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The Evolution of Telehealth and Telepharmacy

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The Evolution of Telehealth and Telepharmacy

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, telepharmacy is currently growing at a rapid pace, however, many states still have not adopted this practice yet or are not aligned with each other regarding the types of telepharmacy services that should be permissible. During this session, we will move through the timeline of how telehealth and telepharmacy first began, where the industries are now, and how much further we have to go. We cover the law, the practice, and the money to help stakeholders understand all considerations that are at play when thinking about telehealth and telepharmacy.

Transcript

Reema Taneja - Hello, everyone. Welcome to the Evolution of Telehealth and Telepharmacy. My name is Reema Taneja, and I am a Healthcare Innovation Attorney at Nixon Gwilt Law, which is a firm that serves healthcare innovators who are seeking strategic, legal, regulatory, and business guidance to help them achieve their goals of improving lives of people on a global level. I have been with Nixon Gwilt for almost two years now. And I work with clients who are developing creative solutions in the digital health space, which includes telehealth, telepharmacy, virtual care management, and other related industries.

Before we get going on the substance, I do want to share with you what this important notice. This webinar presentation is designed to provide information to the viewer, nothing in this presentation or the accompanying slides should be construed as legal advice to any individual or entity, and is not provided in the context of an attorney-client relationship. Further, nothing in this presentation should be construed as a guarantee of reimbursement.

All right, so here's our agenda for our webinar today. We will start off with a high level overview of telehealth, telepharmacy, teleprescribing, and e-prescribing. Next, we will review the history of telehealth and telepharmacy, followed by how states are currently adopting telepharmacy. Then, I will share with you examples of telepharmacy services. Following that topic, we'll discuss the money, so reimbursement, legal considerations, and enforcement. Next, I will cover examples of telepharmacy business models. And finally, we will explore the future of telehealth and telepharmacy. So, this gives you a good overview of what we will be discussing today. And now we can go ahead and jump in to the substance.

Okay, so as we discuss telehealth and telepharmacy, there are a few key definitions we should become familiar with. These include telehealth, telepharmacy, teleprescribing or online prescribing, and e-prescribing. So, let's go ahead and jump into these four definitions. Per the United States Department of Health and Human Services, Health Resources, and Services Administration, telehealth is defined as the use of electronic information and telecommunications technologies to support and promote long distance clinical healthcare, patient and professional health related education, and public health and health administration. Technologies include video conferencing, the internet, storm forward imaging, streaming media, and landline in wireless communications.

Next we have telepharmacy. Although states have varying definitions of telepharmacy, most states follow some form of the National Association of Boards of Pharmacies definition. This also known as NABP, and NABP defines telepharmacy as the provision of pharmaceutical care through the use of telecommunications and information technologies to patients at a distance. Next, we have tele-prescribing or online prescribing, which is also defined on a state by state basis, similar to how telepharmacy is as well. But generally, it's defined as prescribing a drug or other treatment through telemedicine. And most states do require an established physician-patient relationship, which isn't really the focus of our presentation today, but all that means is that before a practitioner can actually prescribe a drug via telemedicine, he or she must have some relationship with the patient prior to doing so.

So this is something that's you might have heard about in the industry right now, because of COVID-19, there have been a number of waivers that no longer, or I guess temporarily do not require this established physician-patient relationship, but it does vary at the state level as well. And then lastly, we have e-prescribing, which is defined by the Centers for Medicare and Medicaid services also known as CMS. And they describe e-prescribing as a prescriber's ability to electronically send an accurate air free and understandable prescription directly to a pharmacy from the point of care. Based on these definitions, you can see that tele-prescribing and e-prescribing may sound very similar to telepharmacy, but they are indeed different concepts. And we could probably do a whole nother webinar on just those two topics. So we won't really be getting into those two areas today. For today's webinar, we'll be focusing on the practice of telepharmacy along with telehealth, but I thought it was important to at least go through the definitions because the industry stakeholders sometimes do represent the idea that these definitions can be confusing amongst each other because they are related to the same industry. So just to the tone for our webinar today, I just wanted to go through those four definitions.

