Speakers | Biographies

Medicaid Pharmacy Reimbursement Reform: Trends and Recommendations

Mike Winkelman, Pharmacy Consultant (bio)
Nell Geiser, Change to Win Pharmacy Initiative Coordinator (bio)
Mr. Winkelman and Ms. Geiser will discuss opportunities for states to achieve a more transparent and accountable Medicaid pharmacy reimbursement system that can result in significant savings. As states struggle to cut costs while maintaining quality healthcare for vulnerable residents, now is the time for lawmakers and agency officials to advance common-sense reimbursement reforms. Despite positive policy changes related to Federal Upper Limits and Average Whole Price, many states are still losing out and paying significantly more than other payors for pharmacy services. The result is that providers sometimes retain unjustifiable profits, and there is no accurate way to track that spread. In response, some states have successfully implemented highly effective MAC lists, and others are testing new ground using Actual Acquisition Cost, but state officials are still grappling with the question of how best to ensure Medicaid is paying a fair and transparent price for prescriptions. The presentation will include recommended guidelines for reimbursement policy reform and estimates of projected savings if new benchmarks were implemented.

Recent 340B Reform Legislation and Its Implications for States

Bill von Oehsen, President and General Counsel of Safety Net Hospitals for Pharmaceutical Access (bio)
This session will provide an update on changes to the 340B drug discount program under the Affordable Care Act and how such changes will impact states that are interested in partnering with 340B safety net providers to expand access to and lower costs for outpatient pharmaceuticals.

Opportunities for Pricing Reform through Pharmacy Benefit Manager (PBM) Regulation

Speaker: David Balto, Center for American Progress, former Federal Trade Commission Policy Director (bio)
Attorney and antitrust expert David Balto provides background on PBMs and the opportunities to address drug pricing concerns through legislation providing greater transparency and regulating conflicts of interest. Mr. Balto will also discuss whether there are opportunities to regulate PBMs through provisions in the Affordable Care Act and Department of Labor regulations.

What States Should Know about International Regulation of Pharmaceutical Pricing Legislation and the Trans Pacific Partnership (TPP)

Speaker: Sean Flynn, Associate Director, Program on Information Justice and Intellectual Property (bio)
State legislators and officials have been advocating for years that the US Trade Representative refuse the pharmaceutical industry?s demands for a new international framework regulating domestic pharmaceutical pricing regulations. The US is now negotiating a new plurilateral trade agreement ? the Trans Pacific Partnership ? and Big Pharma is again asking for broad-ranging restrictions on domestic price regulation authority.

Pharmaceuticals: State Cost-Containment and Efficiencies Briefs

Speaker: Dick Cauchi, National Conference of State Legislatures (bio)
An NCSL Health Program Director, Dick heads a project on health cost containment as well as prescription drug work. NCSL?s two recent reports, Use of Generic Prescription Drugs and Brand Name Discountsand Prescription Drug Agreements and Volume Purchasingare part of a series of recent tools availableto state legislators struggling to identify state cost savings that don?t eliminate eligibility, benefits or providers.

Supreme Court Update

Speaker: Meredith Jacob, Pharmacy Fellow, PIJIP
Ms. Jacob will provide an update on the current status of litigation before the Supreme Court of interest to states, including IMS. v  Sorrell (datamining).

Why State Legislators should support Senator Sanders bill S.3921 the Ethical Pathway Act of 2010?

Presenters: Michael Behan, Chief Council of Senator Sanders
Judit Rius Sanjuan, Attorney (bio)
Mr. Behan and Ms. Sanjuan will discuss S. 3921, the Ethical Pathway Act of 2010, which would ensure that rules for the approval of pharmaceutical and biological products do not require violations of medical ethics in the testing of products in humans and vertebrate animals. The bill propose to create an ethical pathway in the registration of pharmaceutical and biological products, the practical effect of which would be to eliminate data exclusivity in most cases, in the United States. The elimination of data exclusivity would in some cases accelerate generic entrance into the US market and therefore have a positive impact on the cost of health care products.

Biographies

Mike Winkelman, R.Ph. is President of Winkelman Management Consulting. He has been involved with pharmacy and health care for over forty-five years. His wide-ranging experience includes working in pharmacy benefit management, retail chain pharmacy, and as a consultant for several states and the federal government on both Medicaid and employee drug benefit management.

