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Treating Fluffy from Home: Veterinary Telemedicine Law

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Treating Fluffy from Home: Veterinary Telemedicine Law

Telehealth has exploded in recent years due to the COVID-19 public health emergency, although it has been around for a number of years. Similarly, veterinary telehealth, or as we are calling it, TelePet, is currently growing at a rapid pace, however, many states are not aligned with each other regarding what services can be provided virtually and what needs to happen before TelePet services can be provided. During this webinar, we will move through the timeline of how TelePet first began, where the industry is now, and how much further we have to go. We will cover the law, the practice, and the money to help stakeholders understand all considerations that are at play when thinking about TelePet.

Transcript

Hi there. My name is Kaitlyn O'Connor and I am joined by my colleague Reema Taneja. We are here to talk to you about veterinary telemedicine laws across the United States. Let's dive in. So first and foremost, just a quick little introduction to who we are and why we are the ones talking to you about this. Like I said, my name is Kaitlyn O'Connor. I am Senior Council at Nixon Gwilt Law. Nixon Gwilt is a healthcare innovation law firm. We work with innovative healthcare providers, digital health vendors and life sciences and biotech companies. Reema and I have, more recently, been working together with our TelePet or televeterinary clients. These are clients that we have in the virtual pet health space. We started seeing a little bit of movement in this space, and Reema and I are both dog lovers, so we got really excited about it. And as you can see on your screen, if you're looking at the slides, you can see all of the dogs that the members of our firm have. And actually, I think we have a couple more that have been added since we first made this. So that's us, that's our firm. Reema, do you wanna add anything about your background?

Sure. Hi everyone, I'm Reema and I am Council at Nixon Gwilt Law. As Kaitlyn mentioned, we have started our TelePet practice to address the innovators who are in the veterinary industry and we are really excited to talk to you about TelePet today.

Awesome. Okay, quick important notice, you all know this. This is an informational presentation being presented to you for CLE credit. This does not form an attorney-client relationship, and please do not rely upon this presentation as legal advice. Reema, you wanna go through the agenda?

Yes. So as you know, telehealth has exploded in recent years due to the COVID-19 public health emergency, although it has been around for a number of years. Similarly, veterinary telehealth, or as we are calling it, TelePet, is currently growing at a rapid pace as well. However, many states are not aligned with each other regarding what services can be provided virtually and what needs to happen before TelePet services can be provided. So during this webinar, we will move through the timeline of how TelePet first began, where the industry is now and how much further we have to go. We will cover the law, the practice and the benefits and challenges to adoption.

Awesome. Okay, so... what is TelePet? Reema, I think this is you as well.

Yes. So as we discuss TelePet, we should become familiar with how this modality of veterinary healthcare delivery is defined. Generally, TelePet means the delivery of veterinary medicine services, including examination, consultation, diagnosis, and treatment through electronic communication technologies when the pet parent and pet are located in a different location than the treating veterinarian. The American Veterinary Medical Association, or the AVMA, defines veterinary telemedicine as a subcategory of telehealth that involves use of a tool to exchange medical information electronically, from one site to another, to improve a patient's clinical health status. Examples include using Skype or a mobile app to communicate with a client and visually observe the patient, or a post-operative follow-up examination and discussion. Some states have varying definitions of TelePet, but most states do describe veterinary telemedicine in a similar manner as these definitions that we have just reviewed. And as you can see, it's pretty similar to the broader definition of telehealth, but this is definitely the language that most states are relying on.

