SPEAKER BIOGRAPHIES
(in alphabetical order)
 
Paul E. Barry
Director of International Trade and Health Policy, Boston Scientific Corporation
Paul joined Boston Scientific Corporation’s Washington, D.C.-based government affairs office in January 2002 as director of international trade and health policy. In this position, he is responsible for monitoring and influencing international trade policy and regulation, as well as working with U.S. trade agencies, Administration officials, Members of Congress and health care stakeholders in overseas markets to reduce trade barriers and enhance market access. He also serves as liaison to key industry associations and provides government relations strategy support to BSC’s overseas business units. Paul spent 2003 on assignment in Tokyo with Boston Scientific Japan, K.K., providing government affairs and reimbursement strategy support. Prior to joining BSC, Paul was an associate vice president of global strategy and analysis at the Advanced Medical Technology Association (AdvaMed) in Washington, D.C., where he led development and execution of the association’s trade policy agenda in Japan and Asia-Pacific.
 
Kristin Bass
Health Policy Advisor, US Senate Finance Committee
Kristin Bass is currently a Health Policy Advisor on the United States Senate Committee on Finance for Ranking Member Charles Grassley. At the Committee, Ms. Bass covers a broad range of issues including Medicare Part D and comparative effectiveness research. Prior to Ms. Bass’ tenure with the Committee, she held several senior positions in the private sector including serving as Senior Vice President for Policy at the Healthcare Leadership Council, running the Washington, DC office of WellPoint, and working at the American Association of Health Plans. Ms. Bass is a veteran of health policy reform having worked with decision makers on numerous legislative and regulatory efforts. Ms. Bass holds a Masters of Business Administration from the Yale School of Management.
 
Carrie Bullock
Analyst, Hospital and Ambulatory Policy Group, Division of Outpatient Care, CMS
Carrie Williams Bullock is a CMS analyst in the Hospital and Ambulatory Policy Group, Division of Outpatient Care. Carrie came to CMS to complete a practicum for her graduate studies in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public and remained at the Agency following the completion of her master’s degree in May of 2008. Her primary areas of focus include payment for implantable devices, advanced imaging procedures, and blood and blood products. Prior to joining CMS, Carrie was a manager in the Reimbursement Practice at Avalere Health LLC and a research associate at Covance Health Economics and Outcomes Services.
 
Mary Corkins
President, The Reimbursement Group
Mary Corkins is President of The Reimbursement Group, a consulting organization specializing in strategic planning, reimbursement positioning, and sales support services. Most recently, she served as Director, Reimbursement at St. Francis Medical Technologies, Inc. Ms. Corkins has over twenty years experience in reimbursement in the healthcare industry. She has successfully lobbied to create CMS policy for coverage in cardiology, orthopedic and neurosurgery specialties on behalf of medical device organizations. Her responsibilities have included new technology policy development, managed care contracting, A/R management and coding & reimbursement. Following consulting assignments with such organizations as Columbia Presbyterian Hospital and Johns-Hopkins Hospital, Ms. Corkins joined a national managed care organization managing provider contracts nationwide. Ms. Corkins has held management positions with Cyberonics and CardioNet and was responsible for ensuring appropriate levels of reimbursement for new technologies. Ms. Corkins holds a Master’s of Business Administration in International Business from The University of Toledo, a BA from Michigan State University and certification from the American Academy of Professional Coders.
 

Michael M. Gaba
Partner, Holland and Knight
Michael M. Gaba, Co-Chair of the firm’s national Health Law and Life Sciences Team, is a Partner in the Washington, D.C. office where he practices regulatory and legislative health care law. He counsels and represents medical device and biotech companies before the Food and Drug Administration, the Centers for Medicare & Medicaid Services, and the U.S. Congress on a range of issues related to Medicare Modernization Act (MMA) implementation, regulatory reform, product clearance, labeling, modifications, reclassifications, coverage, coding, reimbursement, and enforcement. Mr. Gaba also represents national not-for-profit organizations before the legislative branch and the NIH on health care policy and funding matters. Mr. Gaba has written extensively and continues to lecture on a range of health care issues. He continues to write and speak on such topics as the MMA landscape, medical device clearance and defending FDA enforcement actions, coverage, coding, and reimbursement strategies.
 
