Moderators
Kirk L. Dobbins, Counsel, King & Spalding, LLP
Kathleen H. McGuan, Partner, Reed Smith LLP
Patrick Morrisey, Partner, Sidley Austin LLP
Lynn S. Snyder, Senior Member, Epstein Becker & Green, PC
Matthew B. Van Hook, Partner, Engel & Novitt, LLP

Speakers
Thomas R. Barker, Acting General Counsel, Department of Health and Human Services
Michael M. Gaba, Partner, Holland & Knight, LLP
Scott Gottlieb, MD, Resident Fellow, American Enterprise Institute
Sheree R. Kanner, Partner, Hogan & Hartson LLP
Jeffrey A. Kelman, MD, Chief Medical Officer, Center of Beneficiary Choices,
Center for Medicare and Medicaid Services
Patrick Lee, MD, Radiologist and founder of Palo Alto Investors
Andrew Ruskin, Partner, Morgan, Lewis & Bochias LLP
Jeffrey E. Shuren, MD, JD, Assistant Commissioner for Policy and Planning, FDA
Mark H. Smith, Senior Government Relations Advisor, King & Spalding
Others being confirmed

Program Description
The Food & Drug Administration (FDA) has been and remains the focus of all new drug and medical device approvals and post-approval monitoring of existing healthcare products and technologies.  However, this agency no longer rules alone.  Given the heightened focus on economic considerations, a sleeping giant has awakened!  The Centers for Medicare and Medicaid Services (CMS) impact all decisions regarding drug development, clinical trials, and post-approval uses and reimbursements.

Gone are the days when drug and device manufacturers and venture capitalists focused solely on FDA when formulating new pharmaceuticals, engineering new devices and evaluating other novel healthcare technologies.  CMS and private sector payers, not FDA, have become the real gatekeepers to the ultimate success of the product.

This conference will give attendees insight into this “real time” change, focusing on the evolving role of CMS:  where “safety & effectiveness” meet “reasonable & necessary”.   How do, or more importantly how should these agencies work together for the advancement of healthcare?

Continuing Legal Education (CLE) Credits
Pending state approvals, CLEs will be awarded.

CLEs to be awarded from the following states:
Pennsylvania 11.00
New York 11.00
Ohio 8.75

CLEs will be published as we gain state approval

Registration Fees
Early Bird Rate (Received before Monday, October 20, 2008)
$820 FDLI Members
$1,195 Non-members
$645 Academics, 501(c)(3) Nonprofit, Government

Standard Rate (Received after Monday, October 20, 2008)
$920 FDLI Members
$1,270 Non-members
$720 Academics, 501(c)(3) Nonprofit, Government

Special CD Price!
Purchase the CD set for just $99 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, DC addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.

Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org.

Conference Registration Policy

DAY ONE November 18

1.  Welcome and Introduction to the Meeting
(Program Committee Representative(s))

2.  Interagency Collaboration

• Kathleen H. McGuan, Partner, Reed Smith, Moderator
• Jeffrey E. Shuren, MD, JD, Assistant Commissioner for Policy & Planning, Office of the Commissioner, Food & Drug Administration
• Michael M. Gaba, Partner, Holland & Knight, LLP
• More speakers to be announced

Break

3.  Clinical Trials – Drugs & Devices

• Matthew B. Van Hook, Partner, Engel & Novitt, Moderator
• More speakers to be announced

Lunch

4.  Comparative Effectiveness

• Kirk L. Dobbins, Counsel, King & Spalding, Moderator
• Andrew Ruskin, Partner, Morgan, Lewis & Bochias LLP
• More speakers to be announced

Break

5.  The Evolving Role of Payers – Private and Public – in Managing Cost and Access

• Patrick Morrisey, Partner, Sidley Austin LLP, Moderator
• Sheree R. Kanner, Partner, Hogan & Hartson LLP
• More speakers to be announced

Adjourn for the day

DAY TWO November 19

6.  Reimbursement Issues on Novel Technologies, Diagnostic Tests,
Venture Capital Issues

• Kirk L. Dobbins, Counsel, King & Spalding, Moderator
• Patrick Lee, MD, Radiologist and founder of Palo Alto Investors
• Scott Gottlieb, MD, Resident Fellow, American Enterprise Institute
• More speakers to be announced

Break

7.  How Important Is an Indication? Off Label Uses and Compendia

• Jeffrey A. Kelman, MD, Chief Medical Officer, Center of Beneficiary Choices, Center for Medicare and Medicaid Services
• More speakers to be announced

Lunch

8.  Forecasting:  Prospects for Comprehensive Federal Healthcare Legislation, More Aggressive Roles for Both Public and Private Payers, Etc.

