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TRANSCRIPT

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Christian Maniquis:

Good afternoon, everyone. Thank you for attending our second installment for our webinar series, and the title for today’s webinar would be a Healthcare Startup Journey: The Key to Success in Healthcare Ventures. Today, we’ll be mostly following up on the discussions that we did on the last webinar that we had with attorney Drew Barnholtz and Holly Little. Mostly we’re going to be diving on those frequently asked questions related to the documents and the other nuances that was previously left undiscussed on the previous webinar.

So, thank you very much for attending. A quick reminder for those attendees and I see a few names from the previous ones. And for the new ones that are in attendance again, welcome. Please be reminded that if you have any questions outside of what is discussed or some clarifications, kindly use the question and answer box and throw in your questions there.

And if we have enough time later for a question and answer portion, we’ll try our best to accommodate. I’m not going to promise that we’re going to be answering each and every questions, or you will be getting all of the answers that you were expecting, but we will do our best. Alright, so let’s get started and without any any further introduction needed, it’s attorney Drew Barnholtz again as our speaker.

This is in collaboration with My Queen Dickens, the founder, and CEO of the Drip Success Formula, and in participation of the Thrive and Hive community. Let’s get started.

Let’s get started with the frequently asked questions. And question number one would be, what are the example of documents that business owners in the space might come across during setup and daily operations?

Drew Barnholtz:

That’s a great question. That’s a great question, Christian. And so typically when you’re deciding to set up your company, if you’re a physician, you’re probably set up a professional corporation, so you’ll want to do Articles of organization for professional corporation depending on which state you’re in, but most states will require that, that “PC” as we call it, you’re the clinic basically. If you’re a provider or a businessperson, then you’ll set up typically LLC, a limited liability company.

But in either way, you need to incorporate your business. You need to become a real business. So, you’ll form those articles of incorporation. Any business licenses that you might need to operate in your local jurisdiction. If you are not a physician, then and your provider or businessperson, you’ll want to get a medical director in place so that it allows you to meet these laws around the division between the business side of the house and the medical side of the house. Typically, a medical director agreement, and often if you are a nurse practitioner or a physician assistant, you might need a collaboration agreement. In states that don’t allow those particular advanced practitioners to participate in independent practice you’ll want professional liability, what they call med mal policies patient intake forms, consent forms, HIPAA authorization forms, standard operating procedures for the actual treatments themselves.

For those other providers or even office staff that you’re going to employ, you might want employment agreements or independent contractor agreements with your vendors for the IV solutions, the medications those are typically, and even if you’re going to do telemedicine, which for IV therapy might be challenging, but any kind of out of state practice documents that might be required, but that’ll get you started and get, you, get you pretty busy. If you’re online, your privacy policy, terms of use. But that’s a good base of documents.

Christian Maniquis:

That’s a very good overview. And in fact, as a client success specialist, I encounter that a lot. I see that in their inquiries, and it’s a strong start to the question and answer portion that we’re going to be having later.

Yeah. Thank you for that answer, Drew. I think we can move on to the next, because we’re going to be tackling a couple of things that you mentioned in your first response. Next step would be is how do consent and intake forms typically support client communication and service delivery in wellness-based business?

I think this is very important and there’s a lot of confusion on this one, Drew. And given that you have 30 years of experience in the industry, yeah. Why not give them your take on this one?

Drew Barnholtz:

Yeah. I think the important thing for providers to understand is that when you’re in the wellness business in particular, therapy’s a little bit different because, if there’s a medical service being provided, but if you are truly in an alternative treatment space and it’s not a medical therapy, right? Then you need to stay in this body of space that is where you are not using words or offering things to your patients that are not in the wellness space.

So those are, you’re not talking about curing or diagnosing or treating, and that’s tough. It’d be like me getting on the call with you and just like literally giving you no advice. It’s you could think about these documents, but, and it’s up to you. A lot of people like them, but it’s really your choice, right?

It is very hard to do that, right? When you’re a practitioner if you’re the business person, it’s a whole different thing. But like you, even when you’re in the wellness-based business, when you’re giving someone treatment, you want them to have informed consent. And that shouldn’t be a foreign concept to anybody.

You want them to know the risks, the benefits, the alternatives to that treatment. You want them to be very clear about what’s not covered and covered by that, what might be outside that conventional medicine. And really understand that if something doesn’t go exactly as they want it to, that they understand where everybody stands in terms of liability, right? Because it is that world, unfortunately. And then you know that you’re charting that and there, and that you’ve taken into account their health history and that you’re reinforcing those instances when there isn’t a medical diagnosis or a treatment, right?

If you’re talking about alternative therapies and you’re getting into supplements and, there’s a whole host of things that aren’t treatments and aren’t medical diagnoses, herbs and things that we deal with clients all the time that are super helpful but just aren’t in that world.

