Narrator: This is the Darshan Talks Podcast. Before this week's podcast, Telemedicine and its New Opportunities, an Interview With Anjali Dooley, Darshan will introduce this episode with a recap for the week of Thursday, July 16th, 2020.
Darshan: Hey everyone. Welcome to another episode of Darshan Talks. It's been a really interesting week so far. I am already looking at some new news and it says that the FDA was looking at an Indian pharmaceutical company, Vega Life Sciences, and they were upset that they were deleting data from faulty solvent testing. So again, there's a rule in general that if something isn't recorded, it didn't happen. However, the converse of that is not true, if you don't have it recorded, but if you've deleted it, it doesn't mean that it didn't happen. So keep that in mind. Obviously, that caused some problems for this company.
Darshan: The other thing you should probably be looking at is how virtual clinical trials are becoming the new normal. I've done several podcasts that I'm happy to link to in here. Feel free to look at them, but people are talking about virtual clinical trials, and if they're becoming the new normal, are you ready for more of those studies?
Darshan: Additionally, if you start looking at data privacy, CCPA is coming into effect and companies are asking whether they can have some delays, especially in light of COVID. However, California is not necessarily changing its mind about its enforcement deadline.
Darshan: There are some other interesting issues. For example, there is a question about using the homeless population in phase one drug trials. And that borders on unethical. I'd love to hear your thoughts and comments on whether it's unethical to use homeless people in phase one drug trials, even if they want to be part of it. Similarly, there was a Washington Post article on a patient's experience in the coronavirus vaccine trial. And the reason I find that to be interesting is the fact that it reminds us that patients continue to talk even when the trial is on, so there's a whole discussion about, well, what happens if they unblind the study mistakenly? What is the impact of that? Well, patients are talking, whether or not you choose to accept that, it's still happening.
Darshan: There's another writeup out there about this gentleman who was a sales rep for Novartis in 1999 and he ended up actually bribing doctors and wearing a wire for the feds. So for those of you who think that no one's listening, someone in your own office could be the one listening if you're behaving unethically.
Darshan: There are some discussions about what happens when COVID meds come out. Bill Gates thinks that should go to those people who need it, not the highest bidder. The question is, who needs it? Is it the patients? Is it caregivers? Is it healthcare practitioners? Or is it the rich guy who can afford it? And obviously Bill Gates doesn't think it should be the richest guy, or woman, obviously.
Darshan: There is an interesting article out there from UMass where a professor examines the ethics of biomedical research on soldiers. And that's always been an interesting conundrum. Can soldiers truly give informed consent? What does that look like? Is it a violation if your superior officer asks you, well, orders you to do it? Can you say no?
Darshan: Additionally, there was a discussion about whether bioidentical hormones that are compounded are safe and efficacious. And it turns out the FDA did some research and they aren't happy with the evidence so far. So stay tuned about what this actually looks like in the future.
Darshan: I may have discussed this before, but keep in mind that several companies are coming out and they're talking about whether they want to work with Facebook because they believe that Facebook may be protesting hate and racism. Well, they believe that Facebook isn't doing enough to protest hate and racism. So if that's true, do they want to be part of that process?
Darshan: If you think I missed anything newsworthy or you think that there's something interesting that's going on, feel free to reach out to me on Twitter at @DarshanTalks. Or you can just find me via our website at darshantalks.com.
Narrator: This is the Darshan Talks 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: Hey, everyone. Welcome to another episode of Darshan talks. We have another guest with us. We have Anjali Dooley, and I've known Anjali for several years from the American Bar Association. And Anjali is what I like to refer to as the "woman in the know." She is the person who knows everything about telemedicine. When I have telemedicine questions, I think of asking Anjali. And then there are questions around, okay, we've got telemedicine, we've got some telehealth things, and what does this mean for the future? But Anjali, would you like to introduce herself?
Anjali: Sure. Wow! That's a great intro. Women in the know. I think I'm going to change my Twitter handle to woman in the know. Seriously.
Anjali: So yeah, thank you for inviting me to your podcast. I'm Anjali and I own my own law firm, the law office of Anjali B. Dooley, LLC. I'm in St. Louis, Missouri. I practice nationally, a lot of telemedicine clients and implementation of telemedicine. A lot of things that kind of came to fruition during the pandemic, but have been obviously in this field for a long time. I've acted in different roles, as general counsel, as well as in-house counsel. I'm now in private practice and have been for quite some time. And like Darshan said, I've known him for quite a few years through the American Bar Association. But beyond that, just a colleague and friend, so I'm very happy to be on the show.
Darshan: Awesome. Awesome. So now let me ask you this question, Anjali. You mentioned you're in St. Louis. Do you feel like that confers special advantages for you when you're doing telehealth work? Why is that a good place to be for the type of work that you do?