• Lynn S. Snyder, Senior Member, Epstein Becker & Green, PC, Moderator
• Mark H. Smith, Senior Government Relations Advisor, King & Spalding
• Thomas R. Barker, Acting General Counsel, Department of Health and Human Services
• More speakers to be announced

9.  Program Summary and Conclusion of Conference
(Program Committee Representative(s))

Meeting Date(s) November 18-19, 2008

Hotel Reservations
The Madison Hotel
1177 15th Street, NW
Washington, DC 20005
Phone: 202-862-1600 | 800-424-8577
View Hotel Website

Room Rate
$255 + applicable taxes
Please call the hotel and identify yourself as an FDLI/Food and Drug Law Institute/Better Understanding CMS conference attendee to receive the rate.

Reservation Cut-Off October 19, 2008

Check-in 3 pm
Check-out 12 Noon

Metro Directions
Orange/Blue Line: Take the Orange or the Blue Line to McPherson Square Metro station and exit through the White House exit to McPherson Square Park located at L Street and 15th Street. Cross I Street and walk up 15th Street, cross L Street but continue to walk up 15th Street. The Madison Hotel will be on your right at the intersection of 15th and M Street.

Red Line: Take the Red Line to Farragut North and walk up K Street. Make a left onto 15th and proceed approximately 1.5 blocks to The Madison Hotel, on your right and at the intersection of 15th and M Street.

More Directions

THOMAS R. BARKER is Acting General Counsel of the Department of Health and Human Services (HHS). He is also an assistant professor of health law at George Washington University in Washington, DC. He teaches courses in Medicare and Medicaid law; pharmaceutical law and policy; and introductory health law. Prior to assuming this position, he served as Counselor for Health Policy to the Secretary of HHS. In that role, he served as the principal legal and policy advisor to the Secretary on matters within the jurisdiction of the Centers for Medicare & Medicaid Services (CMS); the Indian Health Service (IHS); and the Health Resources and Services Agency (HRSA). Most recently, he has provided counsel to the Secretary on all issues related to the implementation of Medicare’s new outpatient prescription drug benefit, the development of President Bush’s health care tax and access proposal, and the implementation of the Bush Administration’s health transparency initiative. Previously, Mr. Barker served as Deputy General Counsel of HHS and was the chief attorney for CMS; he was Health Policy counselor to the Administrator of CMS and was a health policy analyst and regulatory counsel for the Massachusetts Hospital Association. He served on Capitol Hill as a legislative aide to the ranking member of the House Appropriations Committee and the ranking member of the House Committee on Ways and Means’ Subcommittee on Health. He is a frequent lecturer and author on healthcare legal matters. Mr. Barker received his BA with honors in English and Political Science from Jacksonville University in Jacksonville, Florida and he graduated magna cum laude from Suffolk University School of Law in Boston.

KIRK L. DOBBINS is Of Counsel with the law firm of Hyman, Phelps & McNamara, P.C. in Washington, D.C. Prior to joining the firm, he was an attorney in the U.S. Department of Health and Human Services (HHS), Office of General Counsel, where he counseled the Centers for Medicare & Medicaid Services (CMS) on a wide variety of Medicare and Medicaid issues. Mr. Dobbins is the recipient of several performance awards from the Office of General Counsel and a commendation from the U.S. Department of Justice. Mr. Dobbins was appointed as Special Assistant United States Attorney for the District of Maryland where he litigated a variety of cases in the Civil Division. Additionally, he is a member of various associations. Mr. Dobbins received his B.S. in biochemistry from the University of Dallas, his J.D. from the University of Houston Law Center, and has done postgraduate study in medicine and public health at the University of Texas.

