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Current Trends in Health Care Investigations and Prosecutions

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Current Trends in Health Care Investigations and Prosecutions

In 2022, health care enforcement remains a focus of federal law enforcement agencies. Over the last few years, the DOJ brought a record-number of prosecutions related to health care fraud and anti-kickback violations, particularly in the realms of telemedicine and laboratory testing services. Perhaps unsurprisingly, prosecutors have also targeted fraud and other criminal schemes related to the COVID-19 pandemic since 2020.
Such investigations and prosecutions can make the acceptance of funds from federal payers (e.g., Medicare, Medicaid) fraught with risk for providers and related entities. In this presentation, we’ll discuss the key issues and claims on which federal prosecutors, often aided by agents from the U.S. Department of Health and Human Services, have focused in recent investigations and prosecutions.

Transcript

- I'm Paul Coggins, and together with Jennifer McCoy, we're going to be talking about what is clearly the hottest topic in white collar criminal law now, which is Healthcare Investigations and Prosecutions. And we're really going to focus in on some of the current cases and some of the current trends we see in the healthcare fraud area.

- And Paul is right when he says this is one of the hottest, hottest areas in enforcement. And we know that in part because of the stats the Justice Department has issued regarding the last fiscal year of 2021. And here on these next few slides, we have some excerpts. This first one states that during fiscal year 2021, the federal government won or negotiated more than five billion, with a B, dollars in healthcare fraud judgements and settlements in addition to other healthcare administrative impositions. Because of these efforts, as well as those of preceding years, almost 1.9 billion was returned to the federal government or paid to private persons in fiscal year 2021. Of this $1.9 billion, the Medicare trust funds received transfers of approximately 1.2 billion in addition to the almost 98.7 million in federal Medicaid money that was similarly transferred separately to the Centers for Medicare and Medicaid Services due to those efforts, which of course when we're talking healthcare, we are often talking about Medicare and Medicaid.

- So Jennifer, what you've done is throw out a lot of big numbers.

- That's right.

- A big number is billions, like the series "Billions." And what you really boil it down to is that healthcare has become a heavily, heavily regulated industry. I never thought I would see an industry regulated as heavily as banking, but I think healthcare has entered that area. And I think in part because the amount of money, the percentage of our national wealth that we spend on healthcare means it's going to be the number one priority for most US attorney's offices for the coming future.

- That's right. I think that's a great point. And to put it into slightly different terms, but also some big numbers, the DOJ has stated that in 2021, they opened 831 new criminal healthcare fraud investigations. They break those down a little bit more and they worked with the HHS's Office of the Inspector General, so the Human Health, Human and Health Services-

- Health and Human Services.

- Health and Human Services. Woo.

- HHS.

- HHS, I never say the full word. They work and partner with that agency. And so that agency also opened up 504 different criminal actions that stemmed from investigations. In addition to criminal, we have a lot of civil actions as well, which can involve some pretty hefty fines. There were 669 new civil actions filed in 2021 related to Medicare and to Medicaid. Those include false claims, unjust enrichment lawsuits, and so on, and so forth. So again, just kind of reiterating what Paul said, this is a very hot topic. There are a lot of new cases and new investigations being brought as we speak.

- And, you know, just to put on my prosecutor's hat from years past, when you throw out 800 plus criminal cases open, it might not sound a lot when you're comparing it with immigration cases or low-level drug cases, but it is a lot in the white collar world, because these cases are more complex. They're harder to investigate, harder to put together. So that's quite a commitment by the Department of Justice, but the Department of Justice is not finished there. Recently, in fact, May 17th of 2021, Attorney General Merrick Garland established the COVID-19 Fraud Enforcement Task Force. And, you know, earlier this year in 2022, he appointed Kevin Chambers as the Department of Justice's director for COVID-19 Fraud Enforcement. The Biden Administration wants to put money where its mouth is and is seeking an additional 36.5 million in next year's justice budget to, quote, bolster efforts to combat pandemic-related fraud. So the DOJ, if these funds come through, plans to hire 120 new prosecutors and some 900 new FBI agents to focus on white collar crime. And HHS-OIG is focused on the use of the COVID-19 bill to target medically unnecessary services. Now the majority of these covid-related enforcement actions in the past have been blatant fraud and abuse. You know, an example that comes to mind is an advertisement of, quote, solar therapy, end quote, as a cure for COVID-19. Who knew that a tan could take care of all our problems?

- If only, I would spend much more time on the beach if that were the case. And, Paul, do you think that, I mean, it sounds like while there's been a lot of enforcement against these blatant COVID-19-related frauds, it sounds like there's more to come. I mean, would you agree that maybe we get a little more into the weeds here in the next few years?

- I absolutely think so, because the reality of the situation is this, a lot of money went out the doors on COVID-related activities. A lot of money went out very quickly with not a lot of underwriting. So whenever you have that much money with that little underwriting, fraud schemes are bound. So they're going to focus, I think, by and large, on blatant frauds in connection, people, you know, just getting the money for one thing and spending it on something totally different. I think those are the kind of blatant frauds we're going to see this COVID-19 Enforcement Team crack down on.