So, it’s important for the client to be fully informed about what it is that they’ve come to get in terms of service. And it also is a good CYA measure for you

Christian Maniquis:

Actually. I see a trend sometimes that most of our inquirers per se have like base templates that they source out.

And I think the specificity that you mentioned there is just the surface of what it has to be than what it is presented, if that makes sense.

Drew Barnholtz:

It makes a lot of sense and we’re always happy to take something that you may have gotten from your medical records vendor or from a prior employer or from a spa that you worked at or from a friend and we can review that or enhance it or draft something from scratch from you.

We’re not going to force anything on you, we’re happy to work with what you got. And beef it up, or we’re happy to draft something from you from scratch, we’re just here to try to, help you get the things that you need and be protected, happy to do it.

Christian Maniquis:

Is one more preferable than the other, Drew?

What’s the the fastest way or is there even a faster way of doing things, using a template or starting from scratch? Because when I, whenever I see or work with clients. None would be better than the other.

That’s just my personal experience with them.

Drew Barnholtz:

My personal preference is to work with our paper, as we say in the law. To start from scratch and work with our paper, because if I’m revising something I’m redlining it. I’m changing this word, this letter. It’s just you’re trying to weave in the things that I think are important or that we at Cohen think are important into that document that you brought.

But for a lot of people, it’s important that they start with something that they get from a source that they think is of high integrity or source that’s important to them. We’re happy to do that, but if you’re asking my particular preference, I prefer to start with a from scratch document that we have and tailor it to the client, tailor it to your clinic and what you’re doing and what you’re trying to achieve with your folks that you’re delivering services to.

Christian Maniquis:

Let’s see, makes a lot of sense actually. If you’re particular with languages and you really want to protect yourself there’s no better way to do it.

Or if you could start with good, everything can be better for, to prove, right?

Drew Barnholtz:

For sure. So, there’s definitely two ways of going at it. I have my preference, but we will work with you either way. Happy to do it.

Christian Maniquis:

Okay. Alright, so let’s move on to the next question. It’s getting more and more interesting.

Next up, what are some general elements often included in a medical director or collaborative agreement? I think you mentioned this one in the first question, Drew. Yeah. And why do business owners explore that?

Drew Barnholtz:

So, if you’re in a state where you have this corporate practice of, or the prohibition against the corporate practice of medicine, they call CPOM, it’s like palm that palm. And you have to have this separation between the business side of the house and the non-clinical functions and the clinical functions, right where the services are delivered.

We typically put in a medical director’s agreement that says, hey, this doc over here is going to provide oversight for the clinical delivery of the clinical services, standard operating procedures really but respectfully is going to be, in a high-level supervisory role.

But things are going to be in there. It’s going to define supervision, the oversight. If you are in a role where you’re an advanced practitioner, like a nurse practitioner or a physician assistant, and you need a collaborative agreement because you don’t have independent practice in your state. Then that agreement separately from the medical drug agreements.

It’s going to talk about the type of supervision that’s required for dispensing of medications for prescriptions, the frequency and method of chart review any standing orders or protocol approvals. And then, brass tax, you got to talk about how you’re going to pay the medical director liability, responsibility, compliance oversight and if there’s something specific in your state as far as NPs or PAs in the collaboration agreement.

You’re really clarifying roles, and especially when the medical director’s not on site. How does that play out? And how does that role fill the need of what you need the medical director to do, but also the legal and compliance structure?

Christian Maniquis:

I’ve seen the way that you answered it Drew, it became more quintessential in my perspective.

And I’m a client success specialist. I’m not an attorney, but I do work with clients as well. So that’s actually a very good explanation of why it’s so important to have that need in place or have the correct one be in place for both the physician and the other medical provider involved.

Okay. Next up, how can having the right document in place help a business stay organized and aligned in general industry expectations?

Drew Barnholtz:

Yeah, look, it’s obviously, having things organized creates operational efficiencies and clarity. It’s going to protect you against legal liability.

If somebody ever comes in, a regulator or somebody that controls licensure, it’s going to show regulatory compliance. But it also, just like a day-to-day basis, going to help you manage your, it’s going to help you manage your staff, your contractors. It’ll make you audit ready, if you’re audited.

It also builds trust with the clients and other professional partners that you have, right? It puts you in a position where your documentation is done right, and your foot forward, or you’re leading in the right way. It’s like people say, is your house in order? So, if your house is in order, from a documentation perspective, it’s the same thing as having your EHR documentation well done, well-oiled machine. Having all these other documents that we’ve talked about, informed consents and notice of privacy practices. And you’re used to doing it, right? You’re going into the pharmacy, you’re going into Doc’s offices, probably places you’ve worked, and there’s a little pad and it says, okay, you need a sign here, right?