Okay, so now let's move to telehealth, the then and now. Although telehealth has recently exploded in recent years, due to the COVID-19 pandemic, telehealth has actually been around since the 1960s. It was first recognized as a form of healthcare delivery because it was needed by the national aeronautics and space administration, which is also known as NASA, and the Nebraska Psychology Institute as referenced by researchers from St. Louis University and Bentley University. So in the 1960s, which was a number of years ago, but still fairly recent, obviously had different rules. We've seen things changing, not only just because of COVID-19, but just because I think CMS and OIG are starting to learn that increased adoption of telehealth does require certain barriers to be removed.

So let's first talk about how the landscape looked before COVID-19. Medicare, for example, had placed a number of statutory restrictions on telehealth. Some of these included geographic location requirements. So in order to provide telehealth services, the location must have been designated as a rural or underserved location. The patient was also required to go to an origining site, such as a rural health clinic for the telehealth visit. This was understandably very burdensome because if telehealth is indeed meant to address rural health areas, the fact that a patient must go to an origining site, such as a rural health clinic for the telehealth visit, seems a little bit counterintuitive.

Another requirement pre-COVID was that the telehealth service must have been captured by an existing telehealth code and only designated eligible providers may provide telehealth services. So some of these restrictions are still in place. Some are waived on a temporary basis, and together CMS and the Office of Inspector General, which is also under the Department of Health and Human Services have issued interim rules and waivers. For example, CMS is currently not requiring that the sites fit within the geographic or rural location. Second, there is currently no preexisting practitioner-patient relationship required before providing telehealth services, providers may also currently opt to waive a patient's Medicare, part B, copay. This is important because typically, all telehealth services do require patients to pay their portion of the copay. So right now, the Office of Inspector General has issued a waiver, which allows providers to mass waive this copay for all their patients. Mass pay means that they don't have to evaluate each patient on a case by basis. Whereas normally, outside of the pandemic, that was a requirement that providers could only waive patient copays if they determined the patient to be in financial need. So that is temporarily waived. Providers can waive such copay on a mass basis, and they do not have to go through this financial need analysis for each patient.

There are also currently no OIG penalties for using a platform that does not meet HIPAA requirements. So typically that is something that is required in order to provide telehealth services, just to ensure that the data is safe. Although the OIG is temporarily suspending any sort of penalties or audits against this topic, we usually still recommend that the platform meet HIPAA requirements, or at least privacy and security standards that do apply to the platform just to ensure there isn't a risk down the line of the patient data becoming breached. There is also currently no requirement of a business associate agreement between the telehealth practitioner and the vendor who might be supplying the platform. But again, we still do recommend that any practitioner or likewise, a vendor, who is engaging in a relationship with the other party, still enter into a business associate agreement. Again, just from a risk perspective, to ensure that the platforms are safe and that the patient data is being protected appropriately. Currently, licensed providers may provide care outside of the state in which they're enrolled in Medicare, but state licensure will still apply. What this means is that there are certain states who are waving an in-state licensure requirement. They are allowing neighboring states, for example, to provide telehealth services to patients located in their state during the COVID-19 pandemic, just to increase access because practitioners are as you know, highly busy right now. And so this is meant to alleviate some of that burden. Next, federally qualified healthcare centers and rural health clinics may now be separately reimbursed for telehealth services. Next, 80 plus codes were added to the telehealth list. And those became effective as of March 1st, 2020, all providers who are eligible to bill Medicare may now bill for telehealth services. And Medicare is also offering the reimbursement of some audio only services, whereas before most of the reimbursed services must have been audio-video.

