
before the Health Care Compliance Association and the Alliance of
Independent Academic Medical Centers.
In Federal service Mr. Hartwig held numerous positions involving greater
responsibilities. He was appointed to the federal Senior Executive
Service in 1994 and spent seven years as the Deputy Inspector General
for Investigations, Office of Inspector General, United States Department
of Health and Human Services. Mr. Hartwig joined the Office of Investigations
in 1978 as a special agent, he conducted criminal health care investigations
in New York, New Jersey, and Puerto Rico. He was promoted to Assistant
Regional Inspector General for Investigations in 1984 and in 1989 was
promoted to Regional Inspector General for Investigations, Philadelphia
Field Office. He began his Federal career in 1972 as an auditor with
the United States General Accounting Office.
Mr. Hartwig has substantial experience in conducting fraud investigations, both
criminal and civil. He has critical experience in health care fraud
issues. He has met with Congressional staff on a number of high profile
topics and has testified before Congressional committees on issues such
as home health agency fraud and Medicare fraud. Mr. Hartwig has also
lectured extensively before numerous seminars and conferences on white-collar
crime and auditing topics.
|
|
John Krayniak |
Supervising Deputy Attorney General Krayniak is the
Director of the Medicaid Fraud Control Unit in the New Jersey
Attorney General's office. Mr. Krayniak has headed the unit for the
past nine and one-half years and has been a Deputy Attorney
General for the past fifteen years. He has also served as a
Supervising Deputy Attorney General in the Organized Crime and
Racketeering Bureau and as Acting Bureau Chief of the state-wide
Narcotics Bureau. Prior to joining the New Jersey Attorney
General's Office, he was a Deputy District Attorney in the
Los Angeles County District Attorney's Office. He served in that
office for over eight years in Trials and the Organized
Crime Unit. He served as a police officer in the Pasadena,
California Police Department for over eight years.
Mr. Krayniak is a graduate of Fairleigh Dickinson University with
a Bachelor of Arts Degree in Political Science. He received his
Juris Doctorate Degree from Southwestern University School of Law
in Los Angeles, California. He is a member of the New Jersey and
California Bars.
Mr. Krayniak has been actively involved in health care fraud issues
for the past nine and one-half years through the National Association
of Medicaid Fraud Control Units in Washington, D.C. He served on the
Executive Committee and the Training and Finance Committees of that
organization. He also served on the Center for Medicare and Medicaid
Services' Technical Assistance Group on Medicaid fraud issues.
Mr. Krayniak has lectured on issues in health care fraud law for the
Institute for Continuing Legal Education in New Jersey, the National
Association of Medicaid Fraud Control Units and professional
seminars. He has testified before two Congressional sub-committees
concerning Medicaid fraud.
|
|
Bruce A. Levy |
Bruce Levy is Counsel to Gibbons, Del Deo, Dolan,
Griffinger & Vecchione. Mr. Levy concentrates his practice on
criminal, civil, and administrative cases arising from federal and
state health care fraud investigations, health care compliance,
The False Claims Act and qui tam cases, corporate investigations
and white collar criminal law. Mr. Levy served as an Assistant
U.S. Attorney with the U.S. Attorney's Office for the District of
New Jersey from 1991-2001 and was the Office's Criminal Health Care
Fraud Coordinator from 1995-2001.
Mr. Levy has taught as an adjunct professor of health care fraud and
abuse at Seton Hall Law School. He is a frequent lecturer to private
and government groups regarding health care fraud issues. |
|
Kevin McAnaney |
Kevin McAnaney is a nationally recognized expert on health
care fraud and abuse. Mr. McAnaney has recently returned to private
practice concentrating on health care fraud and abuse matters, including
compliance reviews, transactional work, and civil and administrative
litigation.
Mr. McAnaney served as the Chief of the Industry Guidance Branch of the
Office of Counsel to the Inspector General from its creation in 1997 until
May 2003. The Industry Guidance Branch is responsible for issuing formal
guidance to the regulated community through advisory opinions, fraud alerts
and special bulletins, compliance guidances, and regulations related to the
fraud and abuse authorities enforced by the Office of Inspector General,
especially the anti-kickback statute and the Ethics in Patient Referrals
Act (“Stark I and II”). Mr. McAnaney also worked closely with the Department
of Justice in developing cases involving the anti-kickback and Stark
statutes, including the use of such claims as predicates for False Claims
Act litigation.
