Kara Wenzel - Hello, my name Kara Wenzel, and I'm a program attorney here at Quimbee. Today I'm gonna be interviewing Kaitlyn O'Connor. Welcome, Kaitlyn.

Kaitlyn O'Connor - Thank you. Happy to be here.

Kara Wenzel - So Kaitlyn is senior counsel at Nixon Gwilt Law. Her specialty is digital health, and that's what we're gonna be talking about today of course. She combines her business and corporate knowledge with healthcare to provide real-world solutions for clients at that interesting intersection. Her practice also focuses on global privacy and security, teledentistry, fraud and abuse, and HIPAA privacy and security. So she provides legal regulatory and business guidance to healthcare providers across the spectrum of care, as well as early stage companies and vendors in the healthcare industry. Kaitlyn's specialty though is remote patient monitoring or RPM, and she leads Nixon Gwilt RPM practice alongside managing partner Carrie Nixon, and Kaitlyn really enjoys working with new RPM vendors to implement practical business solutions and accelerate growth in this really expanding industry it sounds like. Kaitlyn is a graduate of Syracuse University and she went to William & Mary for law school where she was on the business law review. Now she's a member of the Virginia Bar Association and the Connected Health Initiative, as well as the Virginia Cannabis Industry Association. And she's a mentor for Jumpstart Foundry, and that's an investment group that focuses on healthcare technology. So Kaitlyn currently lives in Richmond with her fiance Sean and their two dogs Oshie and Milly. Welcome, Kaitlyn.

Kaitlyn O'Connor - Thank you, Kara. I'm glad to be here. I'm excited.

So thank you again, Kaitlyn, for joining us today, we're gonna be talking about Telehealth 101. Before we get into this, I really wanted to talk about some kind of contexts or when this might occur. Different ways that physicians and nurse practitioners and others might practice telehealth. Is it typically on the phone? I'm guessing more than that?

Kaitlyn O'Connor - Yes, yeah, so I mean, it very much depends on the particular visit and the context for it, but a lot of times it will be on the phone or actually more commonly via video chat, just like we're talking today.

Kara Wenzel - Great. Great. So getting into the legal definition, can you tell us a little bit more about the way that either federal statutes or entities define telehealth? What is this?

Kaitlyn O'Connor - Sure, so I think when we talk about telehealth in the legal context, it's important to keep in mind that there are lots of different ways that people will use the term telehealth. So if you're talking to your friend and someone who's not familiar with the legal context, they might think of telehealth as texting their doctor or talking to them on the phone like we just mentioned, or other areas that are more common like quick back and forth communication. When we talk about telehealth in the legal context, we have to keep in mind that there is actually a federal definition of telehealth. And that's really important if you as an attorney have clients that are trying to get reimbursed by Medicare or by state Medicaid programs or by commercial payers, you'll wanna know that difference. So at the federal level, when we are talking about what Medicare actually pays for telehealth is defined as electronic information and communications technology that is used to support and promote long distance clinical health care, patient and professional health related education and public health and health administration. So it's still a pretty broad definition, but then when we dig into what that actually means and what the details are, there are lots of specifics that apply as well.

So again when you want to get reimbursed at the Medicare level for telehealth, there are lots of restrictions that you're going to want to keep in mind. The first is Medicare only pays for telehealth when the service is delivered via live, interactive, synchronous audio and video communication. So FaceTime, Skype, something like that, Google Meet, a technology where you can actually see the person you're talking to and hear and talk to them all in a live synchronous context. The other requirements that are very important relate to where the patient is located and where the practitioner is located. So the patient has to be located at what Medicare calls an originating site. An originating site is an important term to understand for telehealth when you're thinking about it in the state context and commercial payer context as well, but in Medicare, in particular, it's very important. And originating site is where the patient is located, and there are specific types of originating sites that the patient has to be in, in order for Medicare to pay for the service, and we'll talk about those details in a second.

From there you also need to make sure that the practitioner is located, excuse me, that the practitioner is an eligible practitioner as far as Medicare is concerned, and that they're only treating an established patient. So a patient that they've seen either in person within the last three years, or that someone else in their group practice has seen in-person in the last three years. And then finally, for Medicare to pay for telehealth services, the service that's being provided has to be included on a specific list of services that CMS, the Centers for Medicare & Medicaid Services has designated as eligible for payment when delivered via telehealth. So that's kind of a lot, we'll dig into the details and you'll see where it all comes up later when we talk about specific use cases, but the federal definition includes all of those restrictions that we just talked about. And this is why you may have heard recently about different bills in Congress, relaxations that have taken place during COVID and a general push within the telehealth industry to loosen some of those restrictions going forward to make it a lot easier for patients to access their providers via telehealth.

Kara Wenzel - Got it. Got it. So it sounds like these definitions are really important in a lot of contexts in ensuring that you can get your insurance to pay for a surface that you're receiving as as a patient and likely social security and other reasons. Can you give us, what are some of the top most important definitions that you need to keep in mind when thinking about what constitutes telehealth?