Okay, let's move to telepharmacy, but then, and then now, so telepharmacy of course is not as old as telehealth. The practice did follow shortly after telehealth was adopted to address the lack of pharmacy access in rural America. The practice of telepharmacy started in the early 2000s during the North Dakota Telepharmacy Project. North Dakota State University conducted a study in 2002 to evaluate the safety and efficacy of telepharmacy in the retail and hospital pharmacy settings. The study had positive results and showed that the error rate related to telepharmacy services was below the national average of the error rate presented by providing other forms of traditional pharmacy services. This was a huge outcome from the project, because this is still a concept that's relevant today. But of course, when you're providing healthcare services through a virtual technology, many practitioners are going to be hesitant because it's a different form of care and there is technology involved. So there's some hesitation as to whether virtual healthcare is accurate, whether there will be more errors, whether there will be less. So the fact that this North Dakota Telepharmacy Project showed an outcome that the error rate under telepharmacy services, which was much less, that was a huge thing for the project. Because of the success of the North Dakota Telepharmacy Project, the North Dakota Board of Pharmacy, then permanently implemented telepharmacy regulations in 2003. So as you can see, that wasn't that long ago, and we're seeing now that it's becoming more adopted, the US Navy became the largest user worldwide shortly after North Dakota had adopted its telepharmacy regulations. As you can imagine, there are not pharmacy sites on board, on US Navy ships, for example. So it became a very necessary service for the US Navy. Shortly thereafter, Washington State and Alaska also followed and adopted the practice of telepharmacy. The practice slowly began expanding into other central and western states. The focus of implementation was on rural communities due to the lack of pharmacy access in these locations, which are also known as pharmacy deserts.

 Now, telepharmacy is starting to become adopted in the Eastern states and urban communities. Currently, there are around 26 states that have now adopted telepharmacy according to TeleForm, I say around 26, because states are literally issuing regulations on telepharmacy as we speak. So this number has been changing. It has been increasing at months at a time, and so we say 26 slightly. Now you'll see this chart that was created by TeleForm, it shows you the state adoption on a map. So the green states allow some form of telepharmacy to be practiced. I say some form because certain states don't implement the full extent of telepharmacy services, but they will allow one or two types of this service. The gray states show you which states have not adopted telepharmacy yet, but I am thinking that they will shortly come on board as well.

Now we'll look at the practice of telepharmacy. And first, I will show you a common use case of how telepharmacy is currently being used in practice. This common use case of telepharmacy services involves a patient, of course, where you see at the bottom in green, a primary care physician, which is on the left side and the blue building. We have a telepharmacy in yellow, right in the center, and a tele pharmacist on the right hand side. So the way that this works in practice is that the patient visits or tele visits, her primary care physician or PCP, the PCP then sends an electronic prescription to the telepharmacy. The technician sends images of the prescription and details to the tele pharmacist through telecommunications for review, the tele pharmacist then reviews the prescription and can contact the primary care physician, if she or he identifies any contraindications, has any questions, things like that, the telepharmacist will then approve or disapprove dispensing the drug. At that point, if the telepharmacist does approve dispensing the drug, he or she will coordinate delivery of the prescription with the patient. And the telepharmacist is also available for remote counseling with the patient through real time audio-video, as the patient sees fit.

So this is one example of how telepharmacy is being used right now. The patient has the option of conducting follow up remote counseling after he or she receives his prescription, it's not required, but this is a new service that pharmacies are trying to improve because part of this is to enhance medication adherence. And if the patient, for example, doesn't understand something about his or her medication or his side effects, this is an efficient way for them to just talk to the pharmacist on demand and resolve any issues that they might be experiencing.

Okay, here is another chart of different examples of telepharmacy services. I have divided them up into four categories.

One is medication or disease management, which includes drug therapy monitoring, medication therapy management, which you might know as MTM, and Chronic Care Management or CCM.

The second category is remote verification, which includes remote supervision of a pharmacy technician, prescription verification, and compounding. So compounding for example, you know as a pharmacist in the pharmacy, creating a special product for a specific patient. So the way that this can be enhanced through telepharmacy is say a technician was in the pharmacy and under his or her scope of practice under state law, they were permitted to assist with compounding a certain drug, the pharmacist or the telepharmacist could be available and assisting the technician on audio-video and walking the technician through creating this drug, approving it, et cetera.

The third category that you see here is patient counseling. So we talked about this a little bit before in the previous slide, but this really helps address medication adherence, or, and other questions patients may have about their medications. It allows the telepharmacist to be available to the patient on a more efficient basis instead of the patient having to come in to see the telepharmacy, sorry, to see the pharmacist, or if it's just inefficient, they might not even call up the pharmacist. And then they might just stop taking their medications if they have side effects, for example, or if they can't figure out a question that they have, it might just decrease their medication adherence and cause other issues down the road.

The fourth category and last category for purposes of this slide is medication review. So this includes medication reconciliation, new medication counseling. So this kind of goes hand in hand with patient counseling.

