Season 9 - Episode 417 - Decoding Medical Necessity in Labs: Legal Insights From Dean Viskovich, ESQ

All right, hey everybody, hope you're having a great day. Welcome to the Compliance Guide podcast. As always, let me begin by saying thank you all so much for tuning in, logging on and hanging out with me. As you do, each and every single week, just for a little while, as I get to explore the world of healthcare compliance and health log with a variety of great attorneys, but also individuals who are my friends. And the gentleman who I get to welcome back to the podcast is both a great attorney and a very good friend who I've had the pleasure of working with now for a couple of years. He is just one of the most prolific attorneys that I know in the laboratory space. But we're gonna talk about a few different things today. And Dean's one of the guys who I really enjoy talking with because sometimes I could just wind him up and let him go. And we get all kinds of great, you know, fodder and conversation out of it. But I wanna welcome my very good friend, Dean Viskavitch, to the program once again. Hey Dean, how are you my friend? - Hey, Sean, I'm great. Thank you for having me again. I appreciate the kind words. - Yeah. - Obviously. - Yeah. So, you know, one of the things that I wanted to start with today is something that I had just mentioned to you and you were starting to, you know, get into it. And I said, well, hang on for just a second. There was a terrible tragedy that happened at a hospital in Connecticut where a 26 year old young man who was a dentist or in dental school was admitted to the hospital with flare ups and, you know, issues that were not resolving but actually getting worse. And he was escalated up to the ICU and unfortunately, he passed. And the thing that stuck out to me about this case besides the fact that he was 26 years old and it's a tragedy, you know, to lose somebody so young was that the only physician that saw him on the day of his passing from what I have read and what I understand was a TV doctor. And this was a physician who was doing telehealth, Indie, actually I believe, pronounced this young man's death without any physical evaluation. Now this happened, I believe in 2024 and the family filed suit or 2025 and the family filed suit and it's just now coming to light. But I wanted to get your take on this whole thing with telehealth and, you know, the fact that telehealth served in my humble opinion, its purpose during the public health emergency, right? The COVID-19 emergency. That's exactly what I was going to say. But beyond that, I mean. There's got to be, we have to use a little bit of common sense we have to use a little common sense here with respect to everything. When I go to the doctor, I'd like to think I go to the doctor. I don't remember the last time I've got past the NP or the PA to be honest with you. But that's for general routine stuff, okay? The outgrowth of the PhD in COVID was, we really can't go anywhere. So for seniors and a lot of individuals who needed to continue to consult with their main treating, the best way to do it was through telehealth, obviously. Right. And that was terrific, okay? For a while, the Medicare and reimbursement, we were way behind in telehealth. You weren't even getting reimbursed for anything. It wasn't even allowable. So the PhD sped up the process and caught up with the technology. Exactly what we're doing now. You know, you're in Georgia, I'm in Florida. So this is a wonderful thing, but like anything else, there's limits and common sense needs to be. So if you're doing the initial conversations and evaluations and things like that virtually or telehealth, that's wonderful. Yeah. But when we're in that acute stage, we're in the ER, you know, I see you. We couldn't be any more. I see you stands for intensive care. Okay. We you need that individual in person. You can't substitute for that. I'm sorry. No, I agree. So I asked the bottom. That's the bottom line. Yeah. And you know, the other thing, you know, I have a lot of physicians that I have to get into this conversation with where, you know, they think, man, I could just work from home. I don't have to go into the office. I don't have to see the patients. No, that's not what telehealth is. Telehealth is really at this point for me, for rural health professional shortage areas, for medically underserved areas where patients live an exorbitant distance from, you know, a health care provider. They can't ambulate appropriately to get to where they need to be. You know, it's not merely for convenience for a physician who says, ah, you know, I think I'm going to sleep until nine o'clock today, not shower, brush my teeth. And I'm just going to, you know, get onto a video camera and start evaluating people and build level fours. It just doesn't work that way. That's not what this is. Absolutely. If you're a new radiologist and you're reading MRIs and CT scans, I don't care where you're doing it. Okay. You could do that as long as you're doing it in a timely fashion. Okay. And then when you get that request of that to get it done, yes, you know, you could do that. But some things need to be hands on in the person. I agree. All right. Listen, I just wanted to, it's not rocket stock. It's not, you know, we're not splitting the atom. No, no, no, no. I just wanted to get your take on that because it was something that really bothered me so much yesterday. And I was like, you know, I want to talk to somebody, you know, about this on the podcast. And we just happen to have perfect timing. So let's shift to your biggest main area that I recognize your expertise. And I know you have expertise across the spectrum. But, you know, you want me to jump in and tell you, I was an insurance company trial attorney for over 20 years. Yeah. Okay. So when you're trying cases for a living, you need to be an