Telehealth drug prescribing & the opioid crisis: What every doctor needs to know — Bradley Davidsen

How is the opioid crisis changing regulations around online drug prescribing? What are the online prescribing rules that every physician ought to know? Is an in-person exam necessary for prescribing medication online? How does telehealth drug prescribing work across state lines or internationally? Join health care attorney Brad Davidsen on our next TFSS video podcast as we discuss the pitfalls and promises of prescribing controlled substances over telehealth.

Transcript (click to expand)

[00:15]
Hi Everyone, welcome to another video podcast of Telehealth Failures & Secrets to Success. This week we’re really excited to have Brad, looking by the number of registration, we could tell right away his talk is really insightful, and everyone is looking forward what he has to share. Before we start, is there something you can briefly introduce yourself.

[00:48] Brad:
I have two very young kids, and going to work is what I do between changing diapers and two or three hours sleep every night. Very sensitive to those concerns. And for that reason, I find telehealth even more fascinating every day because I think, boy, if I could just call the physician on my iphone, that would be so much easier than taking her to the doctor’s office. My oldest is three, and my youngest is about 10 months.

[02:16]:
I got my teaching certificate from Michigan state, and I did a lot of children’s programs before I got into law. I drove a bus for a summer camp for about a month and a half. And then I think it was probably better off for everyone that I got into an accident and we said, you know what? I don’t know, I’m very happy that I don’t have a CDL license anymore.

[03:26]
So my name is Brad Davidsen, an Epstein Becker Green. You’re gonna see a picture of me.
Oh, good. The picture didn’t show up, but that’s my contact information. They’ll be in the slides when you get it. I thought I would start with just some really, really jarring statistics. Drug overdoses now the leading cause of death, of americans 50 and over and since 1999, right after I graduated from high school, there has been a 500% increase in the number of deaths related to opioids. 2016, we had 64000 Americans die of overdose, that’s more than the no. Of ppl died in the vietnam war. It’s more than last year died of car crashes and gun violence combined. So it’s just a crazy staggering statistic. We actually had a life expectancy dropped for two years in row, and that hasn’t happened in almost 60 years. So it’s something that people are starting to take more seriously.

[04:55]
The most common treatments for opioid dependence disorder are methadone and suboxone or buprenorphine. And I know buprenorphine comes in a number of different ways that it can be administered in the same with methadone. So to some extent, there may always be in in a clinic period for these drugs, but they’re both schedule to schedule three controlled substances. So they’re very controlled. And in terms of treatment of patients, you have a couple of big issues. 1, because they’re controlled substances, you’re limited in who can write a script for those drugs and it’s only a problem in that there are only so many of those individuals. And then you also have a lack of providers in areas where the crisis has hit hardest in really rural areas. You just have a low concentration of physicians already or practitioners, and then of those practitioners, how many have the expertise to provide this kind of care because it’s certainly something where you don’t need a special license to do it, but having that expert background makes a really big difference in how you’re able to best prescribe for your patients among the other things.

[06:30]
Those three issues seem like they pave the road to telehealth to say, alright, well, set up a camera or through someone’s iphone at home, you can do a combination of therapy and you can loop in a prescriber who can view the record, store and forward. All of this adds up to a good combination of providing care through telehealth, except that you have the Ryan Haight Act which was established in 2008. I’ll give you a little background. So Ryan Haight was a high school I think he was a senior, and he was able to procure a lot of narcotics through an online pharmacy. And this was in, I think, 2003, it was fairly easy to get those kind of things through the internet with no physician interactions. It took them five years to write the law because that’s how it works. And the law was intended to stop this from happening, but what it did was it set up these barriers to establishing a physician patient relationship that would allow you to write a prescription for controlled substances. And it has limited exceptions, but the exceptions are the patient’s already in a hospital or a clinic, or they’re standing right next to another physician who could write the script. So it’s not really an exception, it’s just kind of a farce. But even when it was initially written by congress, they had this thing called the special registration written into the amendments to the controlled substances act, which is supposed to allow DEA to meaningfully, thoughtfully, probably rules to say, under these circumstances if you register with us, we’ll check your background. We’ll do what we feel is necessary to make sure that you are a good risk, if you will. And we’ll give you this ability to write prescriptions through telehealth for controlled substances or may even for a very limited number of controlled substances. It’s completely in DEA’s hand. That was in 2008 and since 2008, they have done nothing with that special registration, which kinda brings us to where we are today.

[09:18]
So since then DEA hasn’t done anything. However, every single state has come up with telehealth laws that somehow either very directly, very clearly, or at least tangentially talk about the prescription of controlled substances. And to even last year our firms, it did a survey a couple of years ago, and so many states came up with new laws that we felt like we had to do an addendum to it, otherwise it would be useless within a year. I think it was something like 48 of the 50 states, some ridiculous number changed their telehealth laws in that period of time in some manner or fashion. So I came up with a list of a couple to give you the idea of just how varied these laws are. So in Michigan, you have a pretty loose standard as a health professional who’s providing a telehealth service to a patient, may prescribe the patient a drug if the health professional is a prescriber who’s acting within the scope of his or her practice in prescribing the drug. That’s a lot of words to say, prescribe like you’re supposed to, and that’s literally… That’s it. If you are in Michigan pretty soon, you’re going to have to act in accordance with the prescription drug monitoring, but almost every state has a prescription drug monitoring program. So that’s not really unique, otherwise act within the standard of care.

