CEO of Parameno Health and former NFL athlete, Keith Gray joins us to share his expertise on running a compliant medical laboratory. Tune in as we dive into CLIA, EKRA, genetic laboratory testing, and key operational processes to ensure your business remains compliant.
Listen to the full episode using the player below, or by visiting one of the links below. Below is the episode’s transcript which has been edited for readability. If you have any questions or would like to learn more, email us at firstname.lastname@example.org.
Intro: [00:00:00] Welcome to Legal 123s with ByrdAdatto. Legal issues, simplified through real client stories and real world experiences. Creating simplicity in three, two, one.
Brad: Welcome back to another episode of Legal 123s with ByrdAdatto, I’m your host Brad Adatto with my cohost Michael Byrd.
Michael: Thanks, Brad. As a business and healthcare law firm details matter. This season’s theme is zoom in. Once we know our big picture vision or strategy, we have to roll up our sleeves to get the work done. With each episode this season we’ll have our typical stories and make sure we talk about specific actions to focus on for 2022.
Brad: Michael, I’m excited for today’s episode because we’re going to combine two of my favorite things.
Michael: We’re talking about cold beer and dad jokes?
Brad: Cold beer, maybe. I’ll drop maybe three of them, cold beer, sure. But healthcare and [00:01:00] the NFL and speaking of the NFL
Michael: No don’t go there. I know you’re a Saints fan, we all know you’re a Saints fan and our ratings will plummet if you start talking
Brad: Okay, one time I’m going to have a whole thing on the Saints. All right. But you know, you hear these terms, Michael, like NFL, NBA, NHL, and we a lot of times assume that the general public actually understands what these abbreviations or acronyms mean.
Michael: Sure. Of course NFL is the National Football League. NBA is the National Basketball League. NHL is the National Hockey League.
Brad: Yeah. And so that had me think about acronyms that you and I, or the legal peoples use all the time. And we as attorneys, we start starting saying things and maybe the general public doesn’t understand, like we say NDA or LOI or POA or SPA or FCA or CLIA or ECRA
Michael: Okay this is reminded me, we all know those a-hole businessmen out there that start dropping acronyms that. They know, people don’t know what they mean, but they act like you should. [00:02:00] And I’m not saying you’re an a-hole. I’m not saying you’re not, but I just want to know where you’re going with all those.
Brad: Well, I thought today we could have a little bit of fun with these strange but true military or government or law acronyms. Even us probably don’t know the common lawyers because you know, there are so many out there that when people start throwing them out there, as you said, you have that look from your dog where he’s like, like looking sideways like what the heck did you just say? So are you ready for it?
Michael: As a judge would say, you have a very short leash.
Brad: Fair, fair enough. All right. The very first one, the LORACS. What does that mean?
Michael: Dr. Seuss?
Brad: No, that’s the Lorax. That stands for Liaison Officer for Recognized and Authorized Classification Societies (LORACS).
Michael: Okay. What’s a classification society?
Brad: I don’t know, it’s the government. All right, ready for the next one? This one sounds like fun though. The DISCO
Michael: Um, okay. [00:03:00] What does that mean?
Brad: Defense Industrial Security Clearance Office
Michael: It really sounds like you’re just stringing a bunch of words together.
Brad: This is our government baby. DRBOB.
Brad: Defense Resale Business Optimization Board.
Michael: I don’t know. I think the leash is getting shorter, Brad.
Brad: Last one. And you know, a lot of people don’t think government has a sense of humor, but this was one of my favorite ones. BEER (Brewers Excise and Economic Relief Act of 2013). And as you know, we all need more beer to make us happy.
Michael: I kind of feel like we got beer and dad jokes all there by the government.
Brad: Thank you government.
Michael: Alright, let’s stop. Our guest is going to hang up on us if we do anymore I think. And let me introduce our guest today. His name is Keith Gray. Keith graduated from the University of Connecticut with a BS in actuarial science and mathematics. It sounds [00:04:00] very impressive. He was an offensive lineman at the University of UConn, played multiple years in the NFL going back to National Football League. And today he is the CEO of Parameno Health, a healthcare management company in Dallas. Keith, welcome.