SME for the, for the, the facts of the case that are you up with. If it's a slip and fall, you have to be familiar with the coefficient of friction and the rise and the run and, and to see if you are so basically as a trial attorney, you have to be a subject matter expert SME for, as the abbreviation for the issues that you're dealing with in that case. Yeah. And when I pivoted to the, uh, healthcare and the lab space, but a part of trying cases, there was always two parts, there's liability and damages. Damages was always medical, dealing with doctors, dealing with, uh, the healthcare, familiarizing yourself with ICD-9s back then, CPT codes, what's medically necessary, what injuries are these people claim will closely related to the accident. So the natural outgrowth, I've always been in a lack of a better word in the healthcare space. And when somebody asked me if I would be interested to pivot to be general counsel chief compliance officer in the healthcare space and wound up, uh, you know, going into the lab space, I am more of a lab specific healthcare attorney, all of my clients currently are either labs or medical billing companies with an emphasis on labs where I, uh, I do the consulting to, to try to what I say maximize reimbursement in the most legal and compliant way. Yep, I'm still in the attorney. Yep. I'm admitted to practice in New York and Florida. And I, I talked and actually I read for a living. Yeah, well, you and me both and that's why I think we get along so well because you know, before I even answer my first email, each day, the first thing I'm doing is combing through, you know, the, uh, federal register, the releases from the centers for Medicare Medicaid services, the office of inspector general, the press releases from DOJ. I, I typically read for about two hours before I even start my first email each morning, but you know, you and I share the privilege of sitting on a board of directors together for, uh, and, uh, you know, a laboratory client that is pretty big and they continue to grow. And, you know, we have had the opportunity to advise as board members, with me also serving in a compliance officer role for this organization. And talk about, you know, the goings on in the insurance space with respect to genomics testing, you know, the, um, PCR testing, all of these things that are really going on. And, you know, the emphasis that has always been on lab testing, but now more so, I think than ever before. And, you know, I want to talk about why billing companies that, you know, focus on laboratories as clients, um, need to pay close attention to what we're talking about and why laboratories, irrespective of where you're located, how big you are, you got to pay attention. I had a laboratory in the Northeast, go through a, uh, TPE on it. And, you know, wound up speaking multiple times with the, who I had built a very good cadence with, nice open dialogue. Any time I had a question about the claims, I called, she called me if she was lacking information. And then one day out of nowhere, she just started ghosting me. And I was like, well, this is really strange because I just spoke to this lady the prior week. Well, next thing I know, we're receiving a letter a week after she started ghosting me from the Medicare administrative contractor notifying the laboratory that they were now on a suspension of payments. And I will tell you. I can see it every day. Yeah. And this is a laboratory that I will tell you had at the time more compliance, more safety nets in place, educating referring providers on what is required on an order, why it's required. We actually were doing quarterly audits of ordering providers documentation and giving them feedback at no cost to them to say, hey, you're sending over these requisition forms that are missing critical pieces of information or you're kind of half-assing what you're putting on to the order form. And next thing I know, this client goes from a suspension to a revocation. And then it was $780,000 that they were withholding and the laboratory couldn't sustain and they forced them out of business. And now it's at the DOJ. And we can't figure out what's going on. I mean, we have an idea. And I think my very good friend, Andrew Feldman is going to do an incredible job as he does, in all the cases that he takes on. But I mean, this is how quick, like in a matter of 45 days, this laboratory was out of business. I mean, you withhold $745,780,000, whatever it was. And they can't make payroll, they can't buy their supplies. You know, they're on a suspension or revocation. I mean, that's it. Game over. Game over. And you know, the government doesn't have to respond until they're ready to respond. So I see it all the time. Yeah, so it's extremely frustrating. Yeah, so let's talk about some of the major things that you're actually seeing and what you're dealing with with your laboratory client. So, all listeners who are tuned in for this one have a solid understanding of the facts of what's really going on out there and what you're dealing with. Well, the big thing, you know, we can't get around the fact that this is a third party pay-or-health care system and you're getting reimbursed from these entities, private and public Medicare, Medicaid, and the big five. Okay, signage humana at Blue Cross and United. That's where we're at. Okay, and it all comes down to me for the most part initially this medical necessity. You can't get around that in the lab space. The only two documents that a lab has is a requisition form in a final report. And neither of them support medical necessity pursuant to the pay-or-polices in the CMS guidelines and whatever the LCDs are saying and whatever the maps are putting out though. This is not rocket science. So you need to have a terrific relationship with the ordering provider because the only documents that support medical necessity