Like many “non-invasive” procedures, IV therapy has been the Wild West from a compliance perspective. Tune in as we share a client story and address whether IV therapy is considered the practice of medicine. We also discuss the rules and regulations surrounding IV therapy, RN scope of practice, and the good faith exam.
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Intro: [00:00:00] Welcome to Legal 123s with ByrdAdatto. Legal issues simplified through real client stories and real world experiences, creating simplicity in 3, 2, 1.
Brad: Welcome back to another episode of Legal 123s, with ByrdAdatto. I’m your host, Brad Adatto with my co-host Michael Byrd.
Michael: As a business and healthcare law firm, we meet a lot of interesting people and learn their amazing stories. This season’s theme, Brad, is hard conversations. We’ll take real client stories, of course we’ll scrub their names to protect confidentiality, and these stories will be built around confronting and having these hard conversations that don’t all have great outcomes, but there are a lot of teachable moments.
Brad: There are. Now, Michael, we just recently got back from our Christmas break, and is it true that Santa left you a lump of coal?
Michael: He did, Brad. The coal had a label on it that said “Your partner named Brad”.
Brad: Oh, [00:01:00] I walked into that one.
Michael: Well, speaking of Christmas, Brad. Did you get any Star Wars figurines?
Brad: No. In fact, I think Santa hates me. I mean, this is the second or third year in a row with no Star Wars action figures. I am very sad about that.
Michael: But he does think of you as cole.
Brad: No, it’s true.
Brad: Well, while we are on the topic of Christmas, do you have any favorite Christmas songs?
Michael: Yeah. So, I am going to go with the Little Drummer Boy, that’s a classic. Baby, its cold outside, which people say is naughty, but it’s not nearly as naughty as a lot of other songs I hear. Of course the classic Mama got run over by a reindeer.
Brad: That does seem like a song that you would like.
Michael: How about you?
Brad: Yeah, there’s a couple out there that every time I hear it, it just kind of warns my heart. Like the first one is like you, The Little Drummer boy, but it’s by Johnny Cash.
Michael: Oh, nice.
Brad: This will be no surprise to you, the 12 Days of Christmas by John Denver, then Muppets.
Michael: Not shocking at all.
Brad: Yes, and Jingle Bell Rock by [00:02:00] Bobby Helms, which is a great classic one, and then in my family we have a family song that we all love to listen to. It’s called The Christmas CanCan by Straight No Chaser. Audience members and Michael, if you have not heard of it, look it up. It’s pretty funny.
Michael: Never heard it, and I have to admit, Brad, I’m over Christmas songs at this point. I’m over saturated, but I will give it a try next November if you remind me.
Brad: November? You mean you don’t start in August like everybody else?
Michael: No, no. Halloween has to pass.
Brad: Okay, I agree with you on that one. Generally at this point in the show is when I start asking you all the top 10 types of questions, in this case, the top 10 Christmas songs. But to save you the pain of getting it wrong and in the Christmas spirit, I’m just going to list them out for you. You’re welcome to answer as we go through, but according to Spotify, okay, this is my resource here.
Brad: All-time Global Top Christmas Songs are, Number 10, Do They know its [00:03:00] Christmas, 1984 version by Band-Aid. Number 9, Snowman by Sia.
Michael: Never heard it.
Brad: Number 8, Mistletoe by Justin Bieber.
Michael: The Beibs.
Michael: My kids would be happy.
Brad: Number 7, It’s the most wonderful time of the year by Andy Williams.
Michael: That’s a classic.
Brad: Number 6 is one of my favorites. Again, Jingle Bell Rock by Bobby Helms, so we’re in good company.
Brad: Number 5, Rockin’ Around the Christmas Tree by Brando Brenda Lee.
Brad: Number 4, it’s beginning to look a lot like Christmas by Michael Bublé.
Michael: Oh, another modern guy coming in.
Michael: All right.
Brad: Or as I like to call him, bubbles. Number 3, Santa Tell Me by Ariana Grande.
Michael: Oh, again, kids would be happy. My teenagers.
Brad: Yes. Number 2, Last Christmas by Wham.
Michael: Oh man, we’re talking about hitting our demographic. Classic eighties.