Keith: Thank you for having me.
Brad: Keith, over the years we have had a chance to catch up and hear about your really cool life and you have this cool story. And so I think from our audience perspective, I’m really excited for them to share your story with us, but let’s kind of go back and take a big step back. You have this interesting path of where you started. So you always, and you have told me this, you’ve always been interested in health care, but what did you want to do? What led you to ultimately choose UConn?
Keith: Yeah, so as a kid, when I was asked what I wanted to do when I was a bigger [00:05:00] kid, always I looked at my kindergarten picture and I was probably six foot then. And I was like, I’m trying to find me and I’m like, okay, who’s the teacher right there. Like, no that’s actually you, but I surprised a lot of people that my first choice was I wanted to be a physician. I found myself wanting to be just dealing with patients, helping people, whether that was a surgeon or just family practice. I really didn’t know, but I just knew I wanted to be a doctor. And I really, when I broke down all the schools that were offered me to play football, I looked at the different schools of medicine and I was like, all right, I’m going to go to UConn. You know, they had a great facility there. I was like, that’s going to be perfect.
Michael: And did you pick your major as a part of your pathway to go into medicine?
Keith: You know, I wanted to. And so what I [00:06:00] didn’t realize, I had all these plans and visions in my mind to be a physician, but the requirements for football doesn’t really allow you to do residency and all of that. So it wasn’t possible because you got to fit all your classes in like an 8:00 AM to 12:00 PM window because you have got to make it in time for lunch. And then, you know, films started at 1:00 PM and you were done about 8:00 PM. So trying to do all that, it wasn’t possible. So my first two years I actually went undecided because I was stubborn and I’m like, they’re going to let me be a doctor. I was like, I know my parents always told me, you got this scholarship, you know, don’t do communications. Because you want to be on TV after your NFL career or, there’s just not enough spaces to be Tony Romo. So that was my plan. Like I’ll just get a communications degree, I’ll be on TV when it’s all said and done, and they said absolutely not. So I needed to do something meaningful with that [00:07:00] scholarship.
Michael: That’s amazing. And so at what point, we know you went into the NFL, I want to ask you about that in a minute, but at what point did you realize that that was going to be a possibility? Was that all like early on in college or towards then?
Keith: So really, when I couldn’t become a doctor, I said okay, well then I’ll be a physical therapist. They’re like, it’s the same thing. Like the time requirements, just not going to happen. So it was sophomore year and I’m done with all my prerequisites. Like it now it’s like, hey, it’s time so I’ll meet with the educational staff for UConn football. No, you got to pick something. So I went to all the different schools and I’m just like, man. And then math was something that was always easy for me. So I was like, I’m going to be a math major. My dad, he was one and I was like, you know what, I’m just going to do that. And when I went into the [00:08:00] math building, the head of the actuarial program saw me with my football sweats and he said, hey, what are you doing in here? I was like, I’m going to sign up for it to be a, you know, get a math degree. Well, what about actuarial finance? I was like, I don’t know what that is. And so when he told me he sounded great, he said, actuaries have almost a 0% unemployment rate. They make really good money. So when you’re done playing football, you can still make good money. All right, let’s do this.
Brad: Great advice
Keith: You know, it really was, he let me in on a secret, he said you know, basketball has a finance guy, but man, if we get a football player to do actuarial science, we’ll kill the finance department. I see what’s going on here.
Michael: That’s awesome. So you went onto the NFL after UConn. I’d love to hear a little bit about that and hear, were you able to stay connected to healthcare [00:09:00] during your NFL career?
Keith: So after UConn, I went to Carolina, so I was a rookie with the Panthers. I was there with, Cam wasn’t there. I had Jake Malone. I’ll tell you, being there as a rookie and hearing him do the cadence. I had no idea what he was saying. I was just snapping the ball when it’s out. Like I couldn’t figure out, you know, a lot of my family’s from Louisiana on my dad’s side, but man, I’ll tell you he was a tough one to understand.