are the doctors records on the data service that for the day that the patient was treated. And I really think if you dig deep guys, I think they are sending most labs on a bit of a scavenger hunt. And here's why for the date in question that they send you a request for documents. Okay, just think about it. I went to Dr. Weiss on this day and then the doctor ordered a lab test. What are the doctors do on that date of service? He submitted a bill for his in-em to get paid. Okay, and not only that, he submitted records for that date of service which contain the request for the lab's order in his records. Otherwise, he wouldn't get paid. So think about it. Now that the lab is submitting and they don't have those records usually up front, but that's another thing that we can talk about. To get those records continuously or at the, or about the same time that you're getting the order. So to me, I was an insurance company trial attorney for a long time. And my theory opinion is when they're asking for these records from the lab for the data service to support medical necessity, they would have them. They've got them from the ordering physician on the date of service or that doctor would have never gotten paid. So they're just seeing how legitimate your lab is and to see the relationship you have with your ordering providers, to see if you could get them something that they already have. The only way that I could prove this theory is if somebody's, if a lab sued the ordering provider, I mean, not the, you know, the carrier on that and you did discovery and enduring discovery, you requested all of the records and you'd opposed those claims adjusters and say, "Hey, let me ask you a question. For this date of service, did you get the records from the ordering provider for the bill that he submitted on that date and question?" And I'm pretty sure the answer is, "Okay, we had it." Yeah. So, you know, it's really, so it's really interesting that you bring up medical necessity because this is something that I argue all the time at administrative law judge reviews. You know, I make my, I make my arguments, you know, at the first two levels, the reconsideration, the re-determination, but, you know, it falls on deaf deers for the most part, right? Especially. You know, the first level was nothing more than a rubber stamp upholding the, you know, initial denial. You know, at a QIC, it's kind of a, you know, hit or miss, let's see what happens. But, you know, the, you know, when I talk about medical necessity and I speak about it at the administrative law judge level, or I speak about it when I'm testifying in court as an expert, you know, I always explain the fact that, you know, while I'm not a lawyer, I can reasonably say that legally, you know, visits may not meet the threshold of medical necessity, defined by CMS as a service, which, you know, is referred to as the reasonable and necessary standard for the diagnosis of treatment or injury. You know, that winds up exposing providers to fines, penalties, or exclusions from the federal payer program. And, you know, when we talk about medical necessity, you know, as it's outlined in the CMS documentation requirements and evidence-based resources, you know, timely and accurate record keeping to your point becomes critical. Right? Medical records. Yeah. Documentation is everything. Yeah. Medical records should be, you know, you know, created and/or amended within a reasonable period of time. You know, I think the majority of the max, say, you know, within 24 to 48 hours or as soon as practicable to ensure that providers are able to recall details, you know, with a Denda being exceptions rather than the routine, you know, you know, so when we talk about medical necessity, you know, the way that CMS defines it as services or items that are reasonable and necessary for diagnosis, treatment, going from memory, or improving functioning, aligning with the AMA's definition of healthcare services as a prudent physician would provide an accordance with accepted standards of medical necessity. I mean, you know, there's so much to this, right? Because medical necessity ensures patients receive evidence-based, appropriate care, tailored to their actual needs, avoiding unnecessary tests, like what we're talking about. Absolutely. You used to treat a diagnosis. That's basically the 50,000, you know, foot view of what medical necessity is. But for me, you know, medical necessity fosters trust by aligning with ethical principles like, you know, acting into patients' best interest and non-malphesians, you know, avoiding harm, right? You know, that's the first thing that they talk about, you know, in the Hippocratic oath is do no harm, right? Ensuring care decisions prioritize patient welfare over administrative or financial considerations. You know, so, you know, those are the things like when we talk about medical necessity, you know, that to me is really how providers can defend themselves appropriately because they can say, listen, the services that I provide into these patients or the services that I ordered were done in accordance with generally accepted standards of medical practice. And I use my clinical judgment to make those. determinations that almost becomes impenetrable, right? Because, you know, there's a reason why they call it the practice of medicine, Dean, right? I mean, it's not an exact science. And there's a ton of subjectivity. I mean, unless a physician purely acted out of, you know, financial interest for him or herself, and you have, you know, other clinical experts with the same qualifications or higher qualifications who can say, listen, this is not the standard of care. Here's the reason why it's not the standard of care. Here's peer reviewed literature. Here's published information, you know, this doctor acted, you know, you know, in the best interest of him or herself