Nell Geiser is coordinator of the Change to Win Pharmacy Initiative, which works to increase transparency and accountability in pharmacy practices. Change to Win is a partnership of major unions representing 5.5 million members nationally. Founded in 2005 to represent workers in the industries and occupations of the 21st century economy, Change to Win is committed to restoring the American Dream for a new generation of workers, with wages that can support a family, affordable health care, a secure retirement, and opportunity for the future.

Bill von Oehsen is President and General Counsel of Safety Net Hospitals for Pharmaceutical Access (SNHPA) which represents over 600 hospitals participating in the 340B program. He is also a principal in the law firm of Powers Pyles Sutter & Verville, P.C.

David Balto has practiced antitrust law for over 20 years both in the Antitrust Division of the Department of Justice, the Federal Trade Commission and private practice. He has over 15 years of government antitrust experience, as a trial attorney in the Antitrust Division of the Department of Justice and in several senior level positions at the Federal Trade Commission.  David Balto was the Policy Director of the Bureau of Competition of the Federal Trade Commission (1998-2001) and attorney advisor to Chairman Robert Pitofsky (1995-1997).  In these positions, he was a senior advisor in all aspects of the FTC's merger and non- merger enforcement program.  He helped litigate the challenges to the Staples/Office Depot, Drug Wholesalers, and Heinz/Beechnut mergers, the Intel monopolization case, and the challenges to anticompetitive conduct by several pharmaceutical companies. David Balto is a prolific author on antitrust, consumer protection, financial services, intellectual property, and health care competition.  He is a Senior Fellow at the Center for American Progress.

Sean Flynn teaches courses on the intersection of intellectual property, trade law, and human rights and is the Associate Director of the Program on Information Justice and Intellectual Property (PIJIP). At PIJIP, Professor Flynn designs and manages a wide variety of research and advocacy projects that promote public interests in intellectual property and information law and coordinates PIJIP?s academic program, including events, student advising and curriculum development. Professor Flynn?s research examines legal frameworks promoting access to essential goods and services. He serves as counsel for advocacy organizations and state legislatures seeking to promote and defend regulations that promote access to essential medicines. (PIJIP).

Judit Rius Sanjuan works for Knowledge Ecology International (KEI) as Foreign Law Adviser in Washington, DC. Her projects include providing technical assistance to developing countries on intellectual property law and negotiations at the World Health Organization and the World Intellectual Property Organization. In addition, Judit is an adjunct professor at Georgetown Law School where she co-teaches a Human Rights Fact-Finding Seminar on Access to Essential Medicines. Judit collaborates with different nonprofit organizations and is a contributing editor for Knowledge Ecology Studies and other publications' advisory councils. Prior to her present position, Judit worked at the legal department of an international pharmaceutical company. Judit has also worked for an information technology consulting firm and for an intelligent software spin-off company of the Artificial Intelligence Research Institute, under the auspices of the Spanish Ministry of Science and Technology. Judit co-authored the curriculum for the postgraduate course on legal implications of open source software at the Universitat Oberta de Catalunya. She has also worked for Intermon-Oxfam Spain, been a legal intern at Electronic Frontier Foundation and collaborated with the Stanford Center for Internet and Society.

Richard Cauchi, Program Director, Health Program, National Conference of State Legislatures (NCSL), Denver, Colorado. Richard Cauchi is a Health Program Director at the NCSL Denver office, where he directs projects and research on health finance and costs , health insurance and pharmaceuticals. He joined the staff in 1997.  He has written issue reports and presentations on subjects including state insurance reforms, pharmaceutical purchasing and assistance, cost containment and state responses to health reforms. In the past few years he provided special briefings on health policy at national meetings of legislators in California, Georgia, Illinois, Louisiana, New York City, Texas, and Washington, D.C. as well as 20+ state legislative committees. He has addressed the State Legislators Leadership Foundation, the Council on Health Care Economics and Policy, the State Attorneys General Program at Columbia University Law School and the Mexico Federal Legislature. He has been cited in the Wall Street Journal, the New York Times, Modern Healthcare, MSNBC and National Public Radio. Prior to joining NCSL, Richard spent 25 years working on policy analysis and tracking bills in the Massachusetts State Legislature, including a 7-year stint working on Medicaid, health and human services budgets at the Massachusetts Law Reform Institute in Boston.  He majored in history at Tufts University in Massachusetts and also completed graduate courses in Asian studies.  He presently resides in Wheat Ridge, Colorado.