On Thursday, June 21, at the International Biotechnology conference (BIO) in San Diego, I'm on a panel. Speakers are Brian Carey (Foley Hoag LLP), Christopher Hall (President, Veracyte), Dan Todd (Todd Strategies LLC) and myself.
If of interest, my deck is in the cloud here.
The talk outlined in the deck will review the FDA "bombshell regulation" effort of 2014, its fizzle-out after the Trump election, and the rebirth of legislative alternatives (e.g. the DAIA bill in 2017). I also discuss "FDA Lite" regulation of some genetic tests and the slow breakaway from the one-drug, one-gene, one-test paradigm. Regarding payers, I discuss that CMS Parallel Review still has very few examples after five years, while local CED or "CDD" is a quirky saga. In other coverage trends, there will be a short update on PAMA and a discussion of how payers are adapting to gene panels and how the "Laboratory Benefit Management" industry may emerge more rapidly than some think.