So let's now go through a quick timeline, just to understand how long veterinary telemedicine has been around and the kinds of contexts where we have seen it sort of evolve over time. You may be surprised to learn, as I was, that veterinary telemedicine has actually been in practice since about 1980. The first example of veterinary telemedicine occurred when a veterinarian transmitted cardiology records via telephone to a specialist for a consultation. From there, there was sort of limited adoption. No one was really talking about it. I, personally, hadn't really heard of veterinary telemedicine until probably the last year or so. So from 1980 until about 2017, there wasn't really much happening. Then in 2017, the AVMA released the definition that Reema just shared with you. And then a couple of years later, in 2019, adoption of telehealth increased even more. And as you can imagine, around the end of 2019, beginning of 2020, when the COVID 19 pandemic affected all of us, we saw an even greater spike in the number of households that we're leveraging TelePet technology or looking to meet with their veterinarians virtually, both to avoid going into the veterinary clinic, to keep themselves safe at home, and also, you know, sometimes I think people realize it's just not necessary. You don't have to go in person, very similar to telehealth in the human medical context, where sometimes we just don't need to go all the way to our doctor's office. The same can be said to be true in veterinary telemedicine. And so a little bit about the broader TelePet industry and how it exists right now. We see TelePet, or veterinary telemedicine, happening in lots of different ways, one of which is through asynchronous teleprescribing. So filling out an assessment for your veterinarian to review and then issue a prescription for maybe something like flea and tick medication, heartworm medication. Some of those sort of, you know, more well-known things that all dogs or all pets need to have access to. We'll talk in a little while about some of the limitations around teleprescribing, but broadly, you know, asynchronous teleprescribing is one area where we see veterinary telemedicine sort of taking hold. Another is in synchronous veterinary care. So that is video chatting with your veterinarian. Maybe showing your veterinarian a video of your pet or something that the pet is doing live to kind of get their take on it. Or something along those lines. I actually just participated in an asynchronous visit with a veterinarian recently, where I submitted a video of my dog for the veterinarian to take a look at. Turns out she just had hiccups, so everything was fine. But that was an example of the asynchronous situation where it wasn't teleprescribing but it was an asynchronous visit where I sent a video to my veterinarian for them to review on their own time and get back to me in a non-emergent fashion. Other areas where we're seeing early adoption are in things like digital telehealth. So broader use cases around remote monitoring, maybe some wellness. I actually recently purchased a fitness tracker for my dog, so I can make sure she's getting enough exercise every day. And, you know, there are a couple of other use cases there as well. Lab testing, and then pharmaceutical compounding, both of which are probably less, I would say less familiar or less common at this time, the lab testing and the pharmaceutical compounding, but are very common in the human medical context. So those are some areas where we're just now starting to see some companies pop up that will mail you a test for you to maybe test some of your dog's allergies or see if they have something else that might be going on, right from your home. You can take the sample, put it in the prepaid packaging and mail it out to the lab for the lab to then assess and review and maybe share those results with your veterinarian as well if it's something that the vet ordered. And then pharmaceutical compounding. Just like how it works in the human healthcare space, there are remote pharmacies that will compound certain medications for your dog based on what your veterinarian has recommended. On the right side of your screen, we have a little diagram here just to show a few of the other areas, like tele-triage, teleadvice, teleconsulting, telemonitoring, E-prescription, a few other areas to where, again, the veterinarian is in this model or in this diagram at the center of the model. But these are all areas where we've seen adoption of virtual healthcare or virtual technology be really effective in the human healthcare space and I think a lot of companies and a lot of veterinarians and a lot of pet owners have said, hey, why aren't we doing this for our pets as well? We can do it just as well for them. There are some limitations, which again, we'll talk about in a little bit. Of course, our pets can't use their words, so they can't get on and explain to the doctor exactly what hurts or what they're feeling and we have to kinda do the guesswork there. So that creates a little bit more of a challenge, I think, than we see in the human healthcare space. But regardless, it's happening and we've seen a lot of successful use cases thus far.

Okay, so now we will talk about some benefits that we see with the TelePet industry, as well as some challenges. This is more so to provide you with a visual to kind of describe how people in the industry might be viewing TelePet and whether or not to implement it, whether it's worth it. Of course, we do see some pushback from traditional veterinarians who very much value the in-person, face to face opportunity to provide patient care. This is very similar to what we saw with telehealth at the beginning. So it's not necessarily surprising, but of course, it's beneficial to understand how people are thinking about this service in the industry today. So as you can see on the left side, we have a list of what we've noted as the benefits. So number one, the type of TelePet services that can be provided virtually are patient-facing. So this increases access to services and veterinary care across the country. There are many times when veterinarians are booked up, especially after the COVID-19 pandemic started and more and more individuals started adopting pets. We saw a backlog of in-person veterinary care, as well as emergency care, and that still exists today. So TelePet can definitely increase access to medically necessary veterinary services. It also allows flexibility for patient populations of varying geographical and socioeconomic status. So oftentimes not everyone is able to actually go to the veterinarian's office, just in terms of not having access to transportation, not being able to take time off of work. So TelePet can really fill this gap because a client or a pet owner can schedule a virtual visit with their veterinarian, determine whether or not they do need to go in person for the issues that they're experiencing with their pet, or if the veterinarian can help resolve the pet's healthcare condition virtually and then perhaps schedule a follow-up visit at a later time. There's also a potential for 24-hour/extended access. So as we know, most veterinarian offices close, you know, after a normal business day. There are, of course, emergency room centers that allow for 24-hour care. But again, these are very backed up at the moment and TelePet can definitely alleviate some of this concern because you may be able to have veterinarian technicians online beyond a certain time who can then get in touch with the practicing veterinarian for any issues that might need to be escalated to them. There also would be in a lower error rate. So when veterinarians and technicians are able to streamline some of their provision of services electronically, that allows them more time to focus on providing high quality clinical care. And we've seen this in the telemedicine space where a lot of things that could go wrong in the office are able to be addressed through the platform through existing functionalities. TelePet also offers effective patient counseling. So as we've kind of discussed already, there is more of an opportunity for a pet owner to just get on the phone with their veterinarian or get on a video visit, send pictures if they need to of a certain, you know, if there's a skin condition, for example. And that way the veterinarian can pop in very quickly, just talk to the pet parent and be able to address some of their concerns, probably in a more reasonable amount of time than having the pet parents schedule an appointment, for example, to come into the office in person. This will definitely continue to be advantageous as the public health emergency continues, especially for high-risk clients who are pet parents. Again, like we've seen on the telehealth side, many elderly patients have benefited from being able to receive care virtually because they are at higher risk of contracting the virus and they don't necessarily feel safe going out and about just yet. So that's definitely something that's similar to the TelePet space. From an operational perspective, as we mentioned, it is cost and time efficient. So like we've said before in the telehealth space, as well as telepharmacy, which we haven't mentioned yet, but there are very similar prescribing parallels in the TelePet space as well. So this is talking more about prescribing and being able to fill scripts virtually for pet patients who may just need a quick fix. And of course, depending on state law, we'll talk about this in a little bit more detail later, there are certain things that need to be done before a veterinarian can prescribe a drug to a patient, but again, allowing the technicians who are helping with this service to do some of this electronically or virtually, it can allow the team to spend more time on providing high quality care. From a challenge perspective, of course, there is a big piece of technology that is important here, implementing the proper software, making sure that the entire staff knows how to use it, ensuring that pet parents know how to use it. That can certainly be a challenge, and something to keep in mind is, you know, if TelePet companies are either providing the software themselves or outsourcing it. There are a number of things to be aware of in terms of making sure that, not only the technology is functional, but also it's implemented in a way that is user-friendly. There are some state level privacy and security laws that should be noted when a TelePet company is implementing or creating a software. So that definitely seems to be one of the challenges. And then from a legal perspective, there is no interstate veterinary licensure compact, like there are for physicians and nurses on the human side, which allows them to achieve cross-state licensure pretty efficiently. There may also be some additional licensing requirements for veterinarians or companies who are providing the sort of service. And then lastly, in terms of adoption reimbursement, some states are still slow to adopt, meaning that they don't necessarily recognize veterinary telehealth or allow for it, or they might have a limited set of what can be provided virtually. So there's still not in alignment yet. There are some states that still aren't sure if they want to permit this sort of service. So that will definitely be a challenge that will continue probably for a little bit of time. And then lastly, reimbursement-wise, of course, there's no sort of state reimbursement for TelePet services, but there might be certain private payers in the veterinary space who are covering for this.