Brad: Thick accent there’s no doubt about that.
Keith: Yeah, he did. I could never just rest. So during off season and even, you know, Darren, I was trying to figure out, I had a lot of conversations with the team doctor. Surprisingly I did not know [00:10:00] that a lot of them had their own private practices and they were not just the team doctor. So having conversations with them and I did that at UConn, or we pop into the medical staff just because I was curious. And I was just trying to understand the business a little bit more. And it really was the billing aspect. You know, one doctor told me, he said, we go to school to learn how to treat people. We don’t go to school to learn how to run a business. So I invested in some software to help with physician billing. And I started my first business while I was playing. I was Provider Health Care Associates. I started helping them bill and understand how to be their own practice so they didn’t have to sell themselves to the hospitals and things like that.
Michael: That’s amazing. I bet they had not experienced anything like that before with one of the players starting to help.
Keith: You know what, it’s funny I get a [00:11:00] lot like, man, I can’t believe you play football and, right, football and. One of the things I was just always taught as a young kid was don’t limit yourself. Don’t let anybody label you if they are, you know, make sure they can label you as a Christian, so make sure I’m living right. Like if they could point that out. Everything else don’t stick to any limit.
Michael: That’s awesome. I love that. And so we know your story and we know that you ultimately suffered a career ending knee injury and you were drawn to an emerging area in genetic testing. And I’m just curious about that and would love to hear kind of what led you down that path.
Keith: Yeah, so honestly, when I blew my knee, I was on the couch and couldn’t move. There was a machine during the therapy that gave me anxiety or just cranked your knee and stretch it out. And, [00:12:00] you know, I’m just lying there, but you hear that sound and you know its coming. I called the doctor and I just asked him, I said, hey, like I come back, I do it again but I don’t get surgery then what? And he was like, you won’t be able to play with this. So I made the decision. I said, you know what I’m done. I got to see a lot of things, met a lot of cool people from Carolina and Indianapolis. I was thankful for the opportunity. And so when I was on the couch and couldn’t move, my brother had actually came over to visit me one day and he was working for a genetic company for a management company. And when I was listening to the PhD scientists talk about what genetics could do it was amazing to me because when I got my injury, I kept telling the doctor like, hey, I can only take half of what you’re giving me, [00:13:00] like a whole pill is too much. And you’re telling me to do it every four hours. I just can’t. And they’re like, man, you’re a big guy, you’re 320 pounds, this is what you need. And I’m like, absolutely not. So when I realized I had to self-dose myself, because the way that only one pill made me feel, and then I was hearing about time for pharmacogenomics. I was like, oh, game-changing I was all in.
Michael: That’s amazing. Tell us a little bit about what interests you about, or what led you to what you do today at Parameno Health.
Keith: So I have my own personal experience with medication and the adverse event that was causing me. I would take those pills, I mean, it was a nightmare. Sweat, and couldn’t stay awake. I was with RJ and I hated the feeling. So when I heard about that, I started thinking about all the different applications that this could be applied to. I remember always with my mom on Sundays, I’d go [00:14:00] visit her and she spent most of her Sunday with just the different medications for the days of the week. And I’m sitting here, like you have 45 pill bottles, what are these for? And so it’s like, well this one I get water retention because of my diabetes and this one fights the water retention. But when I take that one, I get headaches. So I take two of these and this is causing me chest indigestion. So I take that for them. And I’m sitting here. Wait wait wait, all of this because you take a diabetic pill that caused water retention. It just kept going down the line. So when I took my personal experience and I took her, I got her tested and she went from literally, I want to say more realistic was probably 22 bottles, 22 different medications, all stemming from one that caused issues. And when I saw that go from 22 to 5, I was like, ah, I have got to help other people.
