Director 340B Compliance and State Policy Value, Access & Payment Bristol-Myers Squibb
Sabrina Aery is currently the Director of 340B Compliance and State Policy at Bristol-Myers Squibb and is located in Washington D.C. Sabrina has over 27 years Public Health experience with 18 of those years in the Pharmaceutical Industry in Advocacy, Account Management, Leadership and Health Policy roles. In addition to her work in the Pharmaceutical industry, she has served in leadership roles in Managed Medicaid, a DSH Academic Institution, and with the State of Hawaii, Department of Health.
Senior Director, US Pricing & Government Relations AstraZeneca
Odalys has been in the industry for over 25 years, working in the areas of Sales, Commercial Operations, Distribution, Finance, Market Access, and Government Reporting. Currently she is the Sr. Director of Pricing & Government Reporting at AstraZeneca where she is responsible for the Pricing Team overseeing WAC pricing and the Government Reporting Team in charge of CMS, Federal, PHS, and Medicaid. Odalys is a strategic partner and sits on many cross functional governance committees focusing on financial impacts, compliance risks, Government Reporting implications and overall innovation.
Jonathan Connell, JD, MBA
Associate General Counsel Bristol-Myers Squibb
Jonathan Connell is a Senior Counsel within the U.S. Commercial Law and Compliance organization at Bristol-Myers Squibb. Jonathan has been working in the pharmaceutical industry for 15+ years. His current work includes advising clients regarding government price reporting obligations, fraud and abuse compliance, federal and commercial contracting requirements, the federal anti-kickback statute, coverage and reimbursement issues, addressing US market access challenges, and product promotion regulations. In the pricing area, Mr. Connell regularly advises on government price reporting and compliance, as well as commercial contracting with GPOs, IDNs, MCOs, and specialty pharmacies. Prior to joining BMS, Jonathan was in private practice as a member of Arnold & Porter LLP’s FDA and Healthcare practice. Mr. Connell earned both a JD and a MBA from Duke University. Prior to graduate school, Mr. Connell worked for years as a management consultant to the pharmaceutical industry, focusing on drug pricing strategy, compliance with federal pricing programs, and systems integrations. Mr. Connell is also a regular speaker at pharmaceutical industry seminars and conferences.
Director Pharmacy Services Delaware Health and Social Services
Cynthia Denemark is the pharmacy director for the Delaware Division of Medicaid & Medical Assistance. She has served as the Pharmacy Director for the state’s fiscal agent and the State of Delaware since the early 1990s. She developed and administered Delaware’s Point of Service prescription system, state-wide Prior Authorization Program, the Delaware Prescription Assistance Program, the Manufacturer Rebate Program, and the Prospective DUR system. She has overseen the federal and state rebate programs, and has a wide range of experience doing quality assurance projects from HEDIS measure analysis, retrospective drug utilization review, and coordination with managed care organizations that are part of the Diamond State Health Plan. She received her pharmacy degree from Purdue University and worked in hospitals, health clinics, and in retail settings.
Chris Hatwig is President of Apexus, the organization responsible for managing the Human Resources and Services Administration’s (HRSA’s) 340B Prime Vendor Program (PVP). He works closely with HRSA’s Office of Pharmacy Affairs in Washington, DC, to educate all stakeholders and to improve the integrity and value of the 340B Drug Pricing Program for the nation’s safety-net providers. Participants in the program include more than 36,000 HRSA grantees and disproportionate share hospitals serving the nation’s low-income and uninsured populations. The PVP provides added value by collectively representing the 340B covered entities’ purchases to secure federal sub-ceiling discounts on pharmaceuticals and discounts on other outpatient pharmacy-related products and services.
Mr. Hatwig is consulted frequently about optimizing the benefits of the 340B Program. He routinely makes national and regional presentations related to the 340B Drug Pricing Program, innovative ambulatory pharmacy services, and drug cost containment strategies.
Before joining Apexus, Mr. Hatwig was the director of ambulatory pharmacy services and value analysis programs at Parkland Health & Hospital System in Dallas, where he practiced for 13 years, managing one of the nation’s largest and most progressive ambulatory pharmacy programs serving low-income and uninsured patients. He was responsible for managing Parkland’s network of ambulatory pharmacies, which processed more than two million prescriptions annually and operated with a drug expense budget of $65 million.
Mr. Hatwig received his bachelor’s degree in pharmacy from the University of Arkansas. He completed residencies in hospital pharmacy and hospital pharmacy administration at the University of Wisconsin, culminating in a master’s degree in hospital pharmacy.