And I'll add another challenge that we don't have listed here but that I think is relevant, which is broadband access. So one of the ways that virtual care can have the greatest impact is with respect to rural communities who don't have high quality veterinary offices close by, or maybe they need a specialist for a pet or a surgical procedure for a pet and the closest place to get that is far away, or to get a consultation for surgery or something like that is someplace that's farther away. It's really helpful for pet owners in that community. And this is true for human healthcare as well, but it's helpful for the pet owners in that rural community to be able to call up a doctor via video chat and say, hey, my dog is having this issue or they're limping or whatever it might be, and kind of get a quick response without having to drive, you know, an hour or two hours to the nearest veterinary clinic. And unfortunately, what we have seen, and what I think has been really highlighted during the COVID-19 public health emergency, is that those rural areas that are probably one of the most, or some of the most in need areas for something like veterinary telemedicine, are unfortunately also the most underserved communities when it comes to having substantial broadband access and being able to get on the internet and complete that call. So what we've seen in the human healthcare space is lots of regulatory movement among Congress and states to expand broadband access. And I think that expansion, if and when it takes place, will have a positive impact on the veterinary telemedicine side as well. Because I do think that that low broadband access, or subpar broadband access, is a major challenge here as well, where you've got these rural communities that could really benefit from this new technology, not really being able to leverage it as much as they probably would like to because of those limitations that are outside of their control. All right, so that's sort of a high level overview of the benefits and challenges. We will now kind of dig into the top three legal considerations. So this is where we will really start to dive into some of the more specific challenges around what the differences are from state to state in terms of different laws. And if you're advising a client that's trying to scale very quickly from state to state, that might be kind of difficult. And these are the things you're gonna wanna think about in that situation. These are the things you're gonna have to advise your clients on when they come to you and say, hey, we've got this new technology. We wanna launch it in all 50 states. How can we do that? These are some of the things that you're gonna have to look into. So the first is the veterinary client-patient relationship, or VCPR. If you're in the TelePet space, you will inevitably hear VCPR mentioned. It is one of the biggest issues, sort of most hot button issues, that people are sort of dealing with and trying to address right now. This is how to establish a professional relationship between the veterinarian and the pet and the pet owner. We'll get into some of the details and what the most common examples of those laws look like. We'll also talk about veterinarian teleprescribing. Teleprescribing, in particular, is a huge challenge in both the human healthcare and the animal healthcare space, particularly because of the opioid crisis and how that sort of came about and the ease with which patients used to be able to get opioid prescriptions online. The government recognized that it was probably too easy and contributing to the opioid crisis, and so now they've made those laws very strict and many medications that are prescribed to pets are actually the very same medications, whether it be in a stronger dose or something, or a different format, they actually still are the same drugs that are often prescribed to humans. And so a lot of the laws that apply to prescribing to humans via virtual care also apply in the TelePet space. And we'll talk about what those laws look like. And then finally, we'll talk about corporate practice of veterinary medicine. This is who can and cannot own a business that is treating patients or treating pets, or that is hiring veterinarians or veterinarian technicians to treat pets, whether it be in their state or in another state. And we'll dig into those, we'll get into some additional legal considerations as well, but these are really the top three that Reema and I deal with the most and that we think present some of the biggest challenges to the clients that we see in this space. So Reema, do you wanna sort of go into the concept of VCPR and what those laws are looking like?

