Speaker 1 00:00:00 There's already been some companies that have gotten in trouble for not doing it properly. If you are doing any of the things we talked about wrong, then you should be correcting them and you could potentially be at risk if somebody determines that you've not been compliant. So it's an ever changing landscape for sure.

Speaker 2 00:00:29 Welcome to Off the Chart, a business and medicine podcast featuring lively and informative conversations with health care experts, opinion leaders and practicing physicians about the challenges facing doctors and medical practices. I'm your host, Austin Littrell. This episode features a conversation between Medical Economics Managing Editor, Todd Shryock, and Ericka Adler, a health care attorney with Roetzel & Andress. They're talking about the key issues and risks that doctors need to consider when prescribing GLP-1 medications, from insuring informed consent to navigating long term safety data.

Speaker 3 00:01:05 I'm here with Ericka Adler, a health care attorney and practice group manager at Roetzel & Andress, to talk about GLP-1 drugs and the risks that come with them. Ericka, thanks for joining me.

Speaker 1 00:01:16 My pleasure.

Speaker 3 00:01:18 Let's start with liability.

Speaker 3 00:01:19 Risk. What are the primary legal risks for doctors prescribing GLP one drugs, particularly for weight loss?

Speaker 1 00:01:27 I think from a liability perspective, the risk that doctors are facing is whether they are doing things in a compliant manner, taking into account the state laws that apply to them and the federal laws that apply to them. Right. And I know we're going to talk about some of those. A little more detail. When you want to prescribe, you need to think about. How is your office set up? Am I able to prescribe? Do I have the necessary training and knowledge to be able to do so? Am I going to be delegating this to someone? Am I doing that delegation in a proper way. And that is really kind of the state law analysis of that legal risk. When we talk about the actual drug itself, of course, there's an analysis of, am I getting this drug from the right place? Am I explaining to patients properly what their risks are? Am I documenting that properly so very much similar to any other kind of drug from that perspective? as we talk about prescribing these drugs in different ways, via telemedicine or otherwise, we start getting into additional state and federal law concerns.

Speaker 1 00:02:36 So, as you can see, the kind of laws we need to worry about really depend on the facts scenario and what the individual provider has in mind in terms of introducing that to their practice.

Speaker 3 00:02:49 Let's talk about off label use. What what legal concerns arise when prescribing these drugs off label. And how can physicians mitigate those risks.

Speaker 1 00:02:59 So off label use is very common. It sounds like something bad. You're not supposed to do it right because it's off label. But it is very common not just for weight loss drugs, but for many other drugs. So physicians in every case where they're prescribing something off label, are making a professional decision that they believe it's appropriate for the patient for the use that they're prescribing. So it's the same analysis in this particular case as well. The doctor should be documenting why they're recommending it, why they're comfortable with it. They need to be aware of potential adverse drug events, whether there's rigorous studies to support what they're doing, whether it's going to be effective or not. What the liability product liability is associated with that drug.

Speaker 1 00:03:45 And all of these things need to be communicated to the patient, right. So it's not just the patient asking for something and the doctor saying, hey, yeah, I can do that. Everybody's doing it. Let me prescribe it for you in order to protect the doctor from liability. Ability. That analysis needs to be made on a patient by patient and drug by drug basis. And it needs to be documented. And the patient needs to be told both in writing through a consent form and verbally. I would hope, through discussion with the healthcare provider about the risk and advantages and alternatives, let's say, to taking that drug. So, you know, these are the things that need to be documented, whether a patient faces an adverse event after an off label prescription. I mean, there could be a little bit of an additional risk because, maybe the guidelines were lacking on the reason for which it was prescribed. Right. Whereas if it's used for an FDA purpose, typically, you know, those guidelines are available.

