Foley Hoag LLP partners Brian Carey and Colin Zick will speak at DXcon14 - The Diagnostic Conference, being held September 18-19, 2014 in San Francisco, CA.
Aimed at bringing together the principal thought leaders and executives in personalized medicine from the leading diagnostic companies and pharmaceutical manufacturers, this event will explore the rise of companion diagnostics and how pharma and the diagnostic stakeholders can collaborate to maximize opportunities in this emerging marketplace.
Carey will speak on "Implications of Clinical Laboratory Fee Schedule Reforms: Key Considerations," examining the implications for molecular diagnostic testing of the Protecting Access to Medicare Act of 2014 (PAMA) reforms and the FDA anticipated draft guidance for the regulation of laboratory develop tests (LDTs).
Zick, who co-chairs the firm's Healthcare Practice and Privacy & Data Security Practice, will discuss "Mastering Legal, Regulatory and Compliance Issues Associated with Laboratory Developed Tests," providing an overview on recent compliance and law enforcement developments, particularly in relation to the Office of Inspector General’s recent special fraud alert
that targeted the relationship between blood-testing laboratories and physicians, and a recent expose in The Wall Street Journal
linking this fraud alert to investigations that OIG and the Justice Department are conducting into the practices of a number of laboratories.
The conference will highlight current challenges and subsequent opportunities for launching a diagnostic test in the US marketplace, with areas of focus to include private payors, regulatory and legislative issues, Medicare (CMS), sales and marketing considerations, and pricing.