Kaitlyn O'Connor - Sure. Yeah. So I've mentioned a couple of them already. The first is definitely originating site. Originating site again is where the patient is located at the time of the visit, and as far as Medicare is concerned, the patient must be in a type of facility that they designated as an eligible originating site. Examples of this under Medicare include a physician office, a hospital, a rural health clinic, skilled nursing facility or SNF. What's important to know also is that it does not include the patient's home. So under Medicare, outside of the COVID public health emergency doctors cannot get reimbursed for telehealth services if the patient is in their home when they deliver the service. They have to be in a healthcare facility. And that's kind of, I think something that's very difficult for providers and patients alike to understand when they're first starting to use telehealth because sometimes doesn't make sense, right? If the patient is already at a healthcare facility, why would they need to phone in there a doctor from a different location? And actually one of the reasons for that is specialists.

So, like I said, one example of an eligible originating site is a rural health clinic. You can imagine that in a very rural area, there may not be a lot of specialists available to a patient. So what may happen is a patient goes into their rural health clinic and they don't have the provider, there's maybe a certain cardiologist or an oncologist if they've got cancer, they may need to phone in a specialist that's located in another area. So that's why right now patients aren't allowed to be in their home is because they've got to have a doctor that tells them, okay, this visit is medically necessary, and this is what you have to talk to, to help your condition. And I think that's one thing that we may see change going forward now that we've all experienced the COVID-19 public health emergency, but for right now that that restriction is still going to apply. So remember, originating site is a specific list of facilities and it's where the patient must be located in order for a provider to get reimbursed for a telehealth visit. The other piece of the originating site that's really important is that facility where the patient is located has to be outside of a metropolitan statistical area or MSA, or in a rural Health Professional Shortage Area, HPSA. These are terms that you can very easily go to the CMS website and find out exactly whether or not a particular location falls within them. So I'm not gonna run through all of the different examples, but just keep in mind that it's not just about the facility or the type of building where the patient is, it's also about the geographical area that they're located in when the telehealth visit happens.

Beyond originating site, you also wanna think about the distance site and the eligible practitioner, because outside of Medicare a lot of states will include these terms and their definitions of telehealth. A lot of commercial payers will include these terms and their restrictions for when they're going to pay for telehealth. And so you'll just wanna know what they mean when you see them, so you know where to look after that. And so distant site is the location where the practitioner is located when they're delivering a telehealth service. And then the eligible practitioner, again, is a type of practitioner that Medicare has deemed eligible to provide telehealth services. And like I said, commercial payers and Medicaid programs and states outside of Medicare will also define sometimes certain eligible practitioners that can provide and be reimbursed for telehealth. Under Medicare that includes physicians, nurse practitioners, physician assistants, nurse midwives, clinical nurse specialists and a couple of others, but it does not include a physical therapist or occupational therapist or other types of therapists that are allowed to bill Medicare, but unfortunately right now they aren't allowed to get reimbursed for telehealth services.

One other thing I wanna note really quickly, Kara, is as I'm talking about all of these key terms and the restrictions that are in place, I also wanna be clear that it doesn't mean that providing this service is illegal if it's not delivered in this way, or it doesn't meet these requirements that we're talking about, what we're specifically talking about is whether or not it's going to get paid for by an insurance company. So like you said, whether the patient is going to have it covered and whether the provider or the facility is going to get reimbursed for that service. Doctors can absolutely text their patients, they can absolutely call them up on the phone or use a different type of technology or call their patient who's in their home. They're just not gonna get paid for it under Medicare.

Kara Wenzel - But are you finding that private insurers and perhaps some state programs do things a little bit differently than Medicare, or do they all tend to follow the Medicare rules?

Kaitlyn O'Connor - Yeah, I would say that it's very different from state to state. Some states sort of follow in Medicare's footsteps and they say that telehealth is audio-visual communication or synchronous communication when the patient is at an eligible originating site, and it's only for certain types of services. Other states have brought our definitions. What I can tell you though, is that all 50 state Medicaid programs right now do reimburse for some type of telehealth, whether it's live audio and visual technology or what we refer to a store in forward, which would be like taking a photo and sending it to your doctor for your doctor to review, which is very common in the dermatology context. So every state has a different definition, but in every state you will find some sort of telehealth being reimbursed by Medicaid programs, and you will likely also find some definition of telehealth under the state's laws.

Kara Wenzel - Got it, got it. So going back to commercial payers or private insurance companies, all of us have had at some point or another a disagreement with our insurance company. I know, I was hospitalized for a minor surgery once, and I tried to order what constituted to breakfasts. I wanted eggs, and my pancakes. I was really hungry. They don't let you eat before. So, but I was told, you can't have that your insurance company will not pay it. And it became this huge hassle later on 'cause I insisted, but anyway, all that aside, can you tell us what are some of the things to keep in mind that commercial payers typically ask for?

Kaitlyn O'Connor - Sure. Yeah. So, beyond the reimbursement rules and general definitions of telehealth that we've already talked about, states in some ways are actually ahead of Medicare in terms of loosening some of the restrictions that have historically been in place. So, one really important thing that some states have done is they have implemented what are called parody laws. There are 40 states as of today that have these parody laws in place and more getting on board all the time. And those parody laws actually require commercial and state payers to reimburse for telehealth at the same rate and for the same services that they would pay for services delivered in person. So if you can go to your doctor and you can have the doctor look at a rash on your arm and tell you what kind of cream you need and your commercial insurance will pay for that, they've also got to pay for that via telehealth. There's some nuance to it, right? Some services really cannot be provided in person. So Kara, I'm sure you would have balked at the idea of your surgeons suggesting that they do surgery via telehealth. Those kinds of things, of course, can not be done virtually, but for services that can, in the clinical context, be delivered virtually, commercial payers have to cover them in those states that have those parody laws. And then the other thing that you'll wanna keep in mind, and again, we'll talk about it in a second are licensure laws. Outside of, or excuse me, in the telehealth context licensure laws are going to apply in the same way that they do for in-person services. So doctors will have to be licensed appropriately to treat patients via telehealth.