- Makes sense, well, in addition to COVID-19 enforcement actions, which often focus on the healthcare industry just because of the nature of COVID-19, we have, of course, more traditional healthcare enforcement actions. And I think a lot of our listeners are probably aware of, you know, the usual players here, but we wanted to rattle those off to provide some additional context. So you have just good old run of the mill healthcare fraud under 18 USC, Section 1347. And that can include health insurance and medical billing fraud. So example, you, for example, you might have a provider that upcodes or falsifies records to receive greater reimbursement from an insurer. That would count as some sort of health insurance and medical billing fraud. You have Medicare and Medicaid fraud, which is essentially the same, but against federal programs like Medicare and Medicaid. Home healthcare fraud, that can occur when a home health agency bills an insurer or a program or a patient for unnecessary or unprovided services. Obviously it can be a little bit harder to track the home health provided services, given they're not taking place in a hospital or in a doctor's office. So that area is ripe for prosecution there. Also drug fraud and abuse, which is just like it sounds, fraud and abuse involving drugs. So there's drug pricing fraud in which a provider provides, prescribes unnecessary medication or inflates the prices. Counterfeit drug fraud occurs when a provider knowingly pushes stolen or expired or altered or fake prescription drugs. And drug diversion abuse occurs when a provider keeps a patient's medication for profit. Now getting more into what I think, at least I've been seeing over the last few years, just regular fraud cases that can be brought within the healthcare industry, you have both wire and mail fraud, kind of classics. Obviously those types of cases can be brought if there's just a false statement that's made in a wire or in a mailing that is sent. And a wire can include, you know, something as simple as a phone call. So a lot of times when we're dealing with white collar, whether it be in the healthcare industry or not, it can be relatively easy for a prosecutor to attack those types of actions on. So I'm sure we'll be seeing more of those. More specific to healthcare, we have the Stark Law, which is the physician self-referral law that prohibits physicians from referring patients to receiving designated health services that are payable by Medicare or Medicaid from entities with which the physician or the physician's immediate family member has a financial relationship, unless one of several very technical exceptions applies. Anti-Kickback Statute is somewhat similar. That is a federal statute that imposes criminal penalties on anyone who improperly offers to exchange anything of value to encourage or to induce a referral of business from a federal healthcare program. Now traditionally, that means just what it says, it relates to federal healthcare business. But as we'll learn here in a little bit, the lines between commercial and federal have been blurred a little bit in recent prosecutions. And so this issue of the Anti-Kickback Statute can be sticky, even for those who are dealing only in commercial business or receiving funds only from commercial business. We have some other kind of general things that get brought in the healthcare realm quite often, such as the False Claims Act, causes of action, money laundering, the Travel Act, which for those who don't know, is a federal criminal statute, which forbids the use of the US Mail or interstate or foreign travel for the purposes of engaging in certain specified criminal acts. So basically if you do anything illegal under a state law, you can be prosecuted criminally more often than not under the Federal Travel Act if it involved the US Mail or some type of interstate travel. Same thing with conspiracy. I mean, that gets tacked on often to underlying fraud or Anti-Kickback Statute cases. Paul and I have actually had a few cases recently where there has only been a conspiracy count charged. So for instance, conspiracy to violate the Anti-Kickback Statute, although there's no underlying Anti-Kickback Statute violation that was charged. Which is interesting, but can benefit the government in a few different ways. I mean, by bringing the conspiracy count, you just have to have an overt act and furtherance of it. And then also it can extend the statute of limitations for these matters. So, you know, you might have a client who did one, you know, took one alleged act that violated the Anti-Kickback Statute back in 2015, but if that conspiracy's still going on today or in 2020, the government can reach back to that 2015 act and kinda pull it within the statute of limitations, because the conspiracy's still going on. Of course that's unless you have a withdrawal and a disavowment of the conspiracy, which is a pretty high bar to prove. So that can definitely be a be a tough one to overcome if you're trying to mount a statute of limitations defense if you're facing a conspiracy claim. And there are several other civil and criminal statutes that may apply, including, of course, state claims and each state's going to have their own healthcare statutes, many of which do mirror the federal statutes. But those are just some of the big ones that we see very often in these cases.

- A couple of glosses on that, because, Jennifer, you hit us with a whole artillery here of statutes that they can come after you on, which is true. But a couple of things to kind of footnote, and maybe, you know, thither for a later conversation is the Travel Act. You know, the fact that they can merry up the Travel Act with certain state statutes like commercial bribery statutes in the state, you know, really represents a huge expansion of federal jurisdiction and kind of an unchecked expansion of federal jurisdiction if they're going to reach into all of these state statutes. So we'll talk a little bit more about that today, but we also may want to talk about that later on as sort of its own standalone show. The other thing I would say is I'm glad you put the mail and wire fraud statutes sort of near the top of the list, because in federal prosecution, what's old is new again, and the mail and wire fraud statutes have been called the prosecutor's best friend because they're broad, they encompass any scheme to defraud. It's almost impossible to devise a scheme to defraud without using the mails, without using the phones. If you can do that, you're a better crook than I. And so prosecutors tend to rely upon it, 'cause they're comfortable with it.

- Yeah, and it's interesting, the point you make about the Travel Act, we were talking about the bolstering, or at least the requested bolstering of the DOJ budget, and the potential hiring of 120 new prosecutors and 900 new FBI agents. I mean, it seems as if the Travel Act would be a great way to drum up work for those new hires and perhaps we see them reach into that even more in the next few years then.

