On Friday, October 17, I had the opportunity to give a talk on genomic medicine policy in the U.S. at Harvard (Brigham & Women's Genomic Medicine seminar series.) The deck I presented is here.(Click on the small black down arrow to download).
While the slides are meant to be spoken to and not just read, my "Prolog" is that in a traditional business, you design a product and use sales and marketing to transfer it to customers, and if they like it and want it, you get return on investment. In healthcare, and especially in molecular diagnostics, there are many diverse policy headwinds that make this process more complex and circuitous.
The rest of the deck talks about the transition from molecular stack codes to today's CPT coding and pricing and future PAMA market-based pricing.
I give some examples of potentially shifting business models - while also noting that one man's barriers to innovation are another's protections against excess cost and overutilization. As an example, should out-of-network payment policies for startup labs become onerous enough, there will be more incentive to create on site hospital-based delivery systems, because the hospital is (almost) always in network for its own patients. My point from an MBA perspective is that this "policy based" market force (starve out-of-network labs) may intersect and synergize with new technologic capabilities (e.g., FDA's approval of Prosigna.)
Along the way, I cite the excellent Harvard Business School case study from 2013 by Robert Higgins on Claritas Genomics (here). The last few slides discuss approaches to clinical utility that my coauthor Felix Frueh and I have worked on (here).