February 13, 2020

Darshan: We have previously talked about pharmacy and we've talked about what happened in 2019 and what was the many, many issues that pharmacists should be aware of in 2019. Well, let's talk about what this actually means for 2020.

Narrator: 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 the cannabis issue and we talked about CBD versus THC. I would expect that more states will actually land up passing more cannabis supportive laws. There are already, the majority of states have some version of cannabis supportive laws. However, I expect that there will be more. On the other hand, I do not expect that we will see a law at the federal level which legalizes cannabis. It's an election year. I simply don't see Congress taking that step right now. It would make a lot more sense for them to do it in 2021 or later. Interestingly enough though, I do expect that the FDA will take this opportunity to comment and provide some clarity around what to expect around cannabis. So stay tuned. I expect that as a pharmacist, you might find this to be really, really interesting in how you integrate cannabis into your practice.

Darshan: In the context of Telepharmacy, I expect that we've talked about how, for the most part, Telepharmacy has really taken root in the West coast and in the Midwest. I expect it will continue to expand. You'll see some of the Eastern states continuing to consider Telepharmacy more aggressively. On the other hand, when it comes to TCPA and unwanted, unsolicited auto dial phone calls, I expect that there will continue to be prosecutions, but I don't expect it to be a major issue as we continue, especially for smaller players in the pharmacy space. I expect that they will, to the extent that they do... when I say they, I mean the government, uses the TCPA as a option. I expect that it will primarily be used against the larger companies in 2020. Again, they might pivot but I would be more surprised than not.

Darshan: In terms of privacy, we've talked about how California has gone live with its own version of GDPR, its own privacy law. However, I expect that more states will actually come out. There are various bills across the many states that are going to have privacy implications and significant focus on privacy. However, I would be very surprised if in 2020 you would see a federal privacy law. I expect that to actually happen in 2022 maybe or later than that. I don't see that being a primary goal for any presidential candidate or either a new or an existing president to do in their first year.

Darshan: On the other hand, as it relates to executive movement and non-competes being enforced, we talked about the Rhode Island federal judge who actually scolded a CVS drug middleman basically for moving. However, non-competes have become a area in which a lot of companies are continuing to fight and the government has started pushing back.

Darshan: For example, New York and California generally tend to hate non-competes. However, I expect that, I don't expect non-competes to go away. I think we're going to land up having more of a step back where you need to do a state-by-state analysis and non-competes will continue to be argued in the short term to the longer term.

Darshan: As it relates to drug importation, I expect that we've talked about HHS and they've put out policies and how they will enable for importation of cheaper prescription drugs from Canada and what that policy looks like. It's just out of policy, it's a proposal right now. I don't expect any kind of solidification in 2020. I expect that, to the extent of does become enforced, it'll become something everyone talks about for the presidential primaries and for the actual presidential election. However, in 2020 and 2021 I expect some version of this to actually go into place. On the other hand, as it relates to the DEA, I would expect that the DEA will be allowed to actually ask for more data from pharmacies on a more frequent basis than already exists.

Darshan: We also talked about Surescripts. We talked about how the FTC and Falconer Pharmacy are going after Surescripts for essentially being anti-competitive. I expect that there will be some level of settlement and we will see more competition in this space in the future. And to my friends in the EU and in the UK where there was a first pharmacy that got its first GDPR fine, I expect that there will be an effort to be more compliant. In the U.S. itself, whether you're talking about CCP or you're talking about HIPAA, I expect company pharmacies for the most part, I've figured out the rules around general HIPAA electronic compliance. However, I don't expect that a lot of companies who realize what their offline compliance needs to look like and there may be some OCR fines that come down this path as well.

Darshan: Stay tuned if you disagree with me and let me know if you think that there are things I missed, things that you think should have been discussed. Love to talk to you. You can reach out to me on Twitter @darshantalks or at my website at darshantalks.com. Look forward to hearing from you.

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

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