Brad: And then those who’ve been pacing along with us, the number 1 Christmas song of all time is All I Want for [00:04:00] Christmas is You by Mrs. Carey.
Michael: Mariah Carey?
Michael: I have never heard of that song. I’m just kidding, only a hundred times over the holidays.
Brad: I do have to say something, Michael. Before we really respond to all this, I need you to describe to our audience that off camera right now, Riley has been jumping up and down and objecting to this top 10 list and demanding a recount. I can see it in her eyes. Taylor Swift’s name was not mentioned one time, and I think she might storm out people. Hopefully she’ll stay till the end.
Michael: Well, let’s just pencil in a Taylor Swift song.
Brad: Yeah, Taylor Swift, All I Want for Christmas is you, Riley, I think was the other song that made the top 10 list. She’s happy now, I see.
Michael: Okay, good. Well, all this Christmas talk after Christmas is over. What does that have to do with today’s show?
Brad: Well, it appears because Mariah Carey has the top Christmas song of all time, she thought it’d be a great or good idea to trademark “Queen of Christmas”. [00:05:00]
Michael: Oh yeah. That was all over the news a few weeks ago, right during the middle of the Christmas holidays.
Michael: It was interesting timing.
Brad: Yeah, and according to her application filed by the US Trademark Office, and was filed actually in March in 2021. The trademark would allow her to brand a wide variety of products, including fragrances, lotions, nail polish, jewelry, cups, mugs, sweatshirts, food, drinks, ornaments, and music.
Michael: Oh, she was on it. Much like her marriages, I don’t think this ended well for Mariah.
Brad: Wow, you are correct, Michael. An artist named Elizabeth Chan, who filed an opposition to Carey’s trademark and Carey did not respond to this opposition. For audience members, that means with no response, the trademark office basically said, you’re not going to get it because you didn’t respond. For those who don’t know Chan, she’s made a career out of Christmas album songs, and she deems herself the world’s only full-time pop Christmas recording artist. Her goal, she said, was really to protect against trademark bullying, to allow other [00:06:00] artists, such as herself, to continue using this title.
Michael: Okay, well, I guess Elizabeth Chan is right, but, Brad, I’ll ask you again…
Brad: Oh, you did ask me.
Michael: What does this have to do with today’s show?
Brad: Well, Michael, besides the fact that someone had to have the hard conversation with Carey, that she could not trademark that she was Queen of Christmas.
Michael: Ooh! I would not want to be that person.
Brad: No. I’m not sure yet, but maybe as we go through today’s hard conversation story, you might find a relatable factor.
Michael: I am bracing myself for you trying to force a connection to Mariah Carey.
Brad: What? Michael? I can’t believe you think I would do that. So Michael, let’s just go right into it.
Brad: Our client in the story, we’ll just call her the Queen of IVs.
Michael: No, thumbs down emoji, Brad. You are better than this. I think you’re just using that name, Queen of IVs, to some serious low hanging fruit tied to Mariah Carey.
Brad: Okay, well, I said there might [00:07:00] be some, I didn’t say there were definitely.
Brad: Okay, well, I’ll go with a different name. How about, Nurse IV?
Michael: Let me guess, the nurse provides lots of IVs, and if yes, I will allow it. Very descriptive, but I think for our audience that does not know the term IV, it means Intravenous Therapy. Of course, most people know what an IV is.
Michael: IV therapy has been used to provide nutrition and for rehydration in hospitals and medical practices for decades, but it is trending.
Michael: What the kids say, “It’s trending”.
Brad: Yes. Okay, well, thanks for letting me use it. This story starts off like many of our stories where the potential client has read one of our articles online and set a call with us, and the nurse had read an article titled the 123s of IV Therapy Providers.
Michael: Brad, did you just bring up the title of the article so that everyone can Google it and find out that you wrote it?
Brad: Michael, are you accusing little humble me of self-promotion? [00:08:00]
Michael: Riley, should I even answer him? Using the word humble to describe yourself is the opposite of humble, Brad. Just move on. Yes, audience, if you want to Google it or I’ll save you the time, Brad wrote that article.