Yes. So VCPR, as Kaitlyn mentioned, stands for the veterinarian client-patient relationship. So this mirrors what we have on the human side as the physician-patient relationship. Of course, there's a client or a pet parent who is involved here because, you know, the patient can't communicate directly with the veterinarian. But the states still do require certain things to be done before veterinary care can be provided to a pet patient. And it does vary on a state by state basis, but generally the AVMA requires that the, or sorry, defines the veterinary client-patient relationship as the basis for interaction among veterinarians, their clients, and their patients and states that it is critical to the health of animals. So, like I said, it varies on a state by state basis, but the AVMA provides some guidelines on what generally must be present for VCPR to be established. So in a nutshell, they basically require that the following requirements should be met. Number one, the veterinarian has assumed responsibility for making clinical judgements regarding the health of the patient and the client has agreed to follow the veterinarian's instructions. The veterinarian has sufficient knowledge of the patient to initiate a diagnosis of the condition of the patient. So this means that the vet is personally acquainted with keeping care of the patient by virtue of a timely examination of the patient or medically appropriate and timely visits by the veterinarian to the operation where the patient is managed. So this really just means that the vet has examined the patient in a sufficient manner so that they can sufficiently diagnose the patient and also kind of keep in touch with what's going on with the patient from a health perspective. And sometimes states require that the veterinarian actually physically see that pet in person on a, you know, a month-by-month basis or every three months or something like that, so that they are continuing to be engaged with that patient. Next, the AVMA states that it is generally required that the veterinarian is available for follow-up care, or has at least arranged for either emergency coverage after the visit or continuing care and, sorry, and continuing care and treatment. So this is just to ensure that, you know, if something goes wrong after the virtual visit, that the veterinarian has already shared with the pet parent how they can ensure that they'll receive follow-up treatment. Next, the veterinarian must, of course, provide oversight of treatment compliance and outcomes. So ensuring that they are checking in with the patient and monitoring whether the treatment that they prescribed is addressing the pet's concerns. And then lastly, patient records must be maintained. And as I mentioned before, some states do have privacy and security guidelines for how pet records should be maintained. So that's a separate issue, but definitely something to keep in mind. And then, as I've mentioned, there are implications of providing veterinary care virtually. Some states do allow the veterinarian client-patient relationship to be established virtually, some require in-person care, but there is a difference across the states. All right, Kaitlyn, if you can move to the next slide.

Sure, I also just wanna actually quickly add here that one of the things that Reema and I have been noticing recently as well is that this VCPR concept is one area where we're actually seeing quite a bit of tension between industry and pet owners and regulators. So there is a subset of veterinarians who are very uncomfortable with the concept of veterinary telemedicine. They just don't think that it's appropriate in a lot of contexts, or that they don't think that establishing VCPR virtually is appropriate in a lot of contexts. And so the AVMA has been very actively pushing against virtual establishment of VCPR in many ways. And so that has made it a little bit difficult for adoption. It's also made it a little bit difficult for sweeping changes to happen across many states because the AVMA and their cohort has one sort of view on this and then the pet owners that wanna leverage this technology and the founders that are creating this technology and veterinarians who are comfortable with establishing VCPR virtually are kind of at odds with each other. So I think it'll be interesting, over the next year or so, how this evolves. I think we're gonna see quite a bit of movement. We've already seen some big deals start to take place in terms of mergers and acquisitions. And so I think the TelePet space is really kind of at a point where it's going to grow very quickly, but that's going to require regulatory support. And so I think it'll be interesting to see how that happens over, like I said, the next year or so, as the industry starts to grow and the laws really need to catch up. All right, back to you Reema.