Kara Wenzel - Yeah, I was curious about that. So I live in the D.C. metropolitan area, say for example, I have a client who is a physician licensed in D.C. but they want to be able to treat patients in Maryland and Virginia, which are just a mile or two away. What do they need to know?

Kaitlyn O'Connor - Great question. And in my practice I actually get this question all the time. It's really common for state, or excuse me, for companies that want to provide telehealth services and scale very quickly from state to state, you have to understand what the licensure environment is. The short answer is the provider always has to be licensed where the patient is located at the time of the visit. So if a provider in D.C. wants to treat a patient, who's physically located in Maryland, they've got to be licensed in Maryland to provide that service. And that importantly is not a reimbursement role. That actually is a law that you can violate if you don't comply with it. So a doctor in Maryland, or excuse me, a doctor in D.C. treating a patient that is physically located in Maryland via telehealth when that doctor isn't licensed in Maryland is actually illegal. It can be unlicensed practice of medicine. In some states, it may be a criminal offense, so you'll wanna pay very close attention to the penalties if you don't meet those licensure rules, if your clients are asking you where they have to be licensed, and if they wanna treat patients that are located in states where they're not licensed.

Kara Wenzel - Got it, got it. So it sounds like where you're located for Medicare purposes, for commercial payer purposes, for licensure purposes is all important. So, I'm curious what happens say I go on vacation and I want to have a virtual or need to have usually not like you want to have a medical appointment when you're traveling, I need to have a virtual visit with my doctor. I fly from here to Florida, for example, that my doctor is still here. What comes into play at that point?

Kaitlyn O'Connor - Yeah, so technically speaking, your doctor would probably have to be licensed in Florida. One thing I will say is that some states have started taking this type of situation into account and have some exceptions to their licensure rules for temporary visits to a state where states will recognize that people may go on vacation and they need to be able to access their home doctor while they're on vacation, but generally speaking, if states have not implemented those very specific exceptions for temporary visits, the doctor would have to be licensed in Florida to meet with that patient while they're in Florida, otherwise the patient's gonna have to wait until they come back to meet with their doctor, or they'll have to find a different doctor that's actually licensed in Florida.

Kara Wenzel - Got it. That's a bummer 'cause sometimes you really want to talk to your doctor. They know you best.

Kaitlyn O'Connor - Yeah, it's difficult, it's difficult. And this kind of thing where it's temporary always gets balanced with what's best for the patient, right? It's not the case that Florida is going around and looking for doctors that are meeting with their patients for 15 minutes while they're on vacation and plucking them up and saying, oh, you did that wrong, and they will probably understand that if the patient really needed to meet with their doctor, maybe they had to have a follow-up visit or maybe they had an issue with their medication because they couldn't get it while they were on vacation or something like that. It's probably okay as long as it's best for the patient, but bottom line at the end of the day, if you're making a regular practice of that, it's probably not a good idea. The doctor should just go ahead and get licensed in Florida.

Kara Wenzel - Yeah, I hear you. Okay, that's great advice. So can we talk for a minute about a concern that I'm sure it comes up from time to time, and that's about the standard of care or the quality, I suppose, from a consumer's perspective for a telehealth visit, can it be different? Can it be a bit lower for telehealth and in-person?

Kaitlyn O'Connor - Yeah, this is actually, you're right. This is a question I get pretty frequently, and the answer is absolutely not. The standard of care is the same regardless of the medium in which the service is provided. So if it's in-person or if it's telehealth, the standard of care is gonna stay the same. Doctors and health systems and hospitals and practices that are looking to implement telehealth may wanna check with their state board to see whether that licensing board has specific ethical rules or guidance documents out there because some states or some state medical boards or nursing boards or whoever may have specific rules around things like obtaining informed consent and making sure that the patient understands the benefits and risks of receiving services via telehealth, but generally speaking, the standard of care is the same. I have a couple of examples from Virginia that I think might be helpful where you and I are both located. I'm sure there are others listening to this that are located in other states. Definitely make sure to check with the appropriately, excuse me, appropriate licensing board, but here's what Virginia has to say. So Virginia actually has an entire guidance document about the delivery of telehealth. And this is from the Virginia board of medicine.

This guidance documents specifically relates to telemedicine and it addresses things like prescribing via telehealth, getting informed consent, and the general rules around the standard of care. Here are a couple of things that this guidance document says are important, regardless of the method of delivery practitioners have to make sure that they place the welfare of patients first, they maintain acceptable and appropriate standards of care, they adhere to recognized ethical codes governing the applicable profession, so whether it's a physician or another type of doctor, in Virginia nurse practitioners are actually also licensed in part by our board of medicine. So whatever their licensure level is, and whatever their profession is, they have to adhere to applicable ethical codes. They have to adhere to applicable laws and regulations. Of course, in the case of physicians, they have to provide proper supervision of non-physician clinicians when required to do so. And finally, they have to protect patient confidentiality, so we always get questions as well about HIPAA and medical records rules, and how those apply in the context of telehealth, and the short answer is it's all the same, it doesn't change if you're providing a virtual visit.