MICHAEL M. GABA is a Partner in the law firm of Holland & Knight LLP in Washington, D.C. He is Chairman of the firm’s national Food and Drug Team and its Health Law Team. He practices regulatory and legislative healthcare law, counseling and representing medical device and biotech companies before the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the U.S. Congress on a range of issues related to Medicare Modernization Act (MMA) implementation, regulatory reform, product clearance, inspections, labeling, modifications, reclassifications, coverage, coding, reimbursement, and enforcement. Mr. Gaba also represents a national multi-specialty medical society and National Institutes of Health grantees before the legislative branch on healthcare policy and funding matters. He has written on a range of healthcare issues and continues to write on topics in the MMA landscape, medical device clearance, coverage, coding, and reimbursement strategies. He worked on Capitol Hill in the personal offices of various members of Congress. Mr. Gaba received his B.A. from Franklin & Marshall College and his J.D. from the George Washington University National Law Center.

SCOTT GOTTLIEB, MD is a Senior Fellow with the American Enterprise Institute (AEI), a Washington, DC-based think tank.  He was formerly the Deputy Commissioner for Medical and Scientific Affairs, Food and Drug Administration (FDA) where he was a senior advisor to the Commissioner on all major agency matters including regulations, policy and administrative programs. That office works with all of the FDA Centers on implementing and coordinating the agency’s regulatory and administrative policies aimed at advancing the public health. Prior to his position at FDA, he worked as a Resident Fellow at AEI and also spent time as an American medical correspondent for the British Medical Journal. Additionally, he was a private consultant / speaker to investment firms and the pharmaceutical industry. Previously, Dr. Gottlieb worked as a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services; Director of Medical Policy Development, FDA; and Senior Advisor for Medical Technology to the FDA Commissioner. Dr. Gottlieb received his B.A. in economics from Wesleyan University and his M.D. from Mount Sinai School of Medicine.

SHEREE R. KANNER is a Partner in the law firm of Hogan & Hartson LLP, Washington, DC. Her practice focuses on matters involving clients in the healthcare industry, including coverage and reimbursement, fraud and abuse, Medicare and Medicaid issues and Licensure and Certification. Prior to joining Hogan & Hartson, Ms. Kanner was Chief Counsel for the Centers for Medicare & Medicaid Services (CMS) in the Department of Health and Human Services (HHS). She served as the principal legal advisor to the Administrator of the CMS on all Medicare, Medicaid, State Children’s Health Insurance Program and Health Insurance Portability and Accountability Act of 1996 (HIPPA) issues and she advised senior officials. During her government service, she served as a liaison between the CMS and the Department of Justice (DOJ) on Medicare and Medicaid fraud matters and she was also the HHS representative to the White House National Economic Council’s Antitrust Workgroup. Previously, Ms. Kanner headed the Medicare/Medicaid Fraud and Abuse Team for the Office of the General Counsel, HHS and supervised Medicare and Medicaid litigation for the HHS. Before that, she was associated with the health group of another law firm in Washington, DC. She is a frequent speaker at national health law conferences and has written extensively on Medicare and Medicaid issues. Ms. Kanner received her B.S. from the State University of New York, Stony Brook University and her JD from the University of Michigan Law School.

JEFFREY A. KELMAN, MD is the Chief Medical Officer for the Center for Beneficiary Choice at the Centers for Medicare & Medicaid Services (CMS). Before joining CMS, he served as Medical Director for Collington Episcopal Life Care Center and as Senior Medical Consultant Congressional Budget Office. He is board certified in Internal Medicine, Pulmonary Medicine, Geriatrics and Medical Direction LTC. He was trained at The Peter Bent Brigham Hospital and The National Institutes of Health, NHLBI. Dr. Kelman received his AB and his MM Sc from Brown University and his Doctorate of Medicine  from Harvard Medical School.

PATRICK LEE, MD, MBA is an Investment Analyst with Palo Alto Investors in Palo Alto, CA. He covers the healthcare sector. His prior experience includes a consulting role at McKinsey & Company, where he advised top-10 pharmaceutical companies on management and product strategy. Dr. Lee received his MD from Duke University and is a practicing board certified radiologist.