Anjali: Well, it's smack-dab middle of the United States. No, that's not the reason. But Missouri in general, Midwest in general allows for... We're all knowledgeable. We have great law schools in general. But that being said, healthcare is significant in the Midwest and we have a lot of rural population. And for the telehealth, this is where companies are focusing. Really, when you're looking at telemedicine and telehealth, how can we provide access to care to the majority of the population that is in mid-America? Not everybody lives in New York City, not everybody lives in Chicago, even though Chicago is a Midwest city. And not everybody lives on the coast, which is highly dense and populated. So what we're looking at is providing access to care in rural areas. So we're talking about Missouri, we're talking about downstate Illinois and we're talking about Mississippi, Alabama, which you consider the South, but is in the middle of the nation. Areas of Texas, Nebraska, Ohio, South Dakota, North Dakota. You know, you get the picture.
Anjali: So I think being in the Midwest and knowledgeable about telehealth across the nation and what is going on, assists me in the ability to counsel clients who are entering the market sometimes, or clients that already are dominating the market, but really asking themselves, how can we get to more of the rural population which is poorer, needs access to some of these critical access hospitals and things that are closing down. So a lot of my focus is on those type of areas to being in the Midwest. And my fees are probably a little bit less in the east coast, west coast, but there's that.
Darshan: You say that, and I actually think about, again, just knowing you, you've actually been part of a very successful telehealth startup. And I don't know how comfortable you are with any names or anything, but my point is, you've been part of that entire process where you've taken it from, it's an idea, to it's a developing idea, all the way through sale. I'd love to hear more about your experiences with that. That was in the infancy of telehealth. I say infancy but that was only a few years ago. But telehealth itself has gotten so much more in just the last three months that it almost feels like its infancy. So I'd love to hear about your experiences in a successful startup. What does that look like? What are the hallmarks in telehealth around that?
Anjali: A successful startup. The startup that I dealt with had been, I don't know if you would call it technically a startup, but it had been around for nine-plus years. And telehealth has been around for a long period of time. We know that. It's been 20-plus years that it's been trying to accelerate, accelerate, accelerate. The pandemic just opened the doors, right? So I've been in telehealth for 10-plus years. And this startup was around when they hired me back in 2017. It's telepsychiatry, telebehavioral health. And that also was a growing area of work. But the difference between this startup and any others was the fact that they were focused on rural. They were focused on facilities and not direct to consumer at the time. So there was a lot of challenges in getting them to the level of one, compliance, that is required, and back then the regulatory. And I'm saying back then, because some of this stuff is going to be rolled back anyway. But what I'm trying to say is that the regulatory environment didn't allow them necessarily to expand or scale as rapidly as they possibly could in the environment that it is now.
Anjali: And so getting them, in that perspective, compliance, legal, all of those things that are state-by-state, especially when it comes to telehealth, was very challenging. But their growth, because of what they were trying to accomplish, was accelerated. They grew from seven states, they changed their business model. They grew from 7 states to 30 states and are still growing. So giving access to rural skilled nursing facilities right now, when the pandemic is at its height and growing, especially in states now like Texas and Florida and skilled nursing facilities that need telehealth and telepsychiatry, as well as the rural critical access hospitals. So, it's just they're in the right spot at the right time. Hopefully they... I'm not their general counsel anymore so I don't know where they're going, but I'm assuming that, being a shareholder in the company. I do know that they're growing.
Darshan: There were some hallmarks, I imagine. Things like, you make it sound like it's pure luck. Do you think a successful startup is often just an example of luck or... I mean, I usually believe in the premise that it's luck plus preparation. You can't really obviously diminish the luck part, but what are the right pieces of preparation that a startup, that you would advise as general counsel, as in-house counsel, for them to have if they want to be ready? Is it a compliance issue? Is it a marketing issue? Is it the right C-suite? What do you see as the right fit, if you will?
Anjali: Well, you've named the top three.
Darshan: Did I really?
Anjali: So, the right leadership. Yeah! So there's that. You need the right leadership. And strategy on now telehealth is really dependent on, as I've worked with, like I said, larger 200, $300 million companies, the provider piece is a very big piece of the puzzle for telehealth. I don't care about the technology anymore because there are so many technology solutions and vendors out there that are promoting telehealth. The interoperability with EHRs, your EHR vendor already is probably partnered with a telehealth company at this point. What I'm looking at more-so is what market do you want to saturate? Right now I'm looking at a lot of dietician and nutrition groups, and how do we figure out providers in that group? How do we get providers? How do we set up structures, compliantly, and entities compliantly nationwide to accelerate their growth and provide the service? These are service providers with technology as an efficiency to operationalize and provide efficiency into the services that they're providing. Ultimately, if you do not have the physicians, the clinical providers, whether they're dieticians, nutritionists, physical therapists, chiropractors, I don't care, whatever they are. You don't have, the technology is not the solution. It's the provider-driven service. So that is what we should be looking at, and how to accelerate that through telehealth. And accelerate it compliantly, legally, and expand those services across state lines.