Now, for those of you who may be serving telepharmacy clients or other digital health clients who are interested in integrating telepharmacy into their current business models, it is important to understand what the pros and cons are. The benefits are definitely patient facing, which you might anticipate. So for example, there is a tremendous increased access to pharmacy services. The whole reason telepharmacy started is because there were many and still are many rural health areas, sorry, rural health, sorry. There are many rural areas where patient populations do not have access to pharmacy services. So telepharmacy helps patient populations of varying geographical and socioeconomic status have access to these services that we mentioned in the previous slide. So there might be such a where a patient either doesn't have time between work and caring for their family, or they don't have a car to go from the doctor to the pharmacy. They might rely on public transportation. They may not have the funds to continue going through public transportation, or they might not be able to get a ride from somebody, so you can see how telepharmacy would increase access to pharmacy services just from an efficiency standpoint. There is a potential for 24 hour pharmacy access, which we know there are some entities who are already operating under this model, but of course, it is not the norm. As we discussed previously, there is a lower error rate. So this is a definitely a great outcome that we've seen because a lower error rate allows pharmacists to rely on these telepharmacy technologies and then spend more time providing other high quality pharmacy care, which might not be able to be provided through a technology or a telepharmacy services, or through a telepharmacy service.

Another benefit is a lower error rate, or sorry, another benefit is an effective that it provides effective patient counseling. We talked about this a couple times already, but essentially, this means that the patient has access to the pharmacist through a audio-video or similar platform, and does not have to worry about setting up an appointment or visiting the pharmacy to go ahead and receive that medication counseling, for example. This is certainly an advantageous as the COVID-19 public health emergency continues, especially for high risk patients. We have seen that the elderly patients or patients who are immunocompromised and are not comfortable being around large crowds at the moment, or even in the future, they can take advantage of telepharmacy services in the comfort of their own home. Further from an operational standpoint, providing pharmacy services through virtual means can be more cost and time efficient. So a pharmacist can focus on quality. The challenges that currently exist relate to operations as well, but from a technology implementation perspective, so pharmacists who are interested in integrating telepharmacy services into their model will either need to find a reliable vendor for their platform or build it in-house with a specialized engineering team. While this is a challenge, we are seeing more and more reliable platform providers in the industry. So I think that may be a temporary challenge and not necessarily a permanent one, a more long term challenge, is definitely the legal landscape.

So, as we've talked about, currently, the practice of pharmacy is being adopted on a state by state basis. And there is no interstate pharmacist compact, like there is for physicians and nurses. So if pharmacists who are operating under telepharmacy do want to serve patients in another state, they will need to become licensed in the state where the patient is located. There is no waiver or more efficient process to get their pharmacy licenses similar to how there are for physicians and nurses. That's not to say it can't be done, it's just one of the hurdles that we see. There are also additional licensing requirements. For example, if a telepharmacy is operating a remote dispensing site or a kiosk, some states require the telepharmacy to obtain a separate license to install and operate this kiosk. And they must also pay a separate licensing fee in some states. There are also geographic or staff restrictions. So some states require that there is a physical pharmacy location within a certain number of miles of the telepharmacy.

Another area that depends on state law is the pharmacist to tech ratio. So states will require that there is one pharmacist for every say, three to four pharmacy technicians in terms of supervising the pharmacy technician. Some states say that the pharmacist to technician ratio is the same as the in-person requirement. However, some states don't have ratio requirements. So this is still up in the air. Another challenging aspect of telepharmacy is state adoption and reimbursement. Some states are still slow to adopt. So it will be interesting to see in the coming months and the coming years, how many states are added to that 26 state list of adopting telepharmacy. And as we'll discuss in the coming slides, there is no reimbursement for telepharmacy yet.