KATHLEEN H. McGUAN is a Partner in the Washington, D.C. office Reed Smith LLP.  Her practice focuses on counseling and litigation for clients in the healthcare industry.  She is frequently invited to speak on a variety of healthcare topics, including Part D, fraud and abuse compliance, strategies for handling investigations of providers, and the defense of qui tam suits. Ms McGuan is the former Chief Counsel, Centers for Medicare and Medicaid Services (CMS) and Associate General Counsel, U.S. Department of Health and Human Services.  There she served as the principal legal counselor to the Administrator of CMS on all aspects of CMS’s programs, including Medicare reimbursement to all categories of providers and suppliers, national coverage determinations, fraud and abuse, Medicaid finance, and litigation strategy in cases involving the Medicare or Medicaid programs.  In addition to advising the Administrator, Ms. McGuan routinely participated in policy development and decision meetings in which she advised other senior Department officials.  She worked closely with the Administrator to resolve the novel legal issues that arose in connection with the implementation of the Medicare Part D Prescription Drug program and the operation of the program through the critical first two years of its existence.  Ms. McGuan received her B.A. from American University, her M.A. from the University of Pennsylvania, and her J.D. from The Catholic University Columbus School of Law.

PATRICK MORRISEY is a Partner in the Health Care Practice Group, Sidley Austin Brown & Wood in Washington, D.C. He focuses on healthcare legislative and regulatory matters. He is widely recognized for his knowledge and experience on Medicare, Medicaid and Food and Drug Administration (FDA) legislative and regulatory issues, particularly those involving pharmaceutical companies, devise manufacturers, plans and providers. Until March of 2004, Mr. Morrisey served as the Deputy Staff Director and Chief Health Counsel for the House Energy and Commerce Committee. In that capacity, he served as a principal staff author and key negotiator of the Medicare, Prescription Drug, Improvement, and Modernization Act of 2003. He also helped author bioterrorism and public health legislation and some of the most far-reaching changes to the Federal Food, Drug and Cosmetic Act since its inception. During his tenure with the Committee, Mr. Morrisey regularly advised the Chairman and many Members of Congress on policy matters and served as the Committee's lead healthcare negotiator on matters involving the White House, CMS, FDA, the Ways and Means Committee and the Senate. He has spoken extensively at national healthcare forums on the Medicare prescription drug benefit, Medicare and Medicaid reforms, the modifications to the Hatch-Waxman law and other topics. Before joining the Energy and Commerce Committee, Mr. Morrisey practiced law at another large law firm and represented numerous healthcare providers, including managed care organizations, hospitals, ambulatory surgery centers, physicians, clinical diagnostic laboratories, home health agencies and nurse practitioners. He has also published articles on a wide range of Medicare regulations and counseled several Members of Congress on election law matters. Mr. Morrisey has extensive political experience and has worked for a number of senior public officials, including Congressman Bill Paxon (R-NY), Chairman Tom Bliley (R-VA), Chairman Billy Tauzin (R-LA) and Christine Todd Whitman (R-NJ). In 2000, he pursued the Republican nomination for Congress in New Jersey's 7th Congressional District. A native of New Jersey, Mr. Morrisey graduated with honors from Rutgers College and earned his J.D. from Rutgers Law School.

ANDREW RUSKIN is a Partner in the law firm of Morgan Lewis & Bockius LLP in Washington, DC. His practice focuses on providing counsel on healthcare regulatory matters to pharmaceutical and medical device companies, hospitals and other healthcare service providers, and insurers and other commercial payors. He regularly advices clients on Medicare and Medicaid coverage, reimbursement and compliance issues affecting these entities. He frequently advocates his client’s position to the Centers for Medicare and Medicaid Services (CMS). Mr. Ruskin has appeared before a number of tribunals established to adjudicate Medicare and Medicaid appeals. His practice also includes defending healthcare entities involved in investigations by the U.S. Attorney’s Office or by the Department of Health and Human Services (HHS) Office of the Inspector General. Prior to joining Morgan Lewis & Bockius LLP, he was an attorney in the healthcare practice of a prestigious international law firm. He is an active speaker on an array of topics and frequently speaks to various healthcare groups. Mr. Ruskin received his BA in English and Psychology from Wesleyan University and his JD, magna cum laude, from Case Western Reserve University School of Law where he was an associate editor of the Case Western Reserve Law Review and named to the Order of the Coif. He was also a visiting student at the New York University School of Law.