Brad: All right, well, I’ll humbly move on then. During this call, nurse IV noted that I sounded really good looking on the phone.
Michael: You do have a face made for the telephone, but stick to your story, man.
Brad: I walked in to that one too. All right, well, Nurse IV had been working in a hospital for years and wanted to get out and develop her own business, and in the business she really wanted to just exclusively provide IV therapy and wanted to make sure she had all the proper licenses to open up an IV therapy clinic.
Michael: Okay, well, even wanting compliance sounds good.
Michael: Tell me more.
Brad: So, her first call was actually to her nursing board. She wanted to understand what she should do, and they actually told her, “Go look up the regulations”. Very helpful. As she looked a little bit further, her next call was to the Texas Health and Human Services [00:09:00] because she learned that they are responsible for licensing and regulations. On that call, the person told her that they don’t issue licenses for IV bars, but like any good regulatory person, they actually googled IV laws and that article I may have mentioned did pop up, so he told her maybe she should call me.
Michael: Your humility is oozing out again, Brad. I will say that is pretty cool when a regulator is deferring to you as an authority. I’ll give you a slight hat tip, but don’t record that portion, Riley. What happened next?
Brad: Yeah, so thankfully she did take the advice of the government official, and she did set up a call with us. On that call we discussed the major issues she would face as an RN opening an IV bar in Texas, and we covered the foundational compliance rules, which we’ve talked about in other episodes, ownership diagnosis and treatment plans, and of course delegation and supervision.
Michael: Yeah, classic, that’s exactly what you’re supposed to do. Well, how did she respond [00:10:00] when you told her about the Texas Corporate Practice Medicine Doctor?
Brad: Yeah, well, once she learned that providing IV was the practice of medicine and she couldn’t actually own a medical practice she was a little upset, but we spent a lot of time talking through the MSO model. Actually she grasped the idea pretty quickly.
Michael: So are we going to be talking about some hard conversations today around the MSO model?
Brad: No, not today. We’ll skip everything that has to do with the MSO model because that really didn’t come into play as much as the next major issue.
Michael: The GFE?
Brad: Ah, yes. Well, Michael, I guess that would become technically our second vocabulary word of the day. The GFE. For those who don’t know, that’s the good faith exam or the initial evaluation that must be conducted to render any medical services. It’s a situation in which typically in most states the physician and then in some cases, PA or nurse practitioner, depending on the supervision delegation rules, will determine if that patient is a good candidate for those services and it is known as the good faith exam.[00:11:00] After the good faith exam is conducted, then neither that physician, PA or nurse practitioner can then prescribe the course of treatment and then delegate the performance of this to a non-physician provider, like a nurse. She was a little surprised to learn this and that she couldn’t even own the IV board, and now she’s learned that she can’t be the person to clear the patients, so she did push back a little bit harder.
Michael: Yeah, and I’ve had these calls, it’s a tough pill to swallow when you’re getting surprised like this. I guess on the second half of the show, we can spend a little bit more time on the good faith exam and scope of practice related stuff. Tell me what happened next in the story.
Brad: Well, eventually she agreed to hire us to conduct a whiteboard with her and her, I’m using the term loosely, “medical director”, who we will just call the “King of IV”.
Michael: Rejected again, Brad. Sit down. You’re going to have to work for this Mariah Carey connection, and not just the low hanging king of IV [00:12:00] connection. While we’re at it, now that you’ve got this humility that’s been coming out several times, no, we’re not going to allow you to be called the “Prince of IVs”.
Brad: Oh, dang.
Michael: Let’s just move on.
Brad: I was just about to use that. All right, all right, so let’s just call him “Dr. Hero”.
Michael: Are we going back to one of your superhero movies, Brad?
Brad: No, but very fair question, Michael. Let’s let the story play out and you can see if this name will stick. So the background, Dr. Hero is an ER physician with over 20 years of experience in the ER, so obviously he knows a lot about starting and delegating IVs.
Michael: Yes, so let me guess, he was also surprised that he had to own the practice and clear the patients?