Darshan: So that really leaves me the question, again, this is a slightly biased source because as you know, I'm a pharmacist, but I'm only licensed to practice pharmacy in the state of Pennsylvania. Do you see a future where that becomes a national exam? Not just for the science part of it, but for the law part as well, where people can go, "Look, you can practice across interstate lines." Do you think we're just in the infancy of a concept like that, or is telehealth sort of forcing the state board's hands as we continue? Again, this is crystal ball.
Anjali: I think. Yeah. So I just had a telepharmacy interview down in Florida, and that is the one thing that with pharmacists, that I think they need to be more proactive in lobbying more and getting across state lines, licensure, once they get a licensure in a home state. But ultimately it's still up to the state. I don't care about the... You know, physicians have the Interstate Licensing Compact but you still have to pay the fees, and is it easier to get licensed across state lines? Not really. It's still state board-driven, and I don't know that state boards are going to say, "Hey, we're going to open up our borders for physicians from other areas without going through the rigmarole of actually going through the licensing process."
Anjali: And it's not as easy, and it's still not as easy, and are board's going to still do that? No, I don't see that happening. That's my prediction. And I'm going to stand behind it. If I'm taken down from that prediction, so be it. But I don't see Texas. I don't see... Besides the temporary things about the pandemic, I don't see California, I don't see Texas, I don't see New York, I don't see Illinois lifting any barriers for out of state professionals or providers to come into their state and provide healthcare, even though maybe we should have a nationwide license for physicians. But can we really do that? It's really going to be challenging because it's also revenue-driven by those medical boards.
Darshan: Do you see this as a knowledge issue, or do you see it as a revenue issue? Again, obviously you don't know the inner details of this, but do you think if let's say I as a pharmacist go, "You know what, I want to be able to practice in Delaware and in New Jersey and in Maryland," and I'm willing to pay the monthly cost associated with that. Do you see that being [inaudible 00:18:26], Delaware just wants its piece of the pie and if I'm willing to give them the money, they'll be fine. Or if it's New York or whether it's Chicago, whatever it is. Or what would you see them going, "No, no, no. Darshan, you don't actually understand the laws of how you dispense in Delaware compared to New York, and therefore I don't trust you enough to give you a license." So what are the... I guess I'm... [crosstalk 00:18:50] What are the requirements [crosstalk 00:18:51].
Anjali: I think it's both.
Darshan: ... cost of licensing. Sorry, please continue.
Anjali: Right. Yeah, no, I'm sorry. I think it's both of those. I mean, the laws differ in every state and so to get a uniformity of... For example, take away from pharmacy, let's look at supervision rules from a physician to an MP or a PA, those differ in all 50 states. There are going to be independent nurse practitioners, but they have to have a certain number of hours and those laws are changing as well. So it is a combination of what you just pointed out, is that one, you're not going to be, the laws in every state are not uniform. For example, in Missouri, you can only have six allied health professional... The physician can only supervise/collaborate with six full FTE, and then sometimes there is a geographic 75 mile limitation which they lifted temporarily for the pandemic.
Anjali: So those are a host of different areas that are complex, and to change all 50 states requirements to be uniform is going to be very, very difficult to do. And so how do we comply with the state laws, which doesn't mean that that's a knowledge thing. You know how to be a doctor, you know how to be a pharmacist. And I don't think those actual rules are really that different state to state about how to be a physician or how to be a pharmacist or whatever. But because of the specialty boards, the general boards of medicine, all of those things, I don't think we can get a uniform way, and I think really a lot of that is revenue-driven by the boards of different providers. So I want, not only... If you look at CME across all 50 states and requirements for continuing medical education or... I don't know for pharmacy, you may know better, but are they uniform across all 50 states?
Darshan: No.
Anjali: You know, no. So again, CME, all of those things and board certifications and things like that, that is all I believe at certain levels, revenue-driven.
Darshan: Right. So let me ask you this question. You talked very briefly about the idea of telehealth and how it's been particularly helpful in the context of COVID, especially in rural areas where you can't actually leave and the closest doctor is pretty far away. Obviously driving is not conducive in those times. What were the unique challenges you saw, and what gaps did telehealth fill and now, is this identifying new things? And it also raises a question for me, and feel free to answer however you want this, but you mentioned the concept, Telesite, and you talked about management in those scenarios. How are the bans around prescribing of controlled substances affecting telehealth? Or is that potentially going to be one of the things that we live differently with in a post-COVID world?
Anjali: Right. So that's a lot of questions.