And you’re just saying, fine. But we want to set you up so your businesspeople are also saying, fine. They understand the risks associated with the documents, the informed consent, the notice of privacy practices, the terms of use, those things. But it shows professionalism also for you in your business and in your practice that you want to have, right?

And we want you to have that. So, we want to help facilitate that for you.

Christian Maniquis:

Does this actually impact the interaction with the patients here? Because I often see questions that are associated with those and then it later goes to the patients.

Drew Barnholtz:

I think it does, I think it, it affects Christian, your interaction with your patients because it gives them a security from the from the get-go.

That you are doing things the right way. You’re organized, you’re professional, right? Any human being is going to feel better. If you go to a restaurant and, you go through the drive through and it’s in pieces, right? The menu’s in pieces and it’s a zigzag to get, and then when you get there, there’s nobody there to take your money.

It’d be quite confusing. And they don’t give you a receipt and then you get up to the thing and half your order’s wrong. It’s very confusing, so I think coming in and having a nice professional prior to the visit, having an intake sheet and having the notice of privacy practices and having the informed consent and doing all these things in a nice fashion, it protects you, it makes the patient comfortable. If you’re in a situation where you’re billing third party insurance or governmental insurance, it’s a requirement, right? You have to have proper documentation, so it’s going to help you, I think, holistically to use the holistic medicine jargon, right?

It’s going to help you holistically with your business, for your patient, for yourself, for everything.

Christian Maniquis:

So, it goes with the saying, “first impressions last.”

Drew Barnholtz:

Ain’t that the truth.

Christian Maniquis:

So, it’s a very strong first impression. All right.

Drew Barnholtz:

Yeah. You got one shot at it. That’s what my, that’s what my grandma Lata used to say. You only got one shot to make a first impression, so make it a good one.

Alright. And it goes as well as you mentioned earlier, it goes as well with the regulator. I just deviated to the patient side because I often see it associated with one or the other. But yeah, in my experience with the regulators, it is better to have a policy and a procedure or a form that is understandable, digestible, and you follow what’s literally in it than then just don’t have one at all.

Because when they say, show me the examples of that and show me how that’s used in practice it, you just make it usable. That’s the key to compliance and regulators, that honestly, we’d rather you not have it at all. So, if you’re doing it in a nice, organized fashion with things that people can digest and understand, that’s first in class stuff for sure.

Christian Maniquis:

Actually, I’m excited for the next question because it’s going deeper and deeper, but. I’m learning a lot of stuff today yeah. That’s good. Okay, so next up: what are some scenarios where business owners might benefit from reviewing documents with healthcare focused attorneys?

I think this is a very good question because a lot of the well-established business that we were able to take on from the years past and up to recent. They did start small and then they may have someone that they know that not particularly a healthcare attorney set them up.

Drew Barnholtz:

Sure. Yeah. A lot of you are launching a new business. It’s Mobile IV , it’s in person spa or a clinic or you’re expanding your services. If you’re bringing on a new medical director or provider. If you’re just want to draft or update your client intake or consent forms, if God forbid you, you’ve got a cease and desist or a board complaint. If you are deciding to expand into another state or another city in your state. If you are trying to figure out the Medicare opt-in and opt-out issues, which we deal with a lot, or you want to stay in for, the job that you’re going to keep, but you’re going to do this IV therapy on the side and you want to do that cash-based and how do I navigate that?

We can help you with that. Or if you are acquiring other clinics or being acquired or merging or you have a change of ownership. Those are all scenarios where we want to partner with you, right? To review your documents and make sure you’re on the right path.

It’s kind of the same thing you do with your patients, right? Where they come in and they’ve got a list of things that they want to accomplish. We want to make sure that we set you on the right path and provide you that counseling, that makes sure that you can achieve all your goals.

Christian Maniquis:

Actually, I have a question out of curiosity and just based on a recent client. How often should they have those documents checked or maybe assessed? Because we do have like people come in to inquire about our services and some of their documents are like maybe four years old, eight.

They’ve been using that for a very long time.

Drew Barnholtz:

Yeah. I would say, if you had them reviewed annually, you’re probably good. I don’t think it’s more than that unless there’s some sort of regulatory change. If right now, telemedicine that has been extended the use of telemedicine in lieu of seeing someone in person has been extended through the end of the year.

We know that. I can tell you what’s going to happen next year? I can’t. I have some legislative contacts, but I simply don’t, I don’t know. If there’s a licensure or credentialing issue, clearly, we want to look at that documentation, those policies, procedures, whatever it is prior to expiration.

If there is a standing order or a treatment protocol, we want to review it. If they’re no longer clinically relevant or the scope of practice changes, or there’s a best practice that changes, but more often are, as long as the scope of practice doesn’t change or legal requirements don’t change, an annual look at these things is probably going to be fine. If somebody comes in and does an audit or there’s a complaint or something, we can certainly help you dissect things a little bit further. And if it and coming out of that you need to do some sort of updating, we can help you.