Speaker 1 00:04:48 So there's a little bit risk sometimes in prescribing something for off label use because perhaps it hasn't been studied as greatly. The guidelines aren't there in terms of dosage and potential, you know, adverse impacts with other drugs, etc.. So I think providers do need to be aware of those potential additional risks for off label use as well. a lot of this could be covered through informed consent, letting patients know that it hasn't been fully studied, that there are unknown adverse consequences possible, that it's not FDA approved. perhaps. And I know some doctors do this. they they stay on top of the literature. And every time something comes out that talks about an additional risk or consequence, or adverse effect, they may follow up with the patient. Talk about it with the patient. Again, get a new informed consent sign. Now that is really going above and beyond. But when we're talking about limiting risks that's something that many doctors do.

Speaker 3 00:05:53 Or that informed consent form. Should there be something specific for GLP one drugs? It seems like a lot of the informed consent or kind of boilerplate.

Speaker 3 00:06:03 You need something more specific when when prescribing these meds.

Speaker 1 00:06:07 Well, I think when it comes to off label use, we want to make sure that patients are making a really informed decision. So a tailored consent form, by the way, I think all consent forms really should be tailored to whatever they're being used for. it should include information about the off label use that it is not an approved use by the FDA. It's certainly not illegal. And that can be made clear. and having that kind of really robust description, within the informed consent can only help limit liability. So what you want to have is a clear explanation of why it's being prescribed for use, that the FDA does not approve it. what the risks and benefits are of taking that particular drug. Maybe covering alternative options. Maybe there's other drugs or other types of treatments available. getting the patient's written consent that documents that they understand. They've discussed it. Their questions have been answered. Things like that. keeping open that communication role that we just talked about.

Speaker 1 00:07:11 providing updated knowledge as it becomes available and then documenting everything. So the minute that patient's medical record is requested, you shouldn't be searching for things. Those consent forms should be in there. They should be dated. They should be updated. you know, and otherwise you're doing yourself a real disservice by not having a properly documented record.

Speaker 4 00:07:37 Say, Keith, this is all well and good, but what if someone is looking for more clinical information? Well.

Speaker 5 00:07:43 Then they want to check out our sister site, Patient Care Online, the leading clinical resource for primary care physicians. Again, that's patient care online.com.

Speaker 3 00:07:57 We hear a lot about compounded versions of these drugs. And some patients are seeking them out due to shortages. What are the legal risks that physicians face in prescribing or recommending them?

Speaker 1 00:08:09 I think that's a good question. There's been a lot of lawsuits related to this topic. The problem with compounding pharmacies is that sometimes the the products can be contaminated, tainted, misbranded. you know, and there can be issues now.

Speaker 1 00:08:28 a properly run operated and licensed compound pharmacy should not have these issues. Okay. So it's like anything else. Some some do a good job, some don't do a good job. All right. So if a doctor has a relationship with a great compounding pharmacy, we would hope not to see those issues at all. Not to say they don't occur, okay, because they actually do. when you use a compound pharmacy, you don't always get, you know, everything presented in the same way that we might be used to with a, a CVS or a Walgreens. Right? It's a different kind of product. They're not just buying it from the manufacturer. They're literally recreating the product in their lab. So it really needs to be done kind of perfectly. And that's how those kind of mistakes or contamination can occur sometimes. You know, the level of, you know, keeping things perfectly run, operated and safe are not met at the same standard. So that's kind of sometimes the problem we have. the popularity of these compounding pharmacies really came because there were great shortages, and that shortage has been reduced.

Speaker 1 00:09:36 And you may have heard that, you know, some of these, there were some lawsuits, against physicians who continue to use compounding pharmacies even when the shortage went away. We saw the FDA declare that there's no more shortages. So compounding pharmacy shouldn't be making this anymore. And then there was legal action taken by those compounding pharmacies saying, hey, wait a second. You know, you're being a little arbitrary in saying Experiencing whether this shortage has been reduced, the FDA, FDA did somewhat back off of that. They're saying now, you know, they're going to make sure that there's a wider, you know, correction of the shortage before they enforce anything. So we are still seeing these compounding pharmacies, producing these products. One of the things that doctors get in trouble for when they're using compound pharmacies is they're advertising. if they're saying they're using a certain product, but in fact, they're having it made by a compounding pharmacy. They're not allowed to say that it's the product itself. Right. So if you're saying we sell ozempic or we're providing ozempic to our patients, but it's not ozempic, it's a product made by a compounding pharmacy, you're going to get in trouble.