- Exactly, and the kind of healthcare cases we're seeing now, they can really kind of encompass just about anybody and everybody, the fraud schemes that have been charged, raised from solo ventures by individuals to really widespread activities by institutions, by huge institutions or groups. But the kind of things that we've been seeing charged recently or knowingly billing for services at a level of complexity higher than the services actually provided or documented in the medical records, kind of upcoding, I think what the government's looking for in any kind of case like this is a pattern of this kind of upcoding, are knowingly billing for services not furnished or supplies not provided, or both, and falsifying records to cover this. That's probably, you know, the layup the government if they can find that you were billed, and there's a pattern of this kind of activity, billing for services that were not provided. Medical knowingly, ordering medically unnecessary items or services for patients. There have been some horror cases that have, you know, documented children who have had teeth pulled that were totally healthy, because that was a way to provide medically unnecessary services and to bill for 'em. Those are the kind of cases the government really loves to sink its teeth into, pardon the pun. Paying for referrals of federal healthcare program beneficiaries. Jennifer talked about that. That's another case the government gravitates toward. And billing Medicare for appointments that patients fail to keep or, you know, the infamous example of the doctors who bill, end up billing 28 hours a day for their services, those things, what they used to call wave therapy. When the doctors would pass by and wave at the patients-

- I have not heard that term before-

- Oh, you haven't heard of wave therapy? Oh, we had a number of those cases back when I was US attorney. But anyway, the bottom line is this, any false statement made in a mailing or an email, for example, a fraudulent invoice, or over the phone, can form the basis for a mail or wire fraud. And the government is in off to the races.

- I could see why the mail and wire fraud statutes have earned the reputation of being the prosecutor's sweethearts. You mentioned, you talked about upcoding, and medically unnecessary services. It seems that that would be more of a concern for like critical access hospitals that are allowed to charge more than just the going rate for these Medicare and Medicaid services. I think it seems to me that the government has a little more interest in that and it is looking perhaps with a slightly finer tooth comb at those types of organizations that have more to gain from billing Medicare and Medicaid services.

- Well, probably in the sense that the dollar amounts may be greater. You know, the bigger the institution, the more sophisticated the institution, and perhaps even, you know, the pattern is more set, the pattern is easier to see in a number of cases as opposed to, you know, a solo practitioner just saying, hey, I made mistakes or I didn't have the recordkeeping facilities or the compliance department that a big giant hospital might have.

- That makes sense. Well, and another area within healthcare fraud that we've seen quite a bit of activity or focus on lately would be telemedicine. So obviously, as I'm sure all of us know, 2022, we have appointments over the phone and over Zoom with our, or maybe not Zoom 'cause I understand there's some HIPAA concerns there. So there's another particular software, I think, it's called Doxy, that a lot of doctors are using to conduct telemedicine appointments, which is great and convenient for patients, but also opens the door to, you know, more potentially unchecked activities and other ways to commit fraud and other ways in which the government is there for investigating these things. So this is actually, this slide here is from the Justice Department's website as an example of...

- Called the circle of life.

- Yes, in the telemedicine world, or the telemedicine fraud world anyway. so in this example, you have a telemedicine company, or a marketer who offers free or low cost medical products or testing to a beneficiary. And that beneficiary, the telemedicine doctor passes that on to the patient, orders the products for testing from the telemedicine company and that company sells prescriptions to medical equipment companies or laboratories, whether directly or indirectly. And then the medical equipment company or laboratory bills Medicare and pays a kickback to the telemedicine company. Again, this telemedicine company, this all originated because they were providing something at low cost or perhaps no cost to a telemedicine doctor, but you can see here at the end of this circle of life that they are in fact receiving a kickback from the medical equipment company or the laboratory. So it's really adding one more player to an already complicated chain of events and making it a little more susceptible to this type of fraudulent activity. And I think just by virtue of being in the telehealth kinda sub-industry within Medicare, you can probably expect a little more oversight from the government as they're getting up to speed with what that means, what that entails, and how best to check those types of activities that, you know, frankly weren't around 5 or 10 years ago and have just absolutely exploded over the last few years.

- So, Jennifer, I could see that slide being slapped up by the government in a closing argument in a civil or a criminal case and this being their summary to the jury. Right?

- That's right. Yes, absolutely. And this is a pretty obvious, you know, an obvious scenario wherein there is a payment being made to the telemedicine company that they would not be entitled to other than in the form of a kickback. But there's definitely less obvious examples and it's just something to be careful with if you're venturing into that sub-industry.

- And, you know, at this point I want to talk, 'cause Jennifer brought up the Anti-Kickback Statutes and, you know, there's a federal Anti-Kickback Statute. Some states have many Anti-Kickback Statutes. We'll talk a little bit about those as well, that generally track the federal Anti-Kickback Statute. And, you know, if you're a doctor and you feel like you've got a target on your back, congratulations, you've got a target on your back. The prosecutors really are charging doctors who they believe have accepted money as inducements to participate in a study or, you know, for genetic testing or any other kind of study to purchase test, purchase products. And what's interesting about the inducement, that's a very broad term and, you know, there's no real dollar amount. I mean, the SEC used to tell you occasionally if it was a small dollar case, that $1 could be material. Well, $1 can be an inducement. Now I don't think the government would bring that kind of case, but if the dollars add up, if it's $100 a test that the doctor is getting to participate in a study, the government may add up those dollars and decided, yes, this was an inducement by the doctor to enter into the test, to order the test. And that doctor may find himself or herself sitting in a criminal courtroom, you know, and going through a multi-week trial.

- And it seems that's especially true when we're talking about conspiracy cases, which we touched on a little bit earlier, but you may have a doctor who received only a few hundred dollars, but if it's in connection with a larger conspiracy where in Medicare is perhaps paying out tens of thousands or hundreds of thousands of dollars, seems relatively easy for the government to tack on this doctor who didn't receive very much money, who's all of a sudden involved in a conspiracy with a really high loss amount, even though he may not know the other players or the other labs and whatnot involved in the case.