Prior to joining the Department, Mr. McAnaney was a partner in the
Washington, D.C. office of the Dewey Ballantine law firm where he
practiced in the health care, food and drug, and environmental areas.
From 1981 to 1983, Mr. McAnaney served as Assistant Counsel to New
York Governor Hugh Carey, where he was responsible for the Governor’s
agenda in the health and human services area, including Medicaid. Mr.
McAnaney began his career with the law firm of Kelley Drye & Warren,
during which time he served as the Director of Legal Affairs for the New
York Hospital, one of the premier teaching hospitals in the nation.
Mr. McAnaney is a graduate of the University of North Carolina at Chapel
Hill and the Columbia University School of Law, where he was a Harlan
Fiske Stone Scholar. He is an adjunct professor of law at the University
of Maryland Law School, a member of the Board of Directors of the
American Health Lawyers Association, and a frequent speaker on health
care fraud issues.
|
|
Kathleen McDermott |
Katie McDermott is a Partner in
Sonnenschein's Health Care Group where she represents
medical device and pharmaceutical manufacturers,
clinical research organizations, hospitals,
long-term care providers, payors, and a host of
other health care organizations in connection with a
broad array of health care enforcement, compliance,
litigation, and regulatory counseling matters. She
has been recognized as a leading False Claims Act
practitioner with both government and defense
experience. Specifically, Ms. McDermott
handles criminal, civil, and administrative
investigations and audits undertaken by federal and
state regulatory and enforcement agencies; defends
health care organizations in civil and criminal
False Claims Act qui tam actions, involving
allegations of health care fraud and abuse; conducts
compliance reviews, internal investigations and
audits relating to potential violations of civil and
criminal laws; advises clients on corporate
disclosures to federal and state government
agencies; counsels clients on fraud and abuse
compliance requirements for transactions and
financial arrangements; and conducts compliance
training and education updates for sales and
marketing personnel and Boards of Directors.
Prior to joining private practice,
Ms. McDermott served as an Assistant U.S. Attorney and Health Care Fraud
Coordinator for the U.S. Attorney's Office in Maryland from 1991-1999,
where she directed a multi-agency federal task force
focused on health care fraud investigations and
initiatives. Ms. McDermott
also has extensive trial experience in representing federal agencies,
such as the National Institutes of Health and Food and Drug Administration,
in employment and health-related matters.
Ms. McDermott is a recipient of the U.S. Department
of Health & Human Services Inspector General's Integrity
Award and while in government service participated in several enforcement
policy committees in Washington, including the FBI Health Care Fraud
Working Group and the Attorney General's Health Care Fraud Advisory
Subcommittee. She has extensive experience working with the Department
of Justice, the U.S. Attorney community, various Offices of Inspector
General and other federal enforcement and regulatory agencies both
regionally and in Washington. She publishes and lectures on compliance
and enforcement issues, including recent enforcement trends in the
pharmaceutical industry.
|
|
Carolyn McElroy |
Carolyn McElroy serves as Of Counsel to the firm’s Washington, D.C.
office, practicing in the Health Care Section. She has 20 years experience
in the field of health care fraud and abuse litigation, and served as
Director of the Maryland Medicaid Fraud Control Unit before joining the
defense bar. Today, she provides regulatory counseling and civil and
criminal defense services to a wide range of health care providers,
including pharmaceutical and device manufacturers, durable medical
equipment suppliers, and long term care facilities.
Ms. Elroy is a former President of the National Association of Medicaid Fraud
Control Units, having also chaired its Global Settlement Committee.
She played a principal role in negotiating and settling state Medicaid
interests for all states in many major health care false claims cases
settled during the years she was in the Maryland Attorney General’s office.
In addition, she is the co-author of Detecting and Investigating Fraud in
Managed Care, a book published by Atlantic Information Services in 1998.
Ms. Elroy has testified before various state legislative and federal
Congressional subcommittees on issues related to health care issues,
and is a frequent lecturer at health care seminars across the country.
She is also a recipient of the Exceptional Service Award from the Office
of the Inspector General of Health and Human Services for her
contributions to the laboratory compliance and corporate integrity efforts.