Thank you, okay. So next, here we have a chart of state adoption as it exists currently. This is something the Veterinary Virtual Care Association has created and they keep tabs on what the industry looks like from a state-to-state basis. So in this chart you'll see states where virtual VCPR is explicitly allowed. As you can see, these are the states that are highlighted, in that dark gray, greenish color. So you can see that not many states actually explicitly allow this, and this might be because it is somewhat new, and also, as Kaitlyn mentioned, there are just industries, you know, in the traditional veterinary healthcare space that are not really comfortable with the idea yet. So state veterinary boards are definitely considering it, and as we'll see in the next map, you know, there is some gray area and some things that need to be done before VCPR is considered to be established. But as of now, there are only a handful of states that explicitly, in their state language, allow VCPR to be established virtually. And this map shows which states explicitly prohibit virtual VCPR. So this means that states have created language that says there is no circumstance where VCPR can be established virtually. Again, you will see that it's not many states. It probably looks like about 10 or so, but as you might have noticed, after seeing the first slide, in total, this probably equals 10, 20 or so states. Some that have said virtual VCPR can be established, can, sorry. Some states have said that virtual VCPR can be established explicitly in their state language. And then these are the states that have explicitly said the opposite, where it's absolutely prohibited. And now in the last slide, we'll see a map that says a physical exam, or some sort of exam, needs to be done before any sort of virtual telehealth or veterinary care can be provided. So now you'll see there are more states that have similar language to what we've just discussed. And again, some states don't necessarily say that this physical exam needs to be in person. Some don't say that it can be done virtually. So it definitely is a gray area and it's important to not only read the state language, but also consider how veterinary boards are interpreting virtual TelePet services. And, you know, if there are any enforcement actions that have taken place yet, which, and as it currently stands, there hasn't been much enforcement yet and I think that's most state veterinary boards are still toying with the idea and trying to see how it plays out.

Yeah, so I think that's right. I think that, you know, for the lawyers who are tuning in, what a lot of conversations often come down to, for Reema and I, when we're talking with our clients about VCPR in particular, is just our client's risk tolerance, right? How comfortable are they knowing that maybe the state they're trying to operate in has very gray laws around VCPR. Maybe they have an explicit prohibition, but we've seen that the veterinary board is sort of moving in the right direction. We often have conversations with our clients about how comfortable they are taking on some sort of regulatory risk. If they know the law isn't perfectly in their favor, how can they move forward without putting their entire business at risk? But also while still making sure that their consumers have access to their technology. Reema and I are often talking with the software vendors that provide the software to the veterinarians that are meeting with their patients and they're often having conversations. Our clients are often having conversations with those veterinarians about what the law says and where they're comfortable and where they're not. And so we always like to think about it in terms of what is the risk level? How comfortable are we in saying to our client, we will defend you if, you know, this veterinary board changes their mind or something like that, versus, you know, how difficult is it in the sense that Reema and I are actually gonna say, hey, we're really not comfortable with you guys operating in this state right now. Let's focus on a couple of others and come back to this one later. Which I think that happens in a lot of areas, but in this area in particular where industry is moving, sort of outpacing legislation, we are often having those risk-based conversations. So let's shift gears now and talk a little bit about veterinary teleprescribing. As I mentioned earlier, some of the laws that we're about to talk about came about back in the early 2000s, when the opioid crisis was first sort of being recognized. As we know, it's still continuing and it's still exists, so I don't wanna say, you know, back when it was, you know, happening because it's still happening. But at the inception of our recognition of the opioid crisis, we saw a lot of changes in both federal and state law in terms of teleprescribing. So importantly, like with everything else that we talk about, the definitions and the requirements for teleprescribing vary by state. But generally, when we are talking about, in this presentation, or in the veterinary context, teleprescribing, we are talking about prescribing a medication or other treatment through telemedicine. So the doctor's having a visit with the patient or the pet owner and saying, okay, I think that your dog, my dog's name is Millie, let's go with Millie. Okay, Millie needs a new prescription for her flea and tick, I'm gonna go ahead and write that. Even though we've only met virtually, I'm gonna write that and provide that to you right after this call. That's teleprescribing. As we said, there are both federal and state level implications and requirements. We'll go through a couple of them at a high level now, so you have a summary. But if you're working with clients in particular states, you're definitely going to wanna make sure that you take a look at what the state law says versus what the federal law says about teleprescribing certain medications. So the Food and Drug Administration, or the FDA, requires VCPR and an in-person exam prior to prescribing any drugs. I'm gonna say that again 'cause it's really, really important. The Federal Food and Drug Administration requires that VCPR be established through an in-person exam prior to prescribing any drugs to pets via telemedicine. That's a pretty big barrier. During the public health emergency, this restriction has been relaxed quite a bit to basically temporarily suspend the restriction, to allow for prescribing of medications without that in person exam prior. But when the public health emergency ends, it's very likely that this is going to go back into place. So we're kind of at a point now where during the public health emergency, all of these flexibilities have allowed for new technology to take hold. And we're really keeping an eye on how those companies are going to survive at the end of the public health emergency, if, in fact, we go back to a world where an in-person exam is required. So keep that in mind. There is also something called the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 or the Ryan Haight Act. And this is the big one that really came about in light of the opioid crisis. So the Ryan Haight Act requires at least one in-person exam prior to teleprescribing controlled substances. The thing to keep in mind here is that controlled substances is much broader than you might think. It's not just opioids, it's not just narcotics. There are a lot of medications that are classified as a controlled substance and all of them, from schedules two through five, are going to be restricted by the Ryan Haight Act. And so, you know, usually what Reema and I will do is we'll sit down with our client. If they're planning to prescribe via telemedicine or allow for prescriptions to be issued via their platform. And we will ask what are all of the medications that you expect your veterinarians to prescribe or to need to prescribe? And we take that list, we check it against the controlled substances list and the different schedules under the CSA or the Controlled Substances Act, and we'll go through and say, all right, these ones are okay, these ones are not, these are controlled substances, not a good idea to prescribe them. Although we'll talk a in a second about how state laws might be different, but at a federal level, the Ryan Haight Act is going to prohibit that teleprescribing of all controlled substances. And then there are a couple of other requirements that apply as well. So the prescription has to be issued for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice. Oh, I'm sorry. There is an exception to the Ryan Haight Act. There's a telemedicine exception to the Ryan Haight Act which allows for controlled substances to be prescribed or teleprescribed if the following conditions are met. So if the prescription is issued for a legitimate medical purpose, like I just said, if the telemedicine communication is conducted using audio, visual, real-time, two-way interactive communication system. And if the practitioner is acting in accordance with applicable federal and state laws. That is quite limited because what we haven't detailed here is the definition of telemedicine is very limited under the Ryan Haight Act. So although there is this exception, you'll wanna look very closely at that definition of telemedicine. It's only allowed in a couple of unique circumstances where a provider is covering for another provider or the patient is located or in the presence of, in the physical presence of another provider that has a DEA license, that is allowed to prescribe, which, you know, if the patient is already in the physical presence of another provider that's already allowed to prescribe, the question then becomes, well, why do you need a telehealth visit for this other provider to prescribe? And you know, sometimes it's in the case, sometimes it's the case that they're phoning in a specialist or something like that, but it's very limited. Those are unique circumstances that do not happen often in such a way that would allow for broad adoption without taking into account the Ryan Haight Act. All right, so Reema, I will pass it back over to you to talk about corporate practice, but I quickly just wanna remind everyone that these are at a high level. The federal laws that apply to teleprescribing, many states have similar or very different laws. So just like we talked about with VCPR, you wanna check the state laws as well and see whether the state is going to require an in-person exam or not. Because even if we've still got these FDA flexibilities, or even if you're meeting that telemedicine exception, or in the event that there are permanent changes to federal law, state law is also gonna often have something to say about this as well. So just keep in mind that that's something you're gonna wanna check. All right, corporate practice, Reema.