Partner Arnold & Porter Kaye Scholer LLP
Kristin Hicks is a Partner in Arnold & Porter Kaye Scholer's life sciences and healthcare regulatory practice group. Kristin's practice focuses on counseling and litigation for clients in the pharmaceutical industry. Her work includes advising clients regarding all aspects of government price reporting, including counseling on issues under the 340B program, Medicaid, Medicare, the Federal Supply Schedule program, and the TRICARE retail pharmacy program. She often assists clients in preparing drug price reporting policies and reasonable assumptions, and provides guidance on internal audits and price recalculation projects. She also focuses on fraud and abuse compliance, federal contracting requirements, and legislative and public policy issues. In addition, Kristin represents clients in litigation matters regarding government price reporting requirements.
Felicity Homsted, PharmD, BCPS
Chief Pharmacy Officer Penobscot Community Health Care
Felicity Homsted is Chief Pharmacy for Penobscot Community Health Center Inc. (PCHC); Maine’s largest Federally Qualified Health Center serving over 70,000 patients across the state. She is responsible for the administration of four pharmacies, integrated pharmacy services and PCHC’s accredited community pharmacy and health systems pharmacy administration (HSPA) residency programs.
Dr. Homsted’s specific professional interests are quality improvement, advancing the integrations of pharmacists in the primary care setting, and healthcare advocacy. As Chief Pharmacy Officer for PCHC, Felicity has led the movement of pharmacists beyond the traditional dispensing role to develop a model of clinical integration and collaboration within PCHC.
Director, Government Pricing and Reporting AstraZeneca
Brian is the Director Government Pricing and Reporting at AstraZeneca Pharmaceuticals and has over 11 years of experience in government contracting and pricing. He is responsible for all aspects of government pricing compliance ensuring the company meets their required pricing obligations under Government contracts and the Medicaid, Medicare, Federal (VA/DoD) and 340B pricing programs. Brian also provides strategic input and financial assessments on legislative activity. Brian has a degree in Accounting from Villanova University.
Director of Federal Government Affairs & Policy AstraZeneca
Natalie Morris, J.D., M.P.P., is currently a director in AstraZeneca’s Federal Government Affairs & Policy group where she focuses on the 340B, Medicare, and Medicaid programs. After receiving her J.D. from the University of Virginia School of Law, Natalie practiced in the Health Law group at Hogan Lovells prior to joining the Market Access and Reimbursement team at Avalere Health where she helped clients navigate complex drug coverage and reimbursement issues. Prior to attending law school, Natalie received a Master of Public Policy from George Mason University, where she focused on health policy.
Josh is the federal healthcare programs lawyer for Eli Lilly and Company. He supports government pricing, government strategy, managed healthcare services, and public policy functions at the company. Prior to joining Lilly, Josh was a Senior Associate in the FDA & Life Sciences Practice at King & Spalding.
Stephen E. Ruscus
Partner Morgan, Lewis & Bockius LLP
With more than 23 years of experience, Stephen counsels clients in the defense, technology, life
sciences, manufacturing, services and food industries on supplies and service indefinite delivery,
indefinite quantity (IDIQ) task order contracts, fixed-price, and cost reimbursement contracts and
related Federal Acquisition Regulation provisions, subcontract negotiations and compliance,
government contracts disputes, and federal debarment and suspension.
Stephen conducts investigations and prepares reports under the US Department of Veterans
Affairs (VA), the US Department of Defense (DOD), and the US Department of State voluntary
disclosure programs. He appears before the US Court of Federal Claims, US Courts of Appeals, the
Armed Services Board of Contract Appeals, and the Civilian Board of Contract Appeals. He also
represents clients in bid protests before the GAO and the US Court of Federal Claims.
With respect to federal healthcare supplies and services, Stephen counsels clients on VA, DOD,
and US Department of Health and Human Services (HHS) procurements. He also advises on
government pricing laws and regulations governing manufacturer participation in the Medicaid
Drug Rebate, Medicare, 340B, TRICARE, and Veterans Healthcare Act programs; VA FSS
contracts; and public policy affecting these programs.
Additionally, Stephen counsels clients on the implementation and review of complex government
pricing systems, providing strategic advice on the government pricing, fraud, and abuse
implications of commercial pricing and patient benefit programs.
Stephen E. Ruscus represents clients in government contracts procurement, US federal drug
pricing programs, and in litigation before the Boards of Contract Appeals, the US Court of Federal
Claims, and the US Government Accountability Office (GAO). He also advises in protest practice
before the US Small Business Administration and in matters relating to federal procurement of
commercial items and services, including those under Federal Supply Schedule contracts.