But I’d say annually is probably best, Christian.

Christian Maniquis:

Annually. Alright. Okay. And yeah, that’s what I see as well. Now, time and time again, those, at least those that are able to anticipate changes and do timely checks, continue to operate and grow or prosper. That’s the purpose of doing business.

At least in my standpoint. I think the next one would be the last, so I just want to take a few moments and remind the participants to please send over your questions on the Q&A box, if you have any. And I think we have a few minutes to spare. What we’ll try to do, we’ll try to see which one of those we can accommodate.

Yeah. Next slide please.

Why might thorough documentation be valuable in the event of inspections? You were just discussing this, Drew.

Drew Barnholtz:

Yeah. Look, it’s it demonstrates that your protocols and your practices are, up to snuff with regulatory expectations, right?

It’s going to protect you against fines or disciplinary actions, right? It shows that you’re doing things the right way. It helps you respond, like right away and in an efficient manner during audits or complaints, right? You could, you just take that policy out. You take those examples out. I’ve been in a lot of audits and investigations and complaints with the FDA, with the boards of medicine, and with the departments of health.

The faster you can get back to them, the more confidence they have that you just do things the right way. And it, and also supports continuity when staff are turning over or there’s a transition.

So there, so you want the staff, if you look at the buckets of people that would benefit from this, it’s the staff, it’s the patients and it’s the outside folks, whether it’s regulators or investors or finance banks, whatever it may be, everybody wants to see that documentation.

And most of us see that kind of a pain in the backside. But it really will benefit you and a lot of people just don’t want to deal with it. So, we’re here to help you with it, right? And make it easier.

Christian Maniquis:

So, when it comes to those documentations. How valuable or invaluable are they when it comes to, we’re talking about small startups to average size startups.

How crucial is it?

Drew Barnholtz:

Some of, I’d say these core documents that I’ve referred to are pretty important, right? From a legal and regulatory and patient confidence perspective, and even a licensure perspective. It’s pretty important, that you have that infrastructure, that documentation as your infrastructure, right?

It’s protecting your time, it’s protecting your money, your license, your reputation. I’m not one of those lawyers that like tries to scare you into doing things with us. That’s just not how I roll. But it’s good that your patient knows what informed consent. They know what they’re getting into, right?

They know the value of the treatment and that there are other types of treatments available and that, it’s, there what’s available, right? What IV infusion can and can’t do for them. So, there’s clarity on that, right? And your standard operating procedures tell you how the physician is in alignment with the nurse practitioners and the physician assistants and the RNs and the med techs and everybody’s there. There’s client trust and professionalism that will come from that, and then when you try to scale and get bigger, it reduces stress, right?

So, if for some reason you have an audit or a licensing issue or just renewal, you’re just ready. And if you were to exit your exit or have a sale, you’re ready. Your policies, your agreements, your compliance, it’s all nicely documented. So, I think it’s important to just do things right from the right way. It sets you on a nice path.

Christian Maniquis:

Thank you for that. For expounding on your answer on that, Drew.

Actually, it makes a lot of sense because the next topic of our last installment for this webinar series is actually expanding their business and what are the other things that they can do to perhaps protect themselves, which is actually good. I don’t see any additional questions on the question and answer box.

Now’s the time, guys, for those audience of ours, if you want to send over any questions. I think Drew, it’s because you answered them. You answer the questions very thoroughly; that’s actually a good sign. But yeah, we do encourage we have three minutes to spare.

Drew Barnholtz:

Okay. Don’t be shy.

I’m happy to answer. There’s no question too big or small. If you have questions on your mind, I’m happy to answer ’em.

Christian Maniquis:

I’m not going to do a roll call because I do see a lot of familiar names.

Okay, cool.

That’s actually up to them. I think we’ll just leave the rest of the questions that we have on the FAQs for the next webinar.

Overall, I think I’ve learned a lot, and I surely hope that our audiences learned a lot as well. Again, we thank you for participating in our webinar series. I don’t think that we’re going to be proceeding with the question and answer portion because we don’t have any. But I think it’s a good discussion.

And thank you for those valuable insights.,Drew. I know that you can’t really give legal advice with these types of webinars, but at least I hope with those answers, that was given by our speaker attorney, Drew Barnholtz, A lot of the fog has been removed or relieved.

I would like to extend the invite on the next or the last installment of our webinar series. It will be on the 16th of April, same time, same channel. Watch out for the links. Please do register if you want to participate. It will be with attorney Drew Barnholtz and hopefully if I have the availability of the other attorneys we will have more guest speakers there.

Thank you so much for your time. Thank you Drew. For those valuable insights. Always a pleasure having these conversations with you and we’ll see you guys on the next.

Take care everybody. Thank you.