[10:59]
And there is no additional requirement in order to write that script through telehealth that’s very different from other states. Hawaii is closer to Michigan, Hawaii allows for prescribing any drug except that they have another law that limits prescribing opioid and medical marijuana. Those cannot be done through telehealth, but otherwise, any other controlled substance you are able to prescribe in a way. And then in Indiana, Indiana has something that’s really great and then it’s not so great. So it’s a very thoughtful law. They just changed it last year or maybe even this year, I don’t remember. It allows for the prescription of controlled substances, except for opioids, except you can prescribe an opioid agonist used to treat or manage opioid dependence. So it’s very thoughtful in terms of using telehealth in the opioid crisis, except it’s gotta carve out of all of that to say, it still has to adhere to federal law and Ryan Haight still on the books. So that still says, well, that’s great for all of that, but it’s still against federal law to write that prescription.

[12:30]
Before I move on to some of the other states that puts prescribers in a precarious situation. Because if you… Let’s say you’re treating a patient that’s in Indiana and you’re an Indiana licensed physician. Let’s say you’re even located in Indiana, all of that is an in-state transactions. Maybe you’re balancing, what’s the risk that anyone is going to say anything about this anyway, and what’s the risk that DEA is going to know? Well, if you have a prescription drug monitoring program, then you’re going to have to add that prescription into the database. And then it’s a question of whether or not your state is releasing that data to the federal government. And then you get to the point of, does DEA care? And that’s a point that I’ll make down the road a little bit, but just get into two more states. So this is the opposite end of the spectrum.

[13:34]
New Hampshire, by contrast, says that you cannot prescribe schedule two through four control substances, aexcept non-opioids for people that you’ve already seen in person, which is really like a follow up exception, or maybe a refill exception, and then prescribing any drug to a patient who’s already in a substance abuse and mental health services administration, certified state opioid treatment program. So that’s a very limited exception, even though I think that that is more meaningful than some other states. And then you have Connecticut, in Connecticut just says, you can’t period. That’s not necessarily that thoughtful. And so there are some takeaways from just the short period of these slides. The first being that you have to look at the state laws that are applicable, and that’s going to be the laws in the state where the patient resides. But it’s also going to be the laws of the state where your license, because if you’re worried about a prescription that you write may come back to you in the form of board of medicine saying, hey, what are you writing this prescription for? We say that you can’t write that. You’ve gotta be mindful of that. And you have to understand what’s your risk that that’s going to happen.

[15:11]
One example is abortion causing drugs. There are numbers, states, there aren’t that many. And one actually, one state just in the last year, took the law of its books because of a constitutional argument. But there are a couple of states that say, you cannot prescribe an abortion causing drug through telehealth. Because it’s only a handful of states, It’s very easy that you can miss it. So it’s important to really keep track of these things. Opioids for chronic pain or any other even chronic pain management is a card in a lot of states. They won’t allow you to prescribe a drug for the treatment of chronic pain management through telehealth. And a lot of states are very specific to opioids. In Indiana have that opioid agonist language. I think that that’s languages, is going to catch on. I think we’re gonna see more states talk about opioid agonists because the paradox is that methadone and buprenorphine are both opioids, but they’re used to treat opioid abuse disorders. They’re considered opioid agonist, And I think that that’s a term you’re gonna start to hear a lot more. The second takeaway, which is something that we talked about in the green room before, is that the congress persons are becoming more aware, this industries becoming more aware and exerting pressure. I’m trying to remember there’s a letter written to DEA by an industry advocate, not that long ago pushing for the special registration. There’s a letter written like senators in alaska and in Missouri, I said letters from industry ata. It’s not actually ata. Sorry about that. It’s another a industry participant. But the idea is that it’s on people’s radar finally.

[17:23]
And one thing that even if you see these states that are coming out and saying, you prescribe whatever you want, you still have to be aware Ryan Haight is on the books. However, I’m gonna skip down to the last point here. Enforcement is a licensure issue. It’s not really a DEA enforcement issue. And I say that as… And I looked this up today, actually, there hasn’t been a Ryan Haight enforcement by DEA since 2013. So it’s been a really long time, maybe 2014. And even then, the last piece that I read on the ALJ, the administrative law judge who hears the cases that federal agency brings said that the bar was pretty high in terms of the proof that DEA has to bring of a violation because you can’t just say, well, the patient was in state A and you live in state B. That’s not enough. It’s very easy that a physician, if they’re licensed in state A, could fly to state A and treat a patient if they wanted to. So, DEA actually has to show that that didn’t happen, or at least this one case talked about that. And that’s a really high bar. So I think the enforcement risk under DEA is pretty low and of the cases that are brought a lot of them stem from a physician doing a fair number of things wrong. And most of those things come out of the state board of medicine where you’ve got certain prohibitions or certain standards of care that are set by the board of medicine. And if you’re not in accordance with those, there’s nothing that’s gonna keep them from calling the DEA and saying, hey, would you like to pursue enforcement on this case? So those are some of the takeaways, if I were a physician, I still wouldn’t be that comfortable prescribing controlled substance through telehealth. I think that there are… They’re obviously are physicians out there doing it and it’s a licensure issue. It’s a risk for you. I can appreciate that you’re doing what you think is best for your patients, but it’s still a risk. And it’s one that, in my opinion, is not that hard to get rid of. We just have to change the law. And I think that a lot of people are behind it, but it’s still there.


About the Speaker:

Bradley Davidsen

Bradley S. Davidsen, Esq. is an Associate attorney in Epstein Becker & Green, P.C.’s Health Care and Life Sciences group. Brad’s focuses are in several areas, including: clinical research and negotiating various agreements related to clinical research and clinical trials for drugs, devices, biologics, and combination products; state and federal regulatory and licensure matters; and telehealth / telemedicine issues, primarily including corporate practice of medicine issues and prescribing laws and regulations.

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