All right, so the corporate practice of veterinary medicine is a concept that also, it also exists on the human side. It's just called the corporate practice of medicine, generally. So really what this says is that non-professional entities. So a normal corporation, an LLC, that's not, you know, set up as a professional entity according to the state requirements, cannot provide professional veterinary services or directly employ a veterinarian to provide professional veterinary medical services. So what this means usually at the state level is that either the entity needs to have a veterinarian shareholder, if the state has corporate practice of veterinary medicine restrictions. If the state does not have such prohibitions, then a typical LLC or inc can run a veterinary medical practice. So the reason this came into existence is because of several public policy reasons that were assessed at the state level. We don't wanna see the commercialization of the practice of veterinary medicine. So of course, we have protections in place to make sure that the focus of a practice is to really provide high quality care and not just, you know, to try to run a business from an economic perspective. Another public policy reason is to prevent interference with a veterinarian's independent medical judgment. So we don't wanna see any sort of co-mingling between the financial sides of a business versus the veterinarian really prioritizing what sort of care they need to provide to their patients. So those are at a high level, kind of two key reasons the corporate practice of veterinary medicine came into existence. This also varies on a state-by-state basis, like most concepts we've discussed so far. So, as I mentioned, states that have a corporate practice, a veterinary medicine doctrine often require companies, who want to provide professional veterinary care through a corporation, to set up a professional entity and require the entity to be owned by a veterinarian. States that do not have these doctrines may still have corporate practice, the veterinary medicine rules in place, and vice versa. But again, we need to check the state law to be sure. Some states require a veterinarian-owned professional entity to provide professional veterinary services. So for example, in New York, that is a requirement. And New York is traditionally one of the stricter states in the country when it comes to this concept. So it's a good state to look to for, as a benchmark. Some require a veterinarian medical director or veterinarian in charge, but don't require actual veterinarians to own the entity. So for example, Massachusetts and Virginia, this also protects against the veterinary practice not having enough expertise or focus on providing professional veterinary care in accordance with the standard of care. Other states may require a majority controlling interest be owned by one or more licensed veterinarians. So what this means is that they usually need to have more than 50% ownership. So 51%, for example, in the entity. And then again, other states don't have any sort of corporate practice of veterinary medicine rules or regulations in place. And then, of course, there's more flexibility there. Kaitlyn, is there anything you wanted to add to this slide?