for financial benefit. You know, otherwise, you know, it becomes who's the better storyteller? Who's the one who can connect with a jury and help them understand that what they did was actually in the best interest of the patient. And that this stuff is highly subjective. Absolutely. And that segues into exactly what we spoke about earlier. When we talk about medical necessity, what are we looking for for guidance, especially in the lab space? And as I told you recently, I'm talking very recently, December, I think first to 2025, the first circuit court of appeals on the federal level talked about medical necessity and labs. And specifically what they held was, like I said, remember I told you earlier, the only thing a lab has is a requisition form and a final report. That's right. Okay. And what the court held was I'll read this is a lab may treat a valid physician order as primatasia evidence of medical necessity under 42 USC 1395. And then the burden shifts to the government to affirmally affirmally rebut that showing. So prior to December, we remember with the old Boston growth case up there versus art, that basically said it's not the lab's job to provide medical necessity. And the other thing you have to think about too, that would be like the lab's practicing medicine without a license. If the lab was required to excuse me, provide medical necessity. So finally now we have a federal appellate court decision that says, you know, you could rely on the requisition form, the order signed by the ordering clinician doctor and PPA for medical necessity. And unless the federal government has some evidence that something else was going on, that the lab could rely on that medical necessity. So it's a huge arrow in the quiver of the lab for when we are getting the CMS request for medical documentation and say, hey, I have an idea. Here's my requisition form signed by the ordering provider. This is primatasia evidence that the lab testing that was done was medically necessary, unless you have some other evidence to prove otherwise. So this is something that the labs need to embrace. It needs to be communicated to the lab community, especially in the compliance legal space, which exactly why we are here this morning. And that what that we're doing and it needs to be incorporated in the response to all of the audits that we're getting from the max and their contractors and offenders that they are sending out to do these medical necessity audits who are getting a percentage of whatever they can recover. So this is huge. And we're going to need to incorporate that in our response or our rebuttal to what CMS is relying on for suspensions like you talked about with your client. Yeah. And we talked about this in great detail during our board meeting, right? Because and we hadn't you and I had not even spoken for a while prior to our last board meeting. And you know, we were talking about medical necessity with laboratories and I brought up, you know, United States, X-ray later, Groat V Boston, Heart Diagnostics without even recognizing that you were going to jump into the first circuit court of appeals discussion. And you know, for our listeners, the difference between these is and Dean correct me if I'm if I'm wrong or, you know, if I omit a piece of it. And in Boston diagnostics case, Groat V Boston Heart Diagnostics, you know, 2017. Yeah. Right. The original ruling that came from the judge basically, you know, misstated the fact that the laboratory should be making the determination of medical necessity. But on the second day, of moral arguments, the judge came back and said, I misstated it over spoke because, you know, the clinical laboratory improvement guidelines does not hold for that even the own office of the inspector general's guidelines does not hold for that because at the end of the day, laboratories do not engage and employ clinical personnel who have the capability to make medical necessity determinations. And that would be an overreach and that would be an appropriate. So the judge over overruled himself. And he changed his position on that. And then in the first circuit court, what they actually did was they came out and confirmed what medical necessity is and who can actually determine the medical necessity. And the fact that it is not the laboratory's position that they have the right to rely on the clinical judgment and the informed decision of the ordering physician and or APB. And that is critical in arguments of medical necessity when, you know, CMS or commercial payers saying to a laboratory, we're denying your claim because it failed to meet medical necessity. Well, the argument is here's here's the first circuit court of appeals. Here's, you know, you know, USV Boston Hart, both cases clearly set a precedent to say it is not the laboratory's position, you know, you know, place to determine the medical necessity. And it is in stone. And that's that's to me. Well, here's the bottom line. Okay. The new case, the December case is, what was it? Omni versus meds fine. I think you're looking at them. Okay. But it expanded the holding of Boston, the growth case. Okay. I could, if you want me to get granular, there were three basically holdings that came out of the growth case. Number one, labs cannot and do not make, do not make patient specific medical necessity decisions. Those belong to the physician. Number two, the Medicare statute and lab regulations do not require labs to independently determine medical necessity for every test audit. And number three, labs, however, have duties not to submit false claims, including proper coding, honest billing and avoid schemes that generate unnecessary testing. Okay. Which is great. But they didn't say that the lab could rely on the valid physician order as, as primafasia evidence as medical necessity. So it expanded the growth decision on that it's not the lab's