- And of course, those instructions they're going to get are going to say to the jury, the doctor doesn't have to know the other players. And the other players may be making millions, so the doctor may be making thousands, but Jennifer's right, the doctor may be dragged along. I will say this, and certainly my practice has been gravitated toward doctors and accountants and lawyers who end up going to trial, because they've got a license. And if they get convicted, they're going to lose that license. So a lot of the cases recently that have gone to trial, I think have involved professionals who hold license like doctors.

- Right, and that's a great point, because regardless of the loss amount, if it's a felony, you're going to face licensing issues as a doctor or a healthcare professional.

- Almost certainly going to lose your license, at least for a certain number of years. Now how do these prosecutions begin? Well, we know that assistant United States attorneys litigate both civil and criminal healthcare fraud matters. Sometimes they open parallel matters, both civil and criminal in the same office. And they often get these referrals directly from the investigative agencies. They partner with agencies to create specialized units and strike forces, such as the Opioid Fraud and Abuse Detection Unit. That's a very, very active one now. Of course other cases are qui tam cases brought to them by whistleblowers. For example, you know, the providers' employees, their patients, their contractors, particularly employees who have been terminated, lost their job, tend to be active qui tam litigants. US attorney's offices though are increasingly doing what other agencies like the SEC has done, which is developing through data analytics cases, through data analytics, that spit out anomalies and people that should be, and institutions that should be looked at. In other words, a doctor is prescribing way, way more opioids than, you know, any other doctor in the state of his or her relative size. As I mentioned, many states have their own Anti-kickback Statutes. They generally tend to track the language and the federal Anti-Kickback Statute. As a result, a lot of the US attorney's offices are partnering up with their state AG's offices to pursue healthcare cases. In fact, it's not at all uncommon for state AGs to hire and plant in the United States Attorney's Office special assistant US attorneys who have one foot in the state AG's office, one foot in the US Attorney's office, and they get actively involved in these healthcare investigations. And once they get involved, they have a number of ways to get evidence. They've got in civil investigative demands, they've got search warrants and of course they've got the grand jury to issue subpoenas.

- So again, focusing on kind of what's going on today and why we're talking about this and the increased enforcement in the healthcare arena, we've already talked about telehealth and how that is kind of a, high risk area is a strong word, but it is an area over which there is a lot of enforcement and a lot of investigations that take place. So a few other kind of high risk areas or areas wherein the federal government seems to be interested currently include managed services organizations. So a managed service organization, also known as an MSO, is a company that provides non-clinical services to medical practices or to ambulatory care facilities or other healthcare providers. So by non-clinical services, we mean things like billing and collection, accounts payable, it can be human resources, it can be kind of overall workflow, cycle management, just a number of different things. But as anyone who has been involved in an MSO knows, the structuring of those can be very tricky. There's a lot of regulatory issues involved, not the least of which is, you know, avoidance of any kind of anti-kickback issues, especially in the event that you have any physicians that are invested in the MSO. So we'll talk a little bit more about that, but lots of activity in that arena. Also a lot of concern from the federal government regarding clinic services that are provided by phlebotomists or other hospital employees. Sometimes that is related to the MSO. The MSO may be providing that kind of service or at least managing that kind of service. Or you may have a hospital who's just directly got a phlebotomist in a doctor's clinic, for example. And that allows, among other things, assuming that you, you know, you tick off a number of boxes, that allows you to bill that service as an outpatient medical service through the hospital. So there's a lot of hoops to jump through and it can be hard to tick all of those boxes, and thus we have a lot of room for enforcement when you have a hospital employee who is doing things outside of the hospital and those are ripe for anti-kickback type of prosecutions. The government's also had a lot of investigations involving laboratory and diagnostic testing. For example, the scenario that Paul ran through earlier with a doctor who's being paid, you know, $100 to run certain tests as part of a study, but is still referring such business to a particular lab or a diagnostic testing service, again, right for investigation, right for prosecution, something we'd be aware of. Telehealth we've discussed. COVID-19-related treatments and services. We've discussed the fact that the government is funneling quite a bit of resources and interest into enforcement in that arena. Home health providers we've also touched on. That's another area that is ripe for prosecution. Physical therapy as well. It's another one of their services that, you know, you're providing a service. It's not a medication that you're prescribing, it's not something that's necessarily as tangible, and thus the billing and things can be subject to perhaps more discernment than others. So another thing to be aware of, ambulance and transportation services. Another kind of new phenomenon is the electronic health records that most providers are keeping these days. I believe actually if you're accepting Medicare, you have to keep such records electronically unless you've received, for example, a waiver that would allow you to keep these old school paper records, despite the fact that you're subject to Medicare or Medicaid's regulations. So those electronic health records, not so much like an anti-kickback, Stark Law type of concern. Definitely a patient safety concern. Definitely, you know, some fraud cases that have been brought regarding the maintenance and the recording of those types of records. And it's still something that I think the federal government is grappling with given how new those, you know, that record keeping is. Obviously it also gives the fact that you're keeping electronic health records, provides just a lot of fodder for the government in these cases. Lots of documents, much easier to search through than, you know, the old school paper files that no one can Ctrl + F and look through a certain treatment for. So something to be aware of. Same with medical devices, prescription drugs and opioids. Paul has touched on, I know we've all heard and, you know, possibly been touched by the opioid epidemic. And in light of what a big toll that has taken on the country as a whole, we have a lot of enforcement going on with regards to opioids. Last but not least, nursing homes and facilities. A lot of enforcement happening there regarding, well, you have a lot of patients who are on Medicare, and thus Medicare is going to be very interested in, and HHS is going going to be very interested in what is going on behind those doors that are really being ran off of Medicare funds. And anytime you're accepting that kind of federal health payer money, you're going to have a lot of regulatory framework and laws to keep up with.