Speaker 1 00:10:47 And we did have quite a few clients of ours, who contacted us when they received letters from these large drug manufacturers saying, hey, you're advertising falsely. This is not our product that you're providing. So that is an additional legal risk that some physician practices were facing. So you got to be very careful about that. So with these compound pharmacies, they don't have really the same oversight by the FDA that, FDA approved products do have. So there's always, you know, concerns and issues about that. You just have to be aware.

Speaker 3 00:11:26 Are there legal pitfalls when dealing with insurance denials and prior authorizations for these drugs, and if so, how can physicians navigate their way around them?

Speaker 1 00:11:38 I don't know if pitfalls is the word I would use, but there's certainly a lot of challenges, right? So this drug originally was not for weight loss. It was for conditions like diabetes. And, doctors who used to be able to quite easily prescribe it to patients for diabetes. Once this became so popular and it was being used for many other non diabetes and and weight loss related reason, found that they now have additional hurdles to jump over to prove.

Speaker 1 00:12:06 I really need it for my patient for this actual medical issue, right? So yes, there are challenges when it's being prescribed for an actual FDA approved use because of these shortage issues. And a lot of, you know, insurance companies don't believe you anymore when you say you're prescribing it for your patient, for an actual medical issue, they assume it's for weight loss. Now, does that mean that it can't be prescribed for weight loss? Some drug story. Some insurance companies will say, absolutely, we approve it. Some say we'll only approve it with prior authorization. So every insurance company has the right to set out their own policies. And some of those policies have really changed because of the popularity of these drugs. Another issue we're seeing now more is a patient had diabetes, but it was corrected when they started taking the drug. Now they no longer have diabetes. They no longer can qualify for the drug. But what happens if they don't get the drug? Their diabetes returns. Right. Same thing for weight loss.

Speaker 1 00:13:10 They were classified as having a certain BMI or being obese. They they were able to obtain the drug. They lost weight. Their BMI is down. They're no longer overweight. Now we face additional challenges, with the insurance company. So there's a lot going on in this area. I know the insurance companies are continuing to analyze what the cost is to them to continue to, reimburse for these types of drugs versus the cost of not reimbursing, but paying for other types of health conditions that result from patients with diabetes and obesity and other, you know, conditions for which this drug may be used. So it's a really, kind of an ongoing process. We're all waiting and watching to see what's going to happen. it's ever changing. But certainly I think if you spoke to any doctor And ask them about the situation. It is far different now than it was just a few years ago. and certainly it's an increased burden for them to deal with.

Speaker 3 00:14:10 When it comes to telemedicine. If a physician is prescribing these drugs via telemedicine, what additional legal risks should they be aware of?

Speaker 1 00:14:19 Well, when it comes to telemedicine, in addition to everything that we've just talked about, you have to deal with whether you're doing things in a compliant manner to meet telemedicine requirements.

Speaker 1 00:14:29 Right. and so various states have rules that apply to telemedicine. So you need to know what your state allows or doesn't allow. Via telemedicine, a physician cannot typically prescribe to somebody unless they're licensed in the state in which that patient is sitting. Right. So you can't just prescribe nationally because you want to prescribe this medication. You need to be aware and potentially license in every state in which the patient is sitting. That's why a lot of the companies that you see doing this via telemedicine have Network of doctors set up so that they can make sure that a doctor's license in the city where they're prescribing. but generally the rules for telemedicine are going to be that there's a patient visit, that there's documentation of the patient being, qualified to obtain this medication or any other medication. Those, consent forms need to still be signed and put in the patient file. So the process is very similar. You also need to think about the fact that when it comes to telemedicine, for sure the patient is going to be receiving the medication directly and, you know, self administering.