Kara Wenzel - Yeah, that makes sense. I mean, we would hope that that would be the case. But what about if again you're either on vacation or just out of town, out of state for some reason, and you need a prescription. What are the rules around providers issuing prescriptions through a telehealth visit?

Kaitlyn O'Connor - Well, we could probably do an entire hour on this specific question, but I do wanna just quickly give a high level overview of some of the things that if you are an attorney listening to this, and you have clients that are starting to deliver telehealth services, I wanna make sure you have at least a high level understanding of the rules around prescribing because they're very strict. And a lot of this, by the way, comes out of the opioid crisis that happened several years ago. There was sort of a pandemic of patients being able to go online, fill out an assessment without talking face to face with the doctor and get a prescription for an opioid. So following that Congress passed what is called the Ryan Haight Act of 2008. This is a rule that requires that a provider conduct at least one in-person visit with a patient before that patient can receive a controlled substance over the internet. There is an exception for telemedicine, but it only applies if the patient is physically located in a DEA registered facility or in the physical presence of a DEA licensed provider at the time of the visit. Another really important thing to keep in mind is that controlled substance is actually a broader term than a lot of people think, it doesn't only refer to narcotics, it doesn't only refer to opioids or other drugs that we know are inherently very risky. It applies to all controlled substances on schedules two through five that are listed under the control, excuse me, schedules one through five under the Controlled Substances Act. I always say schedules two through five 'cause as most of us know, schedule one drugs can never be prescribed in any context ever. So schedule two through five drugs, it's important to know that this is always going to apply.

And I'll just give some quick examples of drugs that are listed on schedules two through five, because you may be surprised. One example is lorazepam or more commonly known as Ativan. This is an anxiety medication and its own schedule for, that means that providers cannot prescribe lorazepam via telehealth unless they've complied with those in-person visit requirements. Another is a sleep aid Lunesta. I am not going to try to pronounce the actual name of that, the biological name of that, but that again is a schedule four drug. And then finally, LYRICA, a non-narcotic medication for diabetic nerve pain, which is actually scheduled five. So again, it's not only for narcotics because as you see, we've got a non-narcotic pain medication that is going to be subject to this rule, and it's not only those higher risks schedule to opioids that we already know are quite risky. So that's something that if you've got a client that comes to you and they want to start prescribing to their patients via telehealth, you're gonna wanna make sure you do a deep dive on this. And we'll get into in just a second about what states have to say about this, but that federal role keep in mind is, is going to control. So again, if you've got patients, or excuse me, clients that want to provide telehealth and wants to prescribe, you're gonna wanna make sure that you familiarize yourself with the Ryan Haight Act.

Kara Wenzel - Okay, well, on that same theme tell us a little bit more about state laws. Are they different at all in this context for prescriptions?

Kaitlyn O'Connor - So it depends on the state, as I said the Ryan Haight Act is federal. So federal rules as we know as lawyers are always going to control over state laws. So even if a state has a different role, the DEA technically could still enforce the Ryan Haight Act, but let's talk about what states have to say. So most states actually also require that a provider establish a provider patient relationship through proper examination prior to prescribing or dispensing any medications. That's slightly different than the Ryan Haight Act, which specifically says that a provider has to see a patient in person. What we're seeing in states now is that they are saying you have to establish a provider patient relationship, and more specifically states are saying that you can actually do that via telehealth. For example, in California, there is a specific law that allows for a practitioner-patient relationship to be established via telehealth. So that means a provider would never have to see a patient in person. They would be able to have an exam or a visit with them online and then issue a prescription. Keep in mind that sometimes there are specific rules for what that examination has to look like, but generally speaking some states will allow for it to be done via telehealth in which case the provider could then issue a prescription without ever seeing that patient in person.

Kara Wenzel - Can you give us another example or two, for instance, I remember being asked to fill out several questionnaires before, especially in deep COVID times before a telehealth visit for my son, his pediatrician's office always required that or I have at the dermatologist they wanna know if anything's changed since my last visit two years ago. So would that be a sufficient type of relationship? Just filling out a questionnaire?

Kaitlyn O'Connor - So it probably depends on the last time you saw that provider in person and whether or not you're planning to go see them before they actually write you a prescription. If it's just a follow-up and you've seen provider within the last year or some states and commercial payers will say within the last three years, if you've seen that patient, or excuse me, if you've seen that provider recently enough that the provider knows your condition or your son's condition, and you fill out that questionnaire and nothing has changed, they may then be able to issue a prescription or renew a prescription that you had previously. But if you've never seen that provider before, or if something actually has changed and you have a new condition or a new diagnosis, your provider should probably say, hey, why don't you come in for a visit, or why don't we do a telehealth visit before I go ahead and renew this prescription for you?

Kara Wenzel - Got it, got it. So, speaking of COVID, I'm sure a lot of us have had a reason to prefer a telehealth visit either because we had to, we were forced to because our quarantine, but still needs to speak with a doctor or we're in the process of obtaining a vaccination or couldn't get one yet need to protect family members who are immunocompromised or some other reason. So can you start to go over? I'm sure there are a lot of things that have changed, but what are some of the federal laws or rules that significantly changed since the pandemic?