Brad: Correct. One of the big issues was that Nurse IV had not even budgeted for Dr. Hero really to be a part of the clearance of the patients. They had to agree that [00:13:00] originally, Dr. Hero would just issue certain standing orders for Nurse IV to follow, and their complaint was like every single time a patient comes through, if Dr. Hero has to clear that patient, it’s going to slow down the process. It’s going to be more timely and more effort into it. So we talked about the legal implications. I know, and we can get to that in the second half of the show, but we did eventually agree to that telemedicine, that they could use telemedicine and for Dr. Hero to conduct that good faith exam via telemedicine.
Michael: Okay, so where was the hard conversation?
Brad: Well, we’re not there yet. Dr. Hero and Nurse IV, after the whiteboard decide to speak with other IV bars in. the area to see what they were doing.
Michael: Oh, no. Did they start shifting to the avoidance strategy?
Brad: Actually, no. Once they realized how loose all these other IV bars were in the area, they decided that even though it was more slower and more time intensive, [00:14:00] they wanted to be compliant and really lean into their knowledge.
Michael: Dun, dun, dun. Am I hearing this correctly? They put on their big boy and big girl pants and had the hard conversation with each other on compliance. This is a fantastic outcome.
Brad: Yeah, and believe it or not, it actually gets better. About after a year we put this together and they had the model of the way we typically set it up, and I won’t bore the audience with all the details, but in our mind’s a compliant model. Then about a year later, I get a call from Nurse IV, and she said, “Hey, I have to tell you this story”. On a random weekday, she had this gentleman come in to her IV clinic and she started the patient history and the physical examination, which is allowed within her scope of practice to prepare him for the telemedicine call with Dr. Hero. The patient noted to Nurse IV that he had drank too much the night before and was really, really hungover and that is something she had heard hundreds of times when she was just dealing with patients in general.
Michael: Well, I can think of a few occasions where [00:15:00] this would’ve been a helpful treatment for me back in my college days.
Brad: Yes, I can see that too. Well, when Dr. Hero started the actual good faith exam via telemedicine, as the patient started unpacking certain questions that Dr. Hero started walking him through, he got really concerned that the patient actually was not in fact hungover, but suffering from a heart attack. He recommended the patient immediately go to an emergency room, which just happened to be down the block from the IV clinic location where actually Dr. Hero worked. Again, audience members, full disclosure, Dr. Hero was not working at the ER that day.
Michael: Wow. That is incredible.
Brad: Yeah, and so the patient did arrive. They found out he had suffered a heart attack.
Brad: The ER doctors at the hospital started to stabilize the patient to make sure this obviously would prevent another one. Nurse IV told me she was so thankful that she had not gone with that non-compliant standing orders model because she said she would not have come up with an idea and had diagnosed this patient correctly.
Michael: This story seriously should be the [00:16:00] poster child for the positive reasons to do a good faith exam. It’s amazing. Let’s go to break and talk about some lessons to be learned from the Dr. Hero and Nurse IV story, and maybe talk a little bit more about where compliance is as it relates to IVs.
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Brad: Welcome back to Legal 123s with ByrdAdatto. I’m your host Brad Adatto with my co-host Michael Byrd. Now Michael, this season our theme [00:17:00] is Hard Conversations. Dr. Hero, not to be confused with Dr. King, and Nurse IV had a hard conversation and it was all about compliance.
Michael: Yeah, I mean, let’s kind of reset for a minute. You have a nurse IV, who has this hospital background, wants to start her own deal and an ER doc. They want to do things the right way, which hat tip, even on that front of trying to do the research on the front end. They randomly found some article that you had written. It was just amazing that they just stumbled downward or upward?
Brad: That’s a fair question. I think we could spend hours trying to unpack that.
Michael: Seriously, that’s cool. It’s really cool that you had gotten in front of this IV movement, written this article, and [00:18:00] if you Google IV compliance, it is going to pop right up and she ended up getting in front of you, you told her some news that was really hard to hear because as you said, she didn’t budget for it.