Marc Hartstein
Deputy Director of the Hospital and Ambulatory Policy Group, Center for Medicare Management, CMS
Marc Hartstein has been with the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration) for 19 years. He worked on the Medicare physician fee schedule from 1990 through 1994 and again between 1999 and 2004. In between, he spent several years working on Medicare payment for inpatient hospital services and was a key member of the defense team (and the only non-lawyer) in Regions Hospital v. Shalala before the United States Supreme Court in 1997. Marc has been instrumental in working with Congressional staff in developing provisions of several major Medicare laws including the Balanced Budget Act, the Balanced Budget Refinement Act, the Medicare Modernization Act, the Deficit Reduction Act among others. From December 2004 to September, 2007, Marc was the Deputy Director of the Division of Acute Care where he led major changes to the inpatient prospective payment system. Since February he has been the Deputy Director of the Hospital and Ambulatory Policy Group that includes four Divisions that set payments for approximately $200 billion of Medicare expenditures that affect over 900,000 Medicare providers of hospital care, physician and other services. He has a Masters Degree in public policy from the University of Minnesota’s Hubert H. Humphrey Institute of Public Affairs and a bachelor’s degree in political science and economics from the University of Vermont.
 

Robert S. Kieval
Founder & Chief Technology Officer, CVRx
 Robert Kieval is Founder, Executive Vice President and Chief Technology Officer of CVRx, Inc., a private medical device company located in Minneapolis, MN. He is a member of its Board of Directors, and served as President and CEO of CVRx from its inception in 2001 through October, 2006. During that time, he advanced the company from initial product concept through FDA approval to commence a pivotal clinical trial of CVRx’s flagship product, the Rheos Baroreflex Hypertension Therapy System. In 2006, Dr. Kieval was named an Innovator of the Year by Twin Cities Finance & Commerce. Kieval has over 16 years of medical device industry experience. His previous positions include Business Development Director at ProtoStar, Inc., and divisional Medical Director at Medtronic, Inc. He completed his undergraduate and graduate training at The University of Pennsylvania, where he received doctorate degrees in Veterinary Medicine and in Physiology. In addition to serving as a Director of CVRx, Kieval also currently serves on the Board of the Medical Device Manufacturers Association.

 
Tony Maida
Deputy Chief, Administrative and Civil Remedies Branch Office of Counsel to the Inspector General, HHS
Tony Maida is Deputy Chief of the Administrative and Civil Remedies Branch of the Office of Counsel to the Inspector General, U.S. Department of Health and Human Services. He represents the OIG on a wide range of health care fraud and compliance matters, such as False Claims Act and Civil Monetary Penalties Law cases, exclusion appeals, and the monitoring of Corporate Integrity Agreements. In 2007, he received an Inspector General’s Exceptional Achievement Award for his work on anti-kickback and physician self-referral law cases. Mr. Maida graduated cum laude from Boston University School of Law and magna cum laude from Fordham University.
 
Carla Monacelli
Managing Partner, Argenta Advisors
Carla has worked in the field of reimbursement, healthcare policy, and government relations for over 18 years. In 2001, she co-founded Argenta Reimbursement Advisors (formerly Certus Healthcare), and in 2007 co-founded Argenta TEC Advisors. Prior to establishing Argenta, her career experience included lobbying for at a top Minnesota law firm and payer relations and reimbursement strategy for multiple clients at a large Washington DC healthcare consulting firm, as well as at the Minnesota Council of Health Plans. Carla has developed and implemented strategic reimbursement plans for both biotechnology and medical device companies. She has been involved with the launch or reimbursement strategies for over 30 technologies, including three Orphan Drugs.
Carla has served as Senior Director of Healthcare Affairs for Conceptus, Inc., since 2003 where she has led the strategic reimbursement planning and tactical implementation of the plan. In addition to her role at Argenta Advisors, Carla is currently a co-lead instructor for the Health Policy and the Medical Technology Industry course and an instructor for the Reimbursement Class for the Master of Science and Regulatory Affairs and Services at St. Cloud State University. She is also the current chair of Life Science Alley’s Reimbursement Special Interest Group and a member of the Women’s Health Leadership Trust. She holds a bachelor’s degree in political science from the University of Minnesota.
 