Kaitlyn O'Connor - Sure, so actually a lot, part of the reason that we have seen telehealth become so much more common during COVID is because both the federal government and state governments have significantly relaxed the requirements around telehealth. So, let's just start with Medicare and federal restrictions. We talked about at the beginning of this conversation originating site restrictions, geographic restrictions, restrictions on the types of providers that can provide telehealth services and get reimbursed for them, and the types of services that can be reimbursed via telehealth. All of those restrictions have been significantly loosened under Medicare during the COVID public health emergency.

So right now, under Medicare, there actually are no geographic or rural or originating site restrictions. So that means patients can be located in their home, they can be at the grocery store, they can be in their car, hopefully not driving, but they can be anywhere and do a telehealth visit with their provider and Medicare will pay for it right now. There's also no preexisting practitioner-patient relationship required anymore, temporarily. So right now providers can see new patients via telehealth. Providers can opt to waive the Medicare Part B copay for a lot of different services right now during the public health emergency. If you don't know most patients under original Medicare or Medicare Part B are required to pay a 20% copay for services that they receive, and it's usually very, very risky and very difficult to waive that copay for a patient, because then you start coming into kickback requirements, or you're looking at beneficiary inducement restrictions, healthcare lawyers listening to this probably know what I mean, others may not, again that's another conversation we can have on a different day, but usually it's very difficult to waive a copay for our patient unless for a fact that they have a demonstrated financial need and they can't afford it, you can't waive copays. But now during the public health emergency, you can for a lot of services, including telehealth services.

There are also right now relaxed, I won't say absolutely none but significantly relaxed penalties for using platforms that do not meet HIPAA requirements. So the HHS Office of Inspector General or OIG, like we say for short, actually released a statement at the beginning of the pandemic saying, we understand that providers don't necessarily have the technology in place to conduct telehealth visits with their patients. We also understand that it takes a while, especially for larger health systems and hospitals to adopt new technologies. And so for now, temporarily, it's okay for you to use FaceTime or Skype or even Facebook video chat with your patients. Basically OIG was saying, look, we understand that it's dangerous for patients to come into the office. We understand that technology is hard to adopt for people who haven't used it before and in large systems, even harder to adopt. We wanna make sure that patients have access to their providers, so go ahead and FaceTime them or Skype them, et cetera. If you've got the resources to implement a new technology, I wouldn't rely on that relaxation even during COVID, but OIG is not paying that close attention right now. Well, things are still kind of up in the air. So that's good news, that made it easier for patients to access their providers. Also under Medicare any practitioner that is eligible to bill Medicare can now provide services via telehealth.

So earlier we talked about the fact that physical therapists, occupational therapists are not traditionally allowed to bill for telehealth services under Medicare, during the public health emergency they can. And so that was really exciting for a lot of physical therapists who weren't able to see their patients in person, but could actually deliver a lot of value virtually to them. Licensed providers may provide care outside of the state in which they are enrolled in Medicare, but state licensure rules still apply. So something we didn't necessarily dig into earlier is that in addition to the state licensure rules, Medicare has its own licensure rules, and typically you have to enroll with Medicare in the state or states where you are licensed, and Medicare said during the pandemic, we're gonna make it really easy for providers to treat Medicare patients and other states. We'll talk in a second about what states did that furthered that goal, but during the pandemic, during the public health emergency licensed providers under Medicare can provide care to state to patients in other states. FQHCs and RHCs, which are rural health clinics can now be separately reimbursed for telehealth services when they weren't before and Medicare actually added over 80 codes to that very specific list of services that can be delivered via telehealth. So this further expanded the opportunity for providers to access their patients via telehealth and keep them safe by allowing them to stay at home when there's a pandemic going on, and many of them may be at risk or very vulnerable.

Kara Wenzel - Right. Right. I noticed that all of a sudden, a lot of my providers at least began saying that they now offer telehealth video visits, and before that was not an option. So my guess is that's why that they were permitted to.

Kaitlyn O'Connor - Yep, exactly, exactly. Oh, and one other loosened restriction that I think is really important that I wanna add as well is that Medicare began out allowing some services to actually be provided with audio only. So we talked earlier about the need to FaceTime or video chat with patients temporarily providers for some services not all of the services on that eligible code list, but for some services you can actually call up your patient on the phone and do an audio only visit and get reimbursed for that.

Kara Wenzel - Cool, cool. Did states generally follow the same loosen restrictions that the federal government did in this context?

Kaitlyn O'Connor - Yeah, they did. And that was one of in my, in my opinion, one of the cooler things that happened was that in addition to Medicare loosening their restrictions states in a lot of places actually said you don't need to be licensed in our state at all to treat patients via telehealth during the public health emergency, some are stricter than others. For instance, California's loosened restrictions were specific to patients who had COVID or were suspected of having COVID, but they said, if you're licensed in another state and you're coming into our state, or you're gonna treat our patients via telehealth to help address this very serious COVID problem, you can do that. And in other states they actually said, you don't need to register. It doesn't matter if the patient has COVID or not, you can treat patients in our state via telehealth temporarily during the public health emergency. And the reason for that was really because healthcare providers across the country were so slammed with COVID patients and other patients that they kind of had to do it to make sure that patients could get the care that they needed. So, that was really interesting.