Now we will talk about the money, how are telehealth and telepharmacy currently being reimbursed? So let's start with telehealth. Medicare is covering most telehealth services. Under the 1135 waiver, they recently significantly expanded the types of, and the number of telehealth services that Medicare will reimburse for. In order to be reimbursed, Telehealth services must be included on the list of allowable telehealth codes, which is established annually by Medicare, and it is available on their website. It is a very lengthy list. So that just shows you that Medicare is recognizing the benefits and the medical necessity of telehealth services. CMS also recently expanded its list of eligible providers who can bill for telehealth services. The list now includes physicians, nurse practitioners, physician assistants, nurse midwives, certified nurse anesthetist, clinical psychologists, clinical social workers, registered dieticians, nutrition professionals, physical therapists, occupational therapists, and speech language pathologist. You will see that pharmacists are not on this list, but pharmacists can explore collaborative practice relationships. And, or incident two billing pathways with eligible billing practitioners. Continuing our discussion on reimbursement of telehealth, the Medicaid programs in all 50 states do reimburse for some services provided by live audio-video. It say state by state determination as to which services in particular are reimbursed, but all states do have some form of reimbursement for telehealth services. From the commercial payer perspective, 43 states have laws that relate to commercial coverage of telehealth. So this reflects your typical commercial plans that are on the private payer side. And it is great to see that most states have laws that do either require commercial coverage of telehealth, or at least implement some coverage determinations of their state. Several states do have payment parity laws, which require the same reimbursement for telehealth as for an in person visit, therefore, many states and many payers more specifically are reimbursing for telehealth services at parity with in person visits.

Now we turn to telepharmacy. There is still uncertainty as to whether or not telepharmacy will be, or sorry, is reimbursed by commercial payers. It definitely is not being reimbursed yet at the commercial payer level, nor is it being reimbursed by Medicare or Medicaid. These payers do not directly reimburse for telepharmacy, but because they do involve certain traditional pharmacy services, there is a chance that some of the services could be reimbursed for a different service, but then the pharmacist could contract with the billing practitioner and get paid for their services that way. I think there is an uncertainty right now because telepharmacy is still so new. They still figuring out either how to adopt it, whether to adopt it, which services to allow for. So I think once more states we get on board with actually implementing telepharmacy services, then the reimbursement will come along as well. As I stated before, pharmacists are not eligible providers to bill for general telehealth services, but they can provide services incident to a billing provider. This comes back to a pretty common policy issue in the pharmacy space, which is provider status. So pharmacies have been lobbying for quite some time now to achieve provider status, which would afford them with greater authority and opportunity to provide a larger set of healthcare services. They are already very integral parts of the healthcare delivery system. So, the provider status becomes something that would help them serve as more efficient and get even more involved in the delivery of healthcare. So, this is one other example of where providing tele pharmacies or pharmacists in general with provider status, even if it's for a narrow scope of just telepharmacy services, would help them provide these services to a larger extent.

Now, it's time to talk about the legal considerations. What is at issue when we talk about telepharmacy? First, we need to explore Federal, Fraud, and Abuse. So when pharmacies or pharmacists are considering partnering up with billing practitioners, so for example, hospitals or primary care practices, it is important to understand that the relationship needs to be in compliance with the Federal Fraud Abuse Laws. These include the Anti-Kickback Statute, which is known as AKS, and the Physician Self-Referral Law, which is known as the Stark Law. So the Anti-Kickback Statute is a criminal law that prohibits the knowing and willful payment of remuneration to induce or reward patient referrals or the generation of business involving any item or service payable by a federal healthcare program. So while telepharmacy is not reimbursable directly by a federal healthcare program, if there are services involved that are able to be billed and reimburse for, by a federal healthcare program, the relationship needs to be analyzed under AKS. There are safe harbors associated with AKS, which essentially lists out several requirements that must be met in order to fit within the safe harbor. And if the relationship or the proposed arrangement does fit under a safe harbor, the risk of a fraud abuse violation is much lower. In fact, the OIG in 2020 issued a final rule related to the Anti-Kickback Statute in which they added several flexibilities in terms of the safe harbors to their current list. These focused on value based arrangements. And that shows that the healthcare industry is moving towards more of a value based system, where they are not trying to provide services just on a fee for service basis. They are interested in seeing how different partners and healthcare industry professionals can work together to provide higher quality care to patients.

