Overview
This webinar will explore how FDA’s regulation of manufacturer and payor communications interfaces with the Centers for Medicare and Medicaid Services’ (CMS’s) market access and reimbursement functions, and also will discuss fraud and abuse risks around communications and contracting. The webinar will first provide an overview of how the FDA and CMS legal frameworks interact concerning communications and contracting relating to value, which relates to the clinical and economic profile of the medical product. Speakers will then discuss the anti-kickback law and fraud and abuse considerations, as well as the demand for, and risk entailed in, communicating value in the context of non-payer audiences and in the context of organizations that conduct health technology assessments.
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Speakers
Catherine A. Brandon, Partner, Arnold & Porter LLP
Rochelle Fink, Senior Health Science Project Manager, CDRH, FDA
Moderated by Michael S. Labson, Partner, Covington & Burling LLP
CATHERINE A. BRANDON is a partner at Arnold & Porter LLP where her practice focuses on the intersection of healthcare law and policy. Ms. Brandon counsels life sciences companies, healthcare providers, and related trade and specialty societies on healthcare regulatory, compliance and enforcement matters, as well as public policy issues. Ms. Brandon’s work includes advising pharmaceutical companies and healthcare providers on matters related to healthcare fraud and abuse compliance, including anti-kickback laws and the “Stark” physician self-referral law; Medicare and Medicaid reimbursement and related policies; the Patient Protection and Affordable Care Act; and other regulatory and legislative initiatives affecting the life sciences and healthcare industries. Ms. Brandon has particular experience advising clients on patient support initiatives, contractual arrangements, value-based arrangements and reimbursement, and industry collaborations. As part of her practice, Ms. Brandon regularly represents clients in Congressional, criminal and civil investigations brought by the federal government, as well as conducts internal investigations. From 2015-2016, Ms. Brandon served as Senior Counsel on Oversight at the US Department of Health and Human Services, where she was responsible for developing strategic responses to Congressional oversight and investigations for the Office of the Secretary on issues related to the Centers for Medicare and Medicaid Services, including Affordable Care Act (ACA) implementation, as well as other HHS programs. Ms. Brandon graduated cum laude from the University of Pennsylvania Law School where she served as an Associate Editor for the University of Pennsylvania Law Review. Prior to attending law school, Ms. Brandon worked for various public policy organizations providing communications and public affairs counsel.
ROCHELLE FINK is a Senior Health Science Specialist at FDA. In that capacity, she works on joint CMS-FDA efforts to accelerate the regulatory and coverage decision making process. This responsibility includes spending a portion of each week working in CMS’s Coverage and Analysis Group (CAG) and the remainder of the week working at FDA’s Center for Devices and Radiological Health (CDRH). Dr. Fink is involved in the FDA-CMS Parallel Review Program and CDRH’s Pre-Submission Program. As a registered patent attorney, Dr. Fink works on CDRH’s technology transfer and patent matters. Additionally, she establishes collaborations with CDRH and has been involved in the FDA-Medical Device Innovation Consortium (MDIC) effort. Prior to joining CDRH, Dr. Fink worked in CDER’s Office of Regulatory Policy where her primary responsibilities included responding to citizen petitions. Dr. Fink received her undergraduate and medical degrees from Brown University and her law degree from the University of Pennsylvania Law School. She has worked as an associate at Paul, Weiss, Rifkind, Wharton & Garrison, LLP and Sidley Austin, LLP.
MICHAEL S. LABSON is a partner in the Food, Drug, and Device practice at Covington & Burling LLP. He provides strategic advice to pharmaceutical and biotechnology clients in dealing with FDA and other agencies. He has litigated life sciences cases and works actively on transactional and legislative matters. Mike graduated magna cum laude from Harvard College, and magna cum laude from Harvard Law School, where he was an officer of the Harvard Law Review. He clerked for the Honorable David M. Ebel on the US Court of Appeals for the Tenth Circuit. Mike has been recognized in Chambers USA – America’s Leading Business Lawyers, Washington DC Super Lawyer, LMG Life Sciences, and PLC Life Sciences, Which Lawyer?, and Best Lawyers in America as a leading life sciences regulatory practitioner. He is a Fellow of the American Bar Association, and a member of Covington’s Management Committee.Virtual Learning FAQ
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