Michael: It’s not just a matter of, oh, you need to do this and that instead of this, it’s, and that’s going to cost you money and you gotta have a different corporate structure. She goes forward, she finds her doctor, she gets a whiteboard, they go through it again. They’re still moving forward and I suspected when you shared that they went and talked about what everyone else was doing, that that was going to be the negative turning point. Really they both were heroic in a sense from a compliance perspective because they kept moving towards compliance the entire time, and then they leaned into it when they found out that everyone else was taking shortcuts to do it the right way. [00:19:00] You have to understand that there’s a lot of counterintuitive stuff. We’ve been on other shows where we’ve talked about the IV hydration movement. It’s coming from a lot of people that have hospital training, so there’s a lot of ways they do things in a hospital setting that are different here, and won’t get into it right this moment, but there was a huge push against them leaning into doing this the compliant way, but they did it and then it was just incredible. You don’t ever hear the hero version of this where they actually saved someone’s life.
Michael: Because they did the good faith exam. It’s really amazing. Let’s pause and take a step back and catch up our audience on some of the legal issues that were raised at the start of the story. I know that we speak with a lot of people who want to start IV bars and most, as you might guess, push back with our statement that providing an IV [00:20:00] falls into the practice of medicine.
Brad: Yeah, and this is the issue we run into, is a lot of these people will say, well, these are elective services in this space and therefore, why can’t it just be not the practice of medicine? It’s that they just don’t think of it that way. We’ve talked about this in other episodes, when you use the word “Noninvasive procedures”. Well, it’s really not invasive. IV has become really the Wild West from a compliance perspective because practitioners from different backgrounds, with significant different trainings, replacing IVs, and have decided that this is a great way of making extra cash and that they just can’t foresee how IV therapy would be treated as a practice of medicine. Maybe for an audience who doesn’t really understand, Michael, what constitutes the practice of medicine?
Michael: Yeah, I mean the definition is broad and so it kind of flies in the face of the common sentiment, which is these are non-invasive services, or this is a [00:21:00] wellness therapy, or we do this all day, every day in the hospital, understanding orders or whatever. The reality is that the definition of the practice of medicine is very broad and under Texas law, all procedures that involve the injection of medication or substances, no matter what you call it or how you market it, is considered a medical procedure.
Brad: Wow, well said. It’s like you’ve talked about this before. Now, earlier in the story we discussed the GFE or the Good Faith exam, but we also discussed the use of standing orders. In this case, issuing it to the RN as a tool to actually avoid the good faith exam by the MD or NP or PA, well Michael, we should address this now, so why is that a problem?
Michael: It’s the problem in how it’s used, like a standing order can be okay in the sense that it’s the doctor saying, this is how we do these things, you [00:22:00] hear them called written protocols.
Michael: And under a different name, but the way they’re used is as a replacement for the doctor seeing the patient, and that’s the problem. If it’s a medical procedure, then a doctor, a nurse practitioner, or a PA have to get the patient history and physically examine the patient, and you can’t slap on some blanket, this is how we typically treat patients to cover for a specific individual. Brad, you discussed in the story, all the other IV bars that kind of challenged this theory that they cannot use standing orders. Have we had any other state agree with us?
Brad: Until recently there have been very few states that have actually issued any point by point explanation that the IV therapy was the practice of medicine or even required the good faith exam. All of our knowledge really is based on state rules, medical board rules, [00:23:00] attorney general opinions on similar medical procedures because these procedures have to pierce the skin and inject intravenous substances into the body. We believe based on all these rules that we’re talking about, this falls with a standard care that is needed for the approval of a medical service.
Michael: I mean, exactly. Our process is, is this medical, and if there’s nothing specific dealing with it, how are medical procedures regulated? And that’s how we govern it. I think the audience will note, Brad, you did not answer my question.
Michael: Has any other state agreed with us?
Brad: Yes. The Alabama State Board of Medical Examiners, they have issued a declaratory ruling to address the growing business of retail IV therapy in the state of Alabama. Now the Board of Medical Examiners conducted a statewide investigation on retail IV therapy businesses and found out some interesting things. They found a substantial number of these businesses were not [00:24:00] compliant with Alabama law.
Brad: I know. The Board of Medical Examiners found out that many of these places under qualified individuals or in some cases, unqualified individuals who are administrating IV treatments without the proper oversight of a physician, in some cases without any physician. So this declaratory ruling clarified the regulations on administrating IV therapy and address providing IV therapy that does constitute the practice of medicine on our Alabama law.
