February 6, 2020

Darshan: In the last podcast on pharmacogenomics, we talked about what happened in 2019, the different settlements that happened with the DOJ and what that means for pharmacogenomics companies and for providers in this space.

Speaker 2: This is the DarshanTalks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks, or the show's website at darshantalks.com.

Darshan: We talked about things like kickbacks. We talked about Stark violations. We talked about payments for services not rendered, upcoding. We talked about Primex and GenomeDx. We talked about UTC Lab settlements and Operation Double Helix, and that's all great. And we talked about the LCD, the local coverage decisions, and we talked about the national coverage decisions. And this is all excellent, but what does this mean for 2020? How should a company that's engaged in pharmacogenomics think about what 2020 looks like for them? And what I would expect.

Darshan: So I would think that looking forward, the big thing to think about is you're going to continue to see more enforcement from the Department of Justice, because the Department of Justice is really looking at payments being made by CMS or the various government providers basically, the various government payers. And I don't expect that to slow down because you're going to be looking at are payments being inappropriately made? So that's going to continue.

Darshan: What I think is going to be actually more interesting is I think that the FDA will actually start getting into the fray and you might start seeing claims around misbranding, and I think that's going to be interesting. I don't expect a deluge of that, but I expect that there will be some claims around fraud that you might start seeing, which will land up guiding the industry a little bit more. The FDA has come out and said that they've practiced enforcement discretion for the most part, but I expected that they will land up guiding companies through enforcement. And there have already been some initial forays into this by the FDA.

Darshan: The next thing to look at is what else is the FDA going to do? The FDA, I expect, is actually going to take this opportunity to provide more guidance, so stay tuned. The FDA may actually land up putting on guidance's that say, "Here's the type of evidence you need to be able to make claims. Here's how much evidence is normally expected, here's how much you actually have. How do you meet that gap? And which companies primed to provide that type of evidence."

Darshan: So there are, I expect that in the short term, there will be some winners and losers in that space. So you might see some attrition in 2020 and 2021. If you have questions about what that looks like for you, are you going to be one of the winners or the losers? Feel free to reach out to me. You can find me @DarshanTalks on twitter, or you can find me on my website at darshantalks.com. That's D-A-R-S-H-A-N-T-A-L-K-S dot com. Great talking to you guys.

Speaker 2: This is the DarshanTalks Podcast, regulatory guy, irregular podcast with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks, or the show's website at darshantalks.com.

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