Thomas C. Novelli
Director of Federal Affairs, MDMA
Thomas Novelli is currently the Director of Federal Affairs for the Medical Device Manufacturers Association (MDMA). Mr. Novelli joined MDMA after working on the Committee on Finance for former Chairman and current Ranking Member, Senator Charles Grassley, for nearly four years. At the Committee, he worked on several areas directly affecting the medical device and pharmaceutical industries including Federal reimbursement, drug and device safety and approval, and fraud and abuse in the Medicare and Medicaid programs. Mr. Novelli conducted several high-profile investigations into the pharmaceutical and medical device industries including the investigations of the use of educational grants and off-label marketing, clinical research organizations, and conflicts of interest in the healthcare industry. He is currently working on issues facing the device industry, including ensuring adequate and timely reimbursement for new medical technologies, transparency issues involving manufacturers and physicians, and patent legislation currently before the Congress. Mr. Novelli holds a Master of Arts in Policy, with Honors, from the Catholic University of America and a Bachelor of Arts in Political Science from the University of Dayton.
 
Marcia Nusgart
President, Nusgart Consulting LLC
Marcia Nusgart, president of Nusgart Consulting LLC and the Executive Director of the Coalitions and Alliance that operate under the aegis of Nusgart Consulting LLC, is an industry leader in providing comprehensive strategies to medical device and pharmaceutical manufacturers regarding coding, coverage and reimbursement issues under Medicare and Medicaid. Her accomplishments range from advocating successfully, for the Centers for Medicaid and Medicare Services (CMS) to modernize the HCPCS coding process; to, obtaining new HCPCS codes along with appropriate coverage and payment for manufacturers' products. She currently serves as Executive Director for four distinct medical device manufacturer coalitions specializing in wound care, respiratory care, enteral nutrition and wheelchair seating the Alliance of Wound Care Stakeholders. Ms. Nusgart founded Nusgart Consulting LLC in 1998. Prior to that, she served as Associate Vice President, Home Care for AdvaMed and worked as Director of Home Care for the National Community Pharmacy Association. She holds a Bachelors of Science in Pharmacy from the Ohio State University, and currently serves on the Boards for Women Business Leaders of the U.S. Healthcare Industry Foundation, the Ohio State University College of Pharmacy and Premier Homecare.
 
Brent O'Connell
Argenta TEC-Managing Partner & Chief Medical Officer,
Argenta Advisors
In 2007, Dr. O’Connell joined Argenta Advisors to create Argenta TEC. Prior to establishing Argenta TEC, Dr. O’Connell was employed by Highmark, one of the nation’s largest insurers, for fifteen years. During that time, he held various positions including Medical Director, Vice President & Medical Director, and Vice President and Senior Medical Director. He has extensive experience with all plan operations and medical and payment policy. He was responsible for all medical policy for the company during his time of employment. He served as the Chairman of the BlueCross BlueShield Association’s (BCBSA) Medical Policy Panel for six years and a member of the BCBSA Technology Evaluation Center’s Medical Advisory Panel for four years. He was appointed as a member of the Medicare Coverage Advisory Committee (MedCAC) in 2006. Dr. O’Connell earned his medical degree from Jefferson Medical College in Philadelphia. He completed his pediatric residency program at Polyclinic Medical Center in Harrisburg and was board certified in pediatrics in 1975. Dr. O’Connell received his master’s degree in Health Service Administration in 1998.
 

Ron Podraza
CEO, Reimbursement Principles
Ron Podraza is an attorney who has spent his 32-year career specializing in fundamental issues facing innovative medical products: reimbursement, FDA regulation, company start-ups, and technology transfer. Prior to co-founding Reimbursement Principles, Mr. Podraza served as interim CEO of three investor-backed medical start-up companies and as General Counsel of a leading cardiac rhythm management company. He has first-hand knowledge of the challenges faced by device company executives responsible for raising capital, developing products, launching products, and competing against established products. His goal at Reimbursement Principles is to provide executives with a working knowledge of reimbursement as a tool to achieve their executive duties. Stanford Law School awarded his J.D degree and Georgetown University Law Center awarded his LL.M. Mr. Podraza and Ms. Moora jointly established Reimbursement Principles, Inc., in 1998.

 
Barbara E. Raley
Senior Manager, Strategic Health Policy and Reimbursement,
Advanced Neuromodulation Systems, Inc. A St. Jude Company
Barbara Raley is a senior manager at Advanced Neuromodulation Systems (ANS). In this position, she develops reimbursement policies and cultivates relationships with Medicare, private insurers, and industry decision makers. She also provides reimbursement analyses, secures reimbursement approvals for new products and indications, instructs reimbursement personnel, and monitors developments in the insurance industry. Barbara has 25 years of experience in the field of reimbursement. Her accomplishments include attaining two URAC certifications for her employers, building a reimbursement department, and educating hospitals, ambulatory surgery centers, and physicians about reimbursement procedures. She has also worked as an orthopedics and pain management nurse and has been responsible for recruiting and credentialing physicians to perform medical reviews. Barbara received a nursing degree from Ouachita Memorial Hospital School of Nursing, in Hot Springs, AR.
 