Brad: So part of the season Keith is, [00:15:00] and for our audience as they know, as Michael’s kind of stated, we really like to zoom in and get into the details as to what drives different actions. And so I love the background as to what started this process for you, which obviously started a long time ago when you wanted to be a physician and you just kept seeing those different opportunities blaringly. For some of us, we probably would have ignored it. But for you, it looks like you’re always looking for a way to think through that. But as your career progressed in the medical community, you started getting more involved with these genetic labs. We’d love to talk about how things like CLIA, EKRA and the explosion of telemedicine had some key operational, what processes you had to put in place to ensure your businesses remain compliant.
Keith: Yeah it’s definitely been a challenge. There’s some bad players out there that are just trying to [00:16:00] make a quick dollar and they don’t put the science behind the tests. So a lot of it had to be restructured, so I couldn’t just be a lab. I put a lot of surrounding factors around the lab to help support it so that we could do certain things by compliance check. So one of the things that we have to do to make sure that no one’s taking advantage of the system is we run random audits every week on the genetic samples that we get in. And we call patients, we call the office, we ensure that the doctor is the one ordering, the patient understands why, and we’ve had those conversations because we understand the importance. But we also understand those things, like you said, it’s like, wow, CLIA is paying attention to this. Now there’s EKRA laws that are really preventing the fraud out there and the payments for illegal testing. And so we really put an emphasis on the compliance piece, but [00:17:00] then we topped it off with we have a lot of experienced individuals in genetics that work for us. We put a lot of thought in theory, and to the tests that we create. It’s hard to argue with the science. You know, I look at what other people are doing and then I say, okay, well, how can we make this better? What is out there that they’re not doing, that you really separated? And there, those sort of things that aren’t recognized by insurance but it’s recognized by the science. So we run them, we take the cost for them because we know we’re going to put out a product that we can defend.
Brad: I love that. And our passion at ByrdAdatto is helping others succeed. And you’ve said that throughout this podcast, you keep going back to, is that since the beginning, you always wanted to help others. So when it comes to these testing’s and have you seen this great result, have you heard back from patients or anyone else or the doctors as to what you’re able to do with this genetic test? [00:18:00]
Keith: Yeah. When you say that the one thing that sticks out to me the most, there was a rehab facility and I had received a letter from the CEO of the facility and they said they were struggling with a 17 year old man. He was a smart kid, I guess. And he was just very lethargic. He didn’t want to participate in the rehab, didn’t talk, almost like a zombie he said. I called him, he left his number and I said, hey, I felt that way when I had my surgery. I think he would benefit from a pharmacogenomics test. So we sent him a kit, they tested them, we rushed it back. So I think on a Monday I got the letter, I called them on a Monday. They had the kit on Tuesday, it came back. So one of the things we do to separate ourselves is we’re very high tech, so we want the turnaround time to be fast. So those results got back to him on Wednesday. [00:19:00] When we looked at the medication he was on one of the side effects because he wasn’t able to metabolize, it was that it would make him depressed that he’s taking depression medication that makes them more depressed because it’s not right for him. And so they changed the medication on Wednesday. Thursday, right he’s not at the facility. Friday he comes by himself, he’s talking, he’s alert and I get a personal letter back from the VA. He doesn’t call me, he sends me another letter. And he said that when we talked to that individual, Friday was going to be his last day on earth. He was ready to take his own life. And he had felt thankful that the facility was able to figure out that what was happening to him was something out of his control. And it was the medication causing them to be where he was at. When I got that letter, I was just like, man, this is what it’s all about. It’s not about sales reps and doctors. And like, this is why this science exists. And I just [00:20:00] wish more people knew that.
Michael: So powerful.
Brad: Yeah well first off, thank you for sharing that story. Now I feel like I have got to do something better for myself. I want to thank you again for coming in sharing your story and we’re very thankful.
Keith: And I’m so grateful for you guys having me and you know, I cannot believe you’re a Saints fan. With Indianapolis we’re split, but its okay.
Michael: Keith the next time you’re at the office. Just come hang out with me and we’ll talk. We can unite against Brad.
Michael: Well, we’re going to Keith, let you go and we’re going to go to commercial. And when we come back we will have a wrap-up conversation about the legal compliance things that you want to think about with labs. We’re so grateful that you’re here today.