BILL SARRAILLE is a senior member of the Healthcare Practice group and a nationally-recognized lawyer in healthcare law. Mr. Sarraille concentrates on a variety of healthcare matters, including Medicare and Medicaid reimbursement, coverage and coding, pharmaceutical price reporting, issues related to the marketing and promotion of pharmaceuticals and medical devices, internal investigations, clinical research issues, Stark and Anti-Kickback Law analyses, Medicare and Medicaid audits, healthcare acquisitions and due diligence, compliance program audits, managed care matters, healthcare contracts, administrative litigation, legislative matters, privacy and security, coverage for new devices and services, the Foreign Corrupt Practices Act, international compliance and healthcare contracting, the representation of witnesses and companies before Congressional Committees, and the defense of healthcare criminal and False Claims Act matters. Mr. Sarraille has defended clients in some of the largest healthcare fraud investigations brought by the U.S. Government.
John Shakow, Partner, FDA & Life Sciences Practice Group, King & Spalding – John Shakow is a nationally-recognized expert in all aspects of drug pricing and price reporting. He has counseled pharmaceutical and biotechnology clients on their rights and obligations under the Medicaid, Medicare, Federal Supply Schedule, 340B and TRICARE programs for almost twenty years. John regularly advises manufacturers on the spectrum of regulatory, commercial and litigation matters relating to pricing and government payor programs. He has extensive experience helping clients resolve commercial, strategic, organizational and other legal challenges while maintaining the integrity of their government pricing compliance efforts
John Stancil, R.Ph.
Director of Pharmacy North Carolina Department of Health and Human Services
John joined the N.C. Division of Medical Assistance (DMA) as Director of Pharmacy and DMEPOS Programs in October 2014. John holds a Bachelor of Pharmacy degree from the UNC Eschelman School of Pharmacy. His impressive 30+ year experience in management of hospital, long-term care and retail pharmacy and DME demonstrates his knowledge of the industry. As Senior Account Manager for a national leader in providing pharmacy benefits management services to state Medicaid agencies, he led various pharmacy program initiatives and accounts for many Medicaid agencies across the United States. John’s extensive background in Prior Authorizations, Medication Management Programs and Preferred Drug List aligns with the N.C. DMA’s initiatives.
The NC Medicaid Pharmacy Program provides prescription drug coverage (an optional benefit under federal Medicaid laws) to more than 1.9 million Medicaid and Health Choice beneficiaries, and to individuals enrolled in both Medicaid and Medicare.
Prescription drugs play a significant and increasing role in maintaining health and treating illnesses, giving our beneficiaries the opportunity to become healthier and improve their quality of life. While groundbreaking research continues to lead to new and more effective medications to address a wider range of diseases, many have a significant cost. The N.C. DMA Pharmacy Program staff work proactively to balance health of beneficiaries and the cost of care.
In SFY 2016, gross pharmacy expenditures exceeded $1.8B and represented 13.3% of total Medicaid expenditure. However, net pharmacy expenditure decreased 10.5% to ~$780M representing 5.5% of total Medicaid expenditures, making it less than the net pharmacy expenditures in SFY 2014. This decrease in net pharmacy expenditures was due to a 34.5% increase in drug rebates which exceeded $1B, representing 58.7% of gross pharmacy expenditures.
Pharmacy program management through careful selection of drugs on the NC Medicaid Preferred Drug List (PDL) and maximizing drug rebates are among the ways the N.C. DMA provides access to the right drugs at the most advantageous cost. The result is a pharmacy program that provides the best overall value to beneficiaries, providers and the State.
Amanda Tucker is currently a Gov’t Pricing Senior Analyst at UCB, and prior to joining UCB she was a Medicaid Analyst at Abbvie. She has extensive knowledge in Medicaid invoice processing including setting up, maintaining, and maximizing the return on dispute resolutions with the states. She has worked with both long established dispute programs, as well as establishing newly implemented programs.
William H. von Oehsen
Principal Powers Pyles
Sutter & Verville, PC
William von Oehsen is a Principal in Powers, Pyles, Sutter and Verville, P.C., a law firm specializing in health care law and policy. Mr. von Oehsen has more than 20 years experience on pharmaceutical pricing and reimbursement matters, including the 340B drug discount program, the Medicaid drug rebate program, Medicare Part D, Robinson-Patman, and state Medicaid and pharmacy laws. He helped establish and serves as outside counsel to 340B Health, formerly Safety Net Hospitals for Pharmaceutical Access, an advocacy organization of over 1,300 public and private non-profit hospitals participating in the 340B program. Mr. von Oehsen played a key role in helping to enact the 340B program in 1992, as well as to expand the law in 2010 under the Affordable Care Act. In 1997, he helped organize the 340B Coalition, which now represents a dozen national organizations whose members comprise virtually all of the safety net providers participating in the 340B program. Mr. von Oehsen co-founded and served as co-editor of the Drug Discount Monitor, the first publication to focus specifically on the 340B program and other pharmacy access issues.
