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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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

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