Speaker 1 00:15:36 So you want to be familiar with any rules that may apply in your particular state related to to that as well. And you know, as a side note, because I didn't mention this before, many states do have rules about, who can administer drugs because typically these drugs are administered via injection. Right. And so different states have different rules about who can inject. So in some states an Ma can do it, but in other states it needs to be a physician and or a PA or an MP, depending on the state laws. Right. So, you know, whether you're in your office or doing it via telemedicine, you just need to be aware of who can and cannot inject these medication. Does it affect what you can prescribe for a particular patient in a particular state? So a lot of different things to think about via telemedicine. But assuming you've looked into all of that, telemedicine is certainly available and easily used to prescribe these types of drugs. So just a little homework to make sure you're doing it right.

Speaker 5 00:16:42 Oh, you say you're a practice leader or administrator. We've got just the thing. Our sister site, Physician's Practice. Com your one stop shop for all the expert tips and tricks that will get your practice really humming again. That's physician's practice.

Speaker 3 00:16:59 When it comes to long term From liability, since these drugs are relatively new for weight management. Are there any emerging liability concerns regarding their long term safety or adverse effects?

Speaker 1 00:17:10 I mean, we're not really seeing any long term effects yet that we're really worried about. We knew what some of the side effects of these drugs were because they were being used for another purpose, right. So those are being covered hopefully through proper informed consent. you know, are we starting to see, other impact of people taking these for weight loss only? You know, that's something that everyone's definitely keeping an eye on, but it hasn't become a true issue of liability yet. that isn't, you know, being covered by properly written consent forms. It's definitely an issue of concern, which is why I did mention earlier that everyone really needs to stay on top of any new information, education, consequences that are coming out because of these drugs and immediately communicating with patients about what any, potential risks are if they change from what they were originally.

Speaker 1 00:18:11 Right. So that's where those updated consent forms and communication with patients really become important. you know, I would imagine we'll start to see, you know, potentially new, interactions with drugs that just weren't reported previously. Right? Or, maybe certain conditions, that start to be developed. you know, because people are on these drugs long term for weight loss as opposed for diabetes, and we're just going to have to keep an eye and on it. But there's always potential long term liability, for any physician, which is why you want to make sure that you have appropriate malpractice insurance that's covering you. And that's a good lead into the topic of malpractice insurance, because physicians need to make sure that they have coverage for what they're doing in their office. A lot of specialties that you would not expect to be giving injections for weight loss drugs, or giving injections for weight loss drugs or prescribing it. And if this isn't something that's covered, you know, by the description of services that are covered by your malpractice carrier, then you should be talking with them and letting them know that you're doing this.

Speaker 1 00:19:19 We have heard of some carriers that do not cover for weight loss drugs unless it's specifically, you know, part of their policy. So you want to cover for that. I've also heard that there's at least one state where prescribing off label drugs for weight loss is not permitted, and it would be a violation of the of their Medical Practice Act in that state. Right. Which is something that's covered under malpractice insurance, typically a violation of a medical state law, a licensure law. So really there's a little bit of homework as well with your malpractice carrier, with your state medical board. And they're, you know, I certainly don't know every law that's out there. So you really want to make sure you're talking to someone in your own state and getting legal advice on things that you may not be thinking about that could impact you if you start prescribing.

Speaker 3 00:20:10 If a physician has a relationship with a pharmaceutical company. Are there any legal or ethical concerns for physicians who receive incentives to speak on behalf of, or have some relationship with, the manufacturer of a GLP one drug?

Speaker 1 00:20:26 Absolutely.