Michael: Wow, okay, well, what else did we learn from the Alabama Board of Medical Examiners?
Brad: Well, only a licensed physician, and this is for Alabama, by the way, or a physician’s assistant or certified registered nurse practitioner, or a certified nurse midwife, legally practicing with a physician may diagnose a patient, assess the symptoms, and recommend the IV for the treatment of the patient’s conditions. So our Alabama versions of who qualifies to do the good faith exam for an IV. Additionally, [00:25:00] RNs cannot diagnose if a patient is a good candidate for the IV services, as that is, as you were talking about earlier, outside the scope of an RN. Meaning that, and they actually talked about this, issuing standing orders by the physician to the RN to follow, doesn’t satisfy that the physician’s legal duties to the patient because the physician has a legal duty to it, and as you were talking about earlier, the scope of practice that the nurse practitioner PA, they can have independent medical judgment decision making while an RN, although they can do the physical examination and they can do the patient history, they can’t diagnose the person and that’s where it ends there. Alabama’s the first state that on point by point by point really covers what we just discussed.
Michael: For those of you that are not in Alabama think, okay, well, that doesn’t apply to me, so I’ll just chill and keep on doing what I’m doing, it’s important to know that, [00:26:00] as it relates to compliance on novel areas and the way IV has expanded is novel, so it’s not the typical traditional IV in a hospital setting. It’s now these are retail centers, branded and marketed to secure hangovers, and all that. So states haven’t really known what to do with them, and all it takes is one, and you start to see the dominoes fall. I suspect as we look forward in 2023, you’re going to see other states follow suit because Alabama did a really good job in articulating their interpretation. By the way, it’s exactly how we assert it, and it’s not that we’re super brilliant, it’s because it’s the practice of medicine.
Brad: Do you think that Texas regulator sent my article to the Alabama people, to help them out?
Michael: That’s a very humble observation, Brad. Before your head swells [00:27:00] too much over there, any updates on Dr. Hero?
Brad: These earphones don’t fit me anymore, Riley.
Michael: Oh, Well, what’s going on with Dr. Hero and Nurse IV?
Brad: Yeah, so, they’re still operational. They actually been a great referral source from other entrepreneurs that want to enter the IV bar world because what happens often is they speak to her because she’s been successful, Nurse IV that is, and she often tells them that story about the whole good faith exam issue, and they end up calling us and they want to say, well, I want the compliant model too. It’s a good spot for them because they did, as you said, they leaned into it, and they had the hard conversation and wanted to be compliant. So, Michael, some final thoughts here?
Michael: Well, Brad, you disappointed, you never connected the story to Mariah Carey, so let me do that for you.
Michael: Let me do some stretching real quick, and then we’ll go into it.
Michael: So, Mariah tried to trademark the Queen of Christmas and just [00:28:00] because she had self-titled herself this and has the number one song of all time, still doesn’t make it known or deemed that she has the legal right to be the Queen of Christmas as she found out. Well, Brad, just because you have IV training and you know how to do it, and you’ve been doing it for years in a hospital, and you may be the best RN IV placer in the state, doesn’t make you allowed to own your own IV clinic and be able to clear patients for IVs. Did that work?
Brad: Wow, that’s pretty impressive. You should pat yourself on the back.
Brad: Well, audience members, that’s all the time we have today, but next Wednesdays show we will have our partner and series regular, Jay Reyero, join us to discuss hard conversations and M&A negotiations.
Outro: Thanks again for joining us today, and remember, if you like this episode, please subscribe. Make sure to [00:29:00] give us a five star rating and share with your friends. You can also sign up for the ByrdAdatto newsletter by going to our website ByrdAdatto.com. ByrdAdatto is providing this podcast as a public service. This podcast is for educational purposes only. This podcast does not constitute legal advice, nor does it establish attorney client relationship. Reference to any specific product or entity does not constitute an endorsement or recommendation by ByrdAdatto. The views expressed by guests are their own, and their appearance on the program does not imply an endorsement of them or any entity they represent. Please consult with an attorney on your legal issues.