 And now some states have started to withdraw their public health emergencies. So some of those state level restrictions have actually gone back into play. So right now, in particular, I don't know when this is gonna be posted, but January 28th, 2022, you wanna pay very close attention to the status of the public health emergency, not only at a federal level, but in the states where your clients might be located because some states are no longer allowing those loosened restrictions. And so your providers will no longer be able to get licensed there. What a lot of providers did though, that I think was really interesting is during the temporary public health emergency, they started seeing patients in other states where they were allowed to, without being licensed there, and then in the background just went ahead and submitted to get licensed in that state, so that they could provide continuity to those patients at the end of the public health emergency once they had licensure there. So there are some ways to, or there have been some ways that providers have kind of hedged against that and ensured that patients were still able to, like I said, have continuity there but at the end of the day in most states you're still gonna have to be licensed where the patient is located.

Kara Wenzel - Got it, got it. So is that a tip that you have provided to clients that they should seek licensure in multiple other states just in case these restrictions don't become permanent?

Kaitlyn O'Connor - Yeah, absolutely. So in my practice, I work a lot with digital health companies that are standing up direct to consumer telehealth services, and a lot of them wanted to expand and scale very quickly so that they could address the national pandemic and the national shortage of providers. And that's exactly what I said to them. I said right now in a lot of states, your providers aren't necessarily going to need to be licensed there, but it's not a good long-term strategy because once the public health emergency goes away, those rules go back into effect. So that's exactly what I recommended. I recommended go ahead and start in these states where it's allowed, but in the background start getting your documentation filed as well, so that you can actually get a license and that it will be permanent beyond the public health emergency. And some states made that process easier as well. So even in states where they weren't saying, you can treat patients here without licensure at all, they were saying, we're gonna make this process really easy, and if you just submit this document to us, we'll review it really quickly and we'll approve your licensure right away so that you can go ahead and treat patients. So in addition to being able to treat patients in states where they weren't licensed, it was actually a really good move for providers to just apply for licensure in some states because it was so much easier during the pandemic.

Kara Wenzel - That makes sense. So tell us though, you mentioned earlier that there has been some activity at the federal level, some proposed bills, maybe some rulemaking in the works that might make some of these relaxed to changes to telehealth rules permanent. Can you go through what you're seeing at this point?

Kaitlyn O'Connor - Sure. Yeah. There have been several bills introduced in Congress in the last couple of years even more so in the last year or so to make a lot of these changes permanent. One thing that I don't know if I made entirely clear at the beginning of this conversation is that the restrictions that I talked about under Medicare are actually written into the law. They are federal regulations, they're part of 42 CFR. Don't remember the specific number, but they're actually written into federal regulation. So CMS doesn't have the power to change those on a permanent basis. They've used their emergency authority to remove them temporarily, but on a permanent basis, it would actually require federal law and Congress to pass federal regulations to change that rule on a more permanent basis. And so they started to do so, and there are organizations like the American Telemedicine Association and other stakeholder organizations that are really pushing Congress to make those permanent changes. And I do think that in the near future, we'll see that.

For instance, the American Telemedicine Association just encouraged Congress to extend the federal public health emergency to at least the end of 2024, to give Congress a little bit more time to consider those bills that have been introduced and make permanent changes so that there's no gap between the end of the public health emergency and when those permanent changes go into effect, because I'm sure you can imagine a scenario where at the end of the public health emergency these loosened restrictions suddenly go back into effect and now patients can access their providers or providers can't get reimbursed for services that their patients were very used to receiving. It could be a little bit disruptive. So a lot of organizations have been pushing Congress to make moves that will prevent that gap from happening. So there's a smooth transition back into what I will put in air quotes as "normal times," because I'm not even sure that we're really living in a temporary situation anymore. It feels like things have permanently changed, which is exciting and scary for a number of reasons, but yeah I do think that eventually we will see some permanent relaxation of a lot of these very specific restrictions that we've talked about.

Kara Wenzel - That makes sense. And yeah, hopefully sooner rather than later, so providers can be better prepared for the future of their practice.

Kaitlyn O'Connor - Yeah, yeah, for sure.

Kara Wenzel - So let's go over some of the things you've touched on earlier, but I'm kind of curious about, for instance, understanding those licensure requirements, site requirements and such, who is policing all of this or who's auditing providers.

Kaitlyn O'Connor - Great question. One of the things that OIG the Health and Human Services Office of Inspector General, who is responsible for enforcing these federal regulations and rules that we've talked about. One of the things that they have started doing during the pandemic is auditing providers that are providing telehealth services. That can be very scary. The word audit is very scary for a lot of providers that bill Medicare, but in this context, it actually wasn't scary. OIG was auditing these providers in order to determine how telehealth is being used and more importantly the value of telehealth for patients and how it was moving the needle on patient access and things like that. So there will be a report forthcoming from OIG that details all of the things that they uncovered in these audits that they've conducted. And I think that will probably be the important data that Congress may need to decide whether or not it makes sense for patients and providers for them to make permanent changes. So, the short answer to your question is OIG is responsible for audits, and the longer answer is, they're actually conducting them right now. And we can expect that they will continue to do so going forward, especially if the rules are changed. I think that they will continue to audit to make sure that whatever those rules end up being to keep a close eye and make sure that providers are compliant with them, right? Because if they go through this whole process to change the rules and then providers are still not following them that's gonna be a difficult situation. So they're probably going to continue those audits beyond the pandemic as telehealth becomes more and more common.