The Physician Self-Referral Law, or the Stark Law prohibits a physician from referring a patient to an entity that the physician or the physician's immediate family member has a direct or indirect financial relationship with for a certain designated health service, that is, or are reimbursable by Medicare or Medicaid, unless an exception applies. So this will become relevant if say a physician was financially invested in a pharmacy and then the pharmacy or the telepharmacy for purposes of our discussion, will have to evaluate the proposed arrangement under the Stark Law, just to ensure that the service that is being provided is not DHS. If it is, then we would need to go through an analysis under the Stark Law and see if it applies. And if so, whether exception applies. Similar to the AKS flexibilities that were issued recently, CMS also issued exceptions that offered greater flexibility to entities involved in 2020 as well.

Our second topic in terms of legal considerations is HIPAA. So you might know this as the privacy rule that we refer to when we're talking about patient data, it is the closest thing to a national privacy rule that the United States has. So as part of providing telepharmacy services, as we talked about a little bit before, pharmacies must use HIPAA compliant technologies, as they are usually considered covered entities, HIPAA applies to covered entities and business associates, covered entities include healthcare providers, only if they transmit any information in an electronic form and connection with a transaction for which HHS has adopted its standard. So what this means is if the healthcare provider is for example, electronically billing for services, billing a health insurance company, that would satisfy the transaction requirement. So in this case, an electronic exchange of information to carry out a financial or administrative activity related to healthcare. For example, a healthcare provider will send a claim to a health plan to request payment for medical services, that would apply in the case where a telepharmacy is submitting claims for other services that are covered by a health plan, so then they would be considered a covered entity. Covered entities also apply to health plans and healthcare clearing houses. Business associates are people or entities that perform certain functions or activities that involve the use or disclosure of protected health information on behalf of, or provides services to a covered entity. So this would typically include a software vendor who a pharmacy has engaged with to provide them with a telepharmacy platform, for example, in that case, the telepharmacy must enter into a business associate agreement with the software vendors, just to ensure that any patient data that is considered Protected Health Information or PHI, is being held to the standards that are required by HIPAA.

The next set of legal considerations that we need to explore when talking about telepharmacy are what is available at the state level in terms of state law and boards of pharmacy. So many states have their own versions of the Anti-Kickback Statute and the Stark Law, as well as fee splitting laws. Any financial relationship with a physician must be closely evaluated under relevant federal and state law. As I mentioned in the previous slide, if a physician has an investment interest in a pharmacy, or if it is in some way receiving financial benefit from that pharmacy, then there is a risk that I could run a foul of federal and, or state physician self-referral laws. These splitting laws at the state level basically prohibit a healthcare practitioner from splitting fees with a nonprofessional individual, especially in the cases of patient referrals. So anytime there is a relationship that is involving fees in terms of healthcare services, and more than one healthcare practitioner, we always needs to evaluate it from a fraud and abuse perspective. There are also pharmacist licensing requirements in each state where the patient is located. So for example, if a telepharmacist would like to serve a patient in a state in which she or he is not licensed in, then the telepharmacist will need to go ahead and apply for such license and achieve such license before being able to provide services to that patient. There are also additional pharmacy licensing requirements where the services are being provided. So there might be registration requirements in the state where the patient is located in, that the pharmacy must satisfy in order to provide telepharmacy services in that state. It is also important to consider the adoption of telepharmacy via pilot programs.

So similar to how the North Dakota project rolled out, there are other states that are looking into pilot programs to test out how telepharmacy is working, whether they think they should integrate it into their regulations. So it's always important to be aware of what's going on in your state in terms of pilot programs. There's of course, legislation at the state level where rules are being proposed to implement telepharmacy and allow for these services in the state. And then of course, there is the Board of Pharmacy and the administrative code that will regulate how telepharmacy can be provided and what additional requirements may be at issue.

Next, we will talk about enforcement. The OIG is watching. So first of all, we have mentioned OIG a few times throughout this webinar, but who is OIG? What do they do? What are they responsible for? Why do we care about them when we're talking about telepharmacy? So the OIG is responsible for overseeing fraud, waste, and abuse that is present in federal healthcare programs, which includes Medicare and Medicaid. These are programs that have lots of federal dollars invested in them, and they guide the country's most vulnerable, who are the elderly patients, and those with a low socioeconomic status. Although telepharmacy is not currently covered by a federal healthcare program, there is a likelihood that it will be at some point. And again, it might be provided in conjunction with services that are covered by federal healthcare programs. So it's important to know that the OIG is looking at fraud, waste, and abuse that's present in the telehealth space. OIG is the largest Inspector General's Office in the federal government. So that will give you an idea of how much responsibility they have within the Department of Health and Human Services. The reason it's important to talk about OIG enforcement for purposes of telehealth and telepharmacy is because the COVID-19 public health emergency has triggered heightened scrutiny on any sort of delivery of health care through virtual means because it has exploded so rapidly in recent years, OIG is now taking a look just to make sure that services are being provided appropriately. There's no false billing. They also do want to explore which telehealth flexibility should be made permanent.