- So those are all, Jennifer just outlined a lot of high risk areas we see. I don't, couple of points to make at this juncture before we go to the next slide. One, the level of suspicion aimed at these managed service organizations or MSOs is extremely high. I mean, a lot of prosecutors have it in their head that these things are almost inherently done to induce doctors to order services or as payments to doctors. And so if you're going to do an MSO, you really do need to make sure you've had a qualified healthcare lawyer. We'll talk a little bit about advice of counsel, but you strongly need the advice of counsel to do it, because there's a high degree of suspicion, almost hostility among some prosecutors toward MSOs. And the other thing, just sticker, ambulance and transportation services, we're going to talk to you in a few minutes about a case that if you look at it from the government, you know, was a cutting edge case, if you look at it from the defense side, was a really unwarranted intrusion by the government into a nonprofit activity. But those, Jennifer, that's a good list of high risk areas.

- Those are two very different characterizations.

- You'll see which way I fall, like.

- I've got my guesses, but we'll see. Well, speaking of MSOs, I think these kind of next two slides flow nicely into that because that's one of the areas wherein you were navigating the issues regarding receipt of federal funds. And again, when we're talking federal, we're talking primarily Medicare, medicaid monies. So if you've got a doctor with an elderly population, you can pretty much bet that you're going to have, you know, a lot of Medicare money that's coming in. And I think that, you know, one of our, someone put it that, you know, these days it's rare to find someone who's not accepting Medicare or Medicaid or, you know, veterans benefit, something along those lines. So there's just totally different frameworks that go along with commercial versus federal funds. And as we discussed, under the AKS, it's a felony for a person or an entity to knowingly or willfully offer, pay, solicit or receive any remuneration, so money or other kind of benefits, to induce a person to refer an individual for the furnishing or arranging for the furnishing of any item or service covered by a federal healthcare program or to induce such person to purchase or lease or recommend the purchase or lease of any service or item covered by a federal healthcare program. So that's a lot of words to say, essentially, you clearly cannot pay a provider cash to refer you a Medicare or a Medicaid patient. So a lab can't tell a doctor, hey, if you give us all of your, you know, tests, all of your blood samples, that you need RAND for your Medicare population, we're going to give you like, you know, $100 or $2 a test as kind of a kickback or an incentive to keep giving us your business. That is clearly not allowed. Nor may someone pay a provider cash that is in inflated. So let's say that the lab says, if you give us all your commercial business, we'll pay you $100 per patient, per commercial patient. But wink, wink, nod, nod, if you also send over your federal stuff, we'll pay you 150 for the commercial. So you're inflating that commercial kickback in order to induce the federal monies, which, you know, there's a lot to go around there so that-

- So you're really covertly paying for the federal-

- Correct, Correct.

- Inflating the non-federal to covertly pay for the federal.

- Right.

- That's pretty clear.

- Right.

- Totally wrong.

- Right, and exactly, that is very clearly wrong and that's kind of always been the case. Traditionally, the Anti-Kickback Statute and similar laws have been enforced against recipients of funds that are incurred through federal insurance programs. But in our experience, the DOJ has kind of ramped that up and gotten a bit more creative, specifically with regards to MSOs that accept funds from commercial business. So as we said, nowadays it's odd to find a doctor who doesn't have any federal business. And so, for example, we may have an MSO who receives funds that flow from the lab back to the MSO for commercial business that is referred to that lab. And that same MSO may be smart enough to say, but we don't want any money from federal and we don't want this inflated amount of funds from the commercial to cover the federal. We want nothing to do with federal and we're going to tell our providers that, you know, they don't have to send their federal stuff to the lab and thus we're kind of creating a separation between commercial stuff, commercial patients, and federal patients. That would seem to be kosher. That would seem to not fall within those two kind of obvious buckets of AKS violations where you're either paying directly for federal or you're paying an inflated price on commercial in order to cover and induce the federal. But we've seen in recent years or recent months even, the DOJ take issue with even that separation of the federal and the commercial funds. And the kind of more creative legal theory that we've seen tossed around is you may have the DOJ say, well, sure, MSO, you told this doctor that they did not have to send their federal funds, their federal samples to the lab. However, they did. They did send the federal samples to the same lab. And it kind of, the overall scheme, the overall relationship between the MSO and the lab resulted in like an increased propensity to refer the lab federal business. So that could become an issue. Even if you have an MSO that's saying, we don't want to touch federal. We know some of our, you know, some of our doctors that we're working with do in fact have federal business, but we're not making them send their stuff to the lab, their federal staff to the lab. If you've got all of these doctors who are nonetheless sending their federal business to that lab who is paying for a commercial business, you've gotta kinda look at the overall scheme and see if, you know, but for this arrangement, would that lab be receiving the federal business? And if not, that could be an issue, which I would argue is not really an AKS violation, but, you know, definitely a risky business to be in.