Kara Wenzel - So who should be most concerned about getting audited right now? Is there a particular provider profile or the specialty that HHS is targeting at the moment?

Kaitlyn O'Connor - Well, I think that the types of providers that should be most concerned are those that don't understand these restrictions that we've talked about, which is unfortunate, but there is an opportunity right now while OIG is kind of in good faith doing these audits to become familiar with them. And so I think providers that don't understand the originating site restrictions or the eligible practitioner restrictions or the types of services that can even be delivered via telehealth under Medicare. I think that those providers may want to be concerned because when you submit a claim to Medicare initially, it doesn't necessarily show that it's been done via telehealth, but when an audit happens if OIG finds out that it was delivered via telehealth via the medical record or whatever else they may look at, that could be a fraud claim. And the providers may have to pay back all of the reimbursement that they got initially if they were billing incorrectly or providing the services incorrectly. So that's kind of the big thing that everyone is afraid of when they start doing telehealth is, how do I know that I'm doing this correctly? And what happens if I don't do it right? And what happens if I get audited, and they figure out that it wasn't doing it right? So that's where we as lawyers can really help our clients understand all of these restrictions and not only what the restrictions are, but practically what they mean for your clients. So if you've got a client that's starting a new business, or maybe you're a health care attorney that works with a hospital and the hospital wants to implement telehealth so they can see their patients during the pandemic, you'll wanna make sure that that client really understands what these restrictions are, both at the state and federal level, so that you can make sure they're not doing anything incorrectly and that they're getting reimbursement and that they don't have to worry about an audit happening.

Kara Wenzel - Got it. That makes sense unfortunately. Another thing I just thought of, we all have concerns these days about cyber security and privacy protections. I know, I get phishing attempts probably on a weekly basis, and especially when a lot of sensitive information is being transferred over the internet or even just by phone, what are some of the concerns that providers should pay attention to, or lawyers who counsel them that relate to privacy and cybersecurity?

Kaitlyn O'Connor - Sure, so first and foremost, HIPAA is always going to apply. So you should have secure practices in place, and when we talk about the standard of care and HIPAA and other rules that generally apply to healthcare all of these things are important when we talk about cybersecurity as well, because even though OIG said, you can use these time with your patients, or you can use zoom with your patients. What we also heard a lot about during the pandemic were universities and classes getting hacked via zoom. So that is certainly possible if you're not using a secure technology with your patients when you're conducting visits with them. And so think about encrypted technology that you might be able to adopt. There are tons of solutions out there. Actually, a lot of electronic medical record vendors have telehealth capabilities now. So, maybe to your EHR vendor, talk to other vendors that may have very secure technology and have been staying up to date on these cybersecurity risks. The other thing that you'll wanna keep in mind as an attorney who may be working with providers in this space is that states are very quickly implementing new privacy regulations. Some of which are similar to HIPAA, some of which will apply even when HIPAA doesn't apply. So you'll wanna keep a close eye on those rules as well, and make sure that your clients are complying with them to keep their very sensitive information as protected as possible.

Kara Wenzel - That makes sense. Can we go into worst case scenario, say your provider, or your counsel, one who comes to you and explains I just realized I've been breaking the rules. I neither not compliant because I'm not in the right originating site or I'm completely prohibited at this point and I'm still providing these services, what do I do? How do I get back on track? What would you say?

Kaitlyn O'Connor - Well, first and foremost talk to your lawyer. And so if you're the provider definitely talk to your healthcare attorney, it is really important that if you are an attorney in this space and you're not a healthcare attorney and you don't understand fraud and abuse rules or the False Claims Act, and you've got a client that comes to you and says this contact a lawyer that does know these things because they're very complex and they're very difficult to learn very quickly. And they have really big penalties and really big implications for those clients. So I would say make sure that you understand the rules that are even going to apply. And if a provider recognizes that they've been billing inappropriately in a lot of cases they actually have a duty to pay back the money that they got for those services to Medicare. So, you wanna be very, very certain that they were actually doing it wrong. It should be black and white, this was not okay. And then figure out how they're gonna make that payment back to Medicare, because if OIG finds out and you didn't tell them, then your penalties are gonna be much worse. So, unfortunately in that scenario, the provider recognizes that they're doing something inappropriately they will likely end up having to pay something back to Medicare, and that can be hurtful to the bottom line, it can be hurtful to you as a business, to your reputation. So, that is definitely something that providers should avoid. And as attorneys, we should be working with our providers to help them avoid.

Kara Wenzel - Thank you. That's helpful. On that similar note, can you talk a little bit about some of your top client questions that you frequently get? What is something that you're most often asked about related to telehealth?

Kaitlyn O'Connor - Sure. One of the things that I'm often asked about related to telehealth, a lot of them are actually what we've already talked about. I always get questions about licensure, I always get questions about HIPAA, And then I also get questions about a couple of other laws in the space that I'm not sure whether listeners will be familiar with. So, definitely get questions about the Anti-Kickback Statute and other fraud and abuse rules. There are lots of very creative business models right now that may or may not be running a foul of the Anti-Kickback Statute because in a lot of cases where a practice doesn't have telehealth technology, they may wanna refer patients out to a practice that does have that technology. And if they're getting something of value in return for those referrals, even such as data or valuable information or time with another provider on the phone that could be seen as a kickback, that's kind of an extreme example, but it could be. So I get a lot of questions about business models, and I always wanna look at the Anti-Kickback Statute and then general questions about what can I do via telehealth, what type of technology do I have to use or can I use, can I text my patient? Can I have my patient send me a photo that I look at, lots of general questions about like what can and can't be done, and then those more detailed questions about business models.