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Brad: Welcome back to Legal 123s with ByrdAdatto. I’m your host Brad Adatto with my cohost Michael Byrd. Michael, I’m extremely thankful Keith could join us today and I’m glad our audience was able to hear from an expert who’s running a compliant laboratory. But more importantly, just him sharing his story. That was a very powerful story as to why he got there.
Michael: Yeah. Especially with this season, you know, being the theme of [00:22:00] zoom in, the lab arena is not only highly regulated, but it’s been seeing a lot of enforcement activity over the last few years. Let’s be real. There’s a lot of bad actors in that world. And so it’s so refreshing to hear someone wanting to do it the right way. And he is and he has no choice but to be compliance minded in this world. So Brad, you mentioned a couple of acronyms earlier that some of our audience may not be familiar with. In fact, we know that probably now because there were pretty heavy words. This was back when you were being an a-hole. I mean, I’m not saying you’re being an a-hole. So let’s go into that and get some new vocabulary words out there. Can you give a quick explanation of what you mean by CLIA?
Brad: Yes and by using that word, I actually have to give us two vocabulary words. So the first one is CLIA and that stands for Clinical Laboratory Improvement Amendments. [00:23:00] This is something that the CMS or the Centers for Medicare and Medicaid Services, they are the ones the government, federal government entity that regulates laboratory testing on humans and that’s where CLIA comes from. It basically establishes all the lab testing processes it applies to, and it applies regardless of what the setting is. So if you’re in a hospital or a commercial lab, or if you even have a little lab kit inside your physician’s office, CLIA applies.
Michael: So you mentioned CMS, and CLIA is federal. So does it only apply if you take Medicare and Medicaid?
Brad: Great question, Michael. And no, it actually, it applies any time you’re performing a test. Even one that’s it doesn’t matter who the payer is. So basically CLIA is really, if you think about it from a medical perspective, CLIA is trying to establish the standard of care that you must [00:24:00] follow if you own and operate a lab, regardless if their payer is the federal government or a commercial payer or even a cash payer, this is the standard of care that’s expected for running a CLIA lab.
Michael: So when I’m picturing a lab I’m picturing those large testing machines, spinning vials of blood. Is that what we’re talking about?
Brad: It’s a good picture. That is a type of lab that would be under the CLIA lab. And as you add more technical nuances to it, there’s more things to it. But basically the simple tests that are still cleared by the FDA, for even home use that would also be required by CLIA. So for instance, like a CLIA wave test, or you get a certificate of waiver from CLIA, and that’s pretty common for most of your physician offices. And of course, as we all know with that pandemic thing, going on, a lot of people got very familiar with those COVID tests, which are now their [00:25:00] COVID home test. So again, there’s a waiver that you get from a CLIA lab to get those COVID tests.
Michael: And just a quick follow-up on the waiver. Does that essentially mean that it’s less heavily regulated if it’s falls into that category?
Brad: The type of requirements that are needed to meet it and so the FDA first approves that this is a type of way of which you can grab samples. And then CLIA says that when you’re then taking on the sample and then it is going to be processed different, but it’s the higher levels that like, again, your blood tests or other things, the more stuff that they pull out and try to test, the higher needs of the lab to be more complicated, to your question.
Michael: Got it. Okay. One final question about CLIA. We always talk about every state being different when it comes to most of the healthcare regulations or many of them does that apply here as well?
Brad: Yes, and no. First off, let’s take a step back. You [00:26:00] know, we do a lot of podcasts and we start talking about ownership of medical practices. And the first thing you have to understand is in almost any state, anyone is allowed to own a licensed facility, meaning that you don’t have to be a physician to own this. So such as a hospital or imaging center, and obviously we’re talking about labs. And then second, most states don’t have some state level of licensing for labs. They just basically follow the rules established by CLIA rules and they’re just issuing VLIA licenses and so for instance, we’re right now in Texas. So that’s how it works here in Texas, Texas licensing arm of Texas follows the CLIA rules. There are a few states that have their own rules when it comes to laboratories and require separate state licenses or certifications, or a combination with CLIA. Although New York, like a lot of things in New York, it’s very unique because it created its own laboratory regulatory environment, making New York labs technically exempt from CLIA. [00:27:00] So if you’re doing a lab in New York, you actually don’t follow the CLIA process. You actually have to go through the New York process. And so the question really does boil down to whether or not your state has its own licensing process and certification, or does it simply file CLIA?