- Yeah, It seems like the government is moving the goal post on the AKS prosecutions from clearly direct payments for federal, no, no, can't do that. You can't covertly or indirectly make payments, but what Jennifer just described is really the government saying, well, you've created an environment in which there's liable to be increased, an inducement to increase federal payments even though you, you, Mr. MSO are not receiving any of that money for those payments. Well, that to me, you know, still has to be tested in the courts. So it seems to, sort of creating the environment where more federal referrals are going to take place seems to be a bit of a stretch, but remember this, even if you have commercial, purely commercial provider, you've still got that Travel Act the government has certain, in certain cases, reached into, and said, look, we found a state bribery statute, a state commercial bribery statute. We can't bring the AKS, 'cause there's no federal payment here, but we can sure as heck bring the state case in conjunction with our travel act. So, you know, the distinction between federal and commercial, I think, is really getting blurred. Now I mentioned, I sort of teased you earlier and talked about how I wanted to talk about an ambulance case that we worked on. And it was a qui tam case called US versus Paramedics Plus. And our client was not paramedics plus, but our client was a nonprofit ambulance service. They provided ambulance services to two large cities in Oklahoma, Oklahoma City and Tulsa. And I thought, while my client owned the ambulances and provided the service, they contracted with Paramedics Plus to provide the medical personnel, the drivers, the medical personnel on the ambulances. But Paramedics Plus had, really, a very civic-minded leader and he didn't think Paramedics Plus should make an extravagant profit on this. So they agreed, Paramedics Plus and my client, to a profit cap. And the profit cap, just to make it easy, let's say it was 10%. So once Paramedics Plus made its 10% profit, any amounts it made over that would flow back to the nonprofit ambulance service. Well, there were years in which the profit exceeded the cap and money flowed back to the ambulance service. I think that was perfectly appropriate. The government took the position that because money was flowing from Paramedics Plus to the medical provider, the ambulance service, that was a violation of the Anti-Kickback Statute. Now this was a civil case. It was not a criminal case. I think that profit cap, as long as it's negotiated arms length, as long as it's a genuine profit cap, not some facade or anything of that nature, is entirely appropriate. And I think most lawyers would find it entirely appropriate. It's much like a cost plus government, a cost plus contract the government gets involved in. Nevertheless, the government joined the qui tam case, they brought a civil case, and it survived the motion to dismiss stage in court. We filed a very vigorous motion to dismiss. That did not get the case tossed and the case ultimately got settled. So this hasn't been prosecuted, but I raised this case for two reasons. One, it shows that, you know, provision of ambulance services is definitely something that the government's looking at. It's one of those high risk areas that Jennifer identified. Two, the fact that my client was a nonprofit didn't stop them from being prosecuted. Three, the government took the position, kind of the literal position that when money is flowing from Paramedics Plus back to the medical provider, even if it's in the form of excess over the profit cap, that is an inducement for them to enter the contract with Paramedics Plus and as such fell within the Anti-Kickback Statute. As I said, has it really been tested? We didn't go forward to trial. We certainly didn't get to the Fifth Circuit or the Supreme Court, so there's not a lot of law on this at this point, but it does show how aggressive the government can be about the Anti-Kickback Statute.

- That is...

- Scary.

- It is scary. It is. That is concerning, I mean...

- And just as an aside, Jennifer, I should point out that Paramedics Plus really was forced to settle the case because they, there was a huge sale being negotiated and this qui tam case was blocking a much, much bigger sale. And so paramedics plus almost had a gun to its head, had to settle the case and did settle a case, and that's why it didn't go forward to trial. And there's really no case law here.

- Mm, and I guess you haven't heard of any similar cases that would've provided that case law since then. So it's kind of just out there to be tested someday.

- Out there to be tested, but like I said, you know, clearly a cost plus contract would've been legal, but a cost plus contract, frankly, would've been less attractive to our ambulance service than this profit cap, 'cause in a cost plus, just give you an example, in a cost plus contract, you know, Paramedics Plus, if their cost were 8%, you know, they're going to get the, or they would get, they were going to get, if it was 10%, they were going to get 10% anyway, right? If it was your expenses plus 10%, they're going to get, at a minimum, 10%. In the profit cap situation, it's different. The maximum they could get is 10%, but there were years in which they didn't hit the 10%, in which case they only got 8% or 7%.

- So they should've been a little greedier, is what I'm hearing?

- Yeah, I mean, so the ambulance service, you know, got a better deal from a profit cap than they would've gotten from a cost plus.

- Mm-hmm, interesting. And while y'all were, you know, litigating that case, were there concerns about criminal ramifications, given the stance that the government was taking civilly?

- Well, I think it's fair to say that in most of these cases, the government will open parallel tracks. They'll open a civil investigation and a criminal investigation if they're going to intercede in a qui tam case. And in a qui tam case, you know, the statistics are overwhelming. If the government joins the qui tam, it takes over the qui tam, there's recovery in an overwhelming number percentage, like maybe 90% of the cases. Conversely, if you have a qui tam case in which the government elects not to join and take the case over to intervene in the case, there's no recovery in about 90% of the cases. So the government intervened in this case, they took it over, they litigated it, and a lot of discovery, but at the end of the day, as I said, it was settled.

