Hello, my name is Mei Kwong, I'm the Executive Director for Center for Connected Health Policy. CCHP is the federally designated national telehealth policy research center. We provide technical assistance to those who have questions regarding telehealth policy. The UC Davis School of Medicine has asked me to talk to you today about some of the rules that are in place, and some of the policies are in place both on the federal and the state level that you should be aware of if you are utilizing telehealth to deliver services. A few disclaimers before we get started. Please know that any information provided in today's talk is not to be regarded as legal advice, it is strictly for informational purposes only. CCHP recommends that you consult with legal counsel if you are interested in a formal legal opinion. Also if I happen to mention a company or show a picture of a product, know that neither I nor CCHP has any type of relevant financial interest arrangement or affiliation with such a company. For today's talk, we're going to learn about other laws, and regulations that can impact your use of telehealth such as the Stark, and Anti-Kickback laws, consent laws, liability or malpractice, and other state requirements that you may come across when you're using telehealth to deliver services. First thing we're going to tackle is Stark and Anti-Kickback clause. What these are, are federal laws that sometimes prevent providers, and health entities from making referrals in exchange for compensation. It's basically just to make sure that you don't have some type of financial arrangement that may look a little suspicious where you're referring things to a particular provider where you have this financial gain relationship that you've established there, especially if you are accepting money from Medicare or Medicaid federal funds essentially. Stark and Anti-Kickback are actually receiving an update in 2022. This video is be recorded in 2021, just be aware that there will be updates in 2020 on what these laws will really require. But, the benefit of the updates that you're going to see in 2022 is that they allow more areas in which you have some flexibility. Currently, there are two different types of law. The Stark law prohibits a physician from referring Medicare or Medicaid patients to someone who the physician or their family member might have a financial relationship with. Well, that runs afoul telehealth sometimes is that when you're a primate care provider, for example, you may be referring somebody to a specialist who will be providing services over telehealth, and perhaps you have like some contractual arrangement to do that. For example, you're a physician and you're working in a federally qualified health center, your federally qualified health center has engaged a specialists, say a cardiologist, through a contract to provide those services via telehealth to the clinic's patients. That in itself, the way it's structured, sounds like it might run afoul of the Stark law. But really there are a lot of, say, harbors or exemptions in which you can probably spot that contract in. For example, some of the exemptions that we see are as a bona fide employment arrangement. There are certain elements in order to qualify under that exemptions such as having its identifiable services, services you're paying for our fair market value, and it seems like it's commercially reasonable arrangement that you've had set up with this other provider. While this is something you need to be aware of, know that also in Federal, there's a lot of exceptions, a lot of what they may call safe harbors, which you may be able to slot into your particular situation so you won't run a foul of the law, and the updates in 2022 really broaden or make clear some of these other exemptions in there. It's not going to be too drastic or over all of those type of changes that you're going to see coming in 2020. Anti-Kickback, very similar, prohibits offer payment of or solicitation or receipt of renumeration, that's basically means some type of value are getting some benefit or payment or something, to induce a reward patient referral. You're basically trying to say, you're not having arrangements where you're getting a bit of a kickback, hence the Anti-Kickback name, for referring patients to a particular provider. Which again, sometimes if you have like maybe this contractual arrangement for telehealth, might on its face look like that, but the Anti-Kickback law also does have safe harbors in which they allow for exceptions too. One of the new changes that you're going to see in 2022, at least underneath the Anti-Kickback section, is to allow for more value-based arrangements. That was not something we had prior to these new changes that are coming in 2022, and there are a lot new value-based arrangement models out there, and the benefits to them. But they may have, in the way that they were set up, run a foul of the Anti-Kickback. Laws. There were changes made to that to make that a little bit more accommodating going forward in 2022. It can get very complicated, but just know that there are a lot of flexibilities, a lot exceptions, a lot of as they call them safe harbors. That you can probably your situation does fit into because there have been many telehealth programs that have addressed it that way, where you won't run afoul of these laws. But I just wanted to make sure that you are aware that they exist out there and to look into that or consult an attorney to find a way in which is the best exemption for you to fit into. Consent. Consent is another big thing here. If you're a healthcare provider, you're very familiar with informed consent for delivering healthcare services. You usually have a patient sign something, understanding that they know what they are receiving, the services they are receiving that they'd been like told about like the procedures, etc. But there are specific requirements around telehealth sometimes regarding consent. It's really going to depend on what you're talking about, what program or what jurisdiction you're talking about. First off, know that consent and informed consent are actually two different things. Informed consent usually goes around knowing the risks that are involved, having that explain to the patient that they've been explained to, like what are the risks involved in a certain procedure. You see informed consent usually explicitly said you need to get that around something that's very risky procedure because they want to make sure that the patient is aware of like all the risks that are involved. Consent is more like you agree that you're allowing this to be used. There's usually like less risk or less danger associated with consent is just like, yeah, I know I'm getting my services over video. It's very important to know the difference between the two because depending on your jurisdiction, it might dictate how much information you need to relay to the patient and how much they need to know before they sign off and get consent. On the federal level, there's no statutory requirement to obtain consent. There's nothing in federal law at the moment saying that you need to get prior consent from the patient before you start using telehealth to deliver services. However, Medicare, if you've got a Medicare patient, you're using some telehealth technologies to deliver services. There are some areas where Medicare would say you need to get consent before you do this. They say It's consent because a lot of it really surrounds that the patient understands that it's being delivered through a specific modality and that there may be a co-pay involved. With Medicare it's not for all telehealth services, but there are some specific telehealth services or services that use telehealth technologies to deliver those services where the consent maybe you required. States are really where you see more of the consent requirements. There are some states that have consent requirements in their state laws in regards to telehealth and saying that you must get consent before you start delivering services via telehealth to the patient. A lot of times, in both, this also happens on the federal level. What that consent looks like might be vague. They don't necessarily lay out like, okay, you get X, Y, and Z in your consent for your patient they just say you need to get consent. Sometimes they may say, it can be written or oral. That also leads to a lot of confusion for a provider saying like, how do I record that then, also, how frequently do I need to get this? Is this once a year? Or is this for like every visit I do via telehealth? When do we do that? Is it fine if I just put a little check box in my HR, check that, say like I got consent, is that sufficient? The problem is, is that a lot of administrations, both on the federal and the state level, they don't specify. Providers are left to try to figure it out and try to create best practices themselves. The most that they may say is that you need to get consent. Maybe they might have like a couple elements in there and they can say it can be written or oral or they may pick like it must be written. There is a lot of vagueness, as far as like the other elements to it. Like how frequently you get it, is it just for each particular episode? Can you just do it like once a year? Et cetera. When do you get it? Can it be within the consents of these written in the normal consent forms that you may have a patient signed? Could there be just be a paragraph saying like if telehealth is offered as an option I consent to using it, after consulting with my provider or something, is that's sufficient? All that is really vague. Both again, I said on the state and the federal level. Also sometimes, even if the state doesn't have something in their state laws regarding consent, you're dealing with a Medicaid patient. The Medicaid program may actually ask for something. Be aware of that too. Maybe like an administrative regulation that you have to follow if you're treating Medicaid patients to obtain that consent and may not necessarily be required in state law.