Michael: Are you feeling okay?
Brad: Uh, I went out of mind right there for a little bit.
Michael: Okay. Well also I have never heard you say Texas like a normal human.
Brad: Oh yes. Sorry, Texas.
Michael: There we go. There’s Brad. Okay real quick before we end, we’ve got another term you mentioned earlier EKRA. Can you briefly describe what that is?
Brad: Yeah. So EKRA stands for Eliminating Kickbacks in the Recovery Act Of 2018. Now this actually passed part of a much larger a bill, but it’s really about trying to address the opioid crisis, back in 2018. So EKRA is a federal law that is very similar to those. You’ve heard us talk about the federal anti-kickback law. It’s similar, but it prohibits payments for referrals, but applies [00:28:00] to clinical laboratories. So it’s very focused law in that sense.
Michael: Similar, but not the same.
Brad: Right. So the main difference with EKRA is payer indifferent meaning that a lot of the federal laws that we’ve talked about in the past, they only applied to Medicare, Medicaid, or Tri-Care this. This law EKRA applies to commercial insurance. And so it doesn’t make a difference who’s paying, no matter what the, and let’s go back to payer indifferent. And then most importantly, it really does focus on how employees are being compensated. So on an EKRA you can’t really pay a person based on any referrals, number of tests or procedures performed, what they were billed, or how they receive. And this is a different kind of law because a lot of times with federal laws like the anti-kickback law that was already in place. This is again, focused [00:29:00] on commercial or even cash based ones and so historically the federal anti-kickback law was really the only one out there and it didn’t really concentrate or focus on compensation methods. Now EKRA does.
Michael: Sounds pretty complicated to navigate.
Brad: Yeah. And you know like it’s been a hand grenade in the lab world, it has had a significant impact on the industry and because when EKRA came out, everybody’s trying to figure out how do I compare that to that longstanding federal anti-kickback law that’s been around forever and there’s a lot of frustrations cause it came out and it was basically almost immediately became law. And we’ve talked about this in other episodes is there really isn’t a good guidance or regulations that are out there that tells us how it going to be enforced or what are the safe harbors, which is, again, these are the things we look for when we’re advising your clients, but you know, Michael before the audience all tunes out, let’s hit the pause button and get off CLIA and [00:30:00] EKRA and the other things that impact the lab world. And let’s just zoom in and talk about some specific actions our audience should be considering when navigating complex regulatory environment such as genetic laboratory testing, as Keith is doing.
Michael: We started this episode talking about the a-holes that throw out the acronyms and act like you should know. And a lot of times, we just kind of roll with it and don’t ask the question and in healthcare, that can be a big problem. Like if you just heard someone talking about EKRA in the lab world and just acted like you knew what you’re doing and did what everyone else was doing. You get in trouble because there’s a lot of bad actors in this space, and there’s a lot of bad actors in healthcare. And so hit the pause button. And if you’re going to go into a business like healthcare with the compliance requirements that it has either learn it or get someone to help you guide you through, [00:31:00] kind of the minefield.
Brad: Totally agree, Michael. So Michael that’s all the time we have today, but next Wednesday we have another special guest, Jamie Lynch Vasquez who will be joining us to discuss again, compliance, but this time proper billing and coding of medical procedures.
Outro: Thanks again for joining us today. And remember, if you liked this episode, please subscribe. Make sure to give [00:28:00] us a five- star rating and share with your friends. You can also sign up for the ByrdAdatto newsletter by going to our website at 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 an 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. [00:32:00]