In addition to representing clients on 340B matters, Mr. von Oehsen provides guidance to pharmacies, pharmacy-related vendors and consultants, states, local governments, and other health care entities in their efforts to improve access to pharmaceutical care and to ensure compliance with drug pricing laws. Mr. von Oehsen has experience in counseling clients on matters involving the federal supply schedule and federal ceiling price programs, state pharmaceutical assistance programs, manufacturer patient assistance programs, the Prescription Drug Marketing Act, Medicare Part B, managed care and related authorities. Mr. von Oehsen has testified before the U.S. Congress and numerous state legislatures and provides technical assistance to federal and state policy makers in both the legislative and executive branches. He has handled litigation matters involving pharmaceutical pricing. He also practices in the area of food and drug law.
Mr. von Oehsen received a Bachelor’s degree from Princeton University, an M.T.S. from Harvard University and a J.D. from Georgetown University.
Vice President Assistant General Counsel Pfizer
Debbie Walters-Francique is Vice President, Assistant General Counsel at Pfizer Inc. and is the Legal lead for the Commercial Solutions Platform Legal team who support: Organized Customers, Government Pricing and Government Contracting functions, Patient, Health & Impact which includes HEOR functions, Account Management and Sales functions, Global Trade Controls and various Strategy, Commercial and Medical Operations groups as well as advisory and counseling related to drug pricing transparency.
In addition to supporting day-to-day activities related to the above functions Mrs. Walters-Francique also provides expertise and counsel to a broad range of clients across the entire organization related to the federal and state Anti-Kickback laws, as well as provide key strategic support into the development and evolution of field commercial and medical roles and interactions. She has been with Pfizer since 2000.
Prior to joining Pfizer, Mrs. Walters-Francique was in private practice with the law firm of Shearman & Sterling in their Mergers & Acquisition Group.
Charles Washington, CFE, CPP, CICA
Director, America’s Compliance Division Pfizer
Charles is the Director of Fraud Investigations in Pfizer’s Global Compliance and Security Division and leads an inter-departmental team between Global Compliance and Contract Strategy and Management. His role is to integrate Program Integrity in 340B and other government drug pricing programs across the company. He leads the company’s 340B remediation program and has been successful in building cooperative partnerships with covered entities to successfully navigate program integrity in the 340B terrain. Charles holds a Master’s Degree; he is a Certified Fraud Examiner (CFE); a Certified Internal Control Auditor (CICA); and is a frequent speaker on the manufacturer’s perspective of 340B.
Donna Lee Yesner
Senior Counsel, Morgan Lewis & Bockius LLP
Donna Lee Yesner, a Senior Counsel in Morgan Lewis's FDA Practice focuses her practice on the sale and reimbursement of federal healthcare supplies and services, with an emphasis on pharmaco-economics, government contracts, price reporting, compliance with laws and regulations governing Medicaid, Medicare, Tricare, 340B drug discount programs, debarment, suspension and public policy affecting these programs. Ms. Yesner has experience in all aspects of federal financing and procurement, with particular experience in Federal Supply Schedule contracting, pharmaceutical research and development grants and agreements, claims, and bid protests. She regularly counsels companies regarding compliance with federal healthcare program requirements and the impact of these requirements on their business. Ms. Yesner is Vice-chair of the ABA Public Contracts Section Health Care Contracting Committee and co-chair of the Coalition for Government Procurement Health Care Committee. She has authored numerous articles on procurement, pricing, and reimbursement of medical supplies and lectures frequently on these topics.
Michele Zarychta is Corporate Counsel at Pfizer, Inc. Ms. Zarychta provides legal support to the US Payer and Channel Access and Government Contract departments. She provides expertise and counsel related to fraud and abuse, government pricing, managed care and government contracting, and account management. Ms. Zarychta also provides legal support to the company’s 340B remediation program, which works with covered entities to ensure 340B program integrity. Prior to joining Pfizer, Ms. Zarychta was a commercial litigation associate at a law firm, representing clients in a variety of commercial and healthcare matters.