JEFFREY E. SHUREN, MD, JD, is the Assistant Commissioner for Policy and Planning at the Food and Drug Administration (FDA) and directs the agency’s Office of Policy. Mr. Shuren is board certified in Neurology and before his position as Assistant Commissioner, served as an Assistant Professor of Neurology at the University of Cincinnati. Prior to this, Mr. Shuren held the position of Director of the Division of Items and Devices in the Coverage and Analysis Group at the Centers for Medicare and Medicaid Services, which he joined after having served as Medical Officer for FDA’s Office of Policy for three years. He received both his B.S. and M.D. from Northwestern University and his J.D. from the University of Michigan.

MARK H. SMITH is a senior government relations advisor in King & Spalding’s Government Advocacy and Public Policy Practice Group. His areas of expertise include health care, appropriations, social security, small business, governmental affairs and other public policy issues before the legislative and executive and branches of the federal government. Mr. Smith has more than 19 years of experience in a wide array of health policy issues, providing legislative and regulatory guidance to physician organizations, pharmaceutical and biotechnology companies, trade associations, nonprofit organizations, patient advocacy coalitions, medical research centers, community health centers as well as hospitals and hospital systems. This has included matters involving Medicare/Medicaid coverage and reimbursement, advocacy for increased public health appropriations, regulatory issues and the development of comprehensive federal policy initiatives. Before returning to private practice in 2001, Mr. Smith served for 12 years as a member of the staff of United States Senator Connie Mack (R-FL), most recently as Senior Policy Advisor. He was involved in bipartisan efforts to improve health care quality and access, including initiatives to strengthen and modernize the National Institutes of Health, Medicare, Medicaid, the U.S. Food and Drug Administration, Health Care Financing Administration (now CMS) and other Federal departments, agencies and programs. Mr. Smith received his BA from Western Kentucky University.

LYNN SHAPIRO SNYDER is a Senior Health Law Partner in the National Health Law Practice at Epstein Becker & Green, PC in Washington, DC. She has over twenty-five years of extensive experience in helping a broad spectrum of clients navigate federal, state and international health regulatory issues. She has represented healthcare providers, payers, pharmaceutical/device manufacturers, and those companies that support the healthcare industry. She is a frequent speaker and publishes extensively on Medicare, Medicaid, managed care and a variety of health law regulatory issues. Ms. Snyder serves on the Steering Committee of the firm’s National Health Law Practice, is chair of the Third-Party Payment Practice Group which specializes in legal and regulatory matters arising under third-party payment programs, and 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. Her past experience includes serving as lead defense counsel for several healthcare firms in connection with significant fraud investigations with the federal and state governments. She represents several venture/capital investment banking firms regarding health regulatory compliance issues for large healthcare provider and payer transactions and was a lead health regulatory counsel on the HCA-buyout in 2006. She served as outside general counsel for over ten years to one of the national trade associations for HMOs, PPOs and UROs. Ms. Snyder received her AB in economics magna cum laude from Franklin and Marshall College and her JD from George Washington University National Law Center.

MATTHEW B. VAN HOOK is a Partner with the law firm of Engel & Novitt in Washington, D.C. The firm represents the biotechnology and pharmaceutical industries on legal/regulatory and policy issues. Prior to his current position, Mr. Van Hook was with the firm of Holland & Knight, where he co-chaired that firm’s national Food & Drug Team. He previously served at the Pharmaceutical Research and Manufacturers of America (PhRMA) as Deputy General Counsel. In addition to product development and intellectual property/life-cycle issues related to biomedical discovery (Hatch-Waxman Act; Bayh-Dole), his particular focus areas include the integrity of the drug distribution system, importation and pedigree issues, and evolving compliance requirements related to drug risks and benefits (both pre- and post-approval). He frequently speaks on various FDA-related matters and he served on FDLI’s Drugs and Biologics Committee. Mr. Van Hook received his undergraduate degree from Georgetown University and his J.D. from the University of Michigan.