- Interesting, interesting. Just whole new frontier. Well, kinda shifting back to more well-trodden territory, there are obviously, we've talked about ways in which you can be prosecuted, causes of action the government can bring. Those come with a lot of what's known as safe harbors. So, you know, although you may otherwise be in violation of the Anti-Kickback Statute, like reading the strict text of the statute, there are certain little umbrellas under which you can live and avoid, you know, having an actual AKS violation. Same with the Stark Laws, there's several different laws, especially when you're talking about the state laws. Many AKSs, like Paul's mentioned. There's all kinds of different safe harbors under which you should absolutely seek legal advice and make sure that you are, you are abiding by those safe harbors very literally, very technically, it can be very tedious. And we could spend, you know, we could spend an hour just on the different safe harbors to the AKS, but we have here just a list of different ones. And this is not an exhaustive list. But I think what would be useful is just discussing one of them in particular, focusing on the equipment rental safe harbor. And just to show how very technical this is. So normally if you were providing equipment, if you're a lab, let's say, and you're providing equipment to a doctor's office who's also using, referring business to you, that could, under the strict language of the AKS, be construed as a kickback, and thus a violation of the AKS. However, if you have structured this arrangement such that it falls within the equipment rental safe harbor, you should be, you should not have to worry about prosecution in theory. And, really, this is another way, even if you've determined that you fall outside of the AKS, and let's say you're accepting only commercial funds through an MSO and you've drawn that distinction we've talked about earlier, so maybe you think you're clear and free and you don't need to worry about falling within a safe harbor 'cause really you shouldn't be subject to the AKS, if you want to take a bootstraps and suspenders approach, you could still structure your arrangement to fall within a safe harbor such that you have an added layer of protection. But again, it's a very tedious layer to obtain. So for example, this equipment rental safe harbor requires six different things. The lease arrangement must be set out in writing and signed by the parties. It must cover all of the equipment leased between the parties for the term or the lease, and specify the equipment in writing, of course. It must be intended to provide the lessee with use of the equipment for periodic intervals of time rather than on a full-time basis for the term of the lease. The term of the lease cannot be for less than one year. So you can't say, you know, three months and you're covered. This has to be kind of a more of a commitment than that. The aggregate rental charge must be set in advance, be consistent with fair market value in an arms length transaction and not determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made in whole or in part under a federal healthcare program. And last but not least, the aggregate equipment rental may not exceed that which is reasonably necessary to accomplish the commercially reasonable business purpose of the rental. And there is more to be said there, but I will stop there because I think it's safe to say that that gives you a flavor of how hyper-technical these safe harbors are. And if you're complying with five out of six of these points, that's not good enough. You've got to comply with all six. There's got to be proof of good faith efforts to comply with them. You know, halfwaying it is not going to do it here. And the same goes for all of these different safe harbors. They are all very hyper-technical. And so for instance, when you see employee compensation arrangements, it is not enough to say, well, this person's an employee and we're compensating them as such. It is much more technical than that. You really need to get an attorney in there to explain the requirements to you and to make sure the way that you were implementing their advice ticks off each and every one of these very technical requirements within any of the safe harbors with which you might, on which you might rely.

- So that's shows really how tough it is to fit yourself within one of the safe harbors. And so when we're talking about potential defenses, defenses, you know, arguments you're going to make to the prosecutor to try to induce the prosecutor not to bring a case or, you know, arguments you're going to make to the jury to try to convince them not to convict, you know, obviously you're going to hone in on the elements of the offense and, you know, one of the ones you're going to probably really highlight is lack of proof of willfulness or failure to prove willfulness beyond a reasonable doubt. If you could bring yourself into a safe harbor, great, but it's a hard target to hit. It's an impossible target to hit without a lot of legal structuring and legal advice. And one thing that you do have to keep in mind is even if you fail to hit up safe harbor, like Jennifer said, you have seven boxes, and you only check six, the fact that you check six out of seven boxes might be enough to convince the prosecutor that it wasn't willful. You were doing your best to comply, you just barely missed it. So that might be enough to at least get you out of the criminal arena.

- That's a good point.

- Into the civil arena. There are exceptions in the Stark Law that are set out by statute. Here again, you have to check every box to hit one of these exceptions. There's a voluntary disclosure procedure, but that's rarely used and rarely works. I will use it with great, great caution. You know, there may be expert testimony that you can bring an expert to the fore who will argue that whatever you or your institution was doing was permissible and permitted by the law. I will tell you this, the government never wants to try, certainly not on the criminal side, a case where you've got experts who are going to testify for you, because if the experts disagree, jurors are going to walk away from that and saying, well, the experts can't agree. How is this doctor supposed to know what are-

- Yeah, seems-

- Going to do.

- It seems I do seems to be reasonable doubt perhaps just in and of itself then.

- So that really brings us full circle back to your basic argument in these healthcare cases is lack of intent and advice of counsel. And Jennifer's going to talk a little bit about the advice of counsel defense.