responsibility to prove medical necessity to go one step further and say, the having a valid physician order is evidence of medical necessity. So that has about as granular as we would probably like me to get on that when I'm literally reading the holdings of the of the first circuit court of appeals. But that's, but that's where we're at now. And that's the ammunition that we need in the response to the request for medical necessity. Right. So let me, let me ask you, you know, as we wrap up this segment here, I always love when I get subject matter experts like yourself who are also attorneys who can give some generalized guidance, not legal guidance or legal advice, but generalize regulatory or compliance guidance to our listeners to say, listen, if you're a laboratory or if you're a billing company working on behalf of a laboratory, you know, these are the top three top five things that you must ensure prior to filing a claim. What would you give us some some some practical guidance to say to before you submit those claims or before or you submit documentation on an ADR that has been received, these are the things that you need to ensure are appropriate in your packet of information. - Sure, you wanna hear something very basic. - Absolutely, basic is best. - What is ordered, what is run, what is reported, and what is built must match. - There you go. - Okay, talk about blocking and tackling. That's where it stems from, and what I like to do is reverse engineer the process. Let me look at the payer policies, let me look at the LCDs, and then we know what is being reimbursed as medically necessary, and then let's reformat our requisition forms and final reports consistent what is being reimbursed. Perfect example, I'm here in Florida, we forget this first coast, I do a lot of work in Florida and Texas, which is novitast, okay? When we talk about doing infectious disease and specifically an RPP, okay, by the PCR methodology, and you're building under an age 7, 6, 3, 1, and you're getting $142, it says three to five viral and bacterial targets, okay? So let's reformat our infectious disease, RPP, our infectious disease requisition form, and when we have our ordering provider who wants to do an RPP, let's have a panel that's three to five targets. It's COVID, it's influenza A and B and RSV, and something else that you have in there that is consistent with what is getting reimbursed. So the doctor is ordering you, the lab is running, and the lab is reporting and billing consistent with what the third party payers are paying. Can you bill for six or more targets as an age 7, 6, 3, 2, sure you can? Can you bill for over, I think it's 15 targets, which is an age 7, 6, 3, 3, sure you can, but if you read the first coast in the ANOVA task LCDs, you know what it says? An age 7, 6, 3, 2, an age 7, 6, 3, 3, more than five viral or bacterial targets, it's not medically necessary. Unless of course you're in the hospital setting or you're immunocompromised, and if you are, then you're getting paid as a bundle in the hospital for part A and you're not getting reimbursed and to part B. So this is an excellent example of what I talk about, order, run, report, build, let's do the reverse engineer, and you should be doing that. Not only with infectious disease by the PCR methodology, let's look at genetics, everybody's doing the next gen sequencing, terrific, okay? However, you have to read what the LCDs are saying is reimbursable. These comprehensive moonshot genetic panels are a red flag, okay? When you're doing PGRs, it's a specific drug gene interaction. Let's put that in the, let's put that in the requisition form. Let's do these things up front so we could be more, where I always say, let's be more proactive than reactive when you come to me, when you're getting pushback and audited for not medically necessary testing when the requisition form, the reports, and what the lab is doing is inconsistent with what the third party's payers are deeming medical necessity. So that's what I like to do. I love to get my clinicians involved, my lab directors, my technical supervisors, and communicate to my C suite clients and tell them, hey, we have the answers to the tests. And I literally open up my laptop with my C suite's people and go through the LCDs with them. Go over where it says the ordering clinician is the, it must be the one who orders this test and that ordering clinician must be in charge of the patient's condition and explain to them that a chiro can't be ordering a genetic test for cancer or for cardio. So it's not rocket science, but enlightens them when I literally show that to them in black and white, who can order what is medically necessary? And that's what I like to do on the front end and have you and I basically involved in that process. And I hope I'm a little warm-winded, but this is my soapbox and this is kind of the hill that the labs need to be, to die on to be honest with you. - No, I agree with you 100%, and I think our listeners will greatly appreciate the amount of detail that you've provided for them today. All right, well, that's gonna wrap up this episode of the compliance guy. As always, I wanna thank my very good friend, Dean Viskavitch, attorney, laboratory attorney extraordinaire, subject matter expert in all things laboratory. I will post how you can get in touch with Dean. Should you have any needs for his services related to laboratory appeals or denials? As always, I wanna say thank you to each and every single one of you for tuning in, logging on and hanging out with us just for a little while, as we explored today, the world of laboratory compliance and health law. I'll be back later this week with one more episode of the compliance guy. Can't wait to get into that conversation as well. So until then, remember be good to yourself, but more importantly, y'all be good to each other. Take care.