 So in February of 2021, the OIG made a statement that it is conducting significant oversight work, assessing telehealth services during the public health emergency. They have distinguished in the past between, and sorry, they have distinguished in this statement, telefraud from telehealth fraud. So telefraud includes sham remote visits. This would be what should be a telehealth visit, but is not actually a telehealth visit that would be considered a sham remote visit versus telehealth fraud, which includes inappropriate billing for telehealth visits that are made in connection with telehealth visits. The OIG work plan currently includes nine active audits and inspections around telehealth and virtual care services. Here on this slide, you will see this list of the currently active audits and inspections that are related to telehealth and virtual care services. We expect these will include remote patient monitoring, e-visits, virtual check-ins, and of course, just telehealth in general. The work products are expected to be published in 2022. So this year, and also next year in 2023. So you will see that most of these relate to how Medicaid and Medicare is involved with telehealth in terms of the expansion, in terms of what services were being used during the COVID-19 pandemic, there are also audits being conducted of home health services that were provided as telehealth during the COVID-19 public health emergency. So you can see here, there's a variety of different angles that the OIG is taking and evaluating how telehealth has been used and utilized during the COVID-19 pandemic.

Another agency to consider when we're talking about enforcement action during the COVID-19 pandemic relating to telehealth is the Department of Justice. So the Department of Justice recently issued a national healthcare fraud enforcement action in September of 2021. And this enforcement action involved over 1.4 billion in alleged losses. In terms of telemedicine, 1.1 billion in fraud was committed use in telemedicine, 29 million was related to COVID-19 healthcare fraud. And then you'll see the rest of it was related to substance abuse and illegal opioid distribution schemes. There have also been other enforcement actions related to fraudulent vaccine, card schemes, which you might have seen involved pharmacies creating false COVID-19 vaccine cards and selling them on the black market. There's also been continued, improper billing enforcement action, which this has always existed in the healthcare space for fraudulent billing. And we'll continue to see that probably as it relates to telehealth and telepharmacy as well.

Okay, as we are moving into the closing of our webinar today, I did want to touch base on some potential telepharmacy business models. So we've talked about examples of telepharmacy services and how this practice is being utilized in the pharmacy setting today. But I also want to touch on some potential telepharmacy business models, because if you do have clients who are considering adding these services to their offerings, you will want to have an understanding of what this might look like. So I've broken up the business model examples into four categories here. We have the traditional pharmacy setting, which would include filling scripts, medication reviews, and patient counseling. We have remote consultation sites where scripts are prepared at a central pharmacy and then delivered to rural sites. This can also include patient counseling. The third category is hospital telepharmacy. So this is where you see telepharmacist helping out with prescription processing and verification. We have automated dispensing machines that include nurse and technician assistants over an audio-video interaction. And then we also have practitioner consultation. So there might be a pharmacy center at the hospital, and then they are outsourcing their consultations to the telepharmacist. So say a physician has a question about a certain drug, they can jump on telepharmacy platform and consult with the telepharmacist. And then lastly, we have automated dispensing machines, which are like little kiosks. They offer prescription processing and verification, as well as a means for patient counseling as well. So you can see a common theme amongst most of these business models is patient counseling. There's a huge need for medication adherence improvement, and telepharmacy is definitely a way to attack that.

Okay, so next and last, we will talk about the future. What does the future of telehealth look like, and where are we going with telepharmacy? So we have a couple of thoughts that we are nearly certain about for telehealth and telepharmacy. However, there's still a lot of uncertainty as it relates to these two virtual care delivery modalities. So in terms of near certainty, we are definitely seeing that there is a continued and increasing consumer demand for virtual care services, patients experience an efficiency during the COVID-19 pandemic and still are throughout the public health emergency for more efficient and more accessible care provided through virtual technology, sorry, through a virtual means. So we are going to continue to see that consumers are now used to this modality and will likely want to continue receiving healthcare services where appropriate through telehealth and telepharmacy. There is a focus on telehealth as a supplement two and not a replacement for in person visits. Of course, there will always be cases where an in person visit is medically necessary and telehealth allows practitioners to determine when that might be the case.