Speaker 1 00:20:27 And I would say that the same risk as a relationship you have on any other kind of drug, right. So we've got state depending on the state and federal laws. If you're prescribing this for federal patients, right, that absolutely have restrictions on the ability to prescribe if you have a financial relationship with the manufacturer. Now, most state and federal laws have exceptions that can be satisfied and reporting requirements that can be satisfied. Sometimes this can also require disclosure to the patients It's about those relationships. There are definitely things that you need to think about if you have that kind of financial relationship, but it's the same for any other, you know, drugs you might be prescribing if you have financial relationships with industry. and the same rules apply to products, you might be, telling your patients to buy if you have relationships with industry. So those same rules apply. federal and state anti kickback laws are the biggest ones to be thinking about. You should be talking with your, legal counsel about whether you are handling that properly in order to avoid that risk.

Speaker 3 00:21:40 On the regulatory front. Have there been any recent or anticipated legal regulatory changes affecting how doctors can prescribe GLP one drugs?

Speaker 1 00:21:49 No, we really haven't seen that other than what we've talked about. And we've got the FDA looking at things. We've got some states controlling, you know, prescriptions that are off label. So we see various different, you know, agencies that are keeping an eye on this. And I suspect we're probably not going to see any federal action in this area just because, I think our, the federal government's kind of focus on other things at this time, obviously, and, and kind of cutting down on their resources that are available. So if there is going to be a regulatory change or oversight, we're really going to see it coming. you know, from the state side of things, we may see it coming from malpractice carriers. We may see it coming from the drug companies themselves going after, physicians and compound pharmacies. We may see it coming from, the state licensure of compound pharmacy.

Speaker 1 00:22:48 So we're going to maybe see it happening, but I don't think it's going to be any kind of national federal, change. At least I haven't heard about that. So that's why I think it's really important. You know, whatever you've talked to your lawyer about in terms of what you're doing right now and your compliance with current law? You really need to stay on top of changes that happen very rapidly. Case law that comes out can be very informative. If, you know, if the FDA successfully goes after someone, or if a, you know, a big pharmaceutical company successfully goes after a, a practice or, you know, a compound pharmacy, we want to know because all of that instructs the advice that we're giving our clients, right. So it is an ever evolving kind of situation and something certainly it has been wildly successful for practices financially, for patients. there's a huge demand. I don't see that slowing down. I think, you know, it's a great opportunity for many different practices to interact with their patients more, right? Once you get them in the door, you can start talking about all the different things that are going on with them.

Speaker 1 00:23:57 So we I think most of my doctors see it as a really great opportunity to get face to face, to talk to patients about what's going on with their health. So it's not just, you know, doctors jumping on the bandwagon to prescribe. It has really been a great source of interaction with patients on their medical care. and certainly it's been a financial boon for many as well. but I think that there are some positives and also just some very cautious, steps that need to be taken to make sure that, you continue to do things right. And, you know, there there's already been some companies that have gotten in trouble for not doing it properly. Like I said, there's practices that are getting cease and desist letters. you know, pharmacies that are getting sued. So, you know, just because you haven't been on the radar of anyone yet. If you are doing any of the things we talked about wrong, then you should be correcting them. and you could potentially be at risk. if somebody determines that you've not been compliant.

Speaker 1 00:24:58 So, it's an ever changing landscape for sure.

Speaker 3 00:25:02 Great, Ericka, thanks for joining me.

Speaker 1 00:25:05 Always my pleasure to be here.

Speaker 2 00:25:13 Once again, that was a conversation between Medical Economics Managing Editor, Todd Shryock, and Ericka Adler, a health care attorney with Roetzel & Andress. My name is Austin Littrell, and on behalf of the whole Medical Economics and Physicians Practice teams, I'd like to thank you for listening to the show. I ask you to please subscribe on Apple Podcasts, Spotify, or wherever you get your podcasts, so you don't miss the next episode. Also, if you'd like the best stories that Medical Economics and Physicians Practice publish delivered straight to your email six days of the week, subscribe to our newsletter at MedicalEconomics.com and PhysiciansPractice.com. Off the chart: A Business of Medicine Podcast is executive produced by Chris Mazzolini and Keith Reynolds and produced by Austin Littrell. Medical economics, Physicians Practice and Patient Care Online are all members of the MJH Life Sciences family. Thank you.