Value Based Agreements and Multiple Best Price Scenarios
Jennifer Lospinoso, Managing Director & Consulting Lead at Riparian
Faraz Siddiqui, JD MPH, Associate, Hyman at Phelps & McNamara
Susan Dunne, Senior Director at Riparian
Overview of cell & gene therapy landscape
Medicaid Drug Rebate Program (MDRP) & Values Based Agreement (VBA) regulatory landscape
VBA Best Price & GP reporting considerations
State Medicaid VBA landscape
Increasing Role for clinical value at CMS
Susan Dunne is experienced in all facets of life science manufacturers’ government contracts and price reporting and ensuring compliance with all the statutory and regulatory requirements associated with the federally funded programs including Medicaid, Medicare PHS/340B and VA Programs. She and her team support clients by digging into the underlying transactional sales data that is the foundation of federal program liability and pricing and provide sophisticated data analytics to understand the downstream program impact of commercial and regulatory changes, ensure strategic business decisions and assist in coordinating the resulting interactions with the relevant federal agencies. Susan also works with manufacturers on commercial and government rebate compliance. Prior to her 20 years in consulting, Susan practiced law for over 12 years, in Washington, DC, litigating government contract claims in federal court and counseling manufacturers and contractors in federal pricing compliance.
Jennifer Lospinoso is a Managing Director, Consulting Lead at Riparian. Jennifer brings 20 years of leadership experience in various areas of government and commercial program operations and compliance. Jennifer has extensive experience leading and delivering projects focused on U.S. government program regulatory compliance, gross to net forecasting and operational excellence. Jennifer previously managed government rebates, gross to net and government contracting for a top five pharmaceutical company, and she has assisted brand, generic, emerging and biotech companies, during her tenure as a consultant.
Faraz Siddiqui, JD MPH, provides drug and biologicals manufacturers with strategic regulatory counsel and advice to navigate the FDA review and regulatory process in all phases of the development lifecycle. Faraz focuses on government pricing and reimbursement, counseling life sciences companies that market or distribute FDA-regulated products with HHS, CMS, and OIG regulatory and compliance issues with all government drug discount programs. He also advises companies on False Claims Act and fraud & abuse issues, PhRMA/AdvaMed Code, HIPAA, and complementary state statutes and regulations. Faraz also works with clients on pre-approval issues and expedited drug reviews, and helped clients navigate FDA regulations on orphan drugs and pipeline products. He has helped pharmaceutical companies conducting drug development with services agreements, contract research agreements, clinical trial agreements, quality agreements, distribution agreements, and licensing agreements. He has supported client as brand attorney, providing legal and regulatory advice on promotion, sales, training, and market access. Faraz has a J.D. from Howard University School of Law and a Masters in Public Health from the Johns Hopkins Bloomberg School of Public Health. Faraz uses his public health background to provide a multidisciplinary approach to client support and advocacy.