So for example, if a patient thinks that he or she needs to go to the ER, maybe they are experiencing a severe cough, the patient can jump on a telehealth platform with their practitioner who can walk them through their different symptoms and determine whether or not they do indeed need to visit at the emergency room, for example. And then if they do, a follow up visit could be conducted over telehealth. We also know for certain that there are continuing to be expanded use cases and eligible providers who can offer telehealth services. So what we're seeing in the industry today is various adoptions of telehealth. So for example, we see telepharmacy as a new modality of virtual care. We see teledermatology, we see telebehavioral health. So telehealth has definitely inspired different specialty areas to look into providing their specific care over virtual means. We are certain that we will continue to see that telehealth and telepharmacy are components of health equity. We are seeing user-friendly telehealth platforms continuing to be developed. And also we are experiencing the continued development of best practices, which include use case-specific scenarios. And what this means is that as industry professionals and stakeholders are using telehealth platforms, they are becoming more diligent in determining how to best offer this care to their patients. So for example, what needs to be a part of patient onboarding? The patient needs to make sure they are in a setting where they have good internet connection or proper lighting, low noise in the background. They also have best practices for actual use cases for healthcare and health-specific conditions. So if it's a chronic condition, what might their practitioners want to look for if they're conducting a visit over telehealth? The few things that we are uncertain about are the pace of expansion.

So as you have seen, telehealth has been adopted in all 50 states from the Medicare perspective, but telepharmacy is a little bit slower. Again, it is 40 years behind telehealth, but right now, we're seeing only about half the country as adopting telepharmacy. Again, I do think this year in the coming years, that will change because as we're seeing a more rapid increase in adoption of these services, but it is still uncertain what the pace is going to look like. We are also uncertain of the federal and state statutory and regulatory changes. So this is more specific also in terms of COVID-19, because so many states have issued waivers and actually even at the federal level, the agencies have issued temporary flexibilities. It'll be interesting to see which flexibility are made permanent and how that will impact the future of telehealth and telepharmacy. We are still unsure of payment parity and reimbursement. So is telepharmacy going to become adopted into state Medicaid programs adopted by Medicare? Is it going to be reimbursed at the same level as an in-person pharmacy service? That will be something that we'll have to wait and see. And then lastly, we are still in turn of cross-state licensure for pharmacists. As I mentioned, there is a nurse licensure compact, and one for physicians, but we have not seen this yet for pharmacies. It will definitely be beneficial if they do, if the National Board of Pharmacy, sorry, if the State Boards of Pharmacies do come together and create something similar so that telepharmacy services can be more accessible for patients across state lines.

All right, now that we have concluded the substantive part of this webinar, I have a few assessment questions for you.

So number one, when was telehealth first adopted? The choices are A, the 1940s, B, the 1960s, C, the 1980s, or D, the 2000s? The correct answer is the 1960s.

Assessment question number two, when was telepharmacy first adopted? A, the 1980s, B, the 1990s, C, the early 2000s, or D, the late 2000s? And the correct answer is the early 2000s. As we discussed, telepharmacy was shortly behind the adoption of telehealth, but not too far behind. So they were about 40 years after telepharmacy first became adopted, about 40 years after telehealth did.

Okay, assessment question number three. What is an example of telepharmacy services? Medication or disease management, remote verification, patient counseling, medication review, or all of the above? The correct answer is E, all of the above. As we saw, there are many different forms of telepharmacy services. And these are for examples of how practitioners are currently providing these services.

The last question, assessment question number four, true or false, Medicare currently reimburse for telepharmacy services? A, true, or B, false? The correct answer is B, false, Medicare or other payers currently do not reimburse for telepharmacy, but we hope to see that they will implement coverage shortly.

Presenter(s)

RTJ
Reema Taneja, JD
Counsel
Nixon Gwilt Law

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