- Right, and of course, this is one way to essentially get to lack of intent is you can't be willfully violating the law as is required to bring a criminal prosecution or a criminal conviction anyway, if you are, in good faith, relying on the advice of an attorney whom you retained in order to help you comply with that law. So again, it negates the intent that's required for criminal offenses. But kind of similar to the safe harbors, prosecutors scrutinize the defense of advice of counsel very heavily and they almost shortly contest a jury instruction given on the advice of counsel defense. So at least in any case I've had where we or another one of the defendants have requested an advice of counsel defense, the government has contested that instruction, the jury instruction. So the jury instruction will read, it will basically say, because it can take about an hour to read the jury instruction, so we won't do that here. It will basically say that if you find that this person relied, in good faith, on their attorney's advice, then you can't find them to have willfully violated this statute beyond a reasonable doubt. But it's not so simple as to say that, well, I talked to an attorney one time about MSOs and then I went and created an MSO, and thus I can rely on the advice of counsel, because I got some advice. Rather, there are two basic but very important elements, full disclosure of all pertinent facts to your advice, to your counsel. So if I met with the attorney to talk about structuring an MSO and I just said, I'm thinking about an MSO, what do I do? That's not going to be full disclosure of all the pertinent facts. They need to know the players, they need to know the amount of money that's going to be paid. They need to know all of the details and be able to render advice that is commiserate with all of those facts. If you left out the fact to show an easy one that you're going to be accepting some kind of federal business or federal funds and you otherwise relied on everything the attorney said, but the attorney didn't know federal was at play, you're not going to get the advice of counsel defense, because you did not fully disclose all of the pertinent facts to your legal counsel. And then of course the second prong is good faith reliance on the advice of counsel. So even if I did disclose everything to legal counsel and my attorney turned around and said, well, you need to do A, B, and C in order to make your MSO compliant. And I went forward and did A and B, but disregarded C, that's not good faith reliance. I need to have made a true effort. I may not be perfect, but made a true effort to comply and implement all of the measures that the attorney handed down to me based on the full disclosure of the pertinent facts that I have handed up to her and only then will I get that advice of counsel defense and the accompanying jury instruction. And I guarantee you, you are going to have to fight tooth and nail at trial to get that, because if there is an arguably pertinent fact that the attorney was not aware of, that could be enough to keep you from getting that instruction. Now also you must obviously waive the attorney-client privilege in order to get that advice of counsel. So you can't say, yeah, I relied on advice of counsel, but you can't know what my counsel told me, because that's privileged. You can't use it as a shield and a sword. You have to go ahead and waive that, which can be, you know, has some risks in its own. So something that you need to really think about and make sure that you have the element satisfied before you go down that route. If you're part of an entity that received that advice, it may require a majority vote in order to waive that privilege. I mean, that can depend on the bylaws of the organization. So something to keep in mind that just because you're one member of, let's say, an LLC that received the advice of counsel, you may not have the power within yourself to waive that privilege. And you may have to get the other members on board. Now all that being said, if the advice of counsel is unavailable, either because you don't have the power to waive it for your entity or because you don't meet those two basic elements, then you're going to want to opt for a good faith defense if it applies. And that's, you know, we could talk for an hour about good faith defenses, but if you were trying to comply with the law and there is evidence that you were doing that in good faith, that also negates the willfulness intent that is required for a criminal conviction and thus can really be just as good as the advice of counsel defense. So another really helpful defense to keep in mind.

- Yeah, and one sort of practice tip. If you have a reliance upon counsel defense in a criminal case, the government will often try to take discovery. They will want to talk to your attorney, fight that tooth and tongue. They should not be entitled to do that. It's not set out in the rules, it's not set out in the Federal Rules of Criminal Procedure. So if the government says, well, we think defendant X is going to call his attorney, we want to depose the attorney beforehand. The attorney is like any other witness. The government, they can talk to the government or not talk to the government. But until you waive that privilege, and you may not waive the privilege until after the government has arrested its case and you make a decision at that point whether you want to call the attorney. So bottom line, Jennifer said fight tooth and nail. I'm saying five tooth and tongue to make sure that the government can't take discovery of your attorney that they're not entitled to. So, you know, we've talked before about government interviews. They continue during the trial. Those immunity letters are not worth a whole lot these days if the government does want to talk to you or talk to your attorney. But let's, Jennifer, let's turn our attention now, in our closing minutes, to sort of the key takeaways from the healthcare prosecutions we've talked about.

- Good deal, well, we've said it several times, but we really can't say it enough. The tagline here is that healthcare enforcement actions are a top priority for federal law enforcement and they show no sign of letting up any time soon. So more important now than ever to get your act in order regarding any kind of regulatory structuring framework. Always get legal advice when you're dealing in an industry that is so heavily regulated as this. And in line with that, it's important to implement a compliance program and/or consult with outside counsel. When you're doing that, disclose all pertinent facts and follow advice of that counsel in good faith. Now you don't want to opinion shop. In other words, don't confer with seven different attorneys until you find one that tells you that you can do what it is that you want to do. That is going to be another way that the government tries to fight this advice of counsel defense is, oh, well, you know, you weren't doing this in good faith. You were looking for the riskiest attorney and you were told by six others that you couldn't do this. That's not going to fly either. So you can get more than one opinion, but don't opinion shop for the one that you, you know, that will allow you to take whatever risky path you want to take, for example. Proceed with caution even when you're only accepting funds derived from commercial business. As we talked about with the moving of the goal post, that does not ensure that you are immune from any kind of prosecution now. That the Anti-Kickback Statute, Stark Law, other laws may still apply. And as Paul said, something like a commercial bribery statute under state law may apply, and the government could still go in and get to that through the Travel Act and bring a federal prosecution. So in order to avoid that, even if you think you're outside of the AKS, which you should ask your attorney about, consider compliance with a safe harbor for some extra protection there. Also, proceed with extra caution when you're pursuing arrangements in certain subindustries, these high-risk areas that we've talked about that include telehealth and COVID-19 related care. And last but not least, as Paul touched on a bit ago, know that cooperative interviews no longer signify protection from prosecution. And again, consult with an attorney when you are considering talking to an agent in order to make sure you are protected, even if you were just a subject or rather just a witness in an investigation even.

- We just heard too many horror stories, Jennifer, of doctors who were described as witnesses, who became, you know, gave interviews, became targets, and later became criminal defendants. But one last thing for me is don't despair if you can't get the advice of counsel defense, because I really do believe that at the end of the day, a good faith defense, if a jury believes you are acting in good faith, whether or not you followed every bit of advice from a lawyer, I think that's your strongest defense quite frankly. Well, I want to thank Jennifer. Thank you for joining us. Stay safe, stay healthy, and stay out of prison.

- That's a great, great sign off.


Presenter(s)

Jennifer McCoy
Associate
Locke Lord LLP
Paul Coggins
Co-Chair of Locke Lord's White Collar Criminal Defense and Internal Investigations Practice Group
Locke Lord LLP

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