No, I think you covered it. Since we don't know where listeners might be located, we wanted to provide a couple of different state examples to give listeners a sense of what you might see in your state. No guarantees, every state is different, but these are some of the ones that we work with quite frequently. And so hopefully it's helpful to provide those specific examples. All right, so a few other legal considerations. We're gonna go through this at kind of a high level, but I do wanna make sure that we get through them so that you have sort of an idea of what kinds of questions you might need to ask, in addition to what we've already talked about, if you're working with companies in this space or veterinarians in this space, et cetera. So the first is licensure. Reema talked a little bit earlier on the benefits and challenges slide about the fact that there is no multi-state licensure compact for veterinarians. However, every state does have its own licensure process for veterinarians. Just like physicians, just like other licensed professionals, just like us as lawyers, you've gotta get licensed in the appropriate state if you're a veterinarian and you wanna treat patients there. The rules for how to get licensed and whether or not a license will recognize another state's license, or whether you can have an expedited process, just like with lawyers, varies from state to state. Usually the law will say that the veterinarian must be licensed in the state where the pet is located or the owner is located. So if I'm a veterinarian in New York and my dog or my patient is in Virginia, I would have to be licensed in Virginia in order to treat that patient. Not necessarily in New York, I haven't looked at the New York law, but in some cases, or actually in many cases, you wouldn't have to be licensed. I wouldn't have to be licensed in New York in that context, I would only have to be licensed in Virginia. Pharmacy laws and regulations. So again, like we talked about earlier, many of the medications that are prescribed and dispensed to pets are the same medications that are prescribed and dispensed to humans. And for that reason, and because we generally care about our pets and we want them to have safe medications, there are pharmacy laws and regulations, both at the federal level and from state to state, about who can dispense certain medications, how they can do it, labeling requirements, all of that. So you'll also want to, if your client is in this space and is interested in either dispensing medications or having a third-party relationship with a pharmacy that dispenses medications, you'll wanna make sure that you and your client have a good understanding of what those laws might be and how they might impact their goals. Privacy. So privacy is an interesting one. Reema mentioned earlier that there are privacy laws that apply to pet medical records. But the other important thing to keep in mind is that in a lot of cases, because this is still a human-to-human interaction, your clients may have identifiable information about humans as well. And although it wouldn't be PHI under HIPAA, or protected health information about the owner, it's still gonna be identifiable information. And right now in the US, many, many states are implementing new privacy laws that apply to companies that are holding or processing identifiable data about individuals. So if you've got the name of the pet owner or your client has the name of the pet owner, and maybe their address, because you're sending them medication and their phone number and their email address and other identifiable information or payment processing information, all of those things are still going to be subject to the same state privacy laws that we have in place right now. We don't have a comprehensive federal privacy landscape or law, as you probably know, but that may be coming as well, so that's something to keep in mind. But for right now, the biggest barrier or the biggest challenge is gonna be figuring out what states are going to have privacy rules and staying up to date on them because that's changing very, very quickly right now. More and more states every day are introducing new legislation and passing new legislation. Veterinary record retention rules. So aside from privacy, or in addition to privacy, there are rules about how veterinarians maintain records, how long they have to maintain them, and what they can and can't do with them. So keep that in mind. And then finally, informed consent. Just like in the human healthcare space, veterinarians should be getting informed consent from pet owners that ensure that the pet owner understands, excuse me, understands the potential limitations and implications of having a virtual visit versus an in-person visit and where those barriers might be or where sort of the extension of the service might lie. So at what point are they gonna have to take their pet into the emergency room or go to an in-person visit versus what can and can't be done via telehealth. All right, the future of TelePet, Reema.