Darshan: Sorry.
Anjali: From a telehealth standpoint, what I've seen is a better ability for even physicians that... I'm going to just take my parents for example. I grew up in rural Illinois, or what I rural Illinois, small town Illinois and-
Darshan: So Chicago?
Anjali: [crosstalk 00:23:21] surrounding farmland. Yeah. But I lived in Chicago, which I am a big Chicago fan. So yeah. But that being said is that, what it has allowed them is to be able to communicate with their patients on a regular basis without those patients having to drive in, and they continue to do so. Now, for the challenging part of that is to get people to use, especially positions, to be using compliant technology post-COVID, right? Like right now they're saying, "Oh, I can FaceTime and I can do this," but then post-pandemic, you're going to have to use a HIPAA-compliant technology solution. You can't use iMessage, you cannot use FaceTime and all of those things, right? And the whole informed consent, and all of those things that you have to get into place to continue to use telehealth effectively, incorporate that into your practice.
Anjali: So, I think that's going to be very challenging post-COVID because HIPAA is going to definitely go back into play. I mean, it's going to maybe be a hard stop with that one. Reimbursement, they found that was, okay I can get reimbursed for the telephone visits. I can get reimbursed and create a physician-patient relationship, which I don't necessarily agree with. I think there needs to be some structure around how you create a physician-patient relationship, a new physician-patient relationship via telehealth in general, but definitely by use of telephone. When you don't see the patient via video, and where you don't even have a text message exchange, you just have that phone conversation to create that new patient relationship.
Anjali: What I'm going to see also is going to be challenging is when the licensing across state lines are really closed off, and I'm seeing this rolled back state-by-state now. For example, Missouri didn't give a whole lot of leeway to out-of-state professionals just because we didn't need to, more than likely, although we're a red state right now so I don't know what that really means. But red state as in, you know, when you watch CNN, that COVID is, they're surging in our state. And so that being said, the question is the cross-state licensing.
Anjali: So when that's rolled back, say you saw a patient across state lines, well you're going to have to find a referral in that state, or if you want to grow your practice, how do I grow my practice and continue to see patients in say a state... I'm an Illinois-licensed physician. I'm also a Missouri-licensed physician. I want to continue to see my patients and expand my practice into Missouri. Well, call me. Because I know how to effectively expand that and set up your maybe virtual practices or however you want to expand your practice, how can I do that? But if you're not licensed in Missouri, if you're an Illinois physician and you've seen patients across state lines in Missouri because the governments have allowed it, but now you can't because you're not licensed in Missouri, are you going to continue to see that patient? Or are you going to have to refer that patient to a Missouri doctor in Missouri, or at least licensed in Missouri, to see?
Anjali: So those are going to be some issues that are going to come up fairly quickly in the next five weeks to possibly six months, depending on if the federal government extends the public health emergency, which more than likely I think it's going to extend it to January 1st, at least.
Anjali: And then the second part of the question was the...
Darshan: [inaudible 00:27:48].
Anjali: I think you're getting at the physician-patient relationship, and prescribing across state lines and licensure requirements to do that, and the Ryan Haight Act. And as we know, it's lifted right now, how are we going to continue to do that? Prior to the pandemic, there was lobbying to, especially by telehealth companies that were prescribing, to allow to create that physician-patient relationship via telehealth and for prescription purposes and things like that. So, is that going to stay? I think certain things like that are going to be permanently, probably, staying post pandemic because it's already been on the radar. And I think there's going to be a strong lobby to have that soon. But again, I think there needs to be definitely more structure around that creation of the physician-patient relationship. I think there needs to be documentation requirements, all of those things that need to be there before that level of that in-person consultation, that is a requirement under the Ryan Haight Act, is lifted.
Darshan: So, Anjali, I know we usually, we can keep talking about this, but I kind of wanted to stop the podcast here. What I do want to say is that if people are looking for someone to join the party and predict the future, how do they reach you? Because obviously you're really good at this [crosstalk 00:29:37]. How do they find you? Is it Twitter?
Anjali: Yeah, so how do they... Well, there's so many ways to find me. One, I'm on LinkedIn and I'm on Twitter, but you can find me at Anjali B. Dooley, LLC. You can just Google me and find me. But my law firm is anjalilawoffice.com. A-N-J-A-L-I, lawoffice.com. I don't think I need to spell. But my cell phone number, which I'm happy to give, which is (636) 293-7633. And I definitely, I give out my cell phone number. I really don't care that you have it. But I do have an 800 number, which is 833-ANJALI-5, so, you can reach me there too.
Darshan: 833-ANJALI-5. Good for you.
Anjali: Yeah.
Darshan: Well, thank you again Anjali for coming on. This was awesome. I hope we can do another one soon.
Narrator: This is the Darshan Talks 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.