Erik Rasmussen
Professional Staff Member, US Committee on Ways and Means Subcommittee on Health
Erik Rasmussen is Professional Staff at the Committee on Ways and Means Subcommittee on Health. He was formerly the Chief of Staff to Representative Kenny Hulshof (R-MO9), a member of the House Ways and Means Committee, and subcommittees on Health and Trade. The Ways and Means Committee has primary jurisdiction over Medicare, as well as all tax and trade issues in the House. Before joining Rep. Hulshof, Erik was the Health Policy Advisor to Rep. J.D. Hayworth (R-AZ5), and prior to that Erik was a lobbyist with Jefferson Government Relations where he handled mostly health care and business clients, including the Texas Medical Society, Fortis Health (now Assurant), Aetna, and Holiday Inn. Erik began his career in Washington on the staff of now retired Representative John Edward Porter (R-IL10), who chaired the Labor, Health and Human Services, and Education Subcommittee of Appropriations. Erik is an alum of Brigham Young University, where he majored in Political Science, with a minor in Journalism. Erik sits on the board of the Charles and Annaley Redd Charitable Foundation.
 
Beth Roberts
Partner, Hogan & Hartson
Beth Roberts assists clients with optimizing the value of their innovative medical technologies. She helps clients navigate the complex coding, coverage, and reimbursement challenges faced by their new technologies. Beth counsels clients on Medicare and other health care compliance issues and lobbies U.S. Congress and regulatory agencies on her clients' behalf. Her clients include health care providers; pharmaceutical, biotechnology, and medical device manufacturers; investors; and professional and trade associations.
Prior to joining Hogan & Hartson, Beth served as a judicial clerk for the Honorable John Ferren on the District of Columbia Court of Appeals. While attending law school, Beth served as administrative editor of the Texas International Law Journal.
 
Judy Rosenbloom
President, JR Associates, Inc.
Judy Rosenbloom is founder and president of JR Associates, Inc., a medical device reimbursement consultancy that provides comprehensive coding, coverage and payment strategies for device manufacturers, venture capital firms and healthcare practitioners. For more than a decade, Judy has advocated and achieved successful reimbursement outcomes for a spectrum of new and existing medical technologies. Judy's technical and business knowledge follows years of first-hand management responsibility in clinical and business settings with provider and payer organizations. Clients include multi-national emerging and established device companies who have commercialized their products in the US. She also serves as a reimbursement advisor to several leading academic and professional institutions.
 

Garrett Schwab
Vice President, Clinical and Reimbursement, Emphasys Medical
Garrett has worked in the medical device field for over 16 years in a variety of clinical, reimbursement, marketing and finance roles. Prior to joining Emphasys in 2004 in the role of Director, Clinical Marketing, Garrett was Marketing Manager for Radiant Medical. Prior to joining Radiant Medical, Garrett held positions of increasing responsibility within Guidant and IsoStent. Garrett holds a Bachelor of Arts degree in Economics from Vassar College, and a Masters in Business Administration from the University of Michigan.

 

Jo Ellen Slurzberg
Vice-President Reimbursement and Health Policy, Guided Delivery Systems
Ms. Slurzberg joined Guided Delivery Systems, Inc. in October 2008, a private medical device start up, as Vice President, Health Policy and Strategic Planning. She is responsible for worldwide strategic reimbursement and health policy. Prior to GDS, she worked for Almyra, Inc., a private international medical device holding company as Vice-President of Reimbursement. From 2000-2004, Ms. Slurzberg was part of the executive consulting team at Boston Healthcare Associates, serving as Vice-President of Consulting, leading the strategic reimbursement practice, consulting to the medical device, in vitro diagnostics, pharmaceutical, and biotechnology industry, as well as to various investment banks and venture capital firms. She has over 25 years of experience in the life sciences industry, with a focus on US and EU reimbursement. In 2006, Ms. Slurzberg was elected to serve on the Board of Directors of the Medical Device Manufacturers Association (MDMA) and she chairs the MDMA Reimbursement Working Group. In 2005, MX magazine (Canon Communications) profiled her among four US reimbursement experts for the year and in 2006 was named to the MX Advisory Board. She has conducted training programs and authored publications on general reimbursement, including two Harvard Business School Notes with Professor Regina Herzlinger. She speaks frequently on reimbursement related business planning and development topics.