Kara Wenzel - And what do your clients or people that you are in contact with in the telehealth world, what do they most struggle with to implement?

Kaitlyn O'Connor - I actually think that one of the things that a lot of my clients most struggle with is something called the corporate practice of medicine. Much of my practice, like I said, is working with digital health vendors who want to also provide direct to consumer patient services. So they want to hire doctors and nurse practitioners to treat patients. The difficult part about that is, a lot of my clients like the CEOs and founders of these companies are actually not licensed medical providers. And most states have very strict rules about who can and cannot own a medical practice or who can and cannot own a company that treats patients. So when a non-physician comes to me and says, I wanna go hire California licensed doctors and have those doctors treat patients, they actually can't do that. They have to work, they can partner with a doctor that does that through an arm's length relationship, but my client as a non-physician cannot hire doctors in California and have those doctors treat patients.

And that's something that's difficult to grasp because when you see companies like Doctor on Demand or Teladoc, or these really big telehealth companies that many of us have used, I just had a Doctor on Demand appointment earlier this week. You don't realize that those companies are actually set up the way I just explained. There's a company called doctor on demand, and then there's actually a network of medical practices that Doctor on Demand works with, and hires through a services agreement to treat their patients. So doctor on demand is not one company. It's actually a network of multiple companies and Teladoc is the same way. So that's a little bit difficult for a lot of my clients to grasp when they don't necessarily understand the inner workings behind Teladoc or Doctor on Demand and that they have this very complex corporate structure in the background. And it's also something that attorneys I've actually worked with weren't aware of immediately either. So, very importantly this will also apply if you're an attorney and you have large hospitals and health systems that want to implement National Telehealth Service, this is going to apply to them as well. Because if the hospital is located in New York and they're not owned by a New York physician and they wanna set up a practice in California, or they wanna set up a practice in Texas so that their doctors can treat patients in those states, the corporate practice rules are going to apply to them as well.

Kara Wenzel - Yeah, that sounds a little bit tricky. A lot to think about.

Kaitlyn O'Connor - Yes, yes.

Kara Wenzel - Just to kind of recap briefly, what are some of the top takeaways you want people to understand about the changing landscape of telehealth?

Kaitlyn O'Connor - Yeah, I mean, we'll kind of just revisit at a high level the main points that we've talked about today. The first is there are restrictions that apply to telehealth that will absolutely apply to telehealth beyond the end of the COVID-19 public health emergency. They may be looser than they are right now, but there will be some. The standard of care is always the same via telehealth as it is when services are delivered in person. Tele-prescribing is difficult. There are rules that you'll wanna know if you're advising clients in this space. Other rules like HIPAA, the Anti-Kickback Statute, fraud and abuse laws, the corporate practice of medicine all apply in the telehealth context as well, and states are paying attention because telehealth has really kind of blown up over the last year or so. And so states like California and New Jersey and New York are paying very close attention to business models and all of these different rules that we've talked about.

And then lastly, OIG is conducting audits. Right now those audits are not intended to get anyone in trouble, but it's probably only a matter of time before someone does. So make sure you understand these requirements. If you've got clients that wanna provide telehealth services, make sure you're able to tell them what these rules are and how to comply with them. But you know finally, Kara, this is an evolving space, right? We are still in the middle of a public health emergency, we don't yet know when it's going to end, maybe in the next year, maybe the next couple of years depending on lots of things, but mostly depending on how Congress decides to move. And we are sure to see a lot of changes happening in the next year or two. So you and I may be doing a follow-up conversation to update everyone in a couple of months or in a year, but all of this is because COVID-19 has made a lasting impact on the way that healthcare is delivered. It will be necessary for our legal system and likewise our lawyers to stay up to date and keep up with this and make sure that their clients are adjusting and keeping up as well.

Kara Wenzel - That's so helpful. Thank you so much for that, Kaitlyn.

Kaitlyn O'Connor - Yeah,

Kara Wenzel - Well, we are almost out of time. So I wanna just take a quick second to one, thank you. This has been really enlightening for me, definitely, and two tell people how to contact you.

Kaitlyn O'Connor - Sure. Yeah. Thanks, this has been really great. I am always happy to help. I actually love what Quimbee is doing and doing these CLEs in this very sort of conversational format, because most of us do not like to attend a CLE. So this is really great, and I really thank you guys for having me. I am excited to get into Quimbee and watch some of these CLEs as well. If people wanna contact me, you can email me. My firm is Nixon Gwilt Law. Our website is Nixon Gwilt, N-I-X-O-N G-W-I-L-T law.com. And my email address is my first and last name, Kaitlyn.O'[email protected]. So if you head to our website, you can find my profile and you can contact me directly that way, and my phone number will be available as well.

Kara Wenzel - Wonderful. Thank you, Kaitlyn.

Kaitlyn O'Connor - Of course, thanks for having me, Kara. It's great to talk with you.