Ms. Elroy is admitted to practice in Maryland and the District of
Columbia. She graduated, cum laude, with a degree in Business
Administration from the University of New Hampshire (1974), and earned her
J.D. with Honors from University of Maryland School of Law (1981). |
|
Linda Pissott Reig |
Linda Pissott Reig is a principal of the Porzio
Bromberg & Newman law firm (Morristown, NJ and New
York City) and Vice President of Compliance Services
for Porzio Pharmaceutical Services. Ms. Reig has
extensive experience with the laws and industry
standards relating to the marketing and sale of
prescription drugs, medical devices and biologics.
She worked for many years in Porzio’s Key Client
program where she served as part of the in-house
legal team of a pharmaceutical company several days
a week. She drafts agreements with vendors,
consultants and other third parties, reviews
promotional materials, conducts training, provides
business advice on consulting agreements and
advisory boards, and evaluates continuing medical
education and other sponsorship opportunities. She
evaluates compliance programs and company practices
in connection with annual declarations required by
state law, as well as develops work plans for
development of comprehensive compliance programs for
companies preparing to launch an FDA-approved
product for the first time. In addition, she has
assisted companies in complying with requirements
associated with state marketing disclosure reporting
laws. She also reviews opportunities to work with
key opinion leaders, enter into consulting
arrangements or provide financial support for
programs focused on education or research. She
regularly counsels clients on the various federal
statutes that impact these areas, including the
Food, Drug and Cosmetic Act, the Food & Drug
Administration Modernization Act of 1997, the
Anti-Kickback Statute and False Claims Act, as well
as applicable state laws. Her experience with
industry standards includes the PhRMA Code on
Interactions with Healthcare Professionals, the
AdvaMed Code of Ethics for Interactions with Health
Care Professionals, the ACCME Standards for
Commercial Support and AMA ethical opinions. She
also evaluates gifts to physician, use of market
research services, interactions with managed care
organizations, pre-approval communications,
promotion over the Internet and evaluation of
post-marketing adverse events and implementation of
labeling changes. Ms. Reig has also defended
pharmaceutical and life sciences products in
products liability, class action and consumer fraud
lawsuits.
Ms. Reig is a summa cum laude graduate of Rutgers
Newark College of Arts & Sciences, and cum laude
graduate of Georgetown University Law Center.
Following law school, Ms. Reig was a judicial law
clerk with then New Jersey Supreme Court Justice
Marie L. Garibaldi. She is a past Chairman of the
Board of the New Jersey Defense Association, and
past chairperson of the NJDA’s Products Liability
Committee. She also is a member of the Defense
Research Institute’s Drug & Medical Device Committee
and the NJ State Bar Association Appellate Practice
Committee. |
|
Stuart Portnoy |
Stuart Portnoy, MD
joined Biologics Consulting Group, Inc., as a Senior
Consultant for Medical Devices in August of 2007.
Dr. Portnoy utilizes his broad clinical, technical,
and regulatory expertise to assist clients in the
following areas related to gaining FDA approval of
medical devices: high level regulatory strategy for
medical technologies, product development for
drug/device and biologic/device combination
products, assisting clients with strategy and
development of preclinical testing, designing
clinical protocols and drafting other documents that
comply with FDA regulations and expectations,
representing clients in interactions with FDA,
guiding clients in writing Pre-IDE, IDE, 501(k) and
PMA submissions, and providing clients with a
comprehensive "FDA style" review of submissions.
From 1994-2000, Dr. Portnoy was a Medical Officer in
the Division of Cardiovascular Devices (DCD), Center
for Device Evaluation and Radiological Health (CDRH),
FDA. During his tenure at FDA, Dr. Portnoy helped develop the FDA’s
approach to reviewing drug-eluting stents and other drug/device
combination products. Prior to his experience as a manager, Dr. Portnoy
specialized in the clinical review of cardiac electrophysiology devices
including pacemakers, defibrillators, and EP catheters.
In 2002, Dr. Portnoy joined Pharmanet's Washington,
D.C. office and worked for 5 years as a Medical
Device Consultant advising medical device
manufacturers on regulatory strategy, clinical trial
design, and technical issues to gain FDA
market-approval for new products. Dr. Portnoy is
a graduate of George Washington University School of Medicine and also
has an M.S. in Bioengineering from the University of Pennsylvania. |
|
Peter Safir |
Mr. Safir has been practicing in the food and drug field
for over 20 years and is widely recognized in the pharmaceutical industry
as one of the leading food and drug regulatory lawyers in the country.