Okay, so now we've covered the history, what the industry looks like currently. So now we will talk about what we expect the future of TelePet to look like with certainty and also the things that we're not really sure about right now. So what we can say with near certainty is that there will be a continued and increasing consumer demand for TelePet services. As we've experienced so far, especially during the COVID-19 PHE, is that many pet parents do benefit from being able to receive veterinary care for their pets virtually. So again, there are very long wait times currently at in-person veterinary facilities. It's often hard to get an appointment within a reasonable amount of time. And we, of course, know that veterinarians and technicians are experiencing burnout at the moment, just with the increased need for services. So we definitely expect to see a continued desire from pet parents to receive these services. There will probably also be a focus on TelePet as a supplement to, not a replacement, for in-person visits. So as we've discussed, TelePet is definitely a great way to kind of have that first visit. It's beneficial for triage services. And then also for the veterinarian to determine whether or not the pet does need to come in for an in-person visit. Oftentimes, there are certain conditions that can be resolved or addressed initially through virtual means. But of course, there are certain health conditions that will require an in-person visit, or might just need continuing follow-up care to be received in person. So we will definitely see a focus on TelePet, just serving as an addition to in-person visits. We also will probably continue to see TelePet as a component of health equity. So as we mentioned, not everyone is able to access a veterinary practice in person and TelePet helps serve that gap. There are many user-friendly TelePet platforms that are being created right now. We'll continue to see these to become more functional. Maybe they'll be able to refine certain issues that they might be experiencing at the moment. And so we'll probably continue to see these TelePet platforms to improve and also add in additional functionalities that might not be incorporated at the moment. We'll continue to see development of best practices, including use case specific examples for what sorts of services TelePet could be beneficial for, what health conditions can benefit from TelePet. And we'll also start to see how TelePet is improving these conditions. So I'm sure, you know, state medical board, sorry, state veterinary boards will start to include real life examples of how this is being used in practice and how it can improve certain health conditions for pets. What we are probably not as sure about is the pace of expansion. So as we saw on the state adoption maps, there is a lot of gray area in this space. There are only a handful of states who have explicitly allowed virtual VCPR to be established. There are only a handful of states that explicitly prohibit VCPR from being established virtually. And then there are a bunch of states in the middle that have vague language and are not necessarily sure which way they're going in yet. So we'll have to continue to monitor the pace of expansion, as well as federal and state changes in terms of VCPR, teleprescribing, corporate practice, privacy. So again, we will probably continue to see changes. We are not sure how quickly that will happen, but definitely something to look out for. And then again, in terms of payment and reimbursement, of course, there's no federal or state program that covers veterinary care at the moment. So that translates pretty directly to TelePet care as well. We may see some private insurance companies in the veterinary space cover TelePet services. So I'm sure that's, you know, that's where it's starting. And then we'll kind of have to see whether there is any sort of state coverage for veterinary care in general. And then lastly, in terms of cross-state licensure, there is not really an efficient way for veterinarians to attain licensure in other states in a quick manner, as there are for physicians and nurses on the human side. So we'll have to see if that's something that comes into fruition in the future. All right, so we have some assessment questions here, for you all. For the first one, when did TelePet first begin? The options are 1980, 1990, 2003 and 2007. And Kaitlyn, let's go to the next slide to see what the answer is.

I was gonna start playing the "Jeopardy" theme song.

All right, if you guessed 1980, you are correct. We don't necessarily have funds to reward as they do in "Jeopardy," but be proud of yourself if you got this right.

Yes, and this was, remember, 1980 was when a veterinarian first communicated cardiology records via the phone.

Yes, okay. So assessment question number two. What is or are examples of TelePet services? A, asynchronous teleprescribing, B, synchronous veterinary care, or C, digital telehealth, which includes remote monitoring, wellness and other services. Or D, all of the above. And the answer is all of the above. So again, this is determined at the state level, but many states either have not explicitly included what constitutes veterinary telehealth, so it's vague and open to interpretation. Some states have specifically named these items. So usually there are various cases and all of the above are considered services that can be provided through TelePet. And then our last question, Kaitlyn will go through with you.

Sure, okay. So the third assessment question. True or false, veterinarians can participate in an interstate licensure compact. A for true, B for false. False. Like we said, there is currently no interstate licensure compact in place for veterinarians. I would personally love to see it happen. I think that I would also love to see it happen for us as lawyers, where we're kind of getting there with UVE, but for now, veterinarians do not have an interstate licensure compact. All right, key takeaways before we let you all go. Keep in mind that, like human healthcare, virtual care for pets is an evolving landscape. So as you're working with clients, you may have conversations with them about VCPR or teleprescribing or corporate practice, or any of the things that we talked about, and then a couple months later that could change. So just make sure that if you do have clients in this space, you're keeping an eye on the changes that are happening and updating them and your team as needed. Second key takeaway, VCPR and other important rules are defined at the state level. So while we may have federal laws in place, there are also almost always going to be state level rules that you need to take a look at as well. And that's when you'll start having conversations with your client about the interaction between state and federal law, what type of or what level of risk your clients are willing to take on in light of those laws and the differences there, and, you know, in light of the challenges that they may face when laws are different from state to state and tweaks to the business model that they may have to make in new states. Finally, the last thing we want you all to keep in mind is that in the veterinary telemedicine space, industry is absolutely ahead of federal and state policy, and it continues to outpace it in terms of adoption. So we're at a point where pet owners want this technology. There are companies that have developed technology to make it happen. There are veterinarians very interested in leveraging this type of technology, particularly, as Reema said, during the COVID-19 pandemic, veterinary clinics and emergency rooms have been increasingly overwhelmed. And so it's kind of high time for adoption of veterinary telemedicine to increase, but the federal and state laws are not changing and evolving at the same pace. So just keep that in mind. Again, I think it goes back to the risk level that your clients are willing to take on, what their opportunities might be versus what their risks are, and just be comfortable, kind of having those conversations with your clients. And that is the end of our presentation. We hope that you have learned a lot. We hope that you enjoy this subject matter as much as Reema and I do. And we hope that, you know, next time your dog or cat or pet needs to see the veterinarian, that you're able to leverage veterinary telemedicine, if you so choose. Thank you all so much. Please feel free to reach out to Reema and I with any follow-up questions and we will see you next time.

Thank you.

Presenter(s)

KOJ
Kaitlyn O'Connor, JD
Senior Counsel
Nixon Gwilt Law
RTJ
Reema Taneja, JD
Counsel
Nixon Gwilt Law

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