In recent years, Mr. Safir has worked primarily with the research based
pharmaceutical industry concentrating on marketing practices, life cycle
management, and issues involving drug quality and manufacturing, although
he has also advised clients on food additive and medical device issues.
Mr. Safir advised PhRMA in drafting the new PhRMA Code and has advised
many companies on complying with the Code as well as with Federal and State
Anti-Kickback statutes. He has conducted numerous internal investigations
involving fraud and abuse, advertising and promotional practices and drug
and device GMP compliance issues both in the United States and in Europe
and has defended enforcement actions in the marketing and GMP areas
representing both companies and corporate executives targeted by the FDA.
Mr. Safir has published and spoken widely in the area of drug regulation
and has been a Professorial Lecturer in Food and Drug Law at George
Washington University Law School since 1991. He has also appeared as an
expert witness in cases involving Hatch Waxman issues both before the
Federal Trade Commission and in private litigation.
Mr. Safir has a J.D. from Yale Law School and an A.B. from Princeton
University.
|
|
James Sheehan |
On April 6, 2007,
Governor Eliot Spitzer announced the nomination of
James G. Sheehan to serve as New York State Medicaid
Inspector General. As Medicaid Inspector
General, Mr. Sheehan will oversee the fraud and
abuse enforcement activities of New York's $50
billion Medicaid program. The New York State
Office of the Medicaid Inspector General audits and
investigates Medicaid providers, recovers revenue
through its enforcement system, and develops and
operates automated health care data detection
systems.
Prior to becoming the Medicaid Inspector General,
Mr. Sheehan was the Associate U.S. Attorney for
Civil Programs in the
Eastern District of Pennsylvania. His
practice has emphasized health care fraud since 1987,
and he has personally handled or directly supervised over five hundred
health care fraud cases. In 1997, he was lead counsel in U.S. v.
SmithKline Beecham Clinical Labs, which resulted in a $332 million
recovery for the United States. He has given over three hundred
presentations on health care fraud issues to a variety of professional,
governmental, consumer, and business groups. He received the
Attorney General's Distinguished Service Award in 1992, and again
in 1997, and the Inspector General's Integrity Award in 1990, 1993,
and 1997. |
|
Lynn Shapiro Snyder |
Lynn Shapiro Snyder is
a senior member of Epstein Becker & Green, P.C., and
practices in the area of Health Care and Life
Sciences. Ms. Snyder has almost thirty years
of experience advising clients about federal, state
and international health law issues, including
Medicare, Medicaid, TRICARE, compliance, and managed
care issues. Her clients include health care
providers, payors, pharmaceutical/device
manufacturers and those companies and financial
services firms that support the health care
industry. The firm's Health Care and Life Sciences
Practice is one of the largest health law practices
in the United States. Ms. Snyder co-chairs the
Health Care Fraud Practice Group that focuses on
federal and state fraud issues, including
anti-kickback, self-referral, false claims,
secondary payor issues, and false billings.
She also works on matters in the Pharmaceutical
Industry Health Regulatory Practice Group.
In August 2002, Modern Healthcare magazine
named Ms. Snyder as one of the "100 Most Powerful
People in Healthcare" in its inaugural list.
In April 2005, Modern Healthcare magazine
named Ms. Snyder as one of the "Top 25 Women in
Healthcare." In the May 2006 issue of
Nightingale's Healthcare News, Ms. Snyder was named
one of the "Outstanding Fraud & Compliance Lawyers
for 2006." Ms. Snyder is also a frequent
speaker and publishes extensively. |
|
Chris Zalesky |
Chris Zalesky is
Executive Director, World-wide Health Care
Compliance at Johnson & Johnson. He has more than 20
years experience in regulatory affairs, quality
assurance and research and development functions
within the medical device and pharmaceutical
industries. He received his J.D. degree, cum
laude, from Widener University School of Law and
earned his B.A. degree in biochemistry and molecular
biology from the University of California at Santa
Barbara. He is Regulatory Affairs Certified (RAC).
He has published numerous articles on regulatory and
FDA policy matters and has contributed to
significant regulatory policy and legislative
initiatives in the area of medical device
classification. Mr. Zalesky provides a range of
guidance on commercial and scientific matters and is
